Food and Drug Administration Revitalization Act

        [Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1082 Engrossed in Senate (ES)]

110th CONGRESS
1st Session
S. 1082

_______________________________________________________________________

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to reauthorize drug and device user fees and ensure the
safety of medical products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Food and Drug Administration
Revitalization Act''.

TITLE I--PRESCRIPTION DRUG USER FEES

SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

(a) Short Title.--This title may be cited as the ``Prescription
Drug User Fee Amendments of 2007''.
(b) References in Title.--Except as otherwise specified, whenever
in this title an amendment is expressed in terms of an amendment to a
section or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 102. DRUG FEES.

Section 735 (21 U.S.C. 379g) is amended--
(1) by striking the section designation and all that
follows through ``For purposes of this subchapter:'' and
inserting the following:

``SEC. 735. DRUG FEES.

``(a) Purpose.--It is the purpose of this part that the fees
authorized under this part be dedicated toward expediting the drug
development process, the process for the review of human drug
applications, and postmarket drug safety, as set forth in the goals
identified for purposes of this part in the letters from the Secretary
to the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate and the Chairman of the Committee on Energy and
Commerce of the House of Representatives, as set forth in the
Congressional Record.
``(b) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
subsection (a) during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals. The
report for a fiscal year shall include information on all
previous cohorts for which the Secretary has not given a
complete response on all human drug applications and
supplements in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to the
public on the Internet website of the Food and Drug
Administration.
``(c) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of human drug
applications for the first 5 fiscal years after fiscal year
2012, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
``(D) hold a meeting at which the public may
present its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress the
revised recommendations under paragraph (2), a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(d) Definitions.--For purposes of this part:'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) in subparagraph (A), by striking
``505(b)(1),'' and inserting ``505(b), or'';
(ii) by striking subparagraph (B);
(iii) by redesignating subparagraph (C) as
subparagraph (B); and
(iv) in the matter following subparagraph
(B), as so redesignated, by striking
``subparagraph (C)'' and inserting
``subparagraph (B)'';
(B) in paragraph (3)(C), by--
(i) striking ``the list'' and inserting
``the list (not including the discontinued
section of such list)''; and
(ii) striking ``a list'' and inserting ``a
list (not including the discontinued section of
such a list)'';
(C) in paragraph (4), by inserting before the
period at the end the following: ``(such as capsules,
tablets, and lyophilized products before
reconstitution)'';
(D) by amending paragraph (6)(F) to read as
follows:
``(F) In the case of drugs approved under human
drug applications or supplements, postmarket safety
activities, including--
``(i) collecting, developing, and reviewing
safety information on approved drugs (including
adverse event reports);
``(ii) developing and using improved
adverse event data collection systems
(including information technology systems); and
``(iii) developing and using improved
analytical tools to assess potential safety
problems (including by accessing external data
bases).'';
(E) in paragraph (8)--
(i) by striking ``April of the preceding
fiscal year'' and inserting ``October of the
preceding fiscal year''; and
(ii) by striking ``April 1997'' and
inserting ``October 1996'';
(F) by redesignating paragraph (9) as paragraph
(10); and
(G) by inserting after paragraph (8) the following:
``(9) The term `person' includes an affiliate of such
person.''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``2003'' and inserting ``2008'';
(2) in paragraph (1)--
(A) in subparagraph (D)--
(i) in the heading, by inserting ``or
withdrawn before filing'' after ``refund of fee
if application refused for filing''; and
(ii) by inserting before the period at the
end the following: ``or withdrawn without a
waiver before filing'';
(B) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(C) by inserting after subparagraph (D) the
following:
``(E) Fee for application previously refused for
filing or withdrawn before filing.--An application or
supplement that has been refused for filing or that was
withdrawn before filing, if filed under protest or
resubmitted, shall be subject to the fee under
subparagraph (A) (unless an exception under
subparagraph (C) or (F) applies or the fee is waived or
reduced under subsection (d)), without regard to
previous payment of such a fee and the refund of 75
percent of that fee under subparagraph (D).''; and
(3) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraph
(B)'' and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following:
``(C) Special rules for compounded positron
emission tomography drugs.--
``(i) In general.--Except as provided in
clause (ii), each person who is named as the
applicant in an approved human drug application
for a compounded positron emission tomography
drug shall be subject under subparagraph (A) to
one-fifth of an annual establishment fee with
respect to each such establishment identified
in the application as producing compounded
positron emission tomography drugs under the
approved application.
``(ii) Exception from annual establishment
fee.--Each person who is named as the applicant
in an application described in clause (i) shall
not be assessed an annual establishment fee for
a fiscal year if the person certifies to the
Secretary, at a time specified by the Secretary
and using procedures specified by the
Secretary, that--
``(I) the person is a not-for-
profit medical center that has only 1
establishment for the production of
compounded positron emission tomography
drugs; and
``(II) at least 95 percent of the
total number of doses of each
compounded positron emission tomography
drug produced by such establishment
during such fiscal year will be used
within the medical center.''.
(b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is
amended to read as follows:
``(b) Fee Revenue Amounts.--Except as provided in subsections (c),
(d), (f), and (g), fees under subsection (a) shall be established to
generate the following revenue amounts, in each fiscal year beginning
with fiscal year 2008 and continuing through fiscal year 2012:
$392,783,000, plus an adjustment for workload on $354,893,000 of this
amount. Such adjustment shall be made in accordance with the workload
adjustment provisions in effect for fiscal year 2007, except that
instead of commercial investigational new drug applications submitted
to the Secretary, all commercial investigational new drug applications
with a submission during the previous 12-month period shall be used in
the determination. One-third of the revenue amount shall be derived
from application fees, one-third from establishment fees, and one-third
from product fees.''.
(c) Adjustments to Fees.--
(1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C.
379h(c)(1)) is amended--
(A) in the matter preceding subparagraph (A) by
striking ``The revenues established in subsection (b)''
and inserting ``Beginning with fiscal year 2009, the
revenues established in subsection (b)'';
(B) in subparagraph (A) by striking ``or'' at the
end;
(C) in subparagraph (B) by striking the period at
the end and inserting ``, or,'';
(D) by inserting after subparagraph (B) the
following:
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions, for the
first 5 fiscal years of the previous 6 fiscal years.'';
and
(E) in the matter following subparagraph (C) (as
added by this paragraph), by striking ``fiscal year
2003'' and inserting ``fiscal year 2008''.
(2) Workload adjustment.--Section 736(c)(2) (21 U.S.C.
379h(c)(2)) is amended--
(A) in the matter preceding subparagraph (A,) by
striking ``2004'' and inserting ``2009'';
(B) in the first sentence of subparagraph (A)--
(i) by striking ``, commercial
investigational new drug applications'' and
inserting ``(adjusted for changes in review
activities)''; and
(ii) by inserting before the period at the
end ``, and the change in the number of
commercial investigational new drug
applications with a submission during the
previous 12-month period (adjusted for changes
in review activities)'';
(C) in subparagraph (B), by adding at the end the
following new sentence: ``Further, any adjustment for
changes in review activities made in setting fees and
fee revenue amounts for fiscal year 2009 may not result
in the total workload adjustment being more than 2
percentage points higher than it would be absent the
adjustment for changes in review activities.''; and
(D) by adding at the end the following:
``(C) The Secretary shall contract with an
independent accounting firm to study the adjustment for
changes in review activities applied in setting fees
for fiscal year 2009 and to make recommendations, if
warranted, on future changes in the methodology for
calculating the adjustment for changes in review
activity. After review of the recommendations by the
independent accounting firm, the Secretary shall make
appropriate changes to the workload adjustment
methodology in setting fees for fiscal years 2010
through 2012. If the study is not conducted, no
adjustment for changes in review activities shall be
made after fiscal year 2009.''.
(3) Rent and rent-related cost adjustment.--Section 736(c)
(21 U.S.C. 379h(c)) is amended--
(A) by redesignating paragraphs (3), (4), and (5)
as paragraphs (4), (5), and (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Rent and rent-related cost adjustment.--Beginning
with fiscal year 2010, the Secretary shall, before making the
adjustments under paragraphs (1) and (2), reduce the fee
amounts established in subsection (b), if actual costs paid for
rent and rent-related expenses are less than $11,721,000. The
reductions made under this paragraph, if any, shall not exceed
the amounts by which costs fell below $11,721,000, and shall
not exceed $11,721,000 in any fiscal year.''.
(4) Final year adjustment.--Section 736(c) (21 U.S.C.
379h(c)) is amended--
(A) in paragraph (4), as redesignated by this
subsection--
(i) by striking ``2007'' each place it
appears and inserting ``2012''; and
(ii) by striking ``2008'' and inserting
``2013''; and
(B) in paragraph (5), as redesignated by this
subsection, by striking ``2002'' and inserting
``2007''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is
amended--
(1) in paragraph (1), in the matter preceding subparagraph
(A), by--
(A) inserting ``to a person who is named as the
applicant'' after ``The Secretary shall grant'';
(B) inserting ``to that person'' after ``a waiver
from or a reduction of one or more fees assessed''; and
(C) striking ``finds'' and inserting
``determines'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(3) by inserting after paragraph (1) the following:
``(2) Evaluation.--For the purpose of determining whether
to grant a waiver or reduction of a fee under paragraph (1),
the Secretary shall consider only the circumstances and assets
of the applicant and any affiliate of the applicant.''; and
(4) in paragraph (4), as redesignated by this subsection,
in subparagraph (A), by inserting before the period at the end
``, and that does not have a drug product that has been
approved under a human drug application and introduced or
delivered for introduction into interstate commerce''.
(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 736(g)(3) (21
U.S.C. 379h(g)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section such
sums as are authorized to be assessed and collected under this
section in each of fiscal years 2008 through 2012.''.
(2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
amended to read as follows:
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, plus the amount
estimated to be collected for fiscal year 2011, exceeds the
amount of fees specified in aggregate in appropriation Acts for
such fiscal years, the aggregate amount in excess shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
(f) Conforming Amendments.--
(1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this
section, is amended--
(A) in paragraph (1)(A), by striking ``subsection
(c)(4)'' each place it appears and inserting
``subsection (c)(5)'';
(B) in paragraph (2), by striking ``subsection
(c)(4)'' and inserting ``subsection (c)(5)''; and
(C) in paragraph (3), by striking ``subsection
(c)(4)'' and inserting ``subsection (c)(5)''.
(2) Section 736A(h)(3), as added by section 104 of this
title, is amended by striking ``735(3)'' and inserting
``735(d)(3)''.

SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING
FEES.

Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is
amended by adding after section 736 the following new section:

``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF
PRESCRIPTION DRUG ADVERTISING.

``(a) Types of Direct-to-Consumer Television Advertisement Review
Fees.--Beginning with fiscal year 2008, the Secretary shall assess and
collect fees in accordance with this section as follows:
``(1) Advisory review fee.--
``(A) In general.--Except as provided in
subparagraph (B), each person that on or after October
1, 2007, submits a proposed direct-to-consumer
television advertisement for advisory review by the
Secretary prior to its initial public dissemination
shall be subject to a fee established under subsection
(c)(3).
``(B) Exception for required submissions.--A
direct-to-consumer television advertisement that is
required to be submitted to the Secretary prior to
initial public dissemination shall not be assessed a
fee unless the sponsor designates it as a submission
for advisory review.
``(C) Payment.--The fee required by subparagraph
(A) shall be due not later than October 1 of the fiscal
year in which the direct-to-consumer television
advertisement shall be submitted to the Secretary for
advisory review.
``(D) Modification of advisory review fee.--
``(i) Late payment.--If, on or before
November 1 of the fiscal year in which the fees
are due, a person has not paid all fees that
were due and payable for advisory reviews
identified in response to the Federal Register
notice described in subsection (c)(3)(A), the
fees shall be regarded as late. Such fees shall
be due and payable 20 days before any direct-
to-consumer television advertisement is
submitted by such person to the Secretary for
advisory review. Notwithstanding any other
provision of this section, such fees shall be
due and payable for each of those advisory
reviews in the amount of 150 percent of the
advisory review fee established for that fiscal
year pursuant to subsection (c)(3).
``(ii) Late notice of submission.--If any
person submits any direct-to-consumer
television advertisements for advisory review
that are in excess of the number identified by
that person in response to the Federal Register
notice described in subsection (c)(3)(A), that
person must pay a fee for each of those
advisory reviews in the amount of 150 percent
of the advisory review fee established for that
fiscal year pursuant to subsection (c)(3). Fees
under this subparagraph shall be due 20 days
before the direct-to-consumer television
advertisement is submitted by such person to
the Secretary for advisory review.
``(E) Limits.--
``(i) In general.--The payment of a fee
under this paragraph for a fiscal year entitles
the person that pays the fee to acceptance for
advisory review by the Secretary of 1 direct-
to-consumer television advertisement and
acceptance of 1 resubmission for advisory
review of the same advertisement. The
advertisement shall be submitted for review in
the fiscal year for which the fee was assessed,
except that a person may carry over no more
than 1 paid advisory review submission to the
next fiscal year. Resubmissions may be
submitted without regard to the fiscal year of
the initial advisory review submission.
``(ii) No refund.--Except as provided by
subsection (f), fees paid under this paragraph
shall not be refunded.
``(iii) No waiver, exemption, or
reduction.--The Secretary shall not grant a
waiver, exemption, or reduction of any fees due
or payable under this section.
``(iv) Non-transferability.--The right to
an advisory review is not transferable, except
to a successor in interest.
``(2) Operating reserve fee.--
``(A) In general.--Each person that, on or after
October 1, 2007, is assessed an advisory review fee
under paragraph (1) shall be subject to an operating
reserve fee established under subsection (d)(2) only in
the first fiscal year in which an advisory review fee
is assessed.
``(B) Payment.--Except as provided in subparagraph
(C), the fee required by subparagraph (A) shall be due
not later than October 1 of the first fiscal year in
which the person is required to pay an advisory review
fee under paragraph (1).
``(C) Late notice of submission.--If, in the first
fiscal year of a person's participation in the Program,
that person submits any direct-to-consumer television
advertisements for advisory review that are in excess
of the number identified by that person in response to
the Federal Register notice described in subsection
(c)(3)(A), that person must pay an operating reserve
fee for each of those advisory reviews equal to the
advisory review fee for each submission established
under paragraph (1)(D)(ii). Fees required by this
subparagraph shall be in addition to the fees required
under subparagraph (B), if any. Fees under this
subparagraph shall be due 20 days before any direct-to-
consumer television advertisement is submitted by such
person to the Secretary for advisory review.
``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection
(a)(1) shall be established to generate revenue amounts of $6,250,000
for each of fiscal years 2008 through 2012, as adjusted pursuant to
subsection (c).
``(c) Adjustments.--
``(1) Inflation adjustment.--Beginning with fiscal year
2009, the revenues established in subsection (b) shall be
adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in
the Consumer Price Index for all urban consumers (all
items; United States city average), for the 12-month
period ending June 30 preceding the fiscal year for
which fees are being established;
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance with section 5332 of title 5, as adjusted by
any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees
stationed in the District of Columbia; or
``(C) the average annual change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions, for the
first 5 fiscal years of the previous 6 fiscal years.
The adjustment made each fiscal year by this paragraph shall be
added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2008 under this subsection.
``(2) Workload adjustment.--
``(A) In general.--Beginning with fiscal year 2009,
after the fee revenues established in subsection (b) of
this section are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee
revenues shall be adjusted further for such fiscal year
to reflect changes in the workload of the Secretary
with respect to the submission of proposed direct-to-
consumer television advertisements for advisory review
prior to initial broadcast.
``(B) Determination of workload adjustment.--
``(i) In general.--The workload adjustment
under this paragraph for a fiscal year shall be
determined by the Secretary--
``(I) based upon the number of
direct-to-consumer television
advertisements identified pursuant to
paragraph (3)(A) for that fiscal year,
excluding allowable previously paid
carry over submissions; and
``(II) by multiplying the number of
such advertisements projected for that
fiscal year that exceeds 150 by $27,600
(adjusted each year beginning with
fiscal year 2009 for inflation in
accordance with paragraph (1)).
``(ii) Publication in federal register.--
The Secretary shall publish in the Federal
Register, as part of the notice described in
paragraph (1), the fee revenues and fees
resulting from the adjustment made under this
paragraph and the supporting methodologies.
``(C) Limitation.--Under no circumstances shall the
adjustment made under this paragraph result in fee
revenues for a fiscal year that are less than the fee
revenues established for the prior fiscal year.
``(3) Annual fee setting.--
``(A) Number of advertisements.--The Secretary
shall, 120 days before the start of each fiscal year,
publish a notice in the Federal Register requesting any
person to notify the Secretary within 30 days of the
number of direct-to-consumer television advertisements
the person intends to submit for advisory review by the
Secretary in the next fiscal year. Notification to the
Secretary of the number of advertisements a person
intends to submit for advisory review prior to initial
broadcast shall be a legally binding commitment by that
person to pay the annual advisory review fee for that
number of submissions on or before October 1 of the
fiscal year in which the advertisement is intended to
be submitted. A person shall at the same time also
notify the Secretary if such person intends to use a
paid submission from the previous fiscal year under
subsection (a)(1)(E)(i). If such person does not so
notify the Secretary, all submissions for advisory
review shall be subject to advisory review fees.
``(B) Annual fee.--The Secretary shall, 60 days
before the start of each fiscal year, establish, for
the next fiscal year, the direct-to-consumer television
advertisement advisory review fee under subsection
(a)(1), based on the revenue amounts established under
subsection (b), the adjustments provided under this
subsection and the number of direct-to-consumer
television advertisements identified pursuant to
subparagraph (A), excluding allowable previously paid
carry over submissions. The annual advisory review fee
shall be established by dividing the fee revenue for a
fiscal year (as adjusted pursuant to this subsection)
by the number of direct-to-consumer television
advertisements identified pursuant to subparagraph (A),
excluding allowable previously paid carry over
submissions.
``(C) Fiscal year 2008 fee limit.--Notwithstanding
subsection (b), the fee established under subparagraph
(B) for fiscal year 2008 may not be more than $83,000
per submission for advisory review.
``(D) Annual fee limit.--Notwithstanding subsection
(b), the fee established under subparagraph (B) for a
fiscal year after fiscal year 2008 may not be more than
50 percent more than the fee established for the prior
fiscal year.
``(E) Limit.--The total amount of fees obligated
for a fiscal year may not exceed the total costs for
such fiscal year for the resources allocated for the
process for the advisory review of prescription drug
advertising.
``(d) Operating Reserves.--
``(1) In general.--The Secretary shall establish in the
Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation a Direct-
to-Consumer Advisory Review Operating Reserve, of at least
$6,250,000 in fiscal year 2008, to continue the Program in the
event the fees collected in any subsequent fiscal year pursuant
to subsection (c)(3) do not generate the fee revenue amount
established for that fiscal year.
``(2) Fee setting.--The Secretary shall establish the
operating reserve fee under subsection (a)(2)(A) for each
person required to pay the fee by multiplying the number of
direct-to-consumer television advertisements identified by that
person pursuant to subsection (c)(3)(A) by the advisory review
fee established pursuant to subsection (c)(3) for that fiscal
year. In no case shall the operating reserve fee assessed be
less than the operating reserve fee assessed if the person had
first participated in the Program in fiscal year 2008.
``(3) Use of operating reserve.--The Secretary may use
funds from the reserves under this subsection only to the
extent necessary in any fiscal year to make up the difference
between the fee revenue amount established for that fiscal year
under subsection (b) and the amount of fees collected for that
fiscal year pursuant to subsection (a), or to pay costs of
ending the Program if it is terminated pursuant to subsection
(f) or if it is not reauthorized after fiscal year 2012.
``(4) Refund of operating reserves.--Within 120 days of the
end of fiscal year 2012, or if the Program is terminated
pursuant to subsection (f), the Secretary, after setting aside
sufficient operating reserve amounts to terminate the Program,
shall refund all amounts remaining in the operating reserve on
a pro rata basis to each person that paid an operating reserve
fee assessment. In no event shall the refund to any person
exceed the total amount of operating reserve fees paid by such
person pursuant to subsection (a)(2).
``(e) Effect of Failure To Pay Fees.--Notwithstanding any other law
or regulation of the Secretary, a submission for advisory review of a
direct-to-consumer television advertisement submitted by a person
subject to fees under subsection (a) shall be considered incomplete and
shall not be accepted for review by the Secretary until all fees owed
by such person under this section have been paid.
``(f) Effect of Inadequate Funding of Program.--
``(1) First fiscal year.--If on November 1, 2007, or 120
days after enactment of the Prescription Drug User Fee
Amendments of 2007, whichever is later, the Secretary has
received less than $11,250,000 in advisory review fees and
operating reserve fees combined, the Program shall be
terminated and all collected fees shall be refunded.
``(2) Subsequent fiscal years.--Beginning in fiscal year
2009, if, on November 1 of a fiscal year, the combination of
the operating reserves, annual fee revenues from that fiscal
year, and unobligated fee revenues from prior fiscal years is
less than $9,000,000, adjusted for inflation (in accordance
with subsection (c)(1)), the Program shall be terminated, and
the Secretary shall notify all participants, retain any money
from the unused advisory review fees and the operating reserves
needed to terminate the Program, and refund the remainder of
the unused fees and operating reserves. To the extent required
to terminate the Program, the Secretary shall first use
unobligated advisory review fee revenues from prior fiscal
years, then the operating reserves, and then unused advisory
review fees from the relevant fiscal year.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for the process for the advisory review of prescription
drug advertising.
``(2) Collections and appropriation acts.--The fees
authorized by this section--
``(A) shall be retained in each fiscal year in an
amount not to exceed the amount specified in
appropriation Acts, or otherwise made available for
obligation for such fiscal year; and
``(B) shall be available for obligation only if
appropriated budget authority continues to support at
least the total combined number of full-time equivalent
employees in the Food and Drug Administration, Center
for Drug Evaluation and Research, Division of Drug
Marketing, Advertising, and Communications, and the
Center for Biologics Evaluation and Research,
Advertising and Promotional Labeling Branch supported
in fiscal year 2007.
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section not
less than $6,250,000 for each of fiscal years 2008, 2009, 2010,
2011, and 2012, as adjusted to reflect adjustments in the total
fee revenues made under this section, plus amounts collected
for the reserve fund under subsection (d).
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
collected under this section pursuant to appropriation Acts for
a subsequent fiscal year.
``(h) Definitions.--For purposes of this section:
``(1) The term `advisory review' means reviewing and
providing advisory comments regarding compliance of a proposed
advertisement with the requirements of this Act prior to its
initial public dissemination.
``(2) The term `carry over submission' means a submission
for an advisory review for which a fee was paid in a fiscal
year that is submitted for review in the following fiscal year.
``(3) The term `direct-to-consumer television
advertisement' means an advertisement for a prescription drug
product as defined in section 735(3) intended to be displayed
on any television channel for less than 2 minutes.
``(4) The term `person' includes an individual, a
partnership, a corporation, and an association, and any
affiliate thereof or successor in interest.
``(5) The term `process for the advisory review of
prescription drug advertising' means the activities necessary
to review and provide advisory comments on proposed direct-to-
consumer television advertisements prior to public
dissemination and, to the extent the Secretary has additional
staff resources available under the Program that are not
necessary for the advisory review of direct-to-consumer
television advertisements, the activities necessary to review
and provide advisory comments on other proposed advertisements
and promotional material prior to public dissemination.
``(6) The term `Program' means the Program to assess,
collect, and use fees for the advisory review of prescription
drug advertising established by this section.
``(7) The term `resources allocated for the process for the
advisory review of prescription drug advertising' means the
expenses incurred in connection with the process for the
advisory review of prescription drug advertising for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related
to such officers, employees, and committees, and to
contracts with such contractors;
``(B) management of information, and the
acquisition, maintenance, and repair of computer
resources;
``(C) leasing, maintenance, renovation, and repair
of facilities and acquisition, maintenance, and repair
of fixtures, furniture, scientific equipment, and other
necessary materials and supplies;
``(D) collection of fees under this section and
accounting for resources allocated for the advisory
review of prescription drug advertising; and
``(E) terminating the Program under subsection
(f)(2), if necessary.
``(8) The term `resubmission' means a subsequent submission
for advisory review of a direct-to-consumer television
advertisement that has been revised in response to the
Secretary's comments on an original submission. A resubmission
may not introduce significant new concepts or creative themes
into the television advertisement.
``(9) The term `submission for advisory review' means an
original submission of a direct-to-consumer television
advertisement for which the sponsor voluntarily requests
advisory comments before the advertisement is publicly
disseminated.

``SEC. 736B. SUNSET.

``This part shall cease to be effective on October 1, 2012, except
that subsection (b) of section 736 with respect to reports shall cease
to be effective on January 31, 2013.''.

SEC. 105. SAVINGS CLAUSE.

Notwithstanding section 509 of the Prescription Drug User Fee
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the
amendments made by this title, part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act, as in effect on the day
before the date of enactment of this title, shall continue to be in
effect with respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October 1, 2002,
but before October 1, 2007, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2008.

SEC. 106. TECHNICAL AMENDMENT.

Section 739 (21 U.S.C. 379j-11) is amended in the matter preceding
paragraph (1), by striking ``subchapter'' and inserting ``part''.

SEC. 107. EFFECTIVE DATES.

(a) In General.--Except as provided in subsection (b), the
amendments made by this title shall take effect October 1, 2007.
(b) Exception.--The amendment made by section 104 of this title
shall take effect on the date of enactment of this title.

TITLE II--DRUG SAFETY

SEC. 200. SHORT TITLE.

This title may be cited as the ``Enhancing Drug Safety and
Innovation Act of 2007''.

Subtitle A--Risk Evaluation and Mitigation Strategies

SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ASSESSMENT.

(a) In General.--Subsection (k) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end
the following:
``(3) Routine active surveillance and assessment.--
``(A) Development of the postmarket risk
identification and analysis system.--The Secretary
shall, not later than 2 years after the date of
enactment of the Enhancing Drug Safety and Innovation
Act of 2007, act in collaboration with academic
institutions and private entities to--
``(i) establish minimum standards for
collection and transmission of postmarketing
data elements from electronic health data
systems; and
``(ii) establish, through partnerships, a
validated and integrated postmarket risk
identification and analysis system to integrate
and analyze safety data from multiple sources,
with the goals of including, in aggregate--
``(I) at least 25,000,000 patients
by July 1, 2010; and
``(II) at least 100,000,000
patients by July 1, 2012.
``(B) Data collection activities.--
``(i) In general.--The Secretary shall, not
later than 1 year after the establishment of
the minimum standards and the identification
and analysis system under subparagraph (A),
establish and maintain an active surveillance
infrastructure--
``(I) to collect and report data
for pharmaceutical postmarket risk
identification and analysis, in
compliance with the regulations
promulgated under section 264(c) of the
Health Insurance Portability and
Accountability Act of 1996; and
``(II) that includes, in addition
to the collection and monitoring (in a
standardized form) of data on all
serious adverse drug experiences (as
defined in subsection (o)(2)(C))
required to be submitted to the
Secretary under paragraph (1), and
those events voluntarily submitted from
patients, providers, and drug, when
appropriate, procedures to--
``(aa) provide for adverse
event surveillance by
collecting and monitoring
Federal health-related
electronic data (such as data
from the Medicare program and
the health systems of the
Department of Veterans
Affairs);
``(bb) provide for adverse
event surveillance by
collecting and monitoring
private sector health-related
electronic data (such as
pharmaceutical purchase data
and health insurance claims
data);
``(cc) provide for adverse
event surveillance by
monitoring standardized
electronic health records, as
available;
``(dd) provide for adverse
event surveillance by
collecting and monitoring other
information as the Secretary
deems necessary to create a
robust system to identify
adverse events and potential
drug safety signals;
``(ee) enable the program
to identify certain trends and
patterns with respect to data
reported to the program;
``(ff) enable the program
to provide regular reports to
the Secretary concerning
adverse event trends, adverse
event patterns, incidence and
prevalence of adverse events,
laboratory data, and other
information determined
appropriate, which may include
data on comparative national
adverse event trends; and
``(gg) enable the program
to export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
``(ii) Timeliness of reporting.--The
procedures developed under clause (i) shall
ensure that such data are collected, monitored,
and reported in a timely, routine, and
automatic manner, taking into consideration the
need for data completeness, coding, cleansing,
and transmission.
``(iii) Private sector resources.--To
ensure the establishment of the active
surveillance infrastructure by the date
described under clause (i), the Secretary may,
on a temporary or permanent basis, implement
systems or products developed by private
entities.
``(iv) Complementary approaches.--To the
extent the active surveillance infrastructure
established under clause (i) is not sufficient
to gather data and information relevant to
priority drug safety questions, the Secretary
shall develop, support, and participate in
complementary approaches to gather and analyze
such data and information, including--
``(I) approaches that are
complementary with respect to assessing
the safety of use of a drug in domestic
populations not included in the trials
used to approve the drug (such as older
people, people with comorbidities,
pregnant women, or children); and
``(II) existing approaches such as
the Vaccine Adverse Event Reporting
System and the Vaccine Safety Datalink
or successor databases.
``(v) Authority for contracts.--The
Secretary may enter into contracts with public
and private entities to fulfill the
requirements of this subparagraph.
``(C) Risk identification and analysis.--
``(i) Purpose.--To carry out this
paragraph, the Secretary shall establish
collaborations with other Government, academic,
and private entities, including the Centers for
Education and Research on Therapeutics under
section 912 of the Public Health Service Act,
to provide for the risk identification and
analysis of the data collected under
subparagraph (B) and data that is publicly
available or is provided by the Secretary, in
order to--
``(I) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
``(II) provide the Secretary with
routine access to expertise to study
advanced drug safety data; and
``(III) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
``(ii) Public process for priority
questions.--At least biannually, the Secretary
shall seek recommendations from the Drug Safety
and Risk Management Advisory Committee (or
successor committee) and from other advisory
committees, as appropriate, to the Food and
Drug Administration on--
``(I) priority drug safety
questions; and
``(II) mechanisms for answering
such questions, including through--
``(aa) routine active
surveillance under subparagraph
(B); and
``(bb) when such
surveillance is not sufficient,
postmarket studies under
subsection (o)(4)(B) and
postapproval clinical trials
under subsection (o)(4)(C).
``(iii) Procedures for the development of
drug safety collaborations.--
``(I) In general.--Not later than
180 days after the date of the
establishment of the active
surveillance infrastructure under
subparagraph (B), the Secretary shall
establish and implement procedures
under which the Secretary may routinely
collaborate with a qualified entity
to--
``(aa) clean, classify, or
aggregate data collected under
subparagraph (B) and data that
is publicly available or is
provided by the Secretary;
``(bb) allow for prompt
investigation of priority drug
safety questions, including--

``(AA) unresolved
safety questions for
drugs or classes of
drugs; and

``(BB) for a newly-
approved drug: safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included in the trials
used to approve the
drug (such as older
people, people with
comorbidities, pregnant
women, or children);

``(cc) perform advanced
research and analysis on
identified drug safety risks;
``(dd) convene an expert
advisory committee to oversee
the establishment of standards
for the ethical and scientific
uses for, and communication of,
postmarketing data collected
under subparagraph (B),
including advising on the
development of effective
research methods for the study
of drug safety questions;
``(ee) focus postmarket
studies under subsection
(o)(4)(B) and postapproval
clinical trials under
subsection (o)(4)(C) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
``(ff) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
``(II) Request for specific
methodology.--The procedures described
in subclause (I) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
``(iv) Use of analyses.--The Secretary
shall provide the analyses described under this
subparagraph, including the methods and results
of such analyses, about a drug to the sponsor
or sponsors of such drug.
``(v) Qualified entities.--
``(I) In general.--The Secretary
shall enter into contracts with a
sufficient number of qualified entities
to develop and provide information to
the Secretary in a timely manner.
``(II) Qualification.--The
Secretary shall enter into a contract
with an entity under subclause (I) only
if the Secretary determines that the
entity--
``(aa) has the research
capability and expertise to
conduct and complete the
activities under this
paragraph;
``(bb) has in place an
information technology
infrastructure to support
adverse event surveillance data
and operational standards to
provide security for such data;
``(cc) has experience with,
and expertise on, the
development of drug safety and
effectiveness research using
electronic population data;
``(dd) has an understanding
of drug development and risk/
benefit balancing in a clinical
setting; and
``(ee) has a significant
business presence in the United
States.
``(vi) Contract requirements.--Each
contract with a qualified entity shall contain
the following requirements:
``(I) Ensuring privacy.--The
qualified entity shall provide
assurances that the entity will not use
the data provided by the Secretary in a
manner that violates--
``(aa) the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996; or
``(bb) sections 552 or 552a
of title 5, United States Code,
with regard to the privacy of
individually-identifiable
beneficiary health information.
``(II) Component of another
organization.--If a qualified entity is
a component of another organization--
``(aa) the qualified entity
shall maintain the data related
to the activities carried out
under this paragraph separate
from the other components of
the organization and establish
appropriate security measures
to maintain the confidentiality
and privacy of such data; and
``(bb) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
``(III) Termination or
nonrenewal.--If a contract with a
qualified entity under this
subparagraph is terminated or not
renewed, the following requirements
shall apply:
``(aa) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
``(bb) Disposition of
data.--The entity shall return
to the Secretary all data
disclosed to the entity or, if
returning the data is not
practicable, destroy the data.
``(vii) Competitive procedures.--The
Secretary shall use competitive procedures (as
defined in section 4(5) of the Federal
Procurement Policy Act) to enter into contracts
under clause (v).
``(viii) Review of contract in the even of
a merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this subparagraph
will continue to be met.
``(D) Coordination.--In carrying out this
paragraph, the Secretary shall provide for appropriate
communications to the public, scientific, public
health, and medical communities, and other key
stakeholders, and provide for the coordination of the
activities of private entities, professional
associations, or other entities that may have sources
of surveillance data.''.
(b) Authorization of Appropriations.--To carry out activities under
the amendment made by this section for which funds are made available
under section 736 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h), there are authorized to be appropriated to carry out the
amendment made by this section, in addition to such funds, $25,000,000
for each of fiscal years 2008 through 2012.

SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended by adding at the end the following:
``(o) Risk Evaluation and Mitigation Strategy.--
``(1) In general.--In the case of any drug subject to
subsection (b) or to section 351 of the Public Health Service
Act for which a risk evaluation and mitigation strategy is
approved as provided for in this subsection, the applicant
shall comply with the requirements of such strategy.
``(2) Definitions.--In this subsection:
``(A) Adverse drug experience.--The term `adverse
drug experience' means any adverse event associated
with the use of a drug in humans, whether or not
considered drug related, including--
``(i) an adverse event occurring in the
course of the use of the drug in professional
practice;
``(ii) an adverse event occurring from an
overdose of the drug, whether accidental or
intentional;
``(iii) an adverse event occurring from
abuse of the drug;
``(iv) an adverse event occurring from
withdrawal of the drug; and
``(v) any failure of expected
pharmacological action of the drug.
``(B) New safety information.--The term `new safety
information' with respect to a drug means information
about--
``(i) a serious risk or an unexpected
serious risk with use of the drug that the
Secretary has become aware of since the later
of--
``(I) the date of initial approval
of the drug under this section or
initial licensure of the drug under
section 351 of the Public Health
Service Act; or
``(II) if applicable, the last
assessment of the approved risk
evaluation and mitigation strategy for
the drug; or
``(ii) the effectiveness of the approved
risk evaluation and mitigation strategy for the
drug obtained since the later of--
``(I) the approval of such
strategy; or
``(II) the last assessment of such
strategy.
``(C) Serious adverse drug experience.--The term
`serious adverse drug experience' is an adverse drug
experience that--
``(i) results in--
``(I) death;
``(II) the placement of the patient
at immediate risk of death from the
adverse drug experience as it occurred
(not including an adverse drug
experience that might have caused death
had it occurred in a more severe form);
``(III) inpatient hospitalization
or prolongation of existing
hospitalization;
``(IV) a persistent or significant
incapacity or substantial disruption of
the ability to conduct normal life
functions; or
``(V) a congenital anomaly or birth
defect; or
``(ii) based on appropriate medical
judgment, may jeopardize the patient and may
require a medical or surgical intervention to
prevent an outcome described under clause (i).
``(D) Serious risk.--The term `serious risk' means
a risk of a serious adverse drug experience.
``(E) Signal of a serious risk.--The term `signal
of a serious risk' means information related to a
serious adverse drug experience derived from--
``(i) a clinical trial;
``(ii) adverse event reports under
subsection (k)(1);
``(iii) routine active surveillance under
subsection (k)(3);
``(iv) a postapproval study, including a
study under paragraph (4)(B); or
``(v) peer-reviewed biomedical literature.
``(F) Unexpected serious risk.--The term
`unexpected serious risk' means a serious adverse drug
experience that--
``(i) is not listed in the labeling of a
drug; or
``(ii) is symptomatically and
pathophysiologically related to an adverse drug
experience listed in the labeling of the drug,
but differs from such adverse drug experience
because of greater severity, specificity, or
prevalence.
``(3) Required elements of a risk evaluation and mitigation
strategy.--If a risk evaluation and mitigation strategy for a
drug is required, such strategy shall include--
``(A) the labeling for the drug for use by health
care providers as approved under subsection (c);
``(B) a timetable for submission of assessments of
the strategy, that--
``(i) for a drug no active ingredient
(including any ester or salt of the active
ingredient) of which has been approved in any
other application under this section or section
351 of the Public Health Service Act--
``(I) shall be no less frequently
than 18 months and 3 years after the
drug is initially approved and at a
frequency specified in the strategy for
subsequent years; and
``(II) may be eliminated after the
first 3 years if the Secretary
determines that serious risks of the
drug have been adequately identified
and assessed and are being adequately
managed;
``(ii) for a drug other than a drug
described under clause (i), shall occur at a
frequency determined by the Secretary; and
``(iii) may be increased or reduced in
frequency as necessary as provided for in
paragraph (7)(B)(v)(VI).
``(4) Additional potential evaluation elements of a risk
evaluation and mitigation strategy.--
``(A) Risk evaluation.--If a risk evaluation and
mitigation strategy for a drug is required, such
strategy may include 1 or more of the additional
evaluation elements described in this paragraph, so
long as the Secretary makes the determination required
with respect to each additional included element.
``(B) Postapproval studies.--If the Secretary
determines that the reports under subsection (k)(1) and
routine active surveillance as available under
subsection (k)(3) (including available complementary
approaches under subsection (k)(3)(B)(iv)) will not be
sufficient to--
``(i) assess a signal of a serious risk
with use of a drug; or
``(ii) identify, based on a review of a
demonstrated pattern of use of the drug,
unexpected serious risks in a domestic
population, including older people, people with
comorbidities, pregnant women, or children,
the risk evaluation and mitigation strategy for the
drug may require that the applicant conduct an
appropriate postapproval study, such as a prospective
or retrospective observational study, of the drug
(which shall include a timeframe specified by the
Secretary for completing the study and reporting the
results to the Secretary).
``(C) Postapproval clinical trials.--If the
Secretary determines that the reports under subsection
(k)(1), routine active surveillance as available under
subsection (k)(3) (including available complementary
approaches under subsection (k)(3)(B)(iv)), and a study
or studies under subparagraph (B) will likely be
inadequate to assess a signal of a serious risk with
use of a drug, and there is no effective approved
application for the drug under subsection (j) as of the
date that the requirement is first imposed, the risk
evaluation and mitigation strategy for the drug may
require that the applicant conduct an appropriate
postapproval clinical trial of the drug (which shall
include a timeframe specified by the Secretary for
completing the clinical trial and reporting the results
to the Secretary) to be included in the clinical trial
registry data bank provided for under subsections (i)
and (j) of section 402 of the Public Health Service
Act.
``(5) Additional potential communication elements of a risk
evaluation and mitigation strategy.--
``(A) Risk communication.--If a risk evaluation and
mitigation strategy for a drug is required, such
strategy may include 1 or more of the additional
communication elements described in this paragraph, so
long as the Secretary makes the determination required
with respect to each additional included element.
``(B) Medguide; patient package insert.--The risk
evaluation and mitigation strategy for a drug may
require that the applicant develop for distribution to
each patient when the drug is dispensed either or both
of the following:
``(i) A Medication Guide, as provided for
under part 208 of title 21, Code of Federal
Regulations (or any successor regulations).
``(ii) A patient package insert, if the
Secretary determines that such insert may help
mitigate a serious risk listed in the labeling
of the drug.
``(C) Communication plan.--If the Secretary
determines that a communication plan to health care
providers may support implementation of an element of
the risk evaluation and mitigation strategy for a drug,
such as a labeling change, the strategy may require
that the applicant conduct such a plan, which may
include--
``(i) sending letters to health care
providers;
``(ii) disseminating information about the
elements of the strategy to encourage
implementation by health care providers of
components that apply to such health care
providers, or to explain certain safety
protocols (such as medical monitoring by
periodic laboratory tests); or
``(iii) disseminating information to health
care providers through professional societies
about any serious risks of the drug and any
protocol to assure safe use.
``(D) Prereview.--
``(i) In general.--If the Secretary
determines that prereview of advertisements is
necessary to ensure the inclusion of a true
statement in such advertisements of information
in brief summary relating to a serious risk
listed in the labeling of a drug, or relating
to a protocol to ensure the safe use described
in the labeling of the drug, the risk
evaluation and mitigation strategy for the drug
may require that the applicant submit to the
Secretary advertisements of the drug for
prereview not later than 45 days before
dissemination of the advertisement
``(ii) Specification of advertisements.--
The Secretary may specify the advertisements
required to be submitted under clause (i).
``(E) Specific disclosures.--
``(i) Serious risk; safety protocol.--If
the Secretary determines that advertisements
lacking a specific disclosure about a serious
risk listed in the labeling of a drug or about
a protocol to ensure safe use described in the
labeling of the drug would be false or
misleading, the risk evaluation and mitigation
strategy for the drug may require that the
applicant include in advertisements of the drug
such disclosure.
``(ii) Date of approval.--If the Secretary
determines that advertisements lacking a
specific disclosure of the date a drug was
approved and disclosure of a serious risk would
be false or misleading, the risk evaluation and
mitigation strategy for the drug may require
that the applicant include in advertisements of
the drug such disclosure.
``(iii) Specification of advertisements.--
The Secretary may specify the advertisements
required to include a specific disclosure under
clause (i) or (ii).
``(iv) Required safety surveillance.--If
the approved risk evaluation and mitigation
strategy for a drug requires the specific
disclosure under clause (ii), the Secretary
shall--
``(I) consider identifying and
assessing all serious risks of using
the drug to be a priority safety
question under subsection (k)(3)(B);
``(II) not less frequently than
every 3 months, evaluate the reports
under subsection (k)(1) and the routine
active surveillance as available under
subsection (k)(3) with respect to such
priority drug safety question to
determine whether serious risks that
might occur among patients expected to
be treated with the drug have been
adequately identified and assessed;
``(III) remove such specific
disclosure requirement as an element of
such strategy if such serious risks
have been adequately identified and
assessed; and
``(IV) consider whether a specific
disclosure under clause (i) should be
required.
``(6) Providing safe access for patients to drugs with
known serious risks that would otherwise be unavailable.--
``(A) Allowing safe access to drugs with known
serious risks.--The Secretary may require that the risk
evaluation and mitigation strategy for a drug include
such elements as are necessary to assure safe use of
the drug, because of its inherent toxicity or potential
harmfulness, if the Secretary determines that--
``(i) the drug, which has been shown to be
effective, but is associated with a serious
adverse drug experience, can be approved only
if, or would be withdrawn unless, such elements
are required as part of such strategy to
mitigate a specific serious risk listed in the
labeling of the drug; and
``(ii) for a drug initially approved
without elements to assure safe use, other
elements under paragraphs (3), (4), and (5) are
not sufficient to mitigate such serious risk.
``(B) Assuring access and minimizing burden.--Such
elements to assure safe use under subparagraph (A)
shall--
``(i) be commensurate with the specific
serious risk listed in the labeling of the
drug;
``(ii) within 30 days of the date on which
any element under subparagraph (A) is imposed,
be posted publicly by the Secretary with an
explanation of how such elements will mitigate
the observed safety risk;
``(iii) considering such risk, not be
unduly burdensome on patient access to the
drug, considering in particular--
``(I) patients with serious or
life-threatening diseases or
conditions; and
``(II) patients who have difficulty
accessing health care (such as patients
in rural or medically underserved
areas); and
``(iv) to the extent practicable, so as to
minimize the burden on the health care delivery
system--
``(I) conform with elements to
assure safe use for other drugs with
similar, serious risks; and
``(II) be designed to be compatible
with established distribution,
procurement, and dispensing systems for
drugs.
``(C) Elements to assure safe use.--The elements to
assure safe use under subparagraph (A) shall include 1
or more goals to mitigate a specific serious risk
listed in the labeling of the drug and, to mitigate
such risk, may require that--
``(i) health care providers who prescribe
the drug have particular training or
experience, or are specially certified (which
training or certification with respect to the
drug shall be available to any willing provider
from a frontier area in a widely available
training or certification method (including an
on-line course or via mail) as approved by the
Secretary at minimal cost to the provider);
``(ii) pharmacies, practitioners, or health
care settings that dispense the drug are
specially certified (which certification shall
be available to any willing provider from a
frontier area);
``(iii) the drug be dispensed to patients
only in certain health care settings, such as
hospitals;
``(iv) the drug be dispensed to patients
with evidence or other documentation of safe-
use conditions, such as laboratory test
results;
``(v) each patient using the drug be
subject to certain monitoring; or
``(vi) each patient using the drug be
enrolled in a registry.
``(D) Implementation system.--The elements to
assure safe use under subparagraph (A) that are
described in clauses (ii), (iii), or (iv) of
subparagraph (C) may include a system through which the
applicant is able to take reasonable steps to--
``(i) monitor and evaluate implementation
of such elements by health care providers,
pharmacists, and other parties in the health
care system who are responsible for
implementing such elements; and
``(ii) work to improve implementation of
such elements by such persons.
``(E) Evaluation of elements to assure safe use.--
The Secretary, through the Drug Safety and Risk
Management Advisory Committee (or successor committee)
of the Food and Drug Administration, shall--
``(i) seek input from patients, physicians,
pharmacists, and other health care providers
about how elements to assure safe use under
this paragraph for 1 or more drugs may be
standardized so as not to be--
``(I) unduly burdensome on patient
access to the drug; and
``(II) to the extent practicable,
minimize the burden on the health care
delivery system;
``(ii) at least annually, evaluate, for 1
or more drugs, the elements to assure safe use
of such drug to assess whether the elements--
``(I) assure safe use of the drug;
``(II) are not unduly burdensome on
patient access to the drug; and
``(III) to the extent practicable,
minimize the burden on the health care
delivery system; and
``(iii) considering such input and
evaluations--
``(I) issue or modify agency
guidance about how to implement the
requirements of this paragraph; and
``(II) modify elements under this
paragraph for 1 or more drugs as
appropriate.
``(F) Additional mechanisms to assure access.--The
mechanisms under section 561 to provide for expanded
access for patients with serious or life-threatening
diseases or conditions may be used to provide access
for patients with a serious or life-threatening disease
or condition, the treatment of which is not an approved
use for the drug, to a drug that is subject to elements
to assure safe use under this paragraph. The Secretary
shall promulgate regulations for how a physician may
provide the drug under the mechanisms of section 561.
``(G) Waiver in public health emergencies.--The
Secretary may waive any requirement of this paragraph
during the period described in section 319(a) of the
Public Health Service Act with respect to a qualified
countermeasure described under section 319F-1(a)(2) of
such Act, to which a requirement under this paragraph
has been applied, if the Secretary has--
``(i) declared a public health emergency
under such section 319; and
``(ii) determined that such waiver is
required to mitigate the effects of, or reduce
the severity of, such public health emergency.
``(7) Submission and review of risk evaluation and
mitigation strategy.--
``(A) Proposed risk evaluation and mitigation
strategy.--
``(i) Voluntary proposal.--If there is a
signal of a serious risk with a drug, an
applicant may include a proposed risk
evaluation and mitigation strategy for the drug
in an application, including in a supplemental
application, for the drug under subsection (b)
or section 351 of the Public Health Service
Act.
``(ii) Required proposal.--
``(I) Determination necessary to
require a proposal.--
``(aa) In general.--The
Secretary may require that the
applicant for a drug submit a
proposed risk evaluation and
mitigation strategy for a drug
if the Secretary (acting
through the office responsible
for reviewing the drug and the
office responsible for
postapproval safety with
respect to the drug) determines
that, based on a signal of a
serious risk with the drug, a
risk evaluation and mitigation
strategy is necessary to assess
such signal or mitigate such
serious risk.
``(bb) Non-delegation.--A
determination under item (aa)
for a drug shall be made by
individuals at or above the
level of individuals empowered
to approve a drug (such as
division directors within the
Center for Drug Evaluation and
Research).
``(II) Circumstances in which a
proposal may be required.--The
applicant shall submit a proposed risk
evaluation and mitigation strategy for
a drug--
``(aa) in response to a
letter from the Secretary
(acting through the office
responsible for reviewing the
drug and the office responsible
for postapproval safety with
respect to the drug) sent
regarding an application,
including a supplemental
application, for the drug, if
the Secretary determines that
data or information in the
application indicates that an
element under paragraph (4),
(5), or (6) should be included
in a strategy for the drug;
``(bb) within a timeframe
specified by the Secretary, not
to be less than 45 days, when
ordered by the Secretary
(acting through such offices),
if the Secretary determines
that new safety information
indicates that--

``(AA) the labeling
of the drug should be
changed; or

``(BB) an element
under paragraph (4) or
(5) should be included
in a strategy for the
drug; or

``(cc) within 90 days when
ordered by the Secretary
(acting through such offices),
if the Secretary determines
that new safety information
indicates that an element under
paragraph (6) should be
included in a strategy for the
drug.
``(iii) Content of letter.--A letter under
clause (ii)(II)(aa) shall describe--
``(I) the data or information in
the application that warrants the
proposal of a risk evaluation and
mitigation strategy for the drug; and
``(II) what elements under
paragraphs (4), (5), or (6) should be
included in a strategy for the drug.
``(iv) Content of order.--An order under
item (aa) or (bb) of clause (ii)(II) shall
describe--
``(I) the new safety information
with respect to the drug that warrants
the proposal of a risk evaluation and
mitigation strategy for the drug; and
``(II) whether and how the labeling
of the drug should be changed and what
elements under paragraphs (4), (5), or
(6) should be included in a strategy
for the drug.
``(v) Content of proposal.--A proposed risk
evaluation and mitigation strategy--
``(I) shall include a timetable as
described under paragraph (3)(B); and
``(II) may also include additional
elements as provided for under
paragraphs (4), (5), and (6).
``(B) Assessment and modification of a risk
evaluation and mitigation strategy.--
``(i) Voluntary assessments.--If a risk
evaluation and mitigation strategy for a drug
is required, the applicant may submit to the
Secretary an assessment of, and propose a
modification to, such approved strategy for the
drug at any time.
``(ii) Required assessments.--If a risk
evaluation and mitigation strategy for a drug
is required, the applicant shall submit an
assessment of, and may propose a modification
to, such approved strategy for the drug--
``(I) when submitting an
application, including a supplemental
application, for a new indication under
subsection (b) or section 351 of the
Public Health Service Act;
``(II) when required by the
strategy, as provided for in the
timetable under paragraph (3)(B);
``(III) within a timeframe
specified by the Secretary, not to be
less than 45 days, when ordered by the
Secretary (acting through the offices
described in subparagraph (A)(ii)(I)),
if the Secretary determines that new
safety information indicates that an
element under paragraph (3) or (4)
should be modified or added to the
strategy;
``(IV) within 90 days when ordered
by the Secretary (acting through such
offices), if the Secretary determines
that new safety information indicates
that an element under paragraph (6)
should be modified or added to the
strategy; or
``(V) within 15 days when ordered
by the Secretary (acting through such
offices), if the Secretary determines
that there may be a cause for action by
the Secretary under subsection (e).
``(iii) Content of order.--An order under
subclauses (III), (IV), or (V) of clause (ii)
shall describe--
``(I) the new safety information
with respect to the drug that warrants
an assessment of the approved risk
evaluation and mitigation strategy for
the drug; and
``(II) whether and how such
strategy should be modified because of
such information.
``(iv) Assessment.--An assessment of the
approved risk evaluation and mitigation
strategy for a drug shall include--
``(I) a description of new safety
information, if any, with respect to
the drug;
``(II) whether and how to modify
such strategy because of such
information;
``(III) with respect to any
postapproval study required under
paragraph (4)(B) or otherwise
undertaken by the applicant to
investigate a safety issue, the status
of such study, including whether any
difficulties completing the study have
been encountered;
``(IV) with respect to any
postapproval clinical trial required
under paragraph (4)(C) or otherwise
undertaken by the applicant to
investigate a safety issue, the status
of such clinical trial, including
whether enrollment has begun, the
number of participants enrolled, the
expected completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to requirements under subsections (i)
and (j) of section 402 of the Public
Health Service Act; and
``(V) with respect to any goal
under paragraph (6) and considering
input and evaluations, if applicable,
under paragraph (6)(E), an assessment
of how well the elements to assure safe
use are meeting the goal of increasing
safe access to drugs with known serious
risks or whether the goal or such
elements should be modified.
``(v) Modification.--A modification
(whether an enhancement or a reduction) to the
approved risk evaluation and mitigation
strategy for a drug may include the addition or
modification of any element under subparagraph
(A) or (B) of paragraph (3) or the addition,
modification, or removal of any element under
paragraph (4), (5), or (6), such as--
``(I) a labeling change, including
the addition of a boxed warning;
``(II) adding a postapproval study
or clinical trial requirement;
``(III) modifying a postapproval
study or clinical trial requirement
(such as a change in trial design due
to legitimate difficulties recruiting
participants);
``(IV) adding, modifying, or
removing an element on advertising
under subparagraph (D), (E), or (F) of
paragraph (5);
``(V) adding, modifying, or
removing an element to assure safe use
under paragraph (6); or
``(VI) modifying the timetable for
assessments of the strategy under
paragraph (3)(B), including to
eliminate assessments.
``(C) Review.--The Secretary (acting through the
offices described in subparagraph (A)(ii)(I)) shall
promptly review the proposed risk evaluation and
mitigation strategy for a drug submitted under
subparagraph (A), or an assessment of the approved risk
evaluation and mitigation strategy for a drug submitted
under subparagraph (B).
``(D) Discussion.--The Secretary (acting through
the offices described in subparagraph (A)(ii)(I)) shall
initiate discussions of the proposed risk evaluation
and mitigation strategy for a drug submitted under
subparagraph (A), or of an assessment of the approved
risk evaluation and mitigation strategy for a drug
submitted under subparagraph (B), with the applicant to
determine a strategy--
``(i) if the proposed strategy or
assessment is submitted as part of an
application (including a supplemental
application) under subparagraph (A)(i),
(A)(ii)(II)(aa), or (B)(ii)(I), by the target
date for communication of feedback from the
review team to the applicant regarding proposed
labeling and postmarketing study commitments,
as set forth in the letters described in
section 735(a);
``(ii) if the proposed strategy is
submitted under subparagraph (A)(ii)(II)(bb) or
the assessment is submitted under subclause
(II) or (III) of subparagraph (B)(ii), not
later than 20 days after such submission;
``(iii) if the proposed strategy is
submitted under subparagraph (A)(ii)(II)(cc) or
the assessment is submitted under subparagraph
(B)(i) or under subparagraph (B)(ii)(IV), not
later than 30 days after such submission; or
``(iv) if the assessment is submitted under
subparagraph (B)(ii)(V), not later than 10 days
after such submission.
``(E) Action.--
``(i) In general.--Unless the applicant
requests the dispute resolution process as
described under subparagraph (F) or (G), the
Secretary (acting through the offices described
in subparagraph (A)(ii)(I)) shall approve and
include the risk evaluation and mitigation
strategy for a drug, or any modification to the
strategy (including a timeframe for
implementing such modification), with--
``(I) the action letter on the
application, if a proposed strategy is
submitted under subparagraph (A)(i) or
(A)(ii)(II)(aa) or an assessment of the
strategy is submitted under
subparagraph (B)(ii)(I); or
``(II) an order, which shall be
made public, issued not later than 50
days after the date discussions of such
proposed strategy or modification begin
under subparagraph (D), if a proposed
strategy is submitted under item (bb)
or (cc) of subparagraph (A)(ii)(II) or
an assessment of the strategy is
submitted under subparagraph (B)(i) or
under subclause (II), (III), (IV), or
(V) of subparagraph (B)(ii).
``(ii) Inaction.--An approved risk
evaluation and mitigation strategy shall remain
in effect until the Secretary acts, if the
Secretary fails to act as provided under clause
(i).
``(F) Dispute resolution at initial approval.--If a
proposed risk evaluation and mitigation strategy is
submitted under subparagraph (A)(i) or (A)(ii)(II)(aa)
in an application for initial approval of a drug and
there is a dispute about the strategy, the applicant
shall use the major dispute resolution procedures as
set forth in the letters described in section 735(a).
``(G) Dispute resolution in all other cases.--
``(i) Request for review.--In any case
other than a submission under subparagraph
(A)(i) or (A)(ii)(II)(aa) in an application for
initial approval of a drug if there is a
dispute about the strategy, not earlier than 15
days, and not later than 35 days, after
discussions under subparagraph (D) have begun,
the applicant shall request in writing that the
dispute be reviewed by the Drug Safety
Oversight Board.
``(ii) Scheduling review.--If the applicant
requests review under clause (i), the
Secretary--
``(I)(aa) shall schedule the
dispute for review at 1 of the next 2
regular meetings of the Drug Safety
Oversight Board, whichever meeting date
is more practicable; or
``(bb) may convene a special
meeting of the Drug Safety Oversight
Board to review the matter more
promptly, including to meet an action
deadline on an application (including a
supplemental application);
``(II) shall give advance notice to
the public through the Federal Register
and on the Internet website of the Food
and Drug Administration--
``(aa) that the drug is to
be discussed by the Drug Safety
Oversight Board; and
``(bb) of the date on which
the Drug Safety Oversight Board
shall discuss such drug; and
``(III) shall apply section 301(j),
section 552 of title 5, and section
1905 of title 18, United States Code,
to any request for information about
such review.
``(iii) Agreement after discussion or
administrative appeals.--
``(I) Further discussion or
administrative appeals.--A request for
review under clause (i) shall not
preclude--
``(aa) further discussions
to reach agreement on the risk
evaluation and mitigation
strategy; or
``(bb) the use of
administrative appeals within
the Food and Drug
Administration to reach
agreement on the strategy,
including the major dispute
resolution procedures as set
forth in the letters described
in section 735(a).
``(II) Agreement terminates dispute
resolution.--At any time before a
decision and order is issued under
clause (vi), the Secretary (acting
through the offices described in
subparagraph (A)(ii)(I)) and the
applicant may reach an agreement on the
risk evaluation and mitigation strategy
through further discussion or
administrative appeals, terminating the
dispute resolution process, and the
Secretary shall issue an action letter
or order, as appropriate, that
describes the strategy.
``(iv) Meeting of the board.--At the
meeting of the Drug Safety Oversight Board
described in clause (ii), the Board shall--
``(I) hear from both parties; and
``(II) review the dispute.
``(v) Recommendation of the board.--Not
later than 5 days after such meeting of the
Drug Safety Oversight Board, the Board shall
provide a written recommendation on resolving
the dispute to the Secretary.
``(vi) Action by the secretary.--
``(I) Action letter.--With respect
to a proposed risk evaluation and
mitigation strategy submitted under
subparagraph (A)(i) or (A)(ii)(II)(aa)
or to an assessment of the strategy
submitted under subparagraph
(B)(ii)(I), the Secretary shall issue
an action letter that resolves the
dispute not later than the later of--
``(aa) the action deadline
for the action letter on the
application; or
``(bb) 7 days after
receiving the recommendation of
the Drug Safety Oversight
Board.
``(II) Order.--With respect to a
proposed risk evaluation and mitigation
strategy submitted under item (bb) or
(cc) of subparagraph (A)(ii)(II) or an
assessment of the risk evaluation and
mitigation strategy under subparagraph
(B)(i) or under subclause (II), (III),
(IV), or (V) of subparagraph (B)(ii),
the Secretary shall issue an order,
which (with the recommendation of the
Drug Safety Oversight Board) shall be
made public, that resolves the dispute
not later than 7 days after receiving
the recommendation of the Drug Safety
Oversight Board.
``(vii) Inaction.--An approved risk
evaluation and mitigation strategy shall remain
in effect until the Secretary acts, if the
Secretary fails to act as provided for under
clause (vi).
``(viii) Effect on action deadline.--With
respect to the application or supplemental
application in which a proposed risk evaluation
and mitigation strategy is submitted under
subparagraph (A)(i) or (A)(ii)(II)(aa) or in
which an assessment of the strategy is
submitted under subparagraph (B)(ii)(I), the
Secretary shall be considered to have met the
action deadline for the action letter on such
application if the applicant requests the
dispute resolution process described in this
subparagraph and if the Secretary--
``(I) has initiated the discussions
described under subparagraph (D) by the
target date referred to in subparagraph
(D)(i); and
``(II) has complied with the timing
requirements of scheduling review by
the Drug Safety Oversight Board,
providing a written recommendation, and
issuing an action letter under clauses
(ii), (v), and (vi), respectively.
``(ix) Disqualification.--No individual who
is an employee of the Food and Drug
Administration and who reviews a drug or who
participated in an administrative appeal under
clause (iii)(I) with respect to such drug may
serve on the Drug Safety Oversight Board at a
meeting under clause (iv) to review a dispute
about the risk evaluation and mitigation
strategy for such drug.
``(x) Additional expertise.--The Drug
Safety Oversight Board may add members with
relevant expertise from the Food and Drug
Administration, including the Office of
Pediatrics, the Office of Women's Health, or
the Office of Rare Diseases, or from other
Federal public health or health care agencies,
for a meeting under clause (iv) of the Drug
Safety Oversight Board.
``(H) Use of advisory committees.--The Secretary
(acting through the offices described in subparagraph
(A)(ii)(I)) may convene a meeting of 1 or more advisory
committees of the Food and Drug Administration to--
``(i) review a concern about the safety of
a drug or class of drugs, including before an
assessment of the risk evaluation and
mitigation strategy or strategies of such drug
or drugs is required to be submitted under
subclause (II), (III), (IV), or (V) of
subparagraph (B)(ii);
``(ii) review the risk evaluation and
mitigation strategy or strategies of a drug or
group of drugs; or
``(iii) with the consent of the applicant,
review a dispute under subparagraph (G).
``(I) Process for addressing drug class effects.--
``(i) In general.--When a concern about a
serious risk of a drug may be related to the
pharmacological class of the drug, the
Secretary (acting through the offices described
in subparagraph (A)(ii)(I)) may defer
assessments of the approved risk evaluation and
mitigation strategies for such drugs until the
Secretary has--
``(I) convened, after appropriate
public notice, 1 or more public
meetings to consider possible responses
to such concern; or
``(II) gathered additional
information or data about such concern.
``(ii) Public meetings.--Such public
meetings may include--
``(I) 1 or more meetings of the
applicants for such drugs;
``(II) 1 or more meetings of 1 or
more advisory committees of the Food
and Drug Administration, as provided
for under subparagraph (H); or
``(III) 1 or more workshops of
scientific experts and other
stakeholders.
``(iii) Action.--After considering the
discussions from any meetings under clause
(ii), the Secretary may--
``(I) announce in the Federal
Register a planned regulatory action,
including a modification to each risk
evaluation and mitigation strategy, for
drugs in the pharmacological class;
``(II) seek public comment about
such action; and
``(III) after seeking such comment,
issue an order addressing such
regulatory action.
``(J) International coordination.--The Secretary
(acting through the offices described in subparagraph
(A)(ii)(I)) may coordinate the timetable for submission
of assessments under paragraph (3)(B), a study under
paragraph (4)(B), or a clinical trial under paragraph
(4)(C), with efforts to identify and assess the serious
risks of such drug by the marketing authorities of
other countries whose drug approval and risk management
processes the Secretary deems comparable to the drug
approval and risk management processes of the United
States.
``(K) Effect.--Use of the processes described in
subparagraphs (I) and (J) shall not delay action on an
application or a supplement to an application for a
drug.
``(L) No effect on labeling changes that do not
require preapproval.--In the case of a labeling change
to which section 314.70 of title 21, Code of Federal
Regulations (or any successor regulation), applies for
which the submission of a supplemental application is
not required or for which distribution of the drug
involved may commence upon the receipt by the Secretary
of a supplemental application for the change, the
submission of an assessment of the approved risk
evaluation and mitigation strategy for the drug under
this subsection is not required.
``(8) Drug safety oversight board.--
``(A) In general.--There is established a Drug
Safety Oversight Board.
``(B) Composition; meetings.--The Drug Safety
Oversight Board shall--
``(i) be composed of scientists and health
care practitioners appointed by the Secretary,
each of whom is an employee of the Federal
Government;
``(ii) include representatives from offices
throughout the Food and Drug Administration
(including the offices responsible for
postapproval safety of drugs);
``(iii) include at least 1 representative
each from the National Institutes of Health,
the Department of Health and Human Services
(other than the Food and Drug Administration),
and the Veterans Health Administration; and
``(iv) meet at least monthly to provide
oversight and advice to the Secretary on the
management of important drug safety issues.
``(9) Civil monetary penalty.--Notwithstanding any other
provision of this Act, an applicant (as such term is defined
for purposes of this section) that knowingly fails to comply
with a requirement of an approved risk evaluation and
mitigation strategy under this subsection shall be subject to a
civil money penalty of $250,000 for the first 30-day period
that the applicant is in noncompliance, and such amount shall
double for every 30-day period thereafter that the requirement
is not complied with, not to exceed $2,000,000.''.

SEC. 203. ENFORCEMENT.

(a) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(x) If it is a drug subject to an approved risk evaluation and
mitigation strategy under section 505(o) and the applicant for such
drug fails to--
``(1) make a labeling change required by such strategy
after the Secretary has approved such strategy or completed
review of, and acted on, an assessment of such strategy under
paragraph (7) of such section; or
``(2) comply with a requirement of such strategy with
respect to advertising as provided for under subparagraph (D),
(E), or (F) of paragraph (5) of such section.''.
(b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(f)) is amended--
(1) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively;
(2) by inserting after paragraph (2) the following:
``(3) An applicant (as such term is used in section 505(o))
who knowingly fails to comply with a requirement of an approved
risk evaluation and mitigation strategy under such section
505(o) shall be subject to a civil money penalty of not less
than $15,000 and not more than $250,000 per violation, and not
to exceed $1,000,000 for all such violations adjudicated in a
single proceeding.'';
(3) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(4) in paragraph (4), as so redesignated, by striking
``paragraph (1) or (2)'' each place it appears and inserting
``paragraph (1), (2), or (3)''; and
(5) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.

SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.

Section 351 of the Public Health Service Act (42 U.S.C. 262) is
amended--
(1) in subsection (a)(2), by adding at the end the
following:
``(D) Risk Evaluation and Mitigation Strategy.--A person that
submits an application for a license for a drug under this paragraph
may submit to the Secretary as part of the application a proposed risk
evaluation and mitigation strategy as described under section 505(o) of
the Federal Food, Drug, and Cosmetic Act.''; and
(2) in subsection (j), by inserting ``, including the
requirements under section 505(o) of such Act,'' after ``, and
Cosmetic Act''.

SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(e)) is amended by adding at the end the following: ``The
Secretary may withdraw the approval of an application submitted under
this section, or suspend the approval of such an application, as
provided under this subsection, without first ordering the applicant to
submit an assessment of the approved risk evaluation and mitigation
strategy for the drug under subsection (o)(7)(B)(ii)(V).''.

SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG APPLICATION.

Section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)) is amended by adding at the end the following:
``(E) Risk Evaluation and Mitigation Strategy Requirement.--
``(i) In general.--A drug that is the subject of an
abbreviated new drug application under this subsection shall be
subject to only the following elements of the approved risk
evaluation and mitigation strategy if required under subsection
(o) for the applicable listed drug:
``(I) Labeling, as required under subsection
(o)(3)(A) for the applicable listed drug.
``(II) A Medication Guide or patient package
insert, if required under subsection (o)(5)(B) for the
applicable listed drug.
``(III) Prereview of advertising, if required under
subsection (o)(5)(D) for the applicable listed drug.
``(IV) Specific disclosures in advertising, if
required under subsection (o)(5)(E) for the applicable
listed drug.
``(V) Elements to assure safe use, if required
under subsection (o)(6) for the applicable listed drug,
except that such drug may use a different, comparable
aspect of such elements as are necessary to assure safe
use of such drug if--
``(aa) the corresponding aspect of the
elements to assure safe use for the applicable
listed drug is claimed by a patent that has not
expired or is a method or process that as a
trade secret is entitled to protection; and
``(bb) the applicant certifies that it has
sought a license for use of such aspect of the
elements to assure safe use for the applicable
listed drug.
``(ii) Action by secretary.--For an applicable listed drug
for which a drug is approved under this subsection, the
Secretary--
``(I) shall undertake any communication plan to
health care providers required under section (o)(5)(C)
for the applicable listed drug;
``(II) shall conduct, or contract for, any
postapproval study required under subsection (o)(4)(B)
for the applicable listed drug;
``(III) shall inform the applicant for a drug
approved under this subsection if the approved risk
evaluation and mitigation strategy for the applicable
listed drug is modified; and
``(IV) in order to minimize the burden on the
health care delivery system of different elements to
assure safe use for the drug approved under this
subsection and the applicable listed drug, may seek to
negotiate a voluntary agreement with the owner of the
patent, method, or process for a license under which
the applicant for such drug may use an aspect of the
elements to assure safe use, if required under
subsection (o)(6) for the applicable listed drug, that
is claimed by a patent that has not expired or is a
method or process that as a trade secret is entitled to
protection.''.

SEC. 207. RESOURCES.

(a) User Fees.--Subparagraph (F) of section 735(d)(6) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(d)(6)), as amended
by section 103, is amended--
(1) in clause (ii), by striking ``systems); and'' and
inserting ``systems);''
(2) in clause (iii), by striking ``bases).'' and inserting
``bases); and''; and
(3) by adding at the end the following:
``(iv) reviewing, implementing, and
ensuring compliance with risk evaluation and
mitigation strategies.''.
(b) Additional Fee Revenues for Drug Safety.--Section 736 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), as amended by
section 103, is amended by--
(1) striking the subsection designation and all that
follows through ``.--Except'' and inserting the following:
``(b) Fee Revenue Amounts.--
``(1) In general.--Except''; and
(2) adding at the end the following:
``(2) Additional fee revenues for drug safety.--
``(A) In general.--Subject to subparagraph (C), in
each of fiscal years 2008 through 2012, paragraph (1)
shall be applied by substituting the amount determined
under subparagraph (B) for `$392,783,000'.
``(B) Amount determined.--For any fiscal year 2008
through 2012, the amount determined under this
subparagraph is the sum of--
``(i) $392,783,000; plus
``(ii) the amount equal to--
``(I)(aa) for fiscal year 2008,
$25,000,000;
``(bb) for fiscal year 2009,
$35,000,000;
``(cc) for fiscal year 2010,
$45,000,000;
``(dd) for fiscal year 2011,
$55,000,000; and
``(ee) for fiscal year 2012,
$65,000,000; minus
``(II) the amount equal to one-fifth of the
excess amount in item (bb), provided that--
``(aa) the amount of the total
appropriation for the Food and Drug
Administration for such fiscal year
(excluding the amount of fees
appropriated for such fiscal year)
exceeds the amount of the total
appropriation for the Food and Drug
Administration for fiscal year 2007
(excluding the amount of fees
appropriated for such fiscal year),
adjusted as provided under subsection
(c)(1); and
``(bb) the amount of the total
appropriations for the process of human
drug review at the Food and Drug
Administration for such fiscal year
(excluding the amount of fees
appropriated for such fiscal year)
exceeds the amount of appropriations
for the process of human drug review at
the Food and Drug Administration for
fiscal year 2007 (excluding the amount
of fees appropriated for such fiscal
year), adjusted as provided under
subsection (c)(1).
In making the adjustment under subclause (II)
for any fiscal year 2008 through 2012,
subsection (c)(1) shall be applied by
substituting `2007' for `2008.'
``(C) Limitation.--This paragraph shall not apply
for any fiscal year if the amount described under
subparagraph (B)(ii) is less than 0.''.
(c) Strategic Plan for Information Technology.--Not later than 1
year after the date of enactment of this title, the Secretary of Health
and Human Services (referred to in this title as the ``Secretary'')
shall submit to the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate and the Committee on
Energy and Commerce and the Committee on Appropriations of the House of
Representatives, a strategic plan on information technology that
includes--
(1) an assessment of the information technology
infrastructure, including systems for data collection, access
to data in external health care databases, data mining
capabilities, personnel, and personnel training programs,
needed by the Food and Drug Administration to--
(A) comply with the requirements of this subtitle
(and the amendments made by this subtitle);
(B) achieve interoperability within and among the
centers of the Food and Drug Administration and between
the Food and Drug Administration and product
application sponsors;
(C) utilize electronic health records;
(D) implement routine active surveillance under
section 505(k)(3) (including complementary approaches
under subsection (c) of such section) of the Federal
Food, Drug, and Cosmetic Act, as added by section 201
of this Act; and
(E) communicate drug safety information to
physicians and other health care providers;
(2) an assessment of the extent to which the current
information technology assets of the Food and Drug
Administration are sufficient to meet the needs assessments
under paragraph (1);
(3) a plan for enhancing the information technology assets
of the Food and Drug Administration toward meeting the needs
assessments under paragraph (1); and
(4) an assessment of additional resources needed to so
enhance the information technology assets of the Food and Drug
Administration.

SEC. 208. SAFETY LABELING CHANGES.

(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C the following:

``SEC. 506D. SAFETY LABELING CHANGES.

``(a) New Safety Information.--
``(1) Notification.--The holder of an approved application
under section 505 of this Act or a license under section 351 of
the Public Health Service Act (referred to in this section as a
`holder') shall promptly notify the Secretary if the holder
becomes aware of new safety information that the holder
believes should be included in the labeling of the drug. The
Secretary shall promptly notify the holder if the Secretary
becomes aware of new safety information that the Secretary
believes should be included in the labeling of the drug.
``(2) Discussion regarding labeling changes.--Following
notification pursuant to paragraph (1), the Secretary and
holder shall initiate discussions of the new safety information
in order to reach agreement on whether the labeling for the
drug should be modified to reflect the new safety information
and, if so, on the contents of such labeling changes.
``(3) Supplement.--If the Secretary determines that there
is reasonable scientific evidence that an adverse event is
associated with use of the drug, the Secretary may request the
holder to submit a supplement to an application under section
505 of this Act or to a license under section 351 of the Public
Health Service Act (referred to in this section as a
`supplement') proposing changes to the approved labeling to
reflect the new safety information, including changes to boxed
warnings, contraindications, warnings, precautions, or adverse
reactions (referred to in this section as a `safety labeling
change'). If the Secretary determines that no safety labeling
change is necessary or appropriate based upon the new safety
information, the Secretary shall notify the holder of this
determination in writing.
``(b) Labeling Supplements.--
``(1) In general.--The holder shall submit a supplement
whenever the holder seeks, either at the holder's own
initiative or at the request of the Secretary, to make a safety
labeling change.
``(2) Nonaccelerated process.--Unless the accelerated
labeling review process described in subsection (c) is
initiated, any supplement proposing a safety labeling change
shall be reviewed and acted upon by the Secretary not later
than 30 days after the date the Secretary receives the
supplement. Until the Secretary acts on such a supplement
proposing a safety labeling change, the existing approved
labeling shall remain in effect and be distributed by the
holder without change.
``(3) New safety information.--Nothing in this section
shall prohibit the Secretary from informing health care
professionals or the public about new safety information prior
to approval of a supplement proposing a safety labeling change.
``(c) Accelerated Labeling Review Process.--An accelerated labeling
review process shall be available to resolve disagreements in a timely
manner between the Secretary and a holder about the need for, or
content of, a safety labeling change, as follows:
``(1) Request to initiate accelerated process.--The
accelerated labeling review process shall be initiated upon the
written request of either the Secretary or the holder. Such
request may be made at any time after the notification
described in subsection (a)(1), including during the
Secretary's review of a supplement proposing a safety labeling
change.
``(2) Scientific discussion and meetings.--
``(A) In general.--Following initiation of the
accelerated labeling review process, the Secretary and
holder shall immediately initiate discussions to review
and assess the new safety information and to reach
agreement on whether safety labeling changes are
necessary and appropriate and, if so, the content of
such safety labeling changes.
``(B) Time period.--The discussions under this
paragraph shall not extend for more than 45 calendar
days after the initiation of the accelerated labeling
review process.
``(C) Dispute proceedings.--If the Secretary and
holder do not reach an agreement regarding the safety
labeling changes by not later than 25 calendar days
after the initiation of the accelerated labeling review
process, the dispute automatically shall be referred to
the director of the drug evaluation office responsible
for the drug under consideration, who shall be required
to take an active role in such discussions.
``(3) Request for safety labeling change and failure to
agree.--If the Secretary and holder fail to reach an agreement
on appropriate safety labeling changes by not later than 45
calendar days after the initiation of the accelerated labeling
review process--
``(A) on the next calendar day (other than a
weekend or Federal holiday) after such period, the
Secretary shall--
``(i) request in writing that the holder
make any safety labeling change that the
Secretary determines to be necessary and
appropriate based upon the new safety
information; or
``(ii) notify the holder in writing that
the Secretary has determined that no safety
labeling change is necessary or appropriate;
and
``(B) if the Secretary fails to act within the
specified time, or if the holder does not agree to make
a safety labeling change requested by the Secretary or
does not agree with the Secretary's determination that
no labeling change is necessary or appropriate, the
Secretary (on his own initiative or upon request by the
holder) shall refer the matter for expedited review to
the Drug Safety Oversight Board.
``(4) Action by the drug safety oversight board.--Not later
than 45 days after receiving a referral under paragraph (3)(B),
the Drug Safety Oversight Board shall--
``(A) review the new safety information;
``(B) review all written material submitted by the
Secretary and the holder;
``(C) convene a meeting to hear oral presentations
and arguments from the Secretary and holder; and
``(D) make a written recommendation to the
Secretary--
``(i) concerning appropriate safety
labeling changes, if any; or
``(ii) stating that no safety labeling
changes are necessary or appropriate based upon
the new safety information.
``(5) Consideration of recommendations.--
``(A) Action by the secretary.--The Secretary shall
consider the recommendation of the Drug Safety
Oversight Board made under paragraph (4)(D) and, not
later than 20 days after receiving the recommendation--
``(i) issue an order requiring the holder
to make any safety labeling change that the
Secretary determines to be necessary and
appropriate; or
``(ii) if the Secretary determines that no
safety labeling change is necessary or
appropriate, the Secretary shall notify the
holder of this determination in writing.
``(B) Failure to act.--If the Secretary fails to
act by not later than 20 days after receiving the
recommendation of the Drug Safety Oversight Board, the
written recommendation of the Drug Safety Oversight
Board shall be considered the order of the Secretary
under this paragraph.
``(C) Nondelegation.--The Secretary's authority
under this paragraph shall not be redelegated to an
individual below the level of the Director of the
Center for Drug Evaluation and Research, or the
Director of the Center for Biologics Evaluation and
Research, of the Food and Drug Administration.
``(6) Misbranding.--If the holder, not later than 10 days
after receiving an order under subparagraph (A) or (B) of
paragraph (5), does not agree to make a safety labeling change
ordered by the Secretary, the Secretary may deem the drug that
is the subject of the request to be misbranded.
``(d) Rule of Construction.--Nothing in this section shall be
construed to change the standards in existence on the date of enactment
of this section for determining whether safety labeling changes are
necessary or appropriate.''.
(b) Conforming Amendment.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by section 203, is
further amended by adding at the end the following:
``(y) If it is a drug and the holder does not agree to make a
safety labeling change ordered by the Secretary under section 506D(c)
within 10 days after issuance of such an order.''.

SEC. 209. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND
PROVIDERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by section 251, is amended by adding at the end the
following:
``(r) Postmarket Drug Safety Information for Patients and
Providers.--
``(1) Establishment.--Not later than 1 year after the date
of enactment of the Enhancing Drug Safety and Innovation Act of
2007, the Secretary shall improve the transparency of
pharmaceutical data and allow patients and health care
providers better access to pharmaceutical data by developing
and maintaining an Internet website that--
``(A) provides comprehensive drug safety
information for prescription drugs that are approved by
the Secretary under this section or licensed under
section 351 of the Public Health Service Act; and
``(B) improves communication of drug safety
information to patients and providers.
``(2) Internet website.--The Secretary shall carry out
paragraph (1) by--
``(A) developing and maintaining an accessible,
consolidated Internet website with easily searchable
drug safety information, including the information
found on United States Government Internet websites,
such as the United States National Library of
Medicine's Daily Med and Medline Plus websites, in
addition to other such websites maintained by the
Secretary;
``(B) ensuring that the information provided on the
Internet website is comprehensive and includes, when
available and appropriate--
``(i) patient labeling and patient
packaging inserts;
``(ii) a link to a list of each drug,
whether approved under this section or licensed
under such section 351, for which a Medication
Guide, as provided for under part 208 of title
21, Code of Federal Regulations (or any
successor regulations), is required;
``(iii) a link to the clinical trial
registry data bank provided for under
subsections (i) and (j) of section 402 of the
Public Health Service Act;
``(iv) the most recent safety information
and alerts issued by the Food and Drug
Administration for drugs approved by the
Secretary under this section, such as product
recalls, warning letters, and import alerts;
``(v) publicly available information about
implemented RiskMAPs and risk evaluation and
mitigation strategies under subsection (o);
``(vi) guidance documents and regulations
related to drug safety; and
``(vii) other material determined
appropriate by the Secretary;
``(C) including links to non-Food and Drug
Administration Internet resources that provide access
to relevant drug safety information, such as medical
journals and studies;
``(D) providing access to summaries of the assessed
and aggregated data collected from the active
surveillance infrastructure under subsection (k)(3) to
provide information of known and serious side-effects
for drugs approved by the Secretary under this section
or licensed under such section 351;
``(E) enabling patients, providers, and drug
sponsors to submit adverse event reports through the
Internet website;
``(F) providing educational materials for patients
and providers about the appropriate means of disposing
of expired, damaged, or unusable medications; and
``(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes of the
Internet website.
``(3) Posting of drug labeling.--The Secretary shall post
on the Internet website established under paragraph (1) the
approved professional labeling and any required patient
labeling of a drug approved under this section or licensed
under such section 351 not later than 21 days after the date
the drug is approved or licensed, including in a supplemental
application with respect to a labeling change.
``(4) Private sector resources.--To ensure development of
the Internet website by the date described in paragraph (1),
the Secretary may, on a temporary or permanent basis, implement
systems or products developed by private entities.
``(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to fulfill the
requirements of this subsection.
``(6) Review.--The Advisory Committee on Risk Communication
under section 566 shall, on a regular basis, perform a
comprehensive review and evaluation of the types of risk
communication information provided on the Internet website
established under paragraph (1) and, through other means, shall
identify, clarify, and define the purposes and types of
information available to facilitate the efficient flow of
information to patients and providers, and shall recommend ways
for the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.''.

SEC. 210. ACTION PACKAGE FOR APPROVAL.

Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(l)) is amended by--
(1) redesignating paragraphs (1), (2), (3), (4), and (5) as
subparagraphs (A), (B), (C), (D), and (E), respectively;
(2) striking ``(l) Safety and'' and inserting ``(l)(1)
Safety and''; and
(3) adding at the end the following:
``(2) Action Package for Approval.--
``(A) Action package.--The Secretary shall publish the
action package for approval of an application under subsection
(b) or section 351 of the Public Health Service Act on the
Internet website of the Food and Drug Administration--
``(i) not later than 30 days after the date of
approval of such application for a drug no active
ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other
application under this section or section 351 of the
Public Health Service Act; and
``(ii) not later than 30 days after the third
request for such action package for approval received
under section 552 of title 5, United States Code, for
any other drug.
``(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall publish,
on the Internet website of the Food and Drug Administration,
the materials described in subparagraph (C)(iv) not later than
48 hours after the date of approval of the drug, except where
such materials require redaction by the Secretary.
``(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and shall
include the following:
``(i) Documents generated by the Food and Drug
Administration related to review of the application.
``(ii) Documents pertaining to the format and
content of the application generated during drug
development.
``(iii) Labeling submitted by the applicant.
``(iv) A summary review that documents conclusions
from all reviewing disciplines about the drug, noting
any critical issues and disagreements with the
applicant and how they were resolved, recommendation
for action, and an explanation of any nonconcurrence
with review conclusions.
``(v) If applicable, a separate review from a
supervisor who does not concur with the summary review.
``(vi) Identification by name of each officer or
employee of the Food and Drug Administration who--
``(I) participated in the decision to
approve the application; and
``(II) consents to have his or her name
included in the package.
``(D) Disagreements.--A scientific review of an application
is considered the work of the reviewer and shall not be altered
by management or the reviewer once final. Disagreements by team
leaders, division directors, or office directors with any or
all of the major conclusions of a reviewer shall be document in
a separate review or in an addendum to the review.
``(E) Confidential information.--This paragraph does not
authorize the disclosure of any trade secret or confidential
commercial or financial information described in section
552(b)(4) of title 5, United States Code, unless the Secretary
declares an emergency under section 319 of the Public Health
Service Act and such disclosure is necessary to mitigate the
effects of such emergency.''.

SEC. 211. RISK COMMUNICATION.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:

``SEC. 566. RISK COMMUNICATION.

``(a) Advisory Committee on Risk Communication.--
``(1) In general.--The Secretary shall establish an
advisory committee to be known as the `Advisory Committee on
Risk Communication' (referred to in this section as the
`Committee').
``(2) Duties of committee.--The Committee shall advise the
Commissioner on methods to effectively communicate risks
associated with the products regulated by the Food and Drug
Administration.
``(3) Members.--The Secretary shall ensure that the
Committee is composed of experts on risk communication, experts
on the risks described in subsection (b), and representatives
of patient, consumer, and health professional organizations.
``(4) Permanence of committee.--Section 14 of the Federal
Advisory Committee Act shall not apply to the Committee
established under this subsection.
``(b) Partnerships for Risk Communication.--
``(1) In general.--The Secretary shall partner with
professional medical societies, medical schools, academic
medical centers, and other stakeholders to develop robust and
multi-faceted systems for communication to health care
providers about emerging postmarket drug risks.
``(2) Partnerships.--The systems developed under paragraph
(1) shall--
``(A) account for the diversity among physicians in
terms of practice, affinity for technology, and focus;
and
``(B) include the use of existing communication
channels, including electronic communications, in place
at the Food and Drug Administration.''.

SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended
by section 202, is further amended by adding at the end the following:
``(p) Referral to Advisory Committee.--
``(1) In general.--Prior to the approval of a drug no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under this section or section 351 of the Public Health Service
Act, the Secretary shall refer such drug to a Food and Drug
Administration advisory committee for review at a meeting of
such advisory committee.
``(2) Exception.--Notwithstanding paragraph (1), an
advisory committee review of a drug described under such
paragraph may occur within 1 year after approval of such a drug
if--
``(A) the clinical trial that formed the primary
basis of the safety and efficacy determination was
halted by a drug safety monitoring board or an
Institutional Review Board before its scheduled
completion due to early unanticipated therapeutic
results; or
``(B) the Secretary determines that it would be
beneficial to the public health.''.

SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

(a) In General.--Not later than 1 year after the date of enactment
of this title, the Secretary shall issue a report responding to the
2006 report of the Institute of Medicine entitled ``The Future of Drug
Safety--Promoting and Protecting the Health of the Public''.
(b) Content of Report.--The report issued by the Secretary under
subsection (a) shall include--
(1) an update on the implementation by the Food and Drug
Administration of its plan to respond to the Institute of
Medicine report described under such subsection; and
(2) an assessment of how the Food and Drug Administration
has implemented--
(A) the recommendations described in such Institute
of Medicine report; and
(B) the requirement under paragraph (7) of section
505(o) of the Federal Food, Drug, and Cosmetic Act (as
added by this title), that the appropriate office
responsible for reviewing a drug and the office
responsible for postapproval safety with respect to the
drug act together to assess, implement, and ensure
compliance with the requirements of such section
505(o).

SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

(a) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), this
subtitle shall take effect 180 days after the date of enactment
of this title.
(2) User fees.--The amendments made by subsections (a)
through (c) of section 207 shall take effect on October 1,
2007.
(b) Drugs Deemed To Have Risk Evaluation and Mitigation
Strategies.--
(1) In general.--A drug that was approved before the
effective date of this subtitle shall be deemed to have an
approved risk evaluation and mitigation strategy under section
505(o) of the Federal Food, Drug, and Cosmetic Act (as added by
this subtitle) if there are in effect on the effective date of
this subtitle restrictions on distribution or use--
(A) required under section 314.520 or section
601.42 of title 21, Code of Federal Regulations; or
(B) otherwise agreed to by the applicant and the
Secretary for such drug.
(2) Risk evaluation and mitigation strategy.--The approved
risk evaluation and mitigation strategy deemed in effect for a
drug under paragraph (1) shall consist of the elements
described in subparagraphs (A) and (B) of paragraph (3) of such
section 505(o) and any other additional elements under
paragraphs (4), (5), and (6) in effect for such drug on the
effective date of this subtitle.
(3) Notification.--Not later than 30 days after the
effective date of this subtitle, the Secretary shall notify the
applicant for each drug described in paragraph (1)--
(A) that such drug is deemed to have an approved
risk evaluation and mitigation strategy pursuant to
such paragraph; and
(B) of the date, which, unless a safety issue with
the drug arises, shall be no earlier than 6 months
after the applicant is so notified, by which the
applicant shall submit to the Secretary an assessment
of such approved strategy under paragraph (7)(B) of
such section 505(o), except with respect to the drug
Mifeprex (mifepristone), such assessment shall be
submitted 6 months after the applicant is so notified.
(4) Enforcement only after assessment and review.--Neither
the Secretary nor the Attorney General may seek to enforce a
requirement of a risk evaluation and mitigation strategy deemed
in effect under paragraph (1) before the Secretary has
completed review of, and acted on, the first assessment of such
strategy under such section 505(o).
(c) No Effect on Veterinary Medicine.--This subtitle, and the
amendments made by this subtitle, shall have no effect on the use of
drugs approved under section 505 of the Federal Food, Drug, and
Cosmetic Act by, or on the lawful written or oral order of, a licensed
veterinarian within the context of a veterinarian-client-patient
relationship, as provided for under section 512(a)(5) of such Act.

Subtitle B--Reagan-Udall Foundation for the Food and Drug
Administration

SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.

(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end
the following:

``Subchapter I--Reagan-Udall Foundation for the Food and Drug
Administration

``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

``(a) In General.--A nonprofit corporation to be known as the
Reagan-Udall Foundation for the Food and Drug Administration (referred
to in this subchapter as the `Foundation') shall be established in
accordance with this section. The Foundation shall be headed by an
Executive Director, appointed by the members of the Board of Directors
under subsection (e). The Foundation shall not be an agency or
instrumentality of the United States Government.
``(b) Purpose of Foundation.--The purpose of the Foundation is to
advance the mission of the Food and Drug Administration to modernize
medical, veterinary, food, food ingredient, and cosmetic product
development, accelerate innovation, and enhance product safety.
``(c) Duties of the Foundation.--The Foundation shall--
``(1) taking into consideration the Critical Path reports
and priorities published by the Food and Drug Administration,
identify unmet needs in the development, manufacture, and
evaluation of the safety and effectiveness, including
postapproval, of devices, including diagnostics, biologics, and
drugs, and the safety of food, food ingredients, and cosmetics;
``(2) establish goals and priorities in order to meet the
unmet needs identified in paragraph (1);
``(3) in consultation with the Secretary, identify existing
and proposed Federal intramural and extramural research and
development programs relating to the goals and priorities
established under paragraph (2), coordinate Foundation
activities with such programs, and minimize Foundation
duplication of existing efforts;
``(4) award grants to, or enter into contracts, memoranda
of understanding, or cooperative agreements with, scientists
and entities, which may include the Food and Drug
Administration, university consortia, public-private
partnerships, institutions of higher education, entities
described in section 501(c)(3) of the Internal Revenue Code
(and exempt from tax under section 501(a) of such Code), and
industry, to efficiently and effectively advance the goals and
priorities established under paragraph (2);
``(5) recruit meeting participants and hold or sponsor (in
whole or in part) meetings as appropriate to further the goals
and priorities established under paragraph (2);
``(6) release and publish information and data and, to the
extent practicable, license, distribute, and release material,
reagents, and techniques to maximize, promote, and coordinate
the availability of such material, reagents, and techniques for
use by the Food and Drug Administration, nonprofit
organizations, and academic and industrial researchers to
further the goals and priorities established under paragraph
(2);
``(7) ensure that--
``(A) action is taken as necessary to obtain
patents for inventions developed by the Foundation or
with funds from the Foundation;
``(B) action is taken as necessary to enable the
licensing of inventions developed by the Foundation or
with funds from the Foundation; and
``(C) executed licenses, memoranda of
understanding, material transfer agreements, contracts,
and other such instruments, promote, to the maximum
extent practicable, the broadest conversion to
commercial and noncommercial applications of licensed
and patented inventions of the Foundation to further
the goals and priorities established under paragraph
(2);
``(8) provide objective clinical and scientific information
to the Food and Drug Administration and, upon request, to other
Federal agencies to assist in agency determinations of how to
ensure that regulatory policy accommodates scientific advances
and meets the agency's public health mission;
``(9) conduct annual assessments of the unmet needs
identified in paragraph (1); and
``(10) carry out such other activities consistent with the
purposes of the Foundation as the Board determines appropriate.
``(d) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Foundation shall have a
Board of Directors (referred to in this subchapter as
the `Board'), which shall be composed of ex officio and
appointed members in accordance with this subsection.
All appointed members of the Board shall be voting
members.
``(B) Ex officio members.--The ex officio members
of the Board shall be the following individuals or
their designees:
``(i) The Commissioner.
``(ii) The Director of the National
Institutes of Health.
``(iii) The Director of the Centers for
Disease Control and Prevention.
``(iv) The Director of the Agency for
Healthcare Research and Quality.
``(C) Appointed members.--
``(i) In general.--The ex officio members
of the Board under subparagraph (B) shall, by
majority vote, appoint to the Board 12
individuals, from a list of candidates to be
provided by the National Academy of Sciences.
Of such appointed members--
``(I) 4 shall be representatives of
the general pharmaceutical, device,
food, cosmetic, and biotechnology
industries;
``(II) 3 shall be representatives
of academic research organizations;
``(III) 2 shall be representatives
of Government agencies, including the
Food and Drug Administration and the
National Institutes of Health;
``(IV) 2 shall be representatives
of patient or consumer advocacy
organizations; and
``(V) 1 shall be a representative
of health care providers.
``(ii) Requirement.--The ex officio members
shall ensure the Board membership includes
individuals with expertise in areas including
the sciences of developing, manufacturing, and
evaluating the safety and effectiveness of
devices, including diagnostics, biologics, and
drugs, and the safety of food, food
ingredients, and cosmetics.
``(D) Initial meeting.--
``(i) In general.--Not later than 30 days
after the date of the enactment of the
Enhancing Drug Safety and Innovation Act of
2007, the Secretary shall convene a meeting of
the ex officio members of the Board to--
``(I) incorporate the Foundation;
and
``(II) appoint the members of the
Board in accordance with subparagraph
(C).
``(ii) Service of ex officio members.--Upon
the appointment of the members of the Board
under clause (i)(II), the terms of service of
the ex officio members of the Board as members
of the Board shall terminate.
``(iii) Chair.--The ex officio members of
the Board under subparagraph (B) shall
designate an appointed member of the Board to
serve as the Chair of the Board.
``(2) Duties of board.--The Board shall--
``(A) establish bylaws for the Foundation that--
``(i) are published in the Federal Register
and available for public comment;
``(ii) establish policies for the selection
of the officers, employees, agents, and
contractors of the Foundation;
``(iii) establish policies, including
ethical standards, for the acceptance,
solicitation, and disposition of donations and
grants to the Foundation and for the
disposition of the assets of the Foundation,
including appropriate limits on the ability of
donors to designate, by stipulation or
restriction, the use or recipient of donated
funds;
``(iv) establish policies that would
subject all employees, fellows, and trainees of
the Foundation to the conflict of interest
standards under section 208 of title 18, United
States Code;
``(v) establish licensing, distribution,
and publication policies that support the
widest and least restrictive use by the public
of information and inventions developed by the
Foundation or with Foundation funds to carry
out the duties described in paragraphs (6) and
(7) of subsection (c), and may include charging
cost-based fees for published material produced
by the Foundation;
``(vi) specify principles for the review of
proposals and awarding of grants and contracts
that include peer review and that are
consistent with those of the Foundation for the
National Institutes of Health, to the extent
determined practicable and appropriate by the
Board;
``(vii) specify a cap on administrative
expenses for recipients of a grant, contract,
or cooperative agreement from the Foundation;
``(viii) establish policies for the
execution of memoranda of understanding and
cooperative agreements between the Foundation
and other entities, including the Food and Drug
Administration;
``(ix) establish policies for funding
training fellowships, whether at the
Foundation, academic or scientific
institutions, or the Food and Drug
Administration, for scientists, doctors, and
other professionals who are not employees of
regulated industry, to foster greater
understanding of and expertise in new
scientific tools, diagnostics, manufacturing
techniques, and potential barriers to
translating basic research into clinical and
regulatory practice;
``(x) specify a process for annual Board
review of the operations of the Foundation; and
``(xi) establish specific duties of the
Executive Director;
``(B) prioritize and provide overall direction to
the activities of the Foundation;
``(C) evaluate the performance of the Executive
Director; and
``(D) carry out any other necessary activities
regarding the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of
the Board appointed under paragraph (1)(C) shall be 4
years, except that the terms of offices for the initial
appointed members of the Board shall expire on a
staggered basis as determined by the ex officio
members.
``(B) Vacancy.--Any vacancy in the membership of
the Board--
``(i) shall not affect the power of the
remaining members to execute the duties of the
Board; and
``(ii) shall be filled by appointment by
the appointed members described in paragraph
(1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does
not serve the full term applicable under subparagraph
(A), the individual appointed under subparagraph (B) to
fill the resulting vacancy shall be appointed for the
remainder of the term of the predecessor of the
individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of
the member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(e) Incorporation.--The ex officio members of the Board shall
serve as incorporators and shall take whatever actions necessary to
incorporate the Foundation.
``(f) Nonprofit Status.--The Foundation shall be considered to be a
corporation under section 501(c) of the Internal Revenue Code of 1986,
and shall be subject to the provisions of such section.
``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific
duties and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.
``(h) Administrative Powers.--In carrying out this subchapter, the
Board, acting through the Executive Director, may--
``(1) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and
define their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation
is acquired, held, and transferred;
``(B) general operations of the Foundation are to
be conducted; and
``(C) the privileges granted to the Board by law
are exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information,
services, and facilities of such department or agencies in
carrying out this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the Foundation
under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees;
``(10) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(11) appoint other groups of advisors as may be
determined necessary to carry out the functions of the
Foundation; and
``(12) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry out
its powers, duties, and functions in accordance with this
subchapter.
``(i) Acceptance of Funds From Other Sources.--The Executive
Director may solicit and accept on behalf of the Foundation, any funds,
gifts, grants, devises, or bequests of real or personal property made
to the Foundation, including from private entities, for the purposes of
carrying out the duties of the Foundation.
``(j) Service of Federal Employees.--Federal Government employees
may serve on committees advisory to the Foundation and otherwise
cooperate with and assist the Foundation in carrying out its functions,
so long as such employees do not direct or control Foundation
activities.
``(k) Detail of Government Employees; Fellowships.--
``(1) Detail from federal agencies.--Federal Government
employees may be detailed from Federal agencies with or without
reimbursement to those agencies to the Foundation at any time,
and such detail shall be without interruption or loss of civil
service status or privilege. Each such employee shall abide by
the statutory, regulatory, ethical, and procedural standards
applicable to the employees of the agency from which such
employee is detailed and those of the Foundation.
``(2) Voluntary service; acceptance of federal employees.--
``(A) Foundation.--The Executive Director of the
Foundation may accept the services of employees
detailed from Federal agencies with or without
reimbursement to those agencies.
``(B) Food and drug administration.--The
Commissioner may accept the uncompensated services of
Foundation fellows or trainees. Such services shall be
considered to be undertaking an activity under contract
with the Secretary as described in section 708.
``(l) Annual Reports.--
``(1) Reports to foundation.--Any recipient of a grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement from the Foundation under this section
shall submit to the Foundation a report on an annual basis for
the duration of such grant, contract, fellowship, memorandum of
understanding, or cooperative agreement, that describes the
activities carried out under such grant, contract, fellowship,
memorandum of understanding, or cooperative agreement.
``(2) Report to congress and the fda.--Beginning with
fiscal year 2009, the Executive Director shall submit to
Congress and the Commissioner an annual report that--
``(A) describes the activities of the Foundation
and the progress of the Foundation in furthering the
goals and priorities established under subsection
(c)(2), including the practical impact of the
Foundation on regulated product development;
``(B) provides a specific accounting of the source
and use of all funds used by the Foundation to carry
out such activities; and
``(C) provides information on how the results of
Foundation activities could be incorporated into the
regulatory and product review activities of the Food
and Drug Administration.
``(m) Separation of Funds.--The Executive Director shall ensure
that the funds received from the Treasury are held in separate accounts
from funds received from entities under subsection (i).
``(n) Funding.--From amounts appropriated to the Food and Drug
Administration for each fiscal year, the Commissioner shall transfer
not less than $500,000 and not more than $1,250,000, to the Foundation
to carry out subsections (a), (b), and (d) through (m).''.
(b) Other Foundation Provisions.--Chapter VII (21 U.S.C. 371 et
seq.) (as amended by subsection (a)) is amended by adding at the end
the following:

``SEC. 771. LOCATION OF FOUNDATION.

``The Foundation shall, if practicable, be located not more than 20
miles from the District of Columbia.

``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

``(a) In General.--The Commissioner shall receive and assess the
report submitted to the Commissioner by the Executive Director of the
Foundation under section 770(l)(2).
``(b) Report to Congress.--Beginning with fiscal year 2009, the
Commissioner shall submit to Congress an annual report summarizing the
incorporation of the information provided by the Foundation in the
report described under section 770(l)(2) and by other recipients of
grants, contracts, memoranda of understanding, or cooperative
agreements into regulatory and product review activities of the Food
and Drug Administration.
``(c) Extramural Grants.--The provisions of this subchapter shall
have no effect on any grant, contract, memorandum of understanding, or
cooperative agreement between the Food and Drug Administration and any
other entity entered into before, on, or after the date of enactment of
the Enhancing Drug Safety and Innovation Act of 2007.''.
(c) Conforming Amendment.--Section 742(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the
end the following: ``Any such fellowships and training programs under
this section or under section 770(d)(2)(A)(ix) may include provision by
such scientists and physicians of services on a voluntary and
uncompensated basis, as the Secretary determines appropriate. Such
scientists and physicians shall be subject to all legal and ethical
requirements otherwise applicable to officers or employees of the
Department of Health and Human Services.''.

SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:

``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

``(a) Establishment; Appointment.--The Secretary shall establish
within the Office of the Commissioner an office to be known as the
Office of the Chief Scientist. The Secretary shall appoint a Chief
Scientist to lead such Office.
``(b) Duties of the Office.--The Office of the Chief Scientist
shall--
``(1) oversee, coordinate, and ensure quality and
regulatory focus of the intramural research programs of the
Food and Drug Administration;
``(2) track and, to the extent necessary, coordinate
intramural research awards made by each center of the
Administration or science-based office within the Office of the
Commissioner, and ensure that there is no duplication of
research efforts supported by the Reagan-Udall Foundation for
the Food and Drug Administration;
``(3) develop and advocate for a budget to support
intramural research;
``(4) develop a peer review process by which intramural
research can be evaluated; and
``(5) identify and solicit intramural research proposals
from across the Food and Drug Administration through an
advisory board composed of employees of the Administration that
shall include--
``(A) representatives of each of the centers and
the science-based offices within the Office of the
Commissioner; and
``(B) experts on trial design, epidemiology,
demographics, pharmacovigilance, basic science, and
public health.''.

Subtitle C--Clinical Trials

SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by--
(1) redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
(2) inserting after subsection (i) the following:
``(j) Expanded Clinical Trial Registry Data Bank.--
``(1) Definitions; requirement.--
``(A) Definitions.--In this subsection:
``(i) Applicable device clinical trial.--
The term `applicable device clinical trial'
means--
``(I) a prospective study of health
outcomes comparing an intervention
against a control in human subjects
intended to support an application
under section 515 or 520(m), or a
report under section 510(k), of the
Federal Food, Drug, and Cosmetic Act
(other than a limited study to gather
essential information used to refine
the device or design a pivotal trial
and that is not intended to determine
safety and effectiveness of a device);
and
``(II) a pediatric postmarket
surveillance as required under section
522 of the Federal Food, Drug, and
Cosmetic Act.
``(ii) Applicable drug clinical trial.--
``(I) In general.--The term
`applicable drug clinical trial' means
a controlled clinical investigation,
other than a phase I clinical
investigation, of a product subject to
section 505 of the Federal Food, Drug,
and Cosmetic Act or to section 351 of
this Act.
``(II) Clinical investigation.--For
purposes of subclause (I), the term
`clinical investigation' has the
meaning given that term in section
312.3 of title 21, Code of Federal
Regulations.
``(III) Phase i.--The term `phase
I' has the meaning given that term in
section 312.21 of title 21, Code of
Federal Regulations.
``(iii) Clinical trial information.--The
term `clinical trial information' means those
data elements that are necessary to complete an
entry in the clinical trial registry data bank
under paragraph (2).
``(iv) Completion date.--The term
`completion date' means, with respect to an
applicable drug clinical trial or an applicable
device clinical trial, the date on which the
last patient enrolled in the clinical trial has
completed his or her last medical visit of the
clinical trial, whether the clinical trial
concluded according to the prespecified
protocol plan or was terminated.
``(v) Device.--The term `device' means a
device as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
``(vi) Drug.--The term `drug' means a drug
as defined in section 201(g) of the Federal
Food, Drug, and Cosmetic Act or a biological
product as defined in section 351 of this Act.
``(vii) Responsible party.--The term
`responsible party', with respect to a clinical
trial of a drug or device, means--
``(I) the sponsor of the clinical
trial (as defined in section 50.3 of
title 21, Code of Federal Regulations
(or any successor regulations)) or the
principal investigator of such clinical
trial if so designated by such sponsor;
or
``(II) if no sponsor exists, the
grantee, contractor, or awardee for a
trial funded by a Federal agency or the
principal investigator of such clinical
trial if so designated by such grantee,
contractor, or awardee.
``(B) Requirement.--The Secretary shall develop a
mechanism by which--
``(i) the responsible party for each
applicable drug clinical trial and applicable
device clinical trial shall submit the identity
and contact information of such responsible
party to the Secretary at the time of
submission of clinical trial information under
paragraph (2); and
``(ii) other Federal agencies may identify
the responsible party for an applicable drug
clinical trial or applicable device clinical
trial.
``(2) Expansion of clinical trial registry data bank with
respect to clinical trial information.--
``(A) In general.--
``(i) Expansion of data bank.--To enhance
patient enrollment and provide a mechanism to
track subsequent progress of clinical trials,
the Secretary, acting through the Director of
NIH, shall expand, in accordance with this
subsection, the clinical trials registry of the
data bank described under subsection (i)(3)(A)
(referred to in this subsection as the
`registry data bank'). The Director of NIH
shall ensure that the registry data bank is
made publicly available through the Internet.
``(ii) Content.--Not later than 18 months
after the date of enactment of the Enhancing
Drug Safety and Innovation Act of 2007, and
after notice and comment, the Secretary shall
promulgate regulations to expand the registry
data bank to require the submission to the
registry data bank of clinical trial
information for applicable drug clinical trials
and applicable device clinical trials that--
``(I) conforms to the International
Clinical Trials Registry Platform trial
registration data set of the World
Health Organization;
``(II) includes the city, State,
and zip code for each clinical trial
location, or a toll-free number through
which such location information may be
accessed;
``(III) if the drug is not approved
under section 505 of the Federal Food,
Drug, and Cosmetic Act or licensed
under section 351 of this Act,
specifies whether or not there is
expanded access to the drug under
section 561 of the Federal Food, Drug,
and Cosmetic Act for those who do not
qualify for enrollment in the clinical
trial and how to obtain information
about such access;
``(IV) requires the inclusion of
such other data elements to the
registry data bank as appropriate; and
``(V) becomes effective 90 days
after issuance of the final rule.
``(B) Format and structure.--
``(i) Searchable categories.--The Director
of NIH shall ensure that the public may search
the entries in the registry data bank by 1 or
more of the following criteria:
``(I) The disease or condition
being studied in the clinical trial,
using Medical Subject Headers (MeSH)
descriptors.
``(II) The treatment being studied
in the clinical trial.
``(III) The location of the
clinical trial.
``(IV) The age group studied in the
clinical trial, including pediatric
subpopulations.
``(V) The study phase of the
clinical trial.
``(VI) The source of support for
the clinical trial, which may be the
National Institutes of Health or other
Federal agency, a private industry
source, or a university or other
organization.
``(VII) The recruitment status of
the clinical trial.
``(VIII) The National Clinical
Trial number or other study
identification for the clinical trial.
``(ii) Format.--The Director of the NIH
shall ensure that the registry data bank is
easily used by the public, and that entries are
easily compared.
``(C) Data submission.--The responsible party for
an applicable drug clinical trial shall submit to the
Director of NIH for inclusion in the registry data bank
the clinical trial information described in
subparagraph (A)(ii).
``(D) Truthful clinical trial information.--
``(i) In general.--The clinical trial
information submitted by a responsible party
under this paragraph shall not be false or
misleading in any particular.
``(ii) Effect.--Clause (i) shall not have
the effect of requiring clinical trial
information with respect to an applicable drug
clinical trial or an applicable device clinical
trial to include information from any source
other than such clinical trial involved.
``(E) Changes in clinical trial status.--
``(i) Enrollment.--The responsible party
for an applicable drug clinical trial or an
applicable device clinical trial shall update
the enrollment status not later than 30 days
after the enrollment status of such clinical
trial changes.
``(ii) Completion.--The responsible party
for an applicable drug clinical trial or
applicable device clinical trial shall report
to the Director of NIH that such clinical trial
is complete not later than 30 days after the
completion date of the clinical trial.
``(F) Timing of submission.--The clinical trial
information for an applicable drug clinical trial or an
applicable device clinical trial required to be
submitted under this paragraph shall be submitted not
later than 21 days after the first patient is enrolled
in such clinical trial.
``(G) Posting of data.--
``(i) Applicable drug clinical trial.--The
Director of NIH shall ensure that clinical
trial information for an applicable drug
clinical trial submitted in accordance with
this paragraph is posted publicly within 30
days of such submission.
``(ii) Applicable device clinical trial.--
The Director of NIH shall ensure that clinical
trial information for an applicable device
clinical trial submitted in accordance with
this paragraph is posted publicly within 30
days of clearance under section 510(k) of the
Federal Food, Drug, and Cosmetic Act, or
approval under section 515 or section 520(m) of
such Act, as applicable.
``(H) Voluntary submissions.--A responsible party
for a clinical trial that is not an applicable drug
clinical trial or an applicable device clinical trial
may submit clinical trial information to the registry
data bank in accordance with this subsection.
``(3) Expansion of registry data bank to include results of
clinical trials.--
``(A) Linking registry data bank to existing
results.--
``(i) In general.--Beginning not later than
90 days after the date of enactment of the
Enhancing Drug Safety and Innovation Act of
2007, for those clinical trials that form the
primary basis of an efficacy claim or are
conducted after the drug involved is approved
or after the device involved is cleared or
approved, the Secretary shall ensure that the
registry data bank includes links to results
information for such clinical trial--
``(I) not earlier than 30 days
after the date of the approval of the
drug involved or clearance or approval
of the device involved; or
``(II) not later than 30 days after
such information becomes publicly
available, as applicable.
``(ii) Required information.--
``(I) FDA information.--The
Secretary shall ensure that the
registry data bank includes links to
the following information:
``(aa) If an advisory
committee considered at a
meeting an applicable drug
clinical trial or an applicable
device clinical trial, any
posted Food and Drug
Administration summary document
regarding such applicable drug
clinical trial or applicable
clinical device trial.
``(bb) If an applicable
drug clinical trial was
conducted under section 505A or
505B of the Federal Food, Drug,
and Cosmetic Act, a link to the
posted Food and Drug
Administration assessment of
the results of such trial.
``(cc) Food and Drug
Administration public health
advisories regarding the drug
or device that is the subject
of the applicable drug clinical
trial or applicable device
clinical trial, respectively,
if any.
``(dd) For an applicable
drug clinical trial, the Food
and Drug Administration action
package for approval document
required under section
505(l)(2) of the Food Drug and
Cosmetic Act.
``(ee) For an applicable
device clinical trial, in the
case of a premarket
application, the detailed
summary of information
respecting the safety and
effectiveness of the device
required under section
520(h)(1) of the Federal Food,
Drug, and Cosmetic Act, or, in
the case of a report under
section 510(k) of such Act, the
section 510(k) summary of the
safety and effectiveness data
required under section
807.95(d) of title 21, Code of
Federal Regulations (or any
successor regulations).
``(II) NIH information.--The
Secretary shall ensure that the
registry data bank includes links to
the following information:
``(aa) Medline citations to
any publications regarding each
applicable drug clinical trial
and applicable device clinical
trial.
``(bb) The entry for the
drug that is the subject of an
applicable drug clinical trial
in the National Library of
Medicine database of structured
product labels, if available.
``(iii) Results for existing data bank
entries.--The Secretary may include the links
described in clause (ii) for data bank entries
for clinical trials submitted to the data bank
prior to enactment of the Enhancing Drug Safety
and Innovation Act of 2007, as available.
``(B) Feasibility study.--The Director of NIH
shall--
``(i) conduct a study to determine the
best, validated methods of making the results
of clinical trials publicly available after the
approval of the drug that is the subject of an
applicable drug clinical trial; and
``(ii) not later than 18 months after
initiating such study, submit to the Secretary
any findings and recommendations of such study.
``(C) Negotiated rulemaking.--
``(i) In general.--The Secretary shall
establish a negotiated rulemaking process
pursuant to subchapter IV of chapter 5 of title
5, United States Code, to determine, for
applicable drug clinical trials--
``(I) how to ensure quality and
validate methods of expanding the
registry data bank to include clinical
trial results information for trials
not within the scope of this Act;
``(II) the clinical trials of which
the results information is appropriate
for adding to the expanded registry
data bank; and
``(III) the appropriate timing of
the posting of such results
information.
``(ii) Time requirement.--The process
described in paragraph (1) shall be conducted
in a timely manner to ensure that--
``(I) any recommendation for a
proposed rule--
``(aa) is provided to the
Secretary not later than 21
months after the date of the
enactment of the Enhancing Drug
Safety and Innovation Act of
2007; and
``(bb) includes an
assessment of the benefits and
costs of the recommendation;
and
``(II) a final rule is promulgated
not later than 30 months after the date
of the enactment of the Enhancing Drug
Safety and Innovation Act of 2007,
taking into account the recommendations
under subclause (I) and the results of
the feasibility study conducted under
subparagraph (B).
``(iii) Representation on negotiated
rulemaking committee.--The negotiated
rulemaking committee established by the
Secretary pursuant to clause (i) shall include
members representing--
``(I) the Food and Drug
Administration;
``(II) the National Institutes of
Health;
``(III) other Federal agencies as
the Secretary determines appropriate;
``(IV) patient advocacy and health
care provider groups;
``(V) the pharmaceutical industry;
``(VI) contract clinical research
organizations;
``(VII) the International Committee
of Medical Journal Editors; and
``(VIII) other interested parties,
including experts in privacy
protection, pediatrics, health
information technology, health
literacy, communication, clinical trial
design and implementation, and health
care ethics.
``(iv) Content of regulations.--The
regulations promulgated pursuant to clause (i)
shall establish--
``(I) procedures to determine which
clinical trials results information
data elements shall be included in the
registry data bank, taking into account
the needs of different populations of
users of the registry data bank;
``(II) a standard format for the
submission of clinical trials results
to the registry data bank;
``(III) a standard procedure for
the submission of clinical trial
results information, including the
timing of submission and the timing of
posting of results information, to the
registry data bank, taking into account
the possible impacts on publication of
manuscripts based on the clinical
trial;
``(IV) a standard procedure for the
verification of clinical trial results
information, including ensuring that
free text data elements are non-
promotional; and
``(V) an implementation plan for
the prompt inclusion of clinical trials
results information in the registry
data bank.
``(D) Consideration of world health organization
data set.--The Secretary shall consider the status of
the consensus data elements set for reporting clinical
trial results of the World Health Organization when
promulgating the regulations under subparagraph (C).
``(E) Truthful clinical trial information.--
``(i) In general.--The clinical trial
information submitted by a responsible party
under this paragraph shall not be false or
misleading in any particular.
``(ii) Effect.--Clause (i) shall not have
the effect of requiring clinical trial
information with respect to an applicable drug
clinical trial or an applicable device clinical
trial to include information from any source
other than such clinical trial involved.
``(F) Waivers regarding certain clinical trial
results.--The Secretary may waive any applicable
requirements of this paragraph for an applicable drug
clinical trial or an applicable device clinical trial,
upon a written request from the responsible person, if
the Secretary determines that extraordinary
circumstances justify the waiver and that providing the
waiver is in the public interest, consistent with the
protection of public health, or in the interest of
national security. Not later than 30 days after any
part of a waiver is granted, the Secretary shall
notify, in writing, the appropriate committees of
Congress of the waiver and provide an explanation for
why the waiver was granted.
``(4) Coordination and compliance.--
``(A) Clinical trials supported by grants from
federal agencies.--
``(i) In general.--No Federal agency may
release funds under a research grant to an
awardee who has not complied with paragraph (2)
for any applicable drug clinical trial or
applicable device clinical trial for which such
person is the responsible party.
``(ii) Grants from certain federal
agencies.--If an applicable drug clinical trial
or applicable device clinical trial is funded
in whole or in part by a grant from the Food
and Drug Administration, National Institutes of
Health, the Agency for Healthcare Research and
Quality, or the Department of Veterans Affairs,
any grant or progress report forms required
under such grant shall include a certification
that the responsible party has made all
required submissions to the Director of NIH
under paragraph (2).
``(iii) Verification by federal agencies.--
The heads of the agencies referred to in clause
(ii), as applicable, shall verify that the
clinical trial information for each applicable
drug clinical trial or applicable device
clinical trial for which a grantee is the
responsible party has been submitted under
paragraph (2) before releasing any remaining
funding for a grant or funding for a future
grant to such grantee.
``(iv) Notice and opportunity to remedy.--
If the head of an agency referred to in clause
(ii), as applicable, verifies that a grantee
has not submitted clinical trial information as
described in clause (iii), such agency head
shall provide notice to such grantee of such
non-compliance and allow such grantee 30 days
to correct such non-compliance and submit the
required clinical trial information.
``(v) Consultation with other federal
agencies.--The Secretary shall--
``(I) consult with other agencies
that conduct research involving human
subjects in accordance with any section
of part 46 of title 45, Code of Federal
Regulations (or any successor
regulations), to determine if any such
research is an applicable drug clinical
trial or an applicable device clinical
trial under paragraph (1); and
``(II) develop with such agencies
procedures comparable to those
described in clauses (ii), (iii), and
(iv) to ensure that clinical trial
information for such applicable drug
clinical trials and applicable device
clinical trial is submitted under
paragraph (2).
``(B) Certification to accompany drug, biological
product, and device submissions.--At the time of
submission of an application under section 505 of the
Federal Food, Drug, and Cosmetic Act, section 515 of
such Act, section 520(m) of such Act, or section 351 of
this Act, or submission of a report under section
510(k) of such Act, such application or submission
shall be accompanied by a certification that all
applicable requirements of this subsection have been
met. Where available, such certification shall include
the appropriate National Clinical Trial control
numbers.
``(C) Verification of submission prior to
posting.--In the case of clinical trial information
that is submitted under paragraph (2), but is not made
publicly available pending regulatory approval or
clearance, as applicable, the Director of NIH shall
respond to inquiries from other Federal agencies and
peer-reviewed scientific journals to confirm that such
clinical trial information has been submitted but has
not yet been posted.
``(5) Limitation on disclosure of clinical trial
information.--
``(A) In general.--Nothing in this subsection (or
under section 552 of title 5, United States Code) shall
require the Secretary to publicly disclose, from any
record or source other than the registry data bank
expanded under this subsection, information described
in subparagraph (B).
``(B) Information described.--Information described
in this subparagraph is--
``(i) information submitted to the Director
of NIH under this subsection, or information of
the same general nature as (or integrally
associated with) the information so submitted;
and
``(ii) not otherwise publicly available,
including because it is protected from
disclosure under section 552 of title 5, United
States Code.
``(6) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each fiscal year.''.
(b) Conforming Amendments.--
(1) Prohibited acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end the following:
``(jj)(1) The failure to submit the certification required by
section 402(j)(4)(B) of the Public Health Service Act, or knowingly
submitting a false certification under such section.
``(2) The submission of clinical trial information under subsection
(i) or (j) of section 402 of the Public Health Service Act that is
promotional or false or misleading in any particular under paragraph
(2) or (3) of such subsection (j).''.
(2) Civil money penalties.--Section 303(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended by
section 203, is further amended by--
(A) redesignating paragraphs (4), (5), and (6) as
paragraphs (5), (6), and (7), respectively;
(B) inserting after paragraph (3) the following:
``(4) Any person who violates section 301(jj) shall be subject to a
civil monetary penalty of not more than $10,000 for the first
violation, and not more than $20,000 for each subsequent violation.'';
(C) in paragraph (2)(C), by striking ``paragraph
(4)(A)'' and inserting ``paragraph (5)(A)'';
(D) in paragraph (5), as so redesignated, by
striking ``paragraph (1), (2), or (3)'' each place it
appears and inserting ``paragraph (1), (2), (3), or
(4)''; and
(E) in paragraph (7), as so redesignated, by
striking ``paragraph (5)'' each place it appears and
inserting ``paragraph (6)''.
(3) New drugs and devices.--
(A) Investigational new drugs.--Section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)) is amended in paragraph (4), by adding at the
end the following: ``The Secretary shall update such
regulations to require inclusion in the informed
consent form a statement that clinical trial
information for such clinical investigation has been or
will be submitted for inclusion in the registry data
bank pursuant to subsections (i) and (j) of section 402
of the Public Health Service Act.''.
(B) New drug applications.--Section 505(b) of the
Federal, Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)) is amended by adding at the end the following:
``(6) An application submitted under this subsection shall
be accompanied by the certification required under section
402(j)(4)(B) of the Public Health Service Act. Such
certification shall not be considered an element of such
application.''.
(C) Device reports under section 510(k).--Section
510(k) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(k)) is amended by adding at the end the
following:
``A notification submitted under this subsection that contains clinical
trial data for an applicable device clinical trial (as defined in
section 402(j)(1) of the Public Health Service Act) shall be
accompanied by the certification required under section 402(j)(4)(B) of
such Act. Such certification shall not be considered an element of such
notification.''.
(D) Device premarket approval application.--Section
515(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)) is amended--
(i) in subparagraph (F), by striking ``;
and'' and inserting a semicolon;
(ii) by redesignating subparagraph (G) as
subparagraph (H); and
(iii) by inserting after subparagraph (F)
the following:
``(G) the certification required under section
402(j)(4)(B) of the Public Health Service Act (which
shall not be considered an element of such
application); and''.
(E) Humanitarian device exemption.--Section
520(m)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(c)) is amended in the first sentence in
the matter following subparagraph (C), by inserting at
the end before the period ``and such application shall
include the certification required under section
402(j)(4)(B) of the Public Health Service Act (which
shall not be considered an element of such
application)''.
(c) Preemption.--
(1) In general.--No State or political subdivision of a
State may establish or continue in effect any requirement for
the registration of clinical trials or for the inclusion of
information relating to the results of clinical trials in a
database.
(2) Rule of construction.--The fact of submission of
clinical trial information, if submitted in compliance with
subsection (i) and (j) of section 402 of the Public Health
Service Act (as amended by this section), that relates to a use
of a drug or device not included in the official labeling of
the approved drug or device shall not be construed by the
Secretary or in any administrative or judicial proceeding, as
evidence of a new intended use of the drug or device that is
different from the intended use of the drug or device set forth
in the official labeling of the drug or device. The
availability of clinical trial information through the data
bank under such subsections (i) and (j), if submitted in
compliance with such subsections, shall not be considered as
labeling, adulteration, or misbranding of the drug or device
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.).
(d) Transition Rule; Effective Date of Funding Restrictions.--
(1) Transition rule for clinical trials initiated prior to
expansion of registry data bank.--The responsible party (as
defined in paragraph (1) of section 402(j) of the Public Health
Service Act (as added by this section)) for an applicable drug
clinical trial or applicable device clinical trial (as defined
under such paragraph (1)) that is initiated after the date of
enactment of this subtitle and before the effective date of the
regulations promulgated under paragraph (2) of such section
402(j), shall submit required clinical trial information under
such section not later than 120 days after such effective date.
(2) Funding restrictions.--Subparagraph (A) of paragraph
(4) of such section 402(j) shall take effect 210 days after the
effective date of the regulations promulgated under paragraph
(2) of such section 402(j).
(e) Effective Date.--
(1) In general.--Beginning 90 days after the date of
enactment of this title, the responsible party for an
applicable drug clinical trial or an applicable device clinical
trial (as that term is defined in such section 402(j)) that is
initiated after the date of enactment of this title and before
the effective date of the regulations issued under subparagraph
(A) of paragraph (2) of such subsection, shall submit clinical
trial information under such paragraph (2).
(2) Rulemaking.--
(A) In general.--Except as provided in subparagraph
(B), subsection (c)(1) shall become effective on the
date on which the regulation promulgated pursuant to
section 402(j)(3)(C)(i) of the Public Health Service
Act, as added by this section, becomes effective.
(B) Exception.--Subsection (c)(1) shall apply with
respect to any clinical trial for which the registry
data bank includes links to results information, as
provided for under section 402(j)(3)(A) of such Act, as
added by this section.

Subtitle D--Conflicts of Interest

SEC. 241. CONFLICTS OF INTEREST.

(a) In General.--Subchapter A of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting
at the end the following:

``SEC. 712. CONFLICTS OF INTEREST.

``(a) Definitions.--For purposes of this section:
``(1) Advisory committee.--The term `advisory committee'
means an advisory committee under the Federal Advisory
Committee Act that provides advice or recommendations to the
Secretary regarding activities of the Food and Drug
Administration.
``(2) Financial interest.--The term `financial interest'
means a financial interest under section 208(a) of title 18,
United States Code.
``(b) Appointments to Advisory Committees.--
``(1) Recruitment.--
``(A) In general.--Given the importance of advisory
committees to the review process at the Food and Drug
Administration, the Secretary shall carry out
informational and recruitment activities for purposes
of recruiting individuals to serve as advisory
committee members. The Secretary shall seek input from
professional medical and scientific societies to
determine the most effective informational and
recruitment activities. The Secretary shall also take
into account the advisory committees with the greatest
number of vacancies.
``(B) Recruitment activities.--The recruitment
activities under subparagraph (A) may include--
``(i) advertising the process for becoming
an advisory committee member at medical and
scientific society conferences;
``(ii) making widely available, including
by using existing electronic communications
channels, the contact information for the Food
and Drug Administration point of contact
regarding advisory committee nominations; and
``(iii) developing a method through which
an entity receiving National Institutes of
Health funding can identify a person who the
Food and Drug Administration can contact
regarding the nomination of individuals to
serve on advisory committees.
``(2) Evaluation and criteria.--When considering a term
appointment to an advisory committee, the Secretary shall
review the expertise of the individual and the financial
disclosure report filed by the individual pursuant to the
Ethics in Government Act of 1978 for each individual under
consideration for the appointment, so as to reduce the
likelihood that an appointed individual will later require a
written determination as referred to in section 208(b)(1) of
title 18, United States Code, a written certification as
referred to in section 208(b)(3) of title 18, United States
Code, or a waiver as referred to in subsection (c)(3) of this
section for service on the committee at a meeting of the
committee.
``(c) Granting and Disclosure of Waivers.--
``(1) In general.--Prior to a meeting of an advisory
committee regarding a `particular matter' (as that term is used
in section 208 of title 18, United States Code), each member of
the committee who is a full-time Government employee or special
Government employee shall disclose to the Secretary financial
interests in accordance with subsection (b) of such section
208.
``(2) Financial interest of advisory committee member or
family member.--No member of an advisory committee may vote
with respect to any matter considered by the advisory committee
if such member (or an immediate family member of such member)
has a financial interest that could be affected by the advice
given to the Secretary with respect to such matter, excluding
interests exempted in regulations issued by the Director of the
Office of Government Ethics as too remote or inconsequential to
affect the integrity of the services of the Government officers
or employees to which such regulations apply.
``(3) Waiver.--The Secretary may grant a waiver of the
prohibition in paragraph (2) if such waiver is necessary to
afford the advisory committee essential expertise.
``(4) Limitation.--The Secretary may not grant a waiver
under paragraph (3) for a member of an advisory committee when
the member's own scientific work is involved.
``(5) Disclosure of waiver.--Notwithstanding section
107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the
following shall apply:
``(A) 15 or more days in advance.--As soon as
practicable, but in no case later than 15 days prior to
a meeting of an advisory committee to which a written
determination as referred to in section 208(b)(1) of
title 18, United States Code, a written certification
as referred to in section 208(b)(3) of title 18, United
States Code, or a waiver as referred to in paragraph
(3) applies, the Secretary shall disclose (other than
information exempted from disclosure under section 552
of title 5, United States Code, and section 552a of
title 5, United States Code (popularly known as the
Freedom of Information Act and the Privacy Act of 1974,
respectively)) on the Internet website of the Food and
Drug Administration--
``(i) the type, nature, and magnitude of
the financial interests of the advisory
committee member to which such determination,
certification, or waiver applies; and
``(ii) the reasons of the Secretary for
such determination, certification, or waiver.
``(B) Less than 30 days in advance.--In the case of
a financial interest that becomes known to the
Secretary less than 30 days prior to a meeting of an
advisory committee to which a written determination as
referred to in section 208(b)(1) of title 18, United
States Code, a written certification as referred to in
section 208(b)(3) of title 18, United States Code, or a
waiver as referred to in paragraph (3) applies, the
Secretary shall disclose (other than information
exempted from disclosure under section 552 of title 5,
United States Code, and section 552a of title 5, United
States Code) on the Internet website of the Food and
Drug Administration, the information described in
clauses (i) and (ii) of subparagraph (A) as soon as
practicable after the Secretary makes such
determination, certification, or waiver, but in no case
later than the date of such meeting.
``(d) Public Record.--The Secretary shall ensure that the public
record and transcript of each meeting of an advisory committee includes
the disclosure required under subsection (c)(5) (other than information
exempted from disclosure under section 552 of title 5, United States
Code, and section 552a of title 5, United States Code).
``(e) Annual Report.--Not later than February 1 of each year, the
Secretary shall submit to the Inspector General of the Department of
Health and Human Services, the Committee on Appropriations and the
Committee on Health, Education, Labor, and Pensions of the Senate, and
the Committee on Appropriations and the Committee on Energy and
Commerce of the House of Representatives, a report that describes--
``(1) with respect to the fiscal year that ended on
September 30 of the previous year, the number of vacancies on
each advisory committee, the number of nominees received for
each committee, and the number of such nominees willing to
serve;
``(2) with respect to such year, the aggregate number of
disclosures required under subsection (c)(5) for each meeting
of each advisory committee and the percentage of individuals to
whom such disclosures did not apply who served on such
committee for each such meeting;
``(3) with respect to such year, the number of times the
disclosures required under subsection (c)(5) occurred under
subparagraph (B) of such subsection; and
``(4) how the Secretary plans to reduce the number of
vacancies reported under paragraph (1) during the fiscal year
following such year, and mechanisms to encourage the nomination
of individuals for service on an advisory committee, including
those who are classified by the Food and Drug Administration as
academicians or practitioners.
``(f) Periodic Review of Guidance.--Not less than once every 5
years, the Secretary shall review guidance of the Food and Drug
Administration regarding conflict of interest waiver determinations
with respect to advisory committees and update such guidance as
necessary.''.
(b) Conforming Amendment.--Section 505(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
(1) striking paragraph (4); and
(2) redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (4), (5), (6), and (7), respectively.
(c) Effective Date.--The amendments made by this section shall take
effect on October 1, 2007.

Subtitle E--Other Drug Safety Provisions

SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by this title, is further amended by adding at the end
the following:
``(q) Database for Authorized Generic Drugs.--
``(1) In general.--
``(A) Publication.--The Commissioner shall--
``(i) not later than 9 months after the
date of enactment of the Enhancing Drug Safety
and Innovation Act of 2007, publish a complete
list on the Internet website of the Food and
Drug Administration of all authorized generic
drugs (including drug trade name, brand company
manufacturer, and the date the authorized
generic drug entered the market); and
``(ii) update the list quarterly to include
each authorized generic drug included in an
annual report submitted to the Secretary by the
sponsor of a listed drug during the preceding
3-month period.
``(B) Notification.--The Commissioner shall notify
relevant Federal agencies, including the Centers for
Medicare & Medicaid Services and the Federal Trade
Commission, any time the Commissioner updates the
information described in subparagraph (A).
``(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic drug
included in an annual report submitted to the Secretary by the
sponsor of a listed drug after January 1, 1999.
``(3) Authorized generic drug.--In this section, the term
`authorized generic drug' means a listed drug (as that term is
used in subsection (j)) that--
``(A) has been approved under subsection (c); and
``(B) is marketed, sold, or distributed directly or
indirectly to retail class of trade under a different
labeling, packaging (other than repackaging as the
listed drug in blister packs, unit doses, or similar
packaging for use in institutions), product code,
labeler code, trade name, or trade mark than the listed
drug.''.

SEC. 252. MEDICAL MARIJUANA.

The Secretary shall require that State-legalized medical marijuana
be subject to the full regulatory requirements of the Food and Drug
Administration, including a risk evaluation and mitigation strategy and
all other requirements and penalties of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective
reviews, approval, sale, marketing, and use of pharmaceuticals.

Subtitle F--Antibiotic Access and Innovation

SEC. 261. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, CERTAIN
ANTIBIOTICS.

(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further
amended by adding at the end the following:
``(s) Antibiotic Drugs Submitted Before November 21, 1997.--
``(1) Antibiotic drugs approved before november 21, 1997.--
``(A) In general.--Notwithstanding any provision of
the Food and Drug Administration Modernization Act of
1997 or any other provision of law, a sponsor of a drug
that is the subject of an application described in
subparagraph (B)(i) shall be eligible for, with respect
to the drug, the 3-year exclusivity period referred to
under clauses (iii) and (iv) of subsection (c)(3)(E)
and under clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements of such clauses,
as applicable.
``(B) Application; antibiotic drug described.--
``(i) Application.--An application
described in this clause is an application for
marketing submitted under this section after
the date of enactment of this subsection in
which the drug that is the subject of the
application contains an antibiotic drug
described in clause (ii).
``(ii) Antibiotic drug.--An antibiotic drug
described in this clause is an antibiotic drug
that was the subject of an application approved
by the Secretary under section 507 of this Act
(as in effect before November 21, 1997).
``(2) Antibiotic drugs submitted before november 21, 1997,
but not approved.--
``(A) In general.--Notwithstanding any provision of
the Food and Drug Administration Modernization Act of
1997 or any other provision of law, a sponsor of a drug
that is the subject of an application described in
subparagraph (B)(i) may elect to be eligible for, with
respect to the drug--
``(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and (iv) of
subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable; and
``(II) the 5-year exclusivity period
referred to under clause (ii) of subsection
(c)(3)(E) and under clause (ii) of subsection
(j)(5)(F), subject to the requirements of such
clauses, as applicable; or
``(ii) a patent term extension under
section 156 of title 35, United States Code,
subject to the requirements of such section.
``(B) Application; antibiotic drug described.--
``(i) Application.--An application
described in this clause is an application for
marketing submitted under this section after
the date of enactment of this subsection in
which the drug that is the subject of the
application contains an antibiotic drug
described in clause (ii).
``(ii) Antibiotic drug.--An antibiotic drug
described in this clause is an antibiotic drug
that was the subject of 1 or more applications
received by the Secretary under section 507 of
this Act (as in effect before November 21,
1997), none of which was approved by the
Secretary under such section.
``(3) Limitations.--
``(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to entitle a
drug that is the subject of an approved application
described in subparagraphs (1)(B)(i) or (2)(B)(i), as
applicable, to any market exclusivities or patent
extensions other than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
``(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of use for
which the drug referred to in subparagraph (1)(B)(i) or
(2)(B)(i), as applicable, was approved before the date
of enactment of this subsection.
``(4) Application of certain provisions.--Notwithstanding
section 125, or any other provision, of the Food and Drug
Administration Modernization Act of 1997, or any other
provision of law, and subject to the limitations in paragraphs
(1), (2), and (3), the provisions of the Drug Price Competition
and Patent Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to which an
election is made under paragraph (2)(A).''.
(b) Transition Rule.--With respect to a patent issued on or before
the date of enactment of this Act, any patent information required to
be filed with the Secretary under subsection (b)(1) or (c)(2) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
to be listed on a drug to which subsection (s)(1) of such section 505
(as added by this section) applies shall be filed with such Secretary
not later than 60 days after the date of enactment of this Act.

SEC. 262. ANTIBIOTICS AS ORPHAN PRODUCTS.

(a) Public Meeting.--The Commissioner of Food and Drugs shall
convene a public meeting and, if appropriate, issue guidance, regarding
which serious and life-threatening infectious diseases, such as
diseases due to gram-negative bacteria and other diseases due to
antibiotic-resistant bacteria, potentially qualify for available grants
and contracts under subsection (a) of section 5 of the Orphan Drug Act
(21 U.S.C. 360ee(a)) or other incentives for development.
(b) Grants and Contracts for the Development of Orphan Drugs.--
Subsection (c) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(c))
is amended to read as follows:
``(c) For grants and contracts under subsection (a) there are
authorized to be appropriated--
``(1) such sums as already have been appropriated for
fiscal year 2007; and
``(2) $35,000,000 for each of fiscal years 2008 through
2012.''.

SEC. 263. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CONCENTRATIONS OF
ANTIMICROBIALS.

(a) Definition.--In this section, the term ``clinically susceptible
concentrations'' means specific values which characterize bacteria as
clinically susceptible, intermediate, or resistant to the drug (or
drugs) tested.
(b) Identification.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), through the
Commissioner of Food and Drugs, shall identify and periodically update
clinically susceptible concentrations.
(c) Public Availability.--The Secretary, through the Commissioner
of Food and Drugs, shall make such clinically susceptible
concentrations publicly available within 30 days of the date of
identification and any update under this section.
(d) Effect.--Nothing in this section shall be construed to
restrict, in any manner, the prescribing of antibiotics by physicians,
or to limit the practice of medicine, including for diseases such as
Lyme and tick-borne diseases.

SEC. 264. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S. C.
355), as amended by this subtitle, is amended by adding at the end the
following:
``(t) Certain Drugs Containing Single Enantiomers.--
``(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted
under subsection (b) for a non-racemic drug containing as an
active ingredient a single enantiomer that is contained in a
racemic drug approved in another application under subsection
(b), the applicant may, in the application for such non-racemic
drug, elect to have the single enantiomer not be considered the
same active ingredient as that contained in the approved
racemic drug, if--
``(A)(i) the single enantiomer has not been
previously approved except in the approved racemic
drug; and
``(ii) the application submitted under subsection
(b) for such non-racemic drug--
``(I) includes full reports of new clinical
investigations (other than bioavailability
studies)--
``(aa) necessary for the approval
of the application under subsections
(c) and (d); and
``(bb) conducted or sponsored by
the applicant; and
``(II) does not rely on any investigations
that are part of an application submitted under
subsection (b) for approval of the approved
racemic drug; and
``(B) the application submitted under subsection
(b) for such non-racemic drug is not submitted for
approval of a condition of use--
``(i) in a therapeutic category in which
the approved racemic drug has been approved; or
``(ii) for which any other enantiomer of
the racemic drug has been approved.
``(2) Limitation.--
``(A) No approval in certain therapeutic
categories.--Until the date that is 10 years after the
date of approval of a non-racemic drug described in
paragraph (1) and with respect to which the applicant
has made the election provided for by such paragraph,
the Secretary shall not approve such non-racemic drug
for any condition of use in the therapeutic category in
which the racemic drug has been approved.
``(B) Labeling.--If applicable, the labeling of a
non-racemic drug described in paragraph (1) and with
respect to which the applicant has made the election
provided for by such paragraph shall include a
statement that the non-racemic drug is not approved,
and has not been shown to be safe and effective, for
any condition of use of the racemic drug.
``(3) Definition.--
``(A) In general.--For purposes of this subsection,
the term `therapeutic category' means a therapeutic
category identified in the list developed by the United
States Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and as in
effect on the date of enactment of this subsection.
``(B) Publication by secretary.--The Secretary
shall publish the list described in subparagraph (A)
and may amend such list by regulation.
``(4) Availability.--The election referred to in paragraph
(1) may be made only in an application that is submitted to the
Secretary after the date of enactment of this subsection and
before October 1, 2012.''.

SEC. 265. REPORT.

Not later than January 1, 2012, the Comptroller General of the
United States shall submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives that examines
whether and how this subtitle has--
(1) encouraged the development of new antibiotics and other
drugs; and
(2) prevented or delayed timely generic drug entry into the
market.

TITLE III--MEDICAL DEVICES

SEC. 300. REFERENCES.

Except as otherwise specified, whenever in this title an amendment
is expressed in terms of an amendment to a section or other provision,
the reference shall be considered to be made to a section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).

Subtitle A--Device User Fees

SEC. 301. SHORT TITLE.

This subtitle may be cited as the ``Medical Device User Fee
Amendments of 2007''.

SEC. 302. DEVICE FEES.

Section 737 (21 U.S.C. 379i) is amended--
(1) by striking the section designation and all that
follows through ``For purposes of this subchapter'' and
inserting the following:

``SEC. 737. DEVICE FEES.

``(a) Purpose.--It is the purpose of this part that the fees
authorized under this part be dedicated toward expediting the process
for the review of device applications and for assuring the safety and
effectiveness of devices, as set forth in the goals identified for
purposes of this part in the letters from the Secretary to the Chairman
of the Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.
``(b) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
subsection (a) during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals. The
report for a fiscal year shall include information on all
previous cohorts for which the Secretary has not given a
complete response on all device premarket applications,
supplements, and premarket notifications in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to the
public on the Internet website of the Food and Drug
Administration.
``(c) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of device
applications for the first 5 fiscal years after fiscal year
2012, and for the reauthorization of this part for such fiscal
years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor,
and Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
``(D) hold a meeting at which the public may
present its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress the
revised recommendations under paragraph (2), a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
``(d) Definitions.--For purposes of this part:'';
(2) by redesignating paragraphs (5), (6), (7), and (8), as
paragraphs (7), (8), (9), and (11), respectively;
(3) in paragraph (4)--
(A) in subparagraph (A), by striking ``or an
efficacy supplement,'' and inserting ``an efficacy
supplement, or a 30-day notice,''; and
(B) by adding at the end the following:
``(F) The term `30-day notice' means a supplement to an
approved premarket application or premarket report under
section 515 that is limited to a request to make modifications
to manufacturing procedures or methods of manufacture affecting
the safety and effectiveness of the device.'';
(4) by inserting after paragraph (4) the following:
``(5) The term `request for classification information'
means a request made under section 513(g) for information
respecting the class in which a device has been classified or
the requirements applicable to a device.
``(6) The term `annual fee for periodic reporting
concerning a class III device' means the fee associated with
reports imposed by a premarket application approval order (as
described in section 814.82(a)(7) of title 21, Code of Federal
Regulations), usually referred to as `annual reports.''';
(5) in paragraph (9), as redesignated by paragraph (2)--
(A) by striking ``April of'' and inserting
``October of''; and
(B) by striking ``April 2002'' and inserting
``October 2001'';
(6) by inserting after paragraph (9), as redesignated by
paragraph (2), the following:
``(10) The term `person' includes an affiliate of such
person.''; and
(7) by adding at the end the following:
``(12) The term `establishment subject to a registration
fee' means an establishment required to register with the
Secretary under section 510 at which any of the following types
of activities are conducted:
``(A) Manufacturer.--An establishment that makes by
any means any article that is a device including an
establishment that sterilizes or otherwise makes such
article for or on behalf of a specification developer
or any other person.
``(B) Single-use device reprocessor.--An
establishment that performs manufacturing operations on
a single-use device that has previously been used on a
patient.
``(C) Specification developer.--An establishment
that develops specifications for a device that is
distributed under the establishment's name but that
performs no manufacturing, including establishments
that, in addition to developing specifications, arrange
for the manufacturing of devices labeled with another
establishment's name by a contract manufacturer.
``(13) The term `establishment registration fee' means a
fee assessed under section 738(a)(3) for the registration of an
establishment subject to a registration fee.
``(e) Sunset.--This part shall cease to be effective on October 1,
2012, except that subsection (b) with respect to reports shall cease to
be effective January 31, 2013.''.

SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES.

Section 738 (21 U.S.C. 379j) is amended--
(1) in subsection (a)--
(A) in paragraph (2)--
(i) in the header, by inserting ``, and
annual fee for periodic reporting concerning a
class iii device'' after ``fee'';
(ii) in subparagraph (A)--
(I) in clause (iii), by inserting
``75 percent of'' after ``a fee equal
to'';
(II) in clause (iv), by striking
``21.5'' and inserting ``15'';
(III) in clause (v), by striking
``7.2'' and inserting ``7'';
(IV) by redesignating clauses (vi)
and (vii) as clauses (vii) and (viii),
respectively;
(V) by inserting after clause (v)
the following:
``(vi) For a 30-day notice, a fee equal to
1.6 percent of the fee that applies under
clause (i).'';
(VI) in clause (viii), as
redesignated by subclause (IV)--
(aa) by striking ``1.42''
and inserting ``1.84''; and
(bb) by striking ``,
subject to any adjustment under
subsection (e)(2)(C)(ii)''; and
(VII) by adding at the end the
following:
``(ix) For a request for classification
information, a fee equal to 1.35 percent of the
fee that applies under clause (i).
``(x) For periodic reporting concerning a
class III device, the annual fee shall be equal
to 3.5 percent of the fee that applies under
clause (i).'';
(iii) in subparagraph (C)--
(I) in the first sentence--
(aa) by striking ``or'';
and
(bb) by striking ``except
that'' and all that follows
through the period and
inserting ``, 30-day notice,
request for classification
information, or periodic report
concerning a class III
device.''; and
(II) by striking the third
sentence; and
(iv) in subparagraph (D)--
(I) in clause (iii), by striking
the last two sentences; and
(II) by adding at the end the
following:
``(iv) Modular application withdrawn before
first action.--The Secretary shall refund 75
percent of the application fee paid for a
modular application submitted under section
515(c)(4) that is withdrawn before a second
module is submitted and before a first action
on the first module. If the modular application
is withdrawn after a second or subsequent
module is submitted but before any first
action, the Secretary may return a portion of
the fee. The amount of refund, if any, shall be
based on the level of effort already expended
on the review of the modules submitted.
``(v) Sole discretion to refund.--The
Secretary shall have sole discretion to refund
a fee or portion of the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall
not be reviewable.''; and
(B) by adding at the end the following:
``(3) Annual establishment registration fee.--
``(A) In general.--Except as provided in
subparagraph (B), each establishment subject to a
registration fee shall be subject to a fee for each
initial or annual registration beginning with its
registration for fiscal year 2008.
``(B) Exception for federal or state government
establishment.--No fee shall be required under
subparagraph (A) for an establishment operated by a
Federal or State government entity unless a device
manufactured by the establishment is to be distributed
commercially.
``(C) Payment.--The annual establishment
registration fee shall be due once each fiscal year,
upon the initial registration of the establishment or
upon the annual registration under section 510.'';
(2) by striking subsection (b) and inserting the following:
``(b) Fee Amounts.--Except as provided in subsections (c), (d), and
(e), the fees under subsection (a) shall be based on the following fee
amounts:

----------------------------------------------------------------------------------------------------------------
Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application                                       $185,000   $200,725   $217,787   $236,298   $256,384
----------------------------------------------------------------------------------------------------------------
Establishment Registration Fee                                $1,706     $1,851     $2,008     $2,179  $2,364'';
----------------------------------------------------------------------------------------------------------------

(3) in subsection (c)--
(A) in the heading, by striking ``Annual Fee
Setting.--'' and inserting ``Annual Fee Setting.--'';
(B) in paragraph (1), by striking the second
sentence;
(C) by redesignating paragraphs (2) and (3) as
paragraphs (3) and (4), respectively;
(D) by inserting after paragraph (1) the following:
``(2) Adjustment of annual establishment registration
fee.--
``(A) In general.--When setting the fees for fiscal
year 2010, the Secretary may increase the establishment
registration fee specified in subsection (b) only if
the Secretary estimates that the number of
establishments submitting fees for fiscal year 2009 is
less than 12,250. The percent increase shall be the
percent by which the estimate of establishments
submitting fees in fiscal year 2009 is less than
12,750, but in no case shall the percent increase be
more than 8.5 percent over the amount for such fee
specified in subsection (b) for fiscal year 2010. If
the Secretary makes any adjustment to the establishment
registration fee for fiscal year 2010, then the
establishment registration fee for fiscal years 2011
and 2012 under subsection (b) shall be adjusted as
follows: the fee for fiscal year 2011 shall be equal to
the adjusted fee for fiscal year 2010, increased by 8.5
percent, and the fee for fiscal year 2012 shall be
equal to the adjusted fee for fiscal year 2011,
increased by 8.5 percent.
``(B) Publication in the federal register.--The
Secretary shall publish any determination with respect
to any establishment registration fee adjustment made
under subparagraph (A), and the rationale for such
determination, in the Federal Register.''; and
(E) in paragraph (4)(A), as so redesignated--
(i) by striking ``For fiscal years 2006 and
2007, the'' and inserting ``The''; and
(ii) by striking ``of fiscal year 2008''
and inserting ``of the next fiscal year'';
(4) in subsection (d)--
(A) in paragraph (1), by striking ``, partners, and
parent firms'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``,
partners, and parent firms'';
(ii) in subparagraph (B)--
(I) by striking ``An applicant
shall'' and inserting the following:
``(i) In general.--An applicant shall'';
(II) by striking ``The applicant
shall support'' and inserting the
following:
``(ii) Firms submitting tax returns to the
united states internal revenue service.--The
applicant shall support'';
(III) by striking ``, partners, and
parent firms'' both places the term
appears;
(IV) by striking ``partners, or
parent firms, the'' and inserting
``the'';
(V) by striking ``, partners, or
parent firms, respectively''; and
(VI) by adding at the end the
following:
``(iii) Firms not submitting tax returns to
the united states internal revenue service.--
The applicant shall support its claim that it
meets the definition under subparagraph (A) by
submission of the following:
``(I) A signed certification, in
such form as the Secretary may direct
through a notice published in the
Federal Register, that the applicant
meets the criteria for a small
business.
``(II) A certification, in English,
from the national taxing authority of
the country in which it is
headquartered. Such certification shall
provide the applicant's gross receipts
and sales for the most recent year, in
both the local currency and in United
States dollars, the exchange rate used
in making this conversion to dollars,
and the dates during which these
receipts and sales were collected, and
it shall bear the official seal of the
national taxing authority.
``(III) Identical certifications
shall be provided for each of the
applicant's affiliates.
``(IV) A statement signed by the
head of the applicant or its chief
financial officer that it has submitted
certifications for all of its
affiliates, or that it had no
affiliates, whichever is applicable.'';
and
(iii) in subparagraph (C)--
(I) by striking ``reduced rate of''
and inserting ``reduced rate of--'';
and
(II) by striking ``38 percent'' and
all that follows through the period and
inserting the following:
``(i) 25 percent of the fee established
under such subsection for a premarket
application, a premarket report, a supplement,
or a periodic report concerning a class III
device; and
``(ii) 50 percent of the fee established
under such subsection for a 30-day notice or a
request for classification information.'';
(5) in subsection (e)--
(A) in paragraph (1), by striking ``2004'' and
inserting ``2008''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``,
partners, and parent firms'';
(ii) by striking subparagraph (B) and
inserting the following:
``(B) Evidence of qualification.--
``(i) In general.--An applicant shall pay
the higher fees established by the Secretary
each year unless the applicant submits evidence
that it qualifies for the lower fee rate.
``(ii) Firms submitting tax returns to the
united states internal revenue service.--The
applicant shall support its claim that it meets
the definition under subparagraph (A) by
submission of a copy of its most recent Federal
income tax return for a taxable year, and a
copy of such returns of its affiliates, which
show an amount of gross sales or receipts that
is less than the maximum established in
subparagraph (A). The applicant, and each of
such affiliates, shall certify that the
information provided is a true and accurate
copy of the actual tax forms they submitted to
the Internal Revenue Service. If no tax forms
are submitted for affiliates, the applicant
shall certify that the applicant has no
affiliates.
``(iii) Firms not submitting tax returns to
the united states internal revenue service.--
The applicant shall support its claim that it
meets the definition under subparagraph (A) by
submission of the following:
``(I) A signed certification, in
such form as the Secretary may direct
through a notice published in the
Federal Register, that the applicant
meets the criteria for a small
business.
``(II) A certification, in English,
from the national taxing authority of
the country in which it is
headquartered. Such certification shall
provide the applicant's gross receipts
and sales for the most recent year, in
both the local currency and in United
States dollars, and the exchange rate
used in making such conversion to
dollars, and the dates during which
such receipts and sales were collected,
and it shall bear the official seal of
the national taxing authority.
``(III) Identical certifications
shall be provided for each of the
applicant's affiliates.
``(IV) A statement signed by the
head of the applicant or its chief
financial officer that it has submitted
certifications for all of its
affiliates, or that it had no
affiliates, whichever is applicable.'';
and
(iii) by striking subparagraph (C) and
inserting the following:
``(C) Reduced fees.--For fiscal year 2008 and each
subsequent fiscal year, where the Secretary finds that
the applicant involved meets the definition under
subparagraph (A), the fee for a premarket notification
submission may be paid at 50 percent of the fee that
applies under subsection (a)(2)(A)(viii) and as
established under subsection (c)(1).'';
(6) by striking subsection (f) and inserting the following:
``(f) Effect of Failure To Pay Fees.--
``(1) In general.--A premarket application, premarket
report, supplement, or premarket notification submission, 30-
day notice, request for classification information, or periodic
report concerning a class III device submitted by a person
subject to fees under paragraphs (2) and (3) of subsection (a)
shall be considered incomplete and shall not be accepted by the
Secretary until all fees owed by such person have been paid.
``(2) Registration information.--Registration information
submitted by an establishment subject to a registration fee
under subsection (a)(3) shall be considered incomplete and
shall not be accepted by the Secretary until the registration
fee owed for the establishment has been paid. Until the fee is
paid and the registration is complete, the establishment shall
be deemed to have failed to register in accordance with section
510.'';
(7) in subsection (g)--
(A) by striking paragraph (1) and inserting the
following:
``(1) Performance goals; termination of program.--With
respect to the amount that, under the salaries and expenses
account of the Food and Drug Administration, is appropriated
for a fiscal year for devices and radiological products, fees
may not be assessed under subsection (a) for the fiscal year,
and the Secretary is not expected to meet any performance goals
identified for the fiscal year, if--
``(A) the amount so appropriated for the fiscal
year, excluding the amount of fees appropriated for the
fiscal year, is more than 1 percent less than
$205,720,000 multiplied by the adjustment factor
applicable to such fiscal year; or
``(B) fees were not assessed under subsection (a)
for the previous fiscal year.''; and
(B) in paragraph (2), by striking ``and premarket
notification submissions, and'' and inserting
``premarket notification submissions, 30-day notices,
requests for classification information, periodic
reports concerning a class III device, and
establishment registrations''; and
(8) in subsection (h), by striking paragraphs (3) and (4)
and inserting the following:
``(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this section--
``(A) $48,431,000 for fiscal year 2008;
``(B) $52,547,000 for fiscal year 2009;
``(C) $57,014,000 for fiscal year 2010;
``(D) $61,860,000 for fiscal year 2011; and
``(E) $67,118,000 for fiscal year 2012.
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, added to the amount
estimated to be collected for fiscal year 2011 (which estimate
shall be based upon the amount of fees received by the
Secretary through June 30, 2011), exceeds the amount of fees
specified in aggregate in paragraph (3) for such 4 fiscal
years, the aggregate amount in excess shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2012.''.

SEC. 304. SAVINGS CLAUSE.

Notwithstanding section 107 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the
amendments made by this subtitle, part 3 of subchapter C of chapter VII
of the Federal Food, Drug, and Cosmetic Act, as in effect on the day
before the date of enactment of this subtitle, shall continue to be in
effect with respect to premarket applications, premarket reports,
premarket notification submissions, and supplements (as defined in such
part as of such day) that on or after October 1, 2002, but before
October 1, 2007, were accepted by the Food and Drug Administration for
filing with respect to assessing and collecting any fee required by
such part for a fiscal year prior to fiscal year 2008.

SEC. 305. EFFECTIVE DATE.

The amendments made by this subtitle shall take effect on October
1, 2007.

Subtitle B--Amendments Regarding Regulation of Medical Devices

SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.

Section 704(g) (21 U.S.C. 374(g)) is amended--
(1) in paragraph (1), by striking ``Not later than one year
after the date of enactment of this subsection, the Secretary''
and inserting ``The Secretary'';
(2) in paragraph (2), by--
(A) striking ``Not later than 180 days after the
date of enactment of this subsection, the'' and
inserting ``The Secretary''; and
(B) striking the fifth sentence;
(3) in paragraph (3), by adding at the end the following:
``(F) Such person shall notify the Secretary of any
withdrawal, suspension, restriction, or expiration of
certificate of conformance with the quality systems
standard referred to in paragraph (7) for any device
establishment that such person inspects under this
subsection not later than 30 days after such
withdrawal, suspension, restriction, or expiration.
``(G) Such person may conduct audits to establish
conformance with the quality systems standard referred
to in paragraph (7).'';
(4) by amending paragraph (6) to read as follows:
``(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspection by persons accredited under
paragraph (2) if the following conditions are met:
``(i) The Secretary classified the results of the most
recent inspection of the establishment as `no action indicated'
or `voluntary action indicated'.
``(ii) With respect to inspections of the establishment to
be conducted by an accredited person, the owner or operator of
the establishment submits to the Secretary a notice that--
``(I) provides the date of the last inspection of
the establishment by the Secretary and the
classification of that inspection;
``(II) states the intention of the owner or
operator to use an accredited person to conduct
inspections of the establishment;
``(III) identifies the particular accredited person
the owner or operator intends to select to conduct such
inspections; and
``(IV) includes a certification that, with respect
to the devices that are manufactured, prepared,
propagated, compounded, or processed in the
establishment--
``(aa) at least 1 of such devices is
marketed in the United States; and
``(bb) at least 1 of such devices is
marketed, or is intended to be marketed, in 1
or more foreign countries, 1 of which countries
certifies, accredits, or otherwise recognizes
the person accredited under paragraph (2) and
identified under subclause (III) as a person
authorized to conduct inspections of device
establishments.
``(B)(i) Except with respect to the requirement of subparagraph
(A)(i), a device establishment is deemed to have clearance to
participate in the program and to use the accredited person identified
in the notice under subparagraph (A)(ii) for inspections of the
establishment unless the Secretary, not later than 30 days after
receiving such notice, issues a response that--
``(I) denies clearance to participate as provided under
subparagraph (C); or
``(II) makes a request under clause (ii).
``(ii) The Secretary may request from the owner or operator of a
device establishment in response to the notice under subparagraph
(A)(ii) with respect to the establishment, or from the particular
accredited person identified in such notice--
``(I) compliance data for the establishment in accordance
with clause (iii)(I); or
``(II) information concerning the relationship between the
owner or operator of the establishment and the accredited
person identified in such notice in accordance with clause
(iii)(II).
The owner or operator of the establishment, or such accredited
person, as the case may be, shall respond to such a request not
later than 60 days after receiving such request.
``(iii)(I) The compliance data to be submitted by the owner or
operation of a device establishment in response to a request under
clause (ii)(I) are data describing whether the quality controls of the
establishment have been sufficient for ensuring consistent compliance
with current good manufacturing practice within the meaning of section
501(h) and with other applicable provisions of this Act. Such data
shall include complete reports of inspectional findings regarding good
manufacturing practice or other quality control audits that, during the
preceding 2-year period, were conducted at the establishment by persons
other than the owner or operator of the establishment, together with
all other compliance data the Secretary deems necessary. Data under the
preceding sentence shall demonstrate to the Secretary whether the
establishment has facilitated consistent compliance by promptly
correcting any compliance problems identified in such inspections.
``(II) A request to an accredited person under clause (ii)(II) may
not seek any information that is not required to be maintained by such
person in records under subsection (f)(1).
``(iv) A device establishment is deemed to have clearance to
participate in the program and to use the accredited person identified
in the notice under subparagraph (A)(ii) for inspections of the
establishment unless the Secretary, not later than 60 days after
receiving the information requested under clause (ii), issues a
response that denies clearance to participate as provided under
subparagraph (C).
``(C)(i) The Secretary may deny clearance to a device establishment
if the Secretary has evidence that the certification under subparagraph
(A)(ii)(IV) is untrue and the Secretary provides to the owner or
operator of the establishment a statement summarizing such evidence.
``(ii) The Secretary may deny clearance to a device establishment
if the Secretary determines that the establishment has failed to
demonstrate consistent compliance for purposes of subparagraph
(B)(iii)(I) and the Secretary provides to the owner or operator of the
establishment a statement of the reasons for such determination.
``(iii)(I) The Secretary may reject the selection of the accredited
person identified in the notice under subparagraph (A)(ii) if the
Secretary provides to the owner or operator of the establishment a
statement of the reasons for such rejection. Reasons for the rejection
may include that the establishment or the accredited person, as the
case may be, has failed to fully respond to the request, or that the
Secretary has concerns regarding the relationship between the
establishment and such accredited person.
``(II) If the Secretary rejects the selection of an accredited
person by the owner or operator of a device establishment, the owner or
operator may make an additional selection of an accredited person by
submitting to the Secretary a notice that identifies the additional
selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I)
of this clause, apply to the selection of an accredited person through
a notice under the preceding sentence in the same manner and to the
same extent as such provisions apply to a selection of an accredited
person through a notice under subparagraph (A)(ii).
``(iv) In the case of a device establishment that is denied
clearance under clause (i) or (ii) or with respect to which the
selection of the accredited person is rejected under clause (iii), the
Secretary shall designate a person to review the statement of reasons,
or statement summarizing such evidence, as the case may be, of the
Secretary under such clause if, during the 30-day period beginning on
the date on which the owner or operator of the establishment receives
such statement, the owner or operator requests the review. The review
shall commence not later than 30 days after the owner or operator
requests the review, unless the Secretary and the owner or operator
otherwise agree.'';
(5) in paragraph (7)--
(A) by amending subparagraph (A) to read as
follows:
``(A) Persons accredited under paragraph (2) to
conduct inspections shall record in writing their
inspection observations and shall present the
observations to the device establishment's designated
representative and describe each observation.
Additionally, such accredited person shall prepare an
inspection report in a form and manner designated by
the Secretary to conduct inspections, taking into
consideration the goals of international harmonization
of quality systems standards. Any official
classification of the inspection shall be determined by
the Secretary.''; and
(B) by adding at the end the following:
``(F) For the purpose of setting risk-based
inspectional priorities, the Secretary shall accept
voluntary submissions of reports of audits assessing
conformance with appropriate quality systems standards
set by the International Organization for
Standardization (ISO) and identified by the Secretary
in public notice. If the owner or operator of an
establishment elects to submit audit reports under this
subparagraph, the owner or operator shall submit all
such audit reports with respect to the establishment
during the preceding 2-year periods.''; and
(6) in paragraphs (10)(C)(iii), by striking ``based'' and
inserting ``base''.

SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET
NOTIFICATION.

Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ``2007''
and inserting ``2012''.

SEC. 313. REGISTRATION.

(a) Annual Registration of Producers of Drugs and Devices.--Section
510(b) (21 U.S.C. 359(b)) is amended--
(1) by redesignating the existing text as paragraph (1),
and indenting and relocating it appropriately;
(2) in paragraph (1), as so redesignated, by striking ``or
a device or devices''; and
(3) by adding at the end the following new paragraph:
``(2) Between October 1 and December 31 of each year every
person who owns or operates any establishment in any State
engaged in the manufacture, preparation, propagation,
compounding, or processing of a device or devices shall
register with the Secretary his name, places of business, and
all such establishments.''.
(b) Registration of Foreign Establishments.--Section 510(i)(1) (21
U.S.C. 359(i)(1)) is amended--
(1) by redesignating the existing text as subparagraph (A),
and indenting and relocating it appropriately;
(2) in subparagraph (A), as so redesignated--
(A) by striking ``processing of a drug or a device
that is imported'' and inserting ``processing of a drug
that is imported''; and
(B) by striking ``or device'' each place it
appears; and
(3) by adding after such subparagraph (A) the following new
subparagraph:
``(B) Between October 1 and December 31 of each
year, any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported
or offered for import into the United States shall,
through electronic means in accordance with the
criteria of the Secretary, register with the Secretary
the name and place of business of the establishment,
the name of the United States agent for the
establishment, the name of each importer of such device
in the United States that is known to the
establishment, and the name of each person who imports
or offers for import such device to the United States
for purposes of importation.''.

SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED PREPARED,
PROPAGATED AND COMPOUNDED BY REGISTRANTS; STATEMENTS;
ACCOMPANYING DISCLOSURES.

Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in the matter
preceding subparagraph (A), to read as follows:
``(2) Each person who registers with the Secretary under
this section shall report to the Secretary (i) with regard to
drugs, once during the month of June of each year and once
during the month of December of each year, and (ii) with regard
to devices, once each year between October 1 and December 31,
the following information:''.

SEC. 315. ELECTRONIC REGISTRATION AND LISTING.

Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:
``(p)(1) With regard to any establishment engaged in the
manufacture, preparation, propagation, compounding, or processing of a
drug, registrations under subsections (b), (c), (d), and (i) of this
section (including the submission of updated information) shall be
submitted to the Secretary by electronic means, upon a finding by the
Secretary that the electronic receipt of such registrations is
feasible, unless the Secretary grants a request for waiver of such
requirement because use of electronic means is not reasonable for the
person requesting such waiver.
``(2) With regard to any establishment engaged in the manufacture,
preparation, propagation, compounding, or processing of a device, the
registration and listing information required by this section shall be
submitted to the Secretary by electronic means, unless the Secretary
grants a waiver because electronic registration and listing is not
reasonable for the person requesting such waiver.''.

TITLE IV--PEDIATRIC MEDICAL PRODUCTS

Subtitle A--Best Pharmaceuticals for Children

SEC. 401. SHORT TITLE.

This subtitle may be cited as the ``Best Pharmaceuticals for
Children Amendments of 2007''.

SEC. 402. PEDIATRIC STUDIES OF DRUGS.

(a) In General.--Section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsection (a), by inserting before the period at
the end the following: ``, and, at the discretion of the
Secretary, may include preclinical studies'';
(2) in subsection (b)--
(A) in paragraph (1)(A)(i), by striking ``(D)''
both places it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)''
and inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting
``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II)
the'';
(E) by striking ``(B) if the drug is designated''
and inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting
``(B)(i)'';
(G) by striking ``(i) a listed patent'' and
inserting ``(I) a listed patent'';
(H) by striking ``(ii) a listed patent'' and
inserting ``(II) a listed patent'';
(I) by striking ``(B) if the drug is the subject''
and inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under
section 505(b)(1), the Secretary determines that information
relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the Secretary
makes a written request for pediatric studies (which shall
include a timeframe for completing such studies), the applicant
agrees to the request, such studies are completed using
appropriate formulations for each age group for which the study
is requested within any such timeframe, and the reports thereof
are submitted and accepted in accordance with subsection
(d)(3), and if the Secretary determines that labeling changes
are appropriate, such changes are made within the timeframe
requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) if the
determination made under subsection (d)(3) is made less than 9
months prior to the expiration of such period.'';
(3) in subsection (c)--
(A) in paragraph (1)(A)(i), by striking ``(D)''
both places it appears and inserting ``(E)'';
(B) in paragraph (1)(A)(ii), by striking ``(D)''
and inserting ``(E)'';
(C) by striking ``(1)(A)(i)'' and inserting
``(A)(i)(I)'';
(D) by striking ``(ii) the'' and inserting ``(II)
the'';
(E) by striking ``(B) if the drug is designated''
and inserting ``(ii) if the drug is designated'';
(F) by striking ``(2)(A)'' and inserting
``(B)(i)'';
(G) by striking ``(i) a listed patent'' and
inserting ``(I) a listed patent'';
(H) by striking ``(ii) a listed patent'' and
inserting ``(II) a listed patent'';
(I) by striking ``(B) if the drug is the subject''
and inserting ``(ii) if the drug is the subject'';
(J) by striking ``If'' and all that follows through
``subsection (d)(3)'' and inserting the following:
``(1) In general.--Except as provided in paragraph (2), if
the Secretary determines that information relating to the use
of an approved drug in the pediatric population may produce
health benefits in that population and makes a written request
to the holder of an approved application under section
505(b)(1) for pediatric studies (which shall include a
timeframe for completing such studies), the holder agrees to
the request, such studies are completed using appropriate
formulations for each age group for which the study is
requested within any such timeframe, and the reports thereof
are submitted and accepted in accordance with subsection
(d)(3), and if the Secretary determines that labeling changes
are appropriate, such changes are made within the timeframe
requested by the Secretary--''; and
(K) by adding at the end the following:
``(2) Exception.--The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) if the
determination made under subsection (d)(3) is made less than 9
months prior to the expiration of such period.'';
(4) by striking subsection (d) and inserting the following:
``(d) Conduct of Pediatric Studies.--
``(1) Request for studies.--
``(A) In general.--The Secretary may, after
consultation with the sponsor of an application for an
investigational new drug under section 505(i), the
sponsor of an application for a new drug under section
505(b)(1), or the holder of an approved application for
a drug under section 505(b)(1), issue to the sponsor or
holder a written request for the conduct of pediatric
studies for such drug. In issuing such request, the
Secretary shall take into account adequate
representation of children of ethnic and racial
minorities. Such request to conduct pediatric studies
shall be in writing and shall include a timeframe for
such studies and a request to the sponsor or holder to
propose pediatric labeling resulting from such studies.
``(B) Single written request.--A single written
request--
``(i) may relate to more than 1 use of a
drug; and
``(ii) may include uses that are both
approved and unapproved.
``(2) Written request for pediatric studies.--
``(A) Request and response.--
``(i) In general.--If the Secretary makes a
written request for pediatric studies
(including neonates, as appropriate) under
subsection (b) or (c), the applicant or holder,
not later than 180 days after receiving the
written request, shall respond to the Secretary
as to the intention of the applicant or holder
to act on the request by--
``(I) indicating when the pediatric
studies will be initiated, if the
applicant or holder agrees to the
request; or
``(II) indicating that the
applicant or holder does not agree to
the request and the reasons for
declining the request.
``(ii) Disagree with request.--If, on or
after the date of enactment of the Best
Pharmaceuticals for Children Amendments of
2007, the applicant or holder does not agree to
the request on the grounds that it is not
possible to develop the appropriate pediatric
formulation, the applicant or holder shall
submit to the Secretary the reasons such
pediatric formulation cannot be developed.
``(B) Adverse event reports.--An applicant or
holder that, on or after the date of enactment of the
Best Pharmaceuticals for Children Amendments of 2007,
agrees to the request for such studies shall provide
the Secretary, at the same time as submission of the
reports of such studies, with all postmarket adverse
event reports regarding the drug that is the subject of
such studies and are available prior to submission of
such reports.
``(3) Meeting the studies requirement.--Not later than 180
days after the submission of the reports of the studies, the
Secretary shall accept or reject such reports and so notify the
sponsor or holder. The Secretary's only responsibility in
accepting or rejecting the reports shall be to determine,
within the 180 days, whether the studies fairly respond to the
written request, have been conducted in accordance with
commonly accepted scientific principles and protocols, and have
been reported in accordance with the requirements of the
Secretary for filing.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.'';
(5) by striking subsections (e) and (f) and inserting the
following:
``(e) Notice of Determinations on Studies Requirement.--
``(1) In general.--The Secretary shall publish a notice of
any determination, made on or after the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, that
the requirements of subsection (d) have been met and that
submissions and approvals under subsection (b)(2) or (j) of
section 505 for a drug will be subject to the provisions of
this section. Such notice shall be published not later than 30
days after the date of the Secretary's determination regarding
market exclusivity and shall include a copy of the written
request made under subsection (b) or (c).
``(2) Identification of certain drugs.--The Secretary shall
publish a notice identifying any drug for which, on or after
the date of enactment of the Best Pharmaceuticals for Children
Amendments of 2007, a pediatric formulation was developed,
studied, and found to be safe and effective in the pediatric
population (or specified subpopulation) if the pediatric
formulation for such drug is not introduced onto the market
within 1 year of the date that the Secretary publishes the
notice described in paragraph (1). Such notice identifying such
drug shall be published not later than 30 days after the date
of the expiration of such 1 year period.
``(f) Internal Review of Written Requests and Pediatric Studies.--
``(1) Internal review.--
``(A) In general.--The Secretary shall create an
internal review committee to review all written
requests issued and all reports submitted on or after
the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007, in accordance with
paragraphs (2) and (3).
``(B) Members.--The committee under subparagraph
(A) shall include individuals, each of whom is an
employee of the Food and Drug Administration, with the
following expertise:
``(i) Pediatrics.
``(ii) Biopharmacology.
``(iii) Statistics.
``(iv) Drugs and drug formulations.
``(v) Legal issues.
``(vi) Appropriate expertise, such as
expertise in child and adolescent psychiatry,
pertaining to the pediatric product under
review.
``(vii) One or more experts from the Office
of Pediatric Therapeutics, which may include an
expert in pediatric ethics.
``(viii) Other individuals as designated by
the Secretary.
``(C) Action by committee.--The committee
established under this paragraph may perform a function
under this section using appropriate members of the
committee under subparagraph (B) and need not convene
all members of the committee under subparagraph (B) in
order to perform a function under this section.
``(D) Documentation of committee action.--The
committee established under this paragraph shall
document for each function under paragraphs (2) and
(3), which members of the committee participated in
such function.
``(2) Review of written requests.--All written requests
under this section shall be reviewed and approved by the
committee established under paragraph (1) prior to being
issued.
``(3) Review of pediatric studies.--The committee
established under paragraph (1) shall review all studies
conducted pursuant to this section to make a recommendation to
the Secretary whether to accept or reject such reports under
subsection (d)(3).
``(4) Tracking pediatric studies and labeling changes.--The
committee established under paragraph (1) shall be responsible
for tracking and making available to the public, in an easily
accessible manner, including through posting on the website of
the Food and Drug Administration--
``(A) the number of studies conducted under this
section;
``(B) the specific drugs and drug uses, including
labeled and off-labeled indications, studied under this
section;
``(C) the types of studies conducted under this
section, including trial design, the number of
pediatric patients studied, and the number of centers
and countries involved;
``(D) the number of pediatric formulations
developed and the number of pediatric formulations not
developed and the reasons such formulations were not
developed;
``(E) the labeling changes made as a result of
studies conducted under this section;
``(F) an annual summary of labeling changes made as
a result of studies conducted under this section for
distribution pursuant to subsection (k)(2);
``(G) information regarding reports submitted on or
after the date of enactment of the Best Pharmaceuticals
for Children Amendments of 2007; and
``(H) the number of times the committee established
under paragraph (1) made a recommendation to the
Secretary under paragraph (3), the number of times the
Secretary did not follow such a recommendation to
accept reports under subsection (d)(3), and the number
of times the Secretary did not follow such a
recommendation to reject such reports under section
(d)(3).
``(5) Committee.--The committee established under paragraph
(1) is the committee established under section 505B(f)(1).'';
(6) in subsection (g)--
(A) in paragraph (1)--
(i) by striking ``(c)(1)(A)(ii)'' and
inserting ``(c)(1)(A)(i)(II)''; and
(ii) by striking ``(c)(2)'' and inserting
``(c)(1)(B)'';
(B) in paragraph (2), by striking ``(c)(1)(B)'' and
inserting ``(c)(1)(A)(ii)'';
(C) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;
(D) by striking ``Limitations.--A drug'' and
inserting ``Limitations.--
``(1) In general.--Notwithstanding subsection (c)(2), a
drug''; and
(E) by adding at the end the following:
``(2) Exclusivity adjustment.--
``(A) Adjustment.--
``(i) In general.--With respect to any
drug, if the organization designated under
subparagraph (B) notifies the Secretary that
the combined annual gross sales for all drugs
with the same active moiety exceeded
$1,000,000,000 in any calendar year prior to
the time the sponsor or holder agrees to the
initial written request pursuant to subsection
(d)(2), then each period of market exclusivity
deemed or extended under subsection (b) or (c)
shall be reduced by 3 months for such drug.
``(ii) Determination.--The determination
under clause (i) of the combined annual gross
sales shall be determined--
``(I) taking into account only
those sales within the United States;
and
``(II) taking into account only the
sales of all drugs with the same active
moiety of the sponsor or holder and its
affiliates.
``(B) Designation.--The Secretary shall designate
an organization other than the Food and Drug
Administration to evaluate whether the combined annual
gross sales for all drugs with the same active moiety
exceeded $1,000,000,000 in a calendar year as described
in subparagraph (A). Prior to designating such
organization, the Secretary shall determine that such
organization is independent and is qualified to
evaluate the sales of pharmaceutical products. The
Secretary shall re-evaluate the designation of such
organization once every 3 years.
``(C) Notification.--Once a year at a time
designated by the Secretary, the organization
designated under subparagraph (B) shall notify the Food
and Drug Administration of all drugs with the same
active moiety with combined annual gross sales that
exceed $1,000,000,000 during the previous calendar
year.'';
(7) in subsection (i)--
(A) in the heading, by striking ``Supplements'' and
inserting ``Changes'';
(B) in paragraph (1)--
(i) in the heading, by inserting
``applications and'' after ``pediatric'';
(ii) by inserting ``application or'' after
``Any'';
(iii) by striking ``change pursuant to a
report on a pediatric study under'' and
inserting ``change as a result of any pediatric
study conducted pursuant to''; and
(iv) by inserting ``application or'' after
``to be a priority''; and
(C) in paragraph (2)(A), by--
(i) striking ``If the Commissioner'' and
inserting ``If, on or after the date of
enactment of the Best Pharmaceuticals for
Children Amendments of 2007, the
Commissioner''; and
(ii) striking ``an application with'' and
all that follows through ``on appropriate'' and
inserting ``the sponsor and the Commissioner
have been unable to reach agreement on
appropriate'';
(8) by striking subsection (m);
(9) by redesignating subsections (j), (k), (l), and (n), as
subsections (k), (m), (o), and (p), respectively;
(10) by inserting after subsection (i) the following:
``(j) Other Labeling Changes.--If, on or after the date of
enactment of the Best Pharmaceuticals for Children Amendments of 2007,
the Secretary determines that a pediatric study conducted under this
section does or does not demonstrate that the drug that is the subject
of the study is safe and effective, including whether such study
results are inconclusive, in pediatric populations or subpopulations,
the Secretary shall order the labeling of such product to include
information about the results of the study and a statement of the
Secretary's determination.'';
(11) in subsection (k), as redesignated by paragraph (9)--
(A) in paragraph (1)--
(i) by striking ``a summary of the medical
and'' and inserting ``the medical, statistical,
and''; and
(ii) by striking ``for the supplement'' and
all that follows through the period and
inserting ``under subsection (b) or (c).'';
(B) by redesignating paragraph (2) as paragraph
(3); and
(C) by inserting after paragraph (1) the following:
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of enactment of the Best
Pharmaceuticals for Children Amendments of 2007, the Secretary
shall require that the sponsors of the studies that result in
labeling changes that are reflected in the annual summary
developed pursuant to subsection (f)(4)(F) distribute, at least
annually (or more frequently if the Secretary determines that
it would be beneficial to the public health), such information
to physicians and other health care providers.'';
(12) by inserting after subsection (k), as redesignated by
paragraph (9), the following:
``(l) Adverse Event Reporting.--
``(1) Reporting in year one.--Beginning on the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, during the 1-year period beginning on the date a
labeling change is made pursuant to subsection (i), the
Secretary shall ensure that all adverse event reports that have
been received for such drug (regardless of when such report was
received) are referred to the Office of Pediatric Therapeutics
established under section 6 of the Best Pharmaceuticals for
Children Act (Public Law 107-109). In considering such reports,
the Director of such Office shall provide for the review of the
report by the Pediatric Advisory Committee, including obtaining
any recommendations of such Committee regarding whether the
Secretary should take action under this section in response to
such reports.
``(2) Reporting in subsequent years.--Following the 1-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics all
pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.'';
(13) by inserting after subsection (m), as redesignated by
paragraph (9), the following:
``(n) Referral if Pediatric Studies Not Completed.--
``(1) In general.--Beginning on the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007, if
pediatric studies of a drug have not been completed under
subsection (d) and if the Secretary, through the committee
established under subsection (f), determines that there is a
continuing need for information relating to the use of the drug
in the pediatric population (including neonates, as
appropriate), the Secretary shall carry out the following:
``(A) For a drug for which a listed patent has not
expired, make a determination regarding whether an
assessment shall be required to be submitted under
section 505B. Prior to making such determination, the
Secretary may take not more than 60 days to certify
whether the Foundation for the National Institutes of
Health has sufficient funding at the time of such
certification to initiate 1 or more of the pediatric
studies of such drug referred to in the sentence
preceding this paragraph and fund 1 or more of such
studies in their entirety. Only if the Secretary makes
such certification in the affirmative, the Secretary
shall refer such pediatric study or studies to the
Foundation for the National Institutes of Health for
the conduct of such study or studies.
``(B) For a drug that has no listed patents or has
1 or more listed patents that have expired, the
Secretary shall refer the drug for inclusion on the
list established under section 409I of the Public
Health Service Act for the conduct of studies.
``(2) Public notice.--The Secretary shall give the public
notice of--
``(A) a decision under paragraph (1)(A) not to
require an assessment under section 505B and the basis
for such decision; and
``(B) any referral under paragraph (1)(B) of a drug
for inclusion on the list established under section
409I of the Public Health Service Act.
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.''; and
(14) in subsection (p), as redesignated by paragraph (9)--
(A) striking ``6-month period'' and inserting ``3-
month or 6-month period'';
(B) by striking ``subsection (a)'' and inserting
``subsection (b)''; and
(C) by striking ``2007'' both places it appears and
inserting ``2012''.
(b) Effective Date.--Except as otherwise provided in the amendments
made by subsection (a), such amendments shall apply to written requests
under section 505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) made after the date of enactment of this subtitle.

SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

Section 409I of the Public Health Service Act (42 U.S.C. 284m) is
amended--
(1) by striking subsections (a) and (b) and inserting the
following:
``(a) List of Priority Issues in Pediatric Therapeutics.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Best Pharmaceuticals for Children Amendments
of 2007, the Secretary, acting through the Director of the
National Institutes of Health and in consultation with the
Commissioner of Food and Drugs and experts in pediatric
research, shall develop and publish a priority list of needs in
pediatric therapeutics, including drugs or indications that
require study. The list shall be revised every 3 years.
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary shall consider--
``(A) therapeutic gaps in pediatrics that may
include developmental pharmacology, pharmacogenetic
determinants of drug response, metabolism of drugs and
biologics in children, and pediatric clinical trials;
``(B) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(C) the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including
research networks and trained pediatric investigators.
``(b) Pediatric Studies and Research.--The Secretary, acting
through the National Institutes of Health, shall award funds to
entities that have the expertise to conduct pediatric clinical trials
or other research (including qualified universities, hospitals,
laboratories, contract research organizations, practice groups,
federally funded programs such as pediatric pharmacology research
units, other public or private institutions, or individuals) to enable
the entities to conduct the drug studies or other research on the
issues described in subsection (a). The Secretary may use contracts,
grants, or other appropriate funding mechanisms to award funds under
this subsection.'';
(2) in subsection (c)--
(A) in the heading, by striking ``Contracts'' and
inserting ``Proposed Pediatric Study Requests'';
(B) by striking paragraphs (4) and (12);
(C) by redesignating paragraphs (1), (2), and (3),
as paragraphs (2), (3), and (4);
(D) by inserting before paragraph (2), as
redesignated by subparagraph (C), the following:
``(1) Submission of proposed pediatric study request.--The
Director of the National Institutes of Health shall, as
appropriate, submit proposed pediatric study requests for
consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication identified
under subsection (a). Such a proposed pediatric study request
shall be made in a manner equivalent to a written request made
under subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act, including with respect to the
information provided on the pediatric studies to be conducted
pursuant to the request. The Director of the National
Institutes of Health may submit a proposed pediatric study
request for a drug for which--
``(A)(i) there is an approved application under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act; or
``(ii) there is a submitted application that could
be approved under the criteria of section 505(j) of the
Federal Food, Drug, and Cosmetic Act;
``(B) there is no patent protection or market
exclusivity protection for at least 1 form of the drug
under the Federal Food, Drug, and Cosmetic Act; and
``(C) additional studies are needed to assess the
safety and effectiveness of the use of the drug in the
pediatric population.'';
(E) in paragraph (2), as redesignated by
subparagraph (C)--
(i) by inserting ``based on the proposed
pediatric study request for the indication or
indications submitted pursuant to paragraph
(1)'' after ``issue a written request'';
(ii) by striking ``in the list described in
subsection (a)(1)(A) (except clause (iv))'' and
inserting ``under subsection (a)''; and
(iii) by inserting ``and using appropriate
formulations for each age group for which the
study is requested'' before the period at the
end;
(F) in paragraph (3), as redesignated by
subparagraph (C)--
(i) in the heading, by striking
``contract'';
(ii) by striking ``paragraph (1)'' and
inserting ``paragraph (2)'';
(iii) by striking ``or if a referral
described in subsection (a)(1)(A)(iv) is
made,'';
(iv) by striking ``for contract proposals''
and inserting ``for proposals''; and
(v) by inserting ``in accordance with
subsection (b)'' before the period at the end;
(G) in paragraph (4), as redesignated by
subparagraph (C)--
(i) by striking ``contract''; and
(ii) by striking ``paragraph (2)'' and
inserting ``paragraph (3)'';
(H) in paragraph (5)--
(i) by striking the heading and inserting
``Contracts, grants, or other funding
mechanisms''; and
(ii) by striking ``A contract'' and all
that follows through ``is submitted'' and
inserting ``A contract, grant, or other funding
may be awarded under this section only if a
proposal is submitted'';
(I) in paragraph (6)(A)--
(i) by striking ``a contract awarded'' and
inserting ``an award''; and
(ii) by inserting ``, including a written
request if issued'' after ``with the study'';
and
(3) by inserting after subsection (c) the following:
``(d) Dissemination of Pediatric Information.--Not later than 1
year after the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007, the Secretary, acting through the Director
of the National Institutes of Health, shall study the feasibility of
establishing a compilation of information on pediatric drug use and
report the findings to Congress.''
``(e) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2008; and
``(B) such sums as are necessary for each of the 4
succeeding fiscal years.
``(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this section
until expended.''.

SEC. 404. REPORTS AND STUDIES.

(a) GAO Report.--Not later than January 31, 2011, the Comptroller
General of the United States, in consultation with the Secretary of
Health and Human Services, shall submit to Congress a report that
addresses the effectiveness of section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by
children are tested and properly labeled, including--
(1) the number and importance of drugs for children that
are being tested as a result of the amendments made by this
subtitle and the importance for children, health care
providers, parents, and others of labeling changes made as a
result of such testing;
(2) the number and importance of drugs for children that
are not being tested for their use notwithstanding the
provisions of this subtitle and the amendments made by this
subtitle, and possible reasons for the lack of testing,
including whether the number of written requests declined by
sponsors or holders of drugs subject to section 505A(g)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(g)(2)), has increased or decreased as a result of the
amendments made by this subtitle;
(3) the number of drugs for which testing is being done and
labeling changes required, including the date labeling changes
are made and which labeling changes required the use of the
dispute resolution process established pursuant to the
amendments made by this subtitle, together with a description
of the outcomes of such process, including a description of the
disputes and the recommendations of the Pediatric Advisory
Committee;
(4) any recommendations for modifications to the programs
established under section 505A of the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
Health Service Act (42 U.S.C. 284m) that the Secretary
determines to be appropriate, including a detailed rationale
for each recommendation; and
(5)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of the studies ethical and
safe.
(b) IOM Study.--Not later than 3 years after the date of enactment
of this subtitle, the Secretary of Health and Human Services shall
enter into a contract with the Institute of Medicine to conduct a study
and report to Congress regarding the written requests made and the
studies conducted pursuant to section 505A of the Federal Food, Drug,
and Cosmetic Act. The Institute of Medicine may devise an appropriate
mechanism to review a representative sample of requests made and
studies conducted pursuant to such section in order to conduct such
study. Such study shall--
(1) review such representative written requests issued by
the Secretary since 1997 under subsections (b) and (c) of such
section 505A;
(2) review and assess such representative pediatric studies
conducted under such subsections (b) and (c) since 1997 and
labeling changes made as a result of such studies; and
(3) review the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for pediatric
populations, neonatal assessment tools, and ethical issues in
pediatric clinical trials.

SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

(a) Investment in Tomorrow's Pediatric Researchers.--Section
452G(2) of the Public Health Service Act (42 U.S.C. 285g-10(2)) is
amended by adding before the period at the end the following: ``,
including pediatric pharmacological research''.
(b) Pediatric Research Loan Repayment Program.--Section 487F(a)(1)
of the Public Health Service Act (42 U.S.C. 288-6(a)(1)) is amended by
inserting ``including pediatric pharmacological research,'' after
``pediatric research,''.

SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C.
290b(c)(1)(C)) is amended by striking ``and studies listed by the
Secretary pursuant to section 409I(a)(1)(A) of the is Act and referred
under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 355(a)(d)(4)(C)'' and inserting ``and studies for which the
Secretary issues a certification under section 505A(n)(1)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(n)(1)(A))''.

SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.

Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C.
284m note) is amended by adding at the end the following:
``(d) Continuation of Operation of Committee.--Notwithstanding
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the
advisory committee shall continue to operate during the 5-year period
beginning on the date of enactment of the Best Pharmaceuticals for
Children Amendments of 2007.''.

SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY
COMMITTEE.

Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C.
284m note) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking
``and'' after the semicolon;
(ii) in subparagraph (C), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following:
``(D) provide recommendations to the internal
review committee created under section 505A(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(f)) regarding the implementation of amendments to
sections 505A and 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a and 355c) with respect to
the treatment of pediatric cancers.''; and
(B) by adding at the end the following:
``(3) Continuation of operation of subcommittee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act (5 U.S.C. App.), the Subcommittee shall continue to operate
during the 5-year period beginning on the date of enactment of
the Best Pharmaceuticals for Children Amendments of 2007.'';
and
(2) in subsection (d), by striking ``2003'' and inserting
``2009''.

SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE
NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN DRUG
PRODUCTS.

(a) In General.--Notwithstanding subchapter II of chapter 5, and
chapter 7, of title 5, United States Code (commonly known as the
``Administrative Procedure Act'') and any other provision of law, the
proposed rule issued by the Commissioner of Food and Drugs entitled
``Toll-Free Number for Reporting Adverse Events on Labeling for Human
Drug Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take effect
on January 1, 2008, unless such Commissioner issues the final rule
before such date.
(b) Limitation.--The proposed rule that takes effect under
subsection (a), or the final rule described under subsection (a),
shall, notwithstanding section 17(a) of the Best Pharmaceuticals for
Children Act (21 U.S.C. 355b(a)), not apply to a drug--
(1) for which an application is approved under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(2) that is not described under section 503(b)(1) of such
Act (21 U.S.C. 353(b)(1)); and
(3) the packaging of which includes a toll-free number
through which consumers can report complaints to the
manufacturer or distributor of the drug.

Subtitle B--Pediatric Research Improvement

SEC. 411. SHORT TITLE.

This subtitle may be cited as the ``Pediatric Research Improvement
Act''.

SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, AND DEFERRALS.

Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(a)) is amended--
(1) in paragraph (4)(C), by adding at the end the
following: ``An applicant seeking either a partial or full
waiver on this ground shall submit to the Secretary
documentation detailing why a pediatric formulation cannot be
developed, and, if the waiver is granted, the applicant's
submission shall promptly be made available to the public in an
easily accessible manner, including through posting on the
website of the Food and Drug Administration'';
(2) in paragraph (2)(B), by adding at the end the
following:
``(iii) Information on extrapolation.--A
brief documentation of the scientific data
supporting the conclusion under clauses (i) and
(ii) shall be included in any pertinent reviews
for the application under section 505 or
section 351 of the Public Health Service
Act.''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Deferral.--
``(A) In general.--On the initiative of the
Secretary or at the request of the applicant, the
Secretary may defer submission of some or all
assessments required under paragraph (1) until a
specified date after approval of the drug or issuance
of the license for a biological product if--
``(i) the Secretary finds that--
``(I) the drug or biological
product is ready for approval for use
in adults before pediatric studies are
complete;
``(II) pediatric studies should be
delayed until additional safety or
effectiveness data have been collected;
or
``(III) there is another
appropriate reason for deferral; and
``(ii) the applicant submits to the
Secretary--
``(I) certification of the grounds
for deferring the assessments;
``(II) a description of the planned
or ongoing studies;
``(III) evidence that the studies
are being conducted or will be
conducted with due diligence and at the
earliest possible time; and
``(IV) a timeline for the
completion of such studies.
``(B) Annual review.--
``(i) In general.--On an annual basis
following the approval of a deferral under
subparagraph (A), the applicant shall submit to
the Secretary the following information:
``(I) Information detailing the
progress made in conducting pediatric
studies.
``(II) If no progress has been made
in conducting such studies, evidence
and documentation that such studies
will be conducted with due diligence
and at the earliest possible time.
``(ii) Public availability.--The
information submitted through the annual review
under clause (i) shall promptly be made
available to the public in an easily accessible
manner, including through the website of the
Food and Drug Administration.''.

SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA FOR ALREADY MARKETED
PRODUCTS.

Section 505B(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(b)) is amended--
(1) by striking paragraph (1) and inserting the following:
``(1) In general.--After providing notice in the form of a
written request under section 505A that was declined by the
sponsor or holder, or a letter referencing such declined
written request, and an opportunity for written response and a
meeting, which may include an advisory committee meeting, the
Secretary may (by order in the form of a letter) require the
sponsor or holder of an approved application for a drug under
section 505 or the holder of a license for a biological product
under section 351 of the Public Health Service Act (42 U.S.C.
262) to submit by a specified date the assessments described in
subsection (a)(2) and the written request, as appropriate, for
the labeled indication or indications, if the Secretary finds
that--
``(A)(i) the drug or biological product is used for
a substantial number of pediatric patients for the
labeled indications; and
``(ii) adequate pediatric labeling could confer a
benefit on pediatric patients;
``(B) there is reason to believe that the drug or
biological product would represent a meaningful
therapeutic benefit over existing therapies for
pediatric patients for 1 or more of the claimed
indications; or
``(C) the absence of adequate pediatric labeling
could pose a risk to pediatric patients.'';
(2) in paragraph (2)(C), by adding at the end the
following: ``An applicant seeking either a partial or full
waiver shall submit to the Secretary documentation detailing
why a pediatric formulation cannot be developed, and, if the
waiver is granted, the applicant's submission shall promptly be
made available to the public in an easily accessible manner,
including through posting on the website of the Food and Drug
Administration.''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.''.

SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; ADVERSE EVENT
REPORTING; LABELING CHANGES; AND PEDIATRIC ASSESSMENTS.

Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c) is amended--
(1) redesignating subsection (h) as subsection (j);
(2) in subsection (j), as so redesignated, by striking
``505A(n)'' and inserting ``505A(p)'';
(3) by redesignating subsection (f) as subsection (k);
(4) by redesignating subsection (g) as subsection (l); and
(5) by inserting after subsection (e) the following:
``(f) Review of Pediatric Assessment Requests, Pediatric
Assessments, Deferrals, and Waivers.--
``(1) Review.--The Secretary shall create an internal
committee to review all pediatric assessment requests issued
under this section, all pediatric assessments conducted under
this section, and all deferral and waiver requests made
pursuant to this section. Such internal committee shall include
individuals, each of whom is an employee of the Food and Drug
Administration, with the following expertise:
``(A) Pediatrics.
``(B) Biopharmacology.
``(C) Statistics.
``(D) Drugs and drug formulations.
``(E) Pediatric ethics.
``(F) Legal issues.
``(G) Appropriate expertise, such as expertise in
child and adolescent psychiatry, pertaining to the
pediatric product under review.
``(H) 1 or more experts from the Office of
Pediatric Therapeutics.
``(I) Other individuals as designated by the
Secretary.
``(2) Action by the committee.--The committee established
under paragraph (1) may perform a function under this section
using appropriate members of the committee under paragraph (1)
and need not convene all members of the committee under
paragraph (1) in order to perform a function under this
section.
``(3) Documentation of committee action.--For each drug or
biological product, the committee established under this
paragraph shall document for each function under paragraph (4)
or (5), which members of the committee participated in such
function.
``(4) Review of requests for pediatric assessments,
deferrals, and waivers.--All written requests for a pediatric
assessment issued pursuant to this section and all requests for
deferrals and waivers from the requirement to conduct a
pediatric assessment under this section shall be reviewed and
approved by the committee established under paragraph (1).
``(5) Review of assessments.--The committee established
under paragraph (1) shall review all assessments conducted
under this section to determine whether such assessments meet
the requirements of this section.
``(6) Tracking of assessments and labeling changes.--The
committee established under paragraph (1) is responsible for
tracking and making public in an easily accessible manner,
including through posting on the website of the Food and Drug
Administration--
``(A) the number of assessments conducted under
this section;
``(B) the specific drugs and drug uses assessed
under this section;
``(C) the types of assessments conducted under this
section, including trial design, the number of
pediatric patients studied, and the number of centers
and countries involved;
``(D) the total number of deferrals requested and
granted under this section, and, if granted, the
reasons for such deferrals, the timeline for
completion, and the number completed and pending by the
specified date, as outlined in subsection (a)(3);
``(E) the number of waivers requested and granted
under this section, and, if granted, the reasons for
the waivers;
``(F) the number of pediatric formulations
developed and the number of pediatric formulations not
developed and the reasons any such formulations were
not developed;
``(G) the labeling changes made as a result of
assessments conducted under this section;
``(H) an annual summary of labeling changes made as
a result of assessments conducted under this section
for distribution pursuant to subsection (i)(2); and
``(I) an annual summary of the information
submitted pursuant to subsection (a)(3)(B).
``(7) Committee.--The committee established under paragraph
(1) is the committee established under section 505A(f)(1).
``(g) Labeling Changes.--
``(1) Priority status for pediatric supplement.--Any
supplement to an application under section 505 and section 351
of the Public Health Service Act proposing a labeling change as
a result of any pediatric assessments conducted pursuant to
this section--
``(A) shall be considered a priority supplement;
and
``(B) shall be subject to the performance goals
established by the Commissioner for priority drugs.
``(2) Dispute resolution.--
``(A) Request for labeling change and failure to
agree.--If the Commissioner determines that a sponsor
and the Commissioner have been unable to reach
agreement on appropriate changes to the labeling for
the drug that is the subject of the application or
supplement, not later than 180 days after the date of
the submission of the application or supplement--
``(i) the Commissioner shall request that
the sponsor make any labeling change that the
Commissioner determines to be appropriate; and
``(ii) if the sponsor does not agree to
make a labeling change requested by the
Commissioner, the Commissioner shall refer the
matter to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--
Not later than 90 days after receiving a referral under
subparagraph (A)(ii), the Pediatric Advisory Committee
shall--
``(i) review the pediatric study reports;
and
``(ii) make a recommendation to the
Commissioner concerning appropriate labeling
changes, if any.
``(C) Consideration of recommendations.--The
Commissioner shall consider the recommendations of the
Pediatric Advisory Committee and, if appropriate, not
later than 30 days after receiving the recommendation,
make a request to the sponsor of the application or
supplement to make any labeling changes that the
Commissioner determines to be appropriate.
``(D) Misbranding.--If the sponsor, within 30 days
after receiving a request under subparagraph (C), does
not agree to make a labeling change requested by the
Commissioner, the Commissioner may deem the drug that
is the subject of the application or supplement to be
misbranded.
``(E) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under this Act when a drug
lacks appropriate pediatric labeling. Neither course of
action (the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding
sentence) shall preclude, delay, or serve as the basis
to stay the other course of action.
``(3) Other labeling changes.--If the Secretary makes a
determination that a pediatric assessment conducted under this
section does or does not demonstrate that the drug that is the
subject of such assessment is safe and effective, including
whether such assessment results are inconclusive, in pediatric
populations or subpopulations, the Secretary shall order the
labeling of such product to include information about the
results of the assessment and a statement of the Secretary's
determination.
``(h) Dissemination of Pediatric Information.--
``(1) In general.--Not later than 180 days after the date
of submission of a pediatric assessment under this section, the
Secretary shall make available to the public in an easily
accessible manner the medical, statistical, and clinical
pharmacology reviews of such pediatric assessments and shall
post such assessments on the website of the Food and Drug
Administration.
``(2) Dissemination of information regarding labeling
changes.--The Secretary shall require that the sponsors of the
assessments that result in labeling changes that are reflected
in the annual summary developed pursuant to subsection
(f)(4)(H) distribute such information to physicians and other
health care providers.
``(3) Effect of subsection.--Nothing in this subsection
shall alter or amend section 301(j) of this Act or section 552
of title 5, United States Code, or section 1905 of title 18,
United States Code.
``(i) Adverse Event Reporting.--
``(1) Reporting in year 1.--During the 1-year period
beginning on the date a labeling change is made pursuant to
subsection (g), the Secretary shall ensure that all adverse
event reports that have been received for such drug (regardless
of when such report was received) are referred to the Office of
Pediatric Therapeutics. In considering such reports, the
Director of such Office shall provide for the review of the
report by the Pediatric Advisory Committee, including obtaining
any recommendations of such committee regarding whether the
Secretary should take action under this Act in response to such
report.
``(2) Reporting in subsequent years.--Following the 1-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics with
all pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such report.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.''.

SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.

Section 505B(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) is amended--
(1) by striking ``estimates'' and inserting ``determines'';
and
(2) by striking ``would'' and inserting ``could''.

SEC. 416. REPORTS.

(a) Institute of Medicine Study.--
(1) In general.--Not later than 3 years after the date of
enactment of this subtitle, the Secretary shall contract with
the Institute of Medicine to conduct a study and report to
Congress regarding the pediatric studies conducted pursuant to
section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) since 1997.
(2) Content of study.--The study under paragraph (1) shall
review and assess--
(A) pediatric studies conducted pursuant to section
505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c) since 1997 and labeling changes made as a
result of such studies; and
(B) the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for
pediatric populations, neonatal assessment tools,
number and type of pediatric adverse events, and
ethical issues in pediatric clinical trials.
(3) Representative sample.--The Institute of Medicine may
devise an appropriate mechanism to review a representative
sample of studies conducted pursuant to section 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) from each
review division within the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research
in order to make the required assessment.
(b) GAO Report.--Not later than September 1, 2010, the Comptroller
General of the United States, in consultation with the Secretary of
Health and Human Services, shall submit to Congress a report that
addresses the effectiveness of section 505B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by
children are tested and properly labeled, including--
(1) the number and importance of drugs for children that
are being tested as a result of this provision and the
importance for children, health care providers, parents, and
others of labeling changes made as a result of such testing;
(2) the number and importance of drugs for children that
are not being tested for their use notwithstanding the
provisions of such section 505B, and possible reasons for the
lack of testing; and
(3) the number of drugs for which testing is being done and
labeling changes required, including the date labeling changes
are made and which labeling changes required the use of the
dispute resolution process established under such section 505B,
together with a description of the outcomes of such process,
including a description of the disputes and the recommendations
of the Pediatric Advisory Committee.

SEC. 417. TECHNICAL CORRECTIONS.

Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended by striking ``one'' and
inserting ``1''.

Subtitle C--Pediatric Medical Devices

SEC. 421. SHORT TITLE.

This subtitle may be cited as the ``Pediatric Medical Device Safety
and Improvement Act of 2007''.

SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 515 the following:

``SEC. 515A. PEDIATRIC USES OF DEVICES.

``(a) New Devices.--
``(1) In general.--A person that submits to the Secretary
an application under section 520(m), or an application (or
supplement to an application) or a product development protocol
under section 515, shall include in the application or protocol
the information described in paragraph (2).
``(2) Required information.--The application or protocol
described in paragraph (1) shall include, with respect to the
device for which approval is sought and if readily available--
``(A) a description of any pediatric subpopulations
that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure; and
``(B) the number of affected pediatric patients.
``(3) Annual report.--Not later than 18 months after the
date of enactment of this section, and annually thereafter, the
Secretary shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report that
includes--
``(A) the number of devices approved in the year
preceding the year in which the report is submitted,
for which there is a pediatric subpopulation that
suffers from the disease or condition that the device
is intended to treat, diagnose, or cure;
``(B) the number of devices approved in the year
preceding the year in which the report is submitted,
labeled for use in pediatric patients;
``(C) the number of pediatric devices approved in
the year preceding the year in which the report is
submitted, exempted from a fee pursuant to section
738(a)(2)(B)(v); and
``(D) the review time for each device described in
subparagraphs (A), (B), and (C).
``(b) Determination of Pediatric Effectiveness Based on Similar
Course of Disease or Condition or Similar Effect of Device on Adults.--
``(1) In general.--If the course of the disease or
condition and the effects of the device are sufficiently
similar in adults and pediatric patients, the Secretary may
conclude that adult data may be used to support a determination
of a reasonable assurance of effectiveness in pediatric
populations, as appropriate.
``(2) Extrapolation between subpopulations.--A study may
not be needed in each pediatric subpopulation if data from one
subpopulation can be extrapolated to another subpopulation.
``(c) Pediatric Subpopulation.--In this section, the term
`pediatric subpopulation' has the meaning given the term in section
520(m)(6)(E)(ii).''.

SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

(a) In General.--Section 520(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (3), by striking ``No'' and inserting
``Except as provided in paragraph (6), no'';
(2) in paragraph (5)--
(A) by inserting ``, if the Secretary has reason to
believe that the requirements of paragraph (6) are no
longer met,'' after ``public health''; and
(B) by adding at the end the following: ``If the
person granted an exemption under paragraph (2) fails
to demonstrate continued compliance with the
requirements of this subsection, the Secretary may
suspend or withdraw the exemption from the
effectiveness requirements of sections 514 and 515 for
a humanitarian device only after providing notice and
an opportunity for an informal hearing.'';
(3) by striking paragraph (6) and inserting the following:
``(6)(A) Except as provided in subparagraph (D), the prohibition in
paragraph (3) shall not apply with respect to a person granted an
exemption under paragraph (2) if each of the following conditions
apply:
``(i)(I) The device with respect to which the exemption is
granted is intended for the treatment or diagnosis of a disease
or condition that occurs in pediatric patients or in a
pediatric subpopulation, and such device is labeled for use in
pediatric patients or in a pediatric subpopulation in which the
disease or condition occurs.
``(II) The device was not previously approved under this
subsection for the pediatric patients or the pediatric
subpopulation described in subclause (I) prior to the date of
enactment of the Pediatric Medical Device Safety and
Improvement Act of 2007.
``(ii) During any calendar year, the number of such devices
distributed during that year does not exceed the annual
distribution number specified by the Secretary when the
Secretary grants such exemption. The annual distribution number
shall be based on the number of individuals affected by the
disease or condition that such device is intended to treat,
diagnose, or cure, and of that number, the number of
individuals likely to use the device, and the number of devices
reasonably necessary to treat such individuals. In no case
shall the annual distribution number exceed the number
identified in paragraph (2)(A).
``(iii) Such person immediately notifies the Secretary if
the number of such devices distributed during any calendar year
exceeds the annual distribution number referred to in clause
(ii).
``(iv) The request for such exemption is submitted on or
before October 1, 2012.
``(B) The Secretary may inspect the records relating to the number
of devices distributed during any calendar year of a person granted an
exemption under paragraph (2) for which the prohibition in paragraph
(3) does not apply.
``(C) A person may petition the Secretary to modify the annual
distribution number specified by the Secretary under subparagraph
(A)(ii) with respect to a device if additional information on the
number of individuals affected by the disease or condition arises, and
the Secretary may modify such number but in no case shall the annual
distribution number exceed the number identified in paragraph (2)(A).
``(D) If a person notifies the Secretary, or the Secretary
determines through an inspection under subparagraph (B), that the
number of devices distributed during any calendar year exceeds the
annual distribution number, as required under subparagraph (A)(iii),
and modified under subparagraph (C), if applicable, then the
prohibition in paragraph (3) shall apply with respect to such person
for such device for any sales of such device after such notification.
``(E)(i) In this subsection, the term `pediatric patients' means
patients who are 21 years of age or younger at the time of the
diagnosis or treatment.
``(ii) In this subsection, the term `pediatric subpopulation' means
1 of the following populations:
``(I) Neonates.
``(II) Infants.
``(III) Children.
``(IV) Adolescents.''; and
(4) by adding at the end the following:
``(7) The Secretary shall refer any report of an adverse event
regarding a device for which the prohibition under paragraph (3) does
not apply pursuant to paragraph (6)(A) that the Secretary receives to
the Office of Pediatric Therapeutics, established under section 6 of
the Best Pharmaceuticals for Children Act (Public Law 107-109)). In
considering the report, the Director of the Office of Pediatric
Therapeutics, in consultation with experts in the Center for Devices
and Radiological Health, shall provide for periodic review of the
report by the Pediatric Advisory Committee, including obtaining any
recommendations of such committee regarding whether the Secretary
should take action under this Act in response to the report.''.
(b) Report.--Not later than January 1, 2012, the Comptroller
General of the United States shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report on the
impact of allowing persons granted an exemption under section 520(m)(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with
respect to a device to profit from such device pursuant to section
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection
(a)), including--
(1) an assessment of whether such section 520(m)(6) (as
amended by subsection (a)) has increased the availability of
pediatric devices for conditions that occur in small numbers of
children, including any increase or decrease in the number of--
(A) exemptions granted under such section 520(m)(2)
for pediatric devices; and
(B) applications approved under section 515 of such
Act (21 U.S.C. 360e) for devices intended to treat,
diagnose, or cure conditions that occur in pediatric
patients or for devices labeled for use in a pediatric
population;
(2) the conditions or diseases the pediatric devices were
intended to treat or diagnose and the estimated size of the
pediatric patient population for each condition or disease;
(3) the costs of the pediatric devices, based on a survey
of children's hospitals;
(4) the extent to which the costs of such devices are
covered by health insurance;
(5) the impact, if any, of allowing profit on access to
such devices for patients;
(6) the profits made by manufacturers for each device that
receives an exemption;
(7) an estimate of the extent of the use of the pediatric
devices by both adults and pediatric populations for a
condition or disease other than the condition or disease on the
label of such devices;
(8) recommendations of the Comptroller General of the
United States regarding the effectiveness of such section
520(m)(6) (as amended by subsection (a)) and whether any
modifications to such section 520(m)(6) (as amended by
subsection (a)) should be made;
(9) existing obstacles to pediatric device development; and
(10) an evaluation of the demonstration grants described in
section 425, which shall include an evaluation of the number of
pediatric medical devices--
(A) that have been or are being studied in
children; and
(B) that have been submitted to the Food and Drug
Administration for approval, clearance, or review under
such section 520(m) (as amended by this Act) and any
regulatory actions taken.
(c) Guidance.--Not later than 180 days after the date of enactment
of this subtitle, the Commissioner of Food and Drugs shall issue
guidance for institutional review committees on how to evaluate
requests for approval for devices for which a humanitarian device
exemption under section 520(m)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.

Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b))
is amended--
(1) in paragraph (21), by striking ``and'' after the
semicolon at the end;
(2) in paragraph (22), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (22) the following:
``(23) shall designate a contact point or office to help
innovators and physicians identify sources of funding available
for pediatric medical device development.''.

SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
AVAILABILITY.

(a) In General.--
(1) Request for proposals.--Not later than 90 days after
the date of enactment of this subtitle, the Secretary of Health
and Human Services shall issue a request for proposals for 1 or
more grants or contracts to nonprofit consortia for
demonstration projects to promote pediatric device development.
(2) Determination on grants or contracts.--Not later than
180 days after the date the Secretary of Health and Human
Services issues a request for proposals under paragraph (1),
the Secretary shall make a determination on the grants or
contracts under this section.
(b) Application.--A nonprofit consortium that desires to receive a
grant or contract under this section shall submit an application to the
Secretary of Health and Human Services at such time, in such manner,
and containing such information as the Secretary may require.
(c) Use of Funds.--A nonprofit consortium that receives a grant or
contract under this section shall facilitate the development,
production, and distribution of pediatric medical devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects
through the development process, including product
identification, prototype design, device development, and
marketing;
(3) connecting innovators and physicians to existing
Federal and non-Federal resources, including resources from the
Food and Drug Administration, the National Institutes of
Health, the Small Business Administration, the Department of
Energy, the Department of Education, the National Science
Foundation, the Department of Veterans Affairs, the Agency for
Healthcare Research and Quality, and the National Institute of
Standards and Technology;
(4) assessing the scientific and medical merit of proposed
pediatric device projects; and
(5) providing assistance and advice as needed on business
development, personnel training, prototype development,
postmarket needs, and other activities consistent with the
purposes of this section.
(d) Coordination.--
(1) National institutes of health.--Each consortium that
receives a grant or contract under this section shall--
(A) coordinate with the National Institutes of
Health's pediatric device contact point or office,
designated under section 424; and
(B) provide to the National Institutes of Health
any identified pediatric device needs that the
consortium lacks sufficient capacity to address or
those needs in which the consortium has been unable to
stimulate manufacturer interest.
(2) Food and drug administration.--Each consortium that
receives a grant or contract under this section shall
coordinate with the Commissioner of Food and Drugs and device
companies to facilitate the application for approval or
clearance of devices labeled for pediatric use.
(3) Effectiveness and outcomes.--Each consortium that
receives a grant or contract under this section shall annually
report to the Secretary of Health and Human Services on--
(A) the effectiveness of activities conducted under
subsection (c);
(B) the impact of activities conducted under
subsection (c) on pediatric device development; and
(C) the status of pediatric device development that
has been facilitated by the consortium.
(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $6,000,000 for each of fiscal
years 2008 through 2012.

SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC
ADVISORY COMMITTEE.

(a) In General.--
(1) Office of pediatric therapeutics.--Section 6(b) of the
Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is
amended by inserting ``, including increasing pediatric access
to medical devices'' after ``pediatric issues''.
(2) Plan for pediatric medical device research.--
(A) In general.--Not later than 270 days after the
date of enactment of this subtitle, the Office of
Pediatric Therapeutics, in collaboration with the
Director of the National Institutes of Health and the
Director of the Agency for Healthcare Research and
Quality, shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a plan for expanding pediatric medical
device research and development. In developing such
plan, the Commissioner of Food and Drugs shall consult
with individuals and organizations with appropriate
expertise in pediatric medical devices.
(B) Contents.--The plan under subparagraph (A)
shall include--
(i) the current status of federally funded
pediatric medical device research;
(ii) any gaps in such research, which may
include a survey of pediatric medical providers
regarding unmet pediatric medical device needs,
as needed; and
(iii) a research agenda for improving
pediatric medical device development and Food
and Drug Administration clearance or approval
of pediatric medical devices, and for
evaluating the short- and long-term safety and
effectiveness of pediatric medical devices.
(b) Pediatric Advisory Committee.--Section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
(1) in subsection (a), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``(including
drugs and biological products) and medical devices''
after ``therapeutics''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``and
505B'' and inserting ``505B, 510(k), 515, and
520(m)'';
(ii) by striking subparagraph (B) and
inserting the following:
``(B) identification of research priorities related
to therapeutics (including drugs and biological
products) and medical devices for pediatric populations
and the need for additional diagnostics and treatments
for specific pediatric diseases or conditions; and'';
and
(iii) in subparagraph (C), by inserting
``(including drugs and biological products) and
medical devices'' after ``therapeutics''.

SEC. 427. POSTMARKET SURVEILLANCE.

(a) Postmarket Surveillance.--Section 522 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) Postmarket Surveillance.--
``(1) In general.--
``(A) Conduct.--The Secretary may by order require
a manufacturer to conduct postmarket surveillance for
any device of the manufacturer that is a class II or
class III device--
``(i) the failure of which would be
reasonably likely to have serious adverse
health consequences;
``(ii) that is expected to have significant
use in pediatric populations; or
``(iii) that is intended to be--
``(I) implanted in the human body
for more than 1 year; or
``(II) a life-sustaining or life-
supporting device used outside a device
user facility.
``(B) Condition.--The Secretary may order a
postmarket surveillance under subparagraph (A) as a
condition to approval or clearance of a device
described in subparagraph (A)(ii).
``(2) Rule of construction.--The provisions of paragraph
(1) shall have no effect on authorities otherwise provided
under the Act or regulations issued under this Act.''; and
(2) in subsection (b)--
(A) by striking ``(b) Surveillance Approval.--
Each'' and inserting the following:
``(b) Surveillance Approval.--
``(1) In general.--Each'';
(B) by striking ``The Secretary, in consultation''
and inserting ``Except as provided in paragraph (2),
the Secretary, in consultation'';
(C) by striking ``Any determination'' and inserting
``Except as provided in paragraph (2), any
determination''; and
(D) by adding at the end the following:
``(2) Longer surveillances for pediatric devices.--The
Secretary may by order require a prospective surveillance
period of more than 36 months with respect to a device that is
expected to have significant use in pediatric populations if
such period of more than 36 months is necessary in order to
assess the impact of the device on growth and development, or
the effects of growth, development, activity level, or other
factors on the safety of the device.''.

TITLE V--OTHER PROVISIONS

SEC. 501. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES
PUBLISHED BY FDA EMPLOYEES.

Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371 et seq.), as amended by section 241, is further
amended by adding at the end the following:

``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES
PUBLISHED BY FDA EMPLOYEES.

``(a) Definition.--In this section, the term `article' means a
paper, poster, abstract, book, book chapter, or other published
writing.
``(b) Policies.--The Secretary, through the Commissioner of Food
and Drugs, shall establish and make publicly available clear written
policies to implement this section and govern the timely submission,
review, clearance, and disclaimer requirements for articles.
``(c) Timing of Submission for Review.--If an officer or employee,
including a Staff Fellow and a contractor who performs staff work, of
the Food and Drug Administration is required by the policies
established under subsection (b) to submit an article to the supervisor
of such officer or employee, or to some other official of the Food and
Drug Administration, for review and clearance before such officer or
employee may seek to publish or present such an article at a
conference, such officer or employee shall submit such article for such
review and clearance not less than 30 days before submitting the
article for publication or presentation.
``(d) Timing for Review and Clearance.--The supervisor or other
reviewing official shall review such article and provide written
clearance, or written clearance on the condition of specified changes
being made, to such officer or employee not later than 30 days after
such officer or employee submitted such article for review.
``(e) Non-Timely Review.--If, 31 days after such submission under
subsection (c), the supervisor or other reviewing official has not
cleared or has not reviewed such article and provided written
clearance, such officer or employee may consider such article not to
have been cleared and may submit the article for publication or
presentation with an appropriate disclaimer as specified in the
policies established under subsection (b).''.

SEC. 502. TECHNICAL AMENDMENTS.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended--
(1) in section 319C-2(j)(3)(B), by striking ``section 319C-
1(h)'' and inserting ``section 319C-1(i)'';
(2) in section 402(b)(4), by inserting ``minority and
other'' after ``reducing'';
(3) in section 403(a)(4)(C)(iv)(III), by inserting ``and
post doctoral training funded through investigator-initiated
research grant awards'' before the semicolon; and
(4) in section 403C(a)--
(A) in the matter preceding paragraph (1), by
inserting ``graduate students supported by NIH for''
after ``with respect to'';
(B) in paragraph (1), by inserting ``such'' after
``percentage of''; and
(C) in paragraph (2), by inserting ``(not including
any leaves of absence)'' after ``average time''.

SEC. 503. SEVERABILITY CLAUSE.

If any provision of this Act, an amendment made this Act, or the
application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this Act,
the amendments made by this Act, and the application of the provisions
of such to any person or circumstances shall not be affected thereby.

SEC. 504. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS.

(a) Findings.--The Senate finds the following:
(1) The Food and Drug Administration has stated that it
requires legislative authority to review follow-on biologics.
(2) Business, consumer, and government purchasers require
competition and choice to ensure more affordable prescription
drug options.
(3) Well-constructed policies that balance the needs of
innovation and affordability have broad bipartisan support.
(b) Sense of the Senate.--It is the sense of the Senate that
legislation should be enacted to--
(1) provide the Food and Drug Administration with the
authority and flexibility to approve biopharmaceuticals subject
to an abbreviated approval pathway;
(2) ensure that patient safety remains paramount in the
system;
(3) establish a regulatory pathway that is efficient,
effective, and scientifically-grounded and that also includes
measures to ensure timely resolution of patent disputes; and
(4) provide appropriate incentives to facilitate the
research and development of innovative biopharmaceuticals.

SEC. 505. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL
DISEASES.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:

``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL
DISEASES.

``(a) Definitions.--In this section:
``(1) AIDS.--The term `AIDS' means the acquired immune
deficiency syndrome.
``(2) AIDS drug.--The term `AIDS drug' means a drug
indicated for treating HIV.
``(3) HIV.--The term `HIV' means the human immunodeficiency
virus, the pathogen that causes AIDS.
``(4) Neglected or tropical disease.--The term `neglected
or tropical disease' means--
``(A) HIV, malaria, tuberculosis, and related
diseases; or
``(B) any other infectious disease that
disproportionately affects poor and marginalized
populations, including those diseases targeted by the
Special Programme for Research and Training in Tropical
Diseases cosponsored by the United Nations Development
Program, UNICEF, the World Bank, and the World Health
Organization.
``(5) Priority review.--The term `priority review', with
respect to a new drug application described in paragraph (6),
means review and action by the Secretary on such application
not later than 180 days after receipt by the Secretary of such
application, pursuant to the Manual of Policies and Procedures
of the Food and Drug Administration.
``(6) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the sponsor
of a tropical disease product that entitles such sponsor, or a
person described under subsection (b)(2), to priority review of
a new drug application submitted under section 505(b)(1) after
the date of approval of the tropical disease product.
``(7) Tropical disease product.--The term `tropical disease
product' means a product that--
``(A) is a new drug, antibiotic drug, biological
product, vaccine, device, diagnostic, or other tool for
treatment of a neglected or tropical disease; and
``(B) is approved by the Secretary for use in the
treatment of a neglected or tropical disease.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a tropical disease product
upon approval by the Secretary of such tropical disease
product.
``(2) Transferability.--The sponsor of a tropical disease
product that receives a priority review voucher under this
section may transfer (including by sale) the entitlement to
such voucher to a sponsor of a new drug for which an
application under section 505(b)(1) will be submitted after the
date of the approval of the tropical disease product.
``(3) Limitation.--A sponsor of a tropical disease product
may not receive a priority review voucher under this section if
the tropical disease product was approved by the Secretary
prior to the date of enactment of this section.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a drug that is the subject of
a priority review voucher shall pay to the Secretary a fee
determined under paragraph (2). Such fee shall be in addition
to any fee required to be submitted by the sponsor under
chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the anticipated costs to the Secretary of implementing
this section.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2007, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The fee required by this
subsection shall be due upon the filing of the new drug
application under section 505(b)(1) for which the
voucher is used.
``(B) Complete application.--An application
described under subparagraph (A) for which the sponsor
requests the use of a priority review voucher shall be
considered incomplete if the fee required by this
subsection is not included in such application.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to
the Food and Drug Administration; and
``(B) shall not be collected for any fiscal year
except to the extent provided in advance in
appropriation Acts.''.

SEC. 506. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by this Act, is amended by adding at the end the
following:
``(s) Citizen Petitions and Petitions for Stay of Agency Action.--
``(1) In general.--
``(A) No delay of consideration or approval.--
``(i) In general.--With respect to a
pending application submitted under subsection
(b)(2) or (j), if a petition is submitted to
the Secretary that seeks to have the Secretary
take, or refrain from taking, any form of
action relating to the approval of the
application, including a delay in the effective
date of the application, clauses (ii) and (iii)
shall apply.
``(ii) No delay of consideration or
approval.--Except as provided in clause (iii),
the receipt and consideration of a petition
described in clause (i) shall not delay
consideration or approval of an application
submitted under subsection (b)(2) or (j).
``(iii) No delay of approval without
determination.--The Secretary shall not delay
approval of an application submitted under
subsection (b)(2) or (j) while a petition
described in clause (i) is reviewed and
considered unless the Secretary determines, not
later than 25 business days after the
submission of the petition, that a delay is
necessary to protect the public health.
``(B) Determination of delay.--With respect to a
determination by the Secretary under subparagraph
(A)(iii) that a delay is necessary to protect the
public health the following shall apply:
``(i) Not later than 5 days after making
such determination, the Secretary shall publish
on the Internet website of the Food and Drug
Administration a detailed statement providing
the reasons underlying the determination. The
detailed statement shall include a summary of
the petition and comments and supplements, the
specific substantive issues that the petition
raises which need to be considered prior to
approving a pending application submitted under
subsection (b)(2) or (j), and any
clarifications and additional data that is
needed by the Secretary to promptly review the
petition.
``(ii) Not later than 10 days after making
such determination, the Secretary shall provide
notice to the sponsor of the pending
application submitted under subsection (b)(2)
or (j) and provide an opportunity for a meeting
with appropriate staff as determined by the
Commissioner to discuss the determination.
``(2) Timing of final agency action on petitions.--
``(A) In general.--Notwithstanding a determination
made by the Secretary under paragraph (1)(A)(iii), the
Secretary shall take final agency action with respect
to a petition not later than 180 days of submission of
that petition unless the Secretary determines, prior to
the date that is 180 days after the date of submission
of the petition, that a delay is necessary to protect
the public health.
``(B) Determination of delay.--With respect to a
determination by the Secretary under subparagraph (A)
that a delay is necessary to protect the public health
the following shall apply:
``(i) Not later than 5 days after making
the determination under subparagraph (A), the
Secretary shall publish on the Internet website
of the Food and Drug Administration a detailed
statement providing the reasons underlying the
determination. The detailed statement should
include the state of the review of the
petition, the specific outstanding issues that
still need to be resolved, a proposed timeframe
to resolve the issues, and any additional
information that has been requested by the
Secretary of the petitioner or needed by the
Secretary in order to resolve the petition and
not further delay an application filed under
subsection (b)(2) or (j).
``(ii) Not later than 10 days after making
the determination under subparagraph (A), the
Secretary shall provide notice to the sponsor
of the pending application submitted under
subsection (b)(2) or (j) and provide an
opportunity for a meeting with appropriate
staff as determined by the Commissioner to
discuss the determination.
``(3) Verifications.--
``(A) Petitions for review.--The Secretary shall
not accept a petition for review unless it is signed
and contains the following verification: `I certify
that, to my best knowledge and belief: (a) this
petition includes all information and views upon which
the petition relies; (b) this petition includes
representative data and/or information known to the
petitioner which are unfavorable to the petition; and
(c) information upon which I have based the action
requested herein first became known to the party on
whose behalf this petition is filed on or about
__________. I received or expect to receive payments,
including cash and other forms of consideration, from
the following persons or organizations to file this
petition: ________. I verify under penalty of perjury
that the foregoing is true and correct.', with the date
of the filing of such petition and the signature of the
petitioner inserted in the first and second blank
space, respectively.
``(B) Supplemental information.--The Secretary
shall not accept for review any supplemental
information or comments on a petition unless the party
submitting such information or comments does so in
written form and that the subject document is signed
and contains the following verification: `I certify
that, to my best knowledge and belief: (a) I have not
intentionally delayed submission of this document or
its contents; and (b) the information upon which I have
based the action requested herein first became known to
me on or about __________. I received or expect to
receive payments, including cash and other forms of
consideration, from the following persons or
organizations to submit this information or its
contents: _____. I verify under penalty of perjury that
the foregoing is true and correct.', with the date of
the submission of such document and the signature of
the petitioner inserted in the first and second blank
space, respectively.
``(4) Annual report on delays in approvals per petition.--
The Secretary shall annually submit to the Congress a report
that specifies--
``(A) the number of applications under subsection
(b)(2) and (j) that were approved during the preceding
1-year period;
``(B) the number of petitions that were submitted
during such period;
``(C) the number of applications whose effective
dates were delayed by petitions during such period and
the number of days by which the applications were so
delayed; and
``(D) the number of petitions that were filed under
this subsection that were deemed by the Secretary under
paragraph (1)(A)(iii) to require delaying an
application under subsection (b)(2) or (j) and the
number of days by which the applications were so
delayed.
``(5) Exception.--This subsection does not apply to a
petition that is made by the sponsor of the application under
subsection (b)(2) or (j) and that seeks only to have the
Secretary take or refrain from taking any form of action with
respect to that application.
``(6) Report by inspector general.--The Office of Inspector
General of the Department of Health and Human Services shall
issue a report not later than 2 years after the date of
enactment of this subsection evaluating evidence of the
compliance of the Food and Drug Administration with the
requirement that the consideration by the Secretary of
petitions that do not raise public health concerns remain
separate and apart from the review and approval of an
application submitted under subsection (b)(2) or (j).
``(7) Definition.--For purposes of this subsection, the
term `petition' includes any request for an action described in
paragraph (1)(A)(i) to the Secretary, without regard to whether
the request is characterized as a petition.''.

SEC. 507. PUBLICATION OF ANNUAL REPORTS.

(a) In General.--The Commissioner on Food and Drugs shall annually
submit to Congress and publish on the Internet website of the Food and
Drug Administration, a report concerning the results of the
Administration's pesticide residue monitoring program, that includes--
(1) information and analysis similar to that contained in
the report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'' as released in June of 2005;
(2) based on an analysis of previous samples, an
identification of products or countries (for imports) that
require special attention and additional study based on a
comparison with equivalent products manufactured, distributed,
or sold in the United States (including details on the plans
for such additional studies), including in the initial report
(and subsequent reports as determined necessary) the results
and analysis of the Ginseng Dietary Supplements Special Survey
as described on page 13 of the report entitled ``Food and Drug
Administration Pesticide Program Residue Monitoring 2003'';
(3) information on the relative number of interstate and
imported shipments of each tested commodity that were sampled,
including recommendations on whether sampling is statistically
significant, provides confidence intervals or other related
statistical information, and whether the number of samples
should be increased and the details of any plans to provide for
such increase; and
(4) a description of whether certain commodities are being
improperly imported as another commodity, including a
description of additional steps that are being planned to
prevent such smuggling.
(b) Initial Reports.--Annual reports under subsection (a) for
fiscal years 2004 through 2006 may be combined into a single report, by
not later than June 1, 2008, for purposes of publication under
subsection (a). Thereafter such reports shall be completed by June 1 of
each year for the data collected for the year that was 2-years prior to
the year in which the report is published.
(c) Memorandum of Understanding.--The Commissioner of Food and
Drugs, the Administrator of the Food Safety and Inspection Service, the
Department of Commerce, and the head of the Agricultural Marketing
Service shall enter into a memorandum of understanding to permit
inclusion of data in the reports under subsection (a) relating to
testing carried out by the Food Safety and Inspection Service and the
Agricultural Marketing Service on meat, poultry, eggs, and certain raw
agricultural products, respectively.

SEC. 508. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT
REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL
EXAMINATIONS.

The Head Start Act (42 U.S.C. 9831 et seq.) is amended by adding at
the end the following:

``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY INTRUSIVE
PHYSICAL EXAMINATIONS.

``(a) In General.--A Head Start agency shall obtain written
parental consent before administration of any nonemergency intrusive
physical examination of a child in connection with participation in a
program under this subchapter.
``(b) Definition.--The term `nonemergency intrusive physical
examination' means, with respect to a child, a physical examination
that--
``(1) is not immediately necessary to protect the health or
safety of the child involved or the health or safety of another
individual; and
``(2) requires incision or is otherwise invasive, or
involves exposure of private body parts.
``(c) Rule of Construction.--Nothing in this section shall be
construed to prohibit agencies from using established methods, for
handling cases of suspected or known child abuse and neglect, that are
in compliance with applicable Federal, State, or tribal law.''.

SEC. 509. SAFETY OF FOOD ADDITIVES.

Not later than 90 days after the date of enactment of this Act, the
Food and Drug Administration shall issue a report on the question of
whether substances used to preserve the appearance of fresh meat may
create any health risks, or mislead consumers.

SEC. 510. IMPROVING GENETIC TEST SAFETY AND QUALITY.

Not later than 30 days after the date of enactment of this Act, the
Secretary shall enter into a contract with the Institute of Medicine to
conduct a study to assess the overall safety and quality of genetic
tests and prepare a report that includes recommendations to improve
Federal oversight and regulation of genetic tests. Such study shall
take into consideration relevant reports by the Secretary's Advisory
Committee on Genetic Testing and other groups and shall be completed
not later than 1 year after the date on which the Secretary entered
into such contract.

SEC. 511. ORPHAN DISEASE TREATMENT IN CHILDREN.

(a) Finding.--The Senate finds that parents of children suffering
from rare genetic diseases known as orphan diseases face multiple
obstacles in obtaining safe and effective treatment for their children
due mainly to the fact that many Food and Drug Administration-approved
drugs used in the treatment of orphan diseases in children may not be
approved for pediatric indications.
(b) Sense of the Senate.--It is the sense of the Senate that the
Food and Drug Administration should enter into a contract with the
Institute of Medicine for the conduct of a study concerning measures
that may be taken to improve the likelihood that Food and Drug
Administration-approved drugs that are safe and effective in treating
children with orphan diseases are made available and affordable for
pediatric indications.

SEC. 512. COLOR CERTIFICATION REPORTS.

Section 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379e) is amended by adding at the end the following:
``(g) Color Certification Reports.--Not later than--
``(1) 90 days after the close of a fiscal year in which
color certification fees are collected, the Secretary shall
submit to Congress a performance report for such fiscal year on
the number of batches of color additives approved, the average
turn around time for approval, and quantifiable goals for
improving laboratory efficiencies; and
``(2) 120 days after the close of a fiscal year in which
color certification fees are collected, the Secretary shall
submit to Congress a financial report for such fiscal year that
includes all fees and expenses of the color certification
program, the balance remaining in the fund at the end of the
fiscal year, and anticipated costs during the next fiscal year
for equipment needs and laboratory improvements of such
program.''.

SEC. 513. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD FACILITY THAT
DENIES ACCESS TO FOOD INSPECTORS.

Notwithstanding any other provision of law, no food product may be
imported into the United States that is the product of a foreign
facility registered under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d) that refuses to permit United States
inspectors, upon request, to inspect such facility or that unduly
delays access to United States inspectors.

SEC. 514. COUNTERFEIT-RESISTANT TECHNOLOGIES.

Notwithstanding any other provision of this Act, the requirement
that the Secretary of Health and Human Services certify that the
implementation of the title of this Act relating to the Importation of
Prescription Drugs will pose no additional risk to the public's health
and safety and will result in a significant reduction in the cost of
covered products to the American consumer shall not apply to the
requirement that the Secretary require that the packaging of any
prescription drug incorporates--
(1) not later than 18 months after the date of enactment of
this Act, a standardized numerical identifier (which, to the
extent practicable, shall be harmonized with international
consensus standards for such an identifier) unique to each
package of such drug, applied at the point of manufacturing and
repackaging (in which case the numerical identifier shall be
linked to the numerical identifier applied at the point of
manufacturing); and
(2) not later than 24 months after the date of enactment of
this Act for the 50 prescription drugs with the highest dollar
volume of sales in the United States, based on the calendar
year that ends of December 31, 2007, and, not later than 30
months after the date of enactment of this Act for all other
prescription drugs--
(A) overt optically variable counterfeit-resistant
technologies that--
(i) are visible to the naked eye, providing
for visual identification of product
authenticity without the need for readers,
microscopes, lighting devices, or scanners;
(ii) are similar to that used by the Bureau
of Engraving and Printing to secure United
States currency;
(iii) are manufactured and distributed in a
highly secure, tightly controlled environment;
and
(iv) incorporate additional layers of
nonvisible convert security features up to and
including forensic capability; or
(B) technologies that have a function of security
comparable to that described in subparagraph (A), as
determined by the Secretary.

SEC. 515. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

(a) Findings.--Congress finds the following:
(1) In 2007, there has been an overwhelming increase in the
volume of aquaculture and seafood that has been found to
contain substances that are not approved for use in food in the
United States.
(2) As of May 2007, inspection programs are not able to
satisfactorily accomplish the goals of ensuring the food safety
of the United States.
(3) To protect the health and safety of consumers in the
United States, the ability of the Secretary of Health and Human
Services to perform inspection functions must be enhanced.
(b) Heightened Inspections.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') is
authorized to, by regulation, enhance, as necessary, the inspection
regime of the Food and Drug Administration for aquaculture and seafood,
consistent with obligations of the United States under international
agreements and United States law.
(c) Report to Congress.--Not later than 90 days after the date of
enactment of this Act, the Secretary shall submit to Congress a report
that--
(1) describes the specifics of the aquaculture and seafood
inspection program;
(2) describes the feasibility of developing a traceability
system for all catfish and seafood products, both domestic and
imported, for the purpose of identifying the processing plant
of origin of such products; and
(3) provides for an assessment of the risks associated with
particular contaminants and banned substances.
(d) Partnerships With States.--Upon the request by any State, the
Secretary may enter into partnership agreements, as soon as practicable
after the request is made, to implement inspection programs regarding
the importation of aquaculture and seafood.
(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section.

SEC. 516. SENSE OF THE SENATE REGARDING CERTAIN PATENT INFRINGEMENTS.

(a) Findings.--The Senate makes the following findings:
(1) Innovation in developing life-saving prescription drugs
saves millions of lives around the world each year.
(2) The responsible protection of intellectual property is
vital to the continued development of new and life-saving drugs
and future growth of the United States economy.
(3) In order to maintain the global competitiveness of the
United States, the United States Trade Representative's Office
of Intellectual Property and Innovation develops and implements
trade policy in support of vital American innovations,
including innovation in the pharmaceutical and medical
technology industries.
(4) The United States Trade Representative also provides
trade policy leadership and expertise across the full range of
interagency initiatives to enhance protection and enforcement
of intellectual property rights.
(5) Strong and fair intellectual property protection,
including patent, copyright, trademark, and data protection
plays an integral role in fostering economic growth and
development and ensuring patient access to the most effective
medicines around the world.
(6) There are concerns that certain countries have engaged
in unfair price manipulation and abuse of compulsory licensing.
Americans bear the majority of research and development costs
for the world, which could undermine the value of existing
United States pharmaceutical patents and could impede access to
important therapies.
(7) There is a growing global threat of counterfeit
medicines and increased need for the United States Trade
Representative and other United States agencies to use
available trade policy measures to strengthen laws and
enforcement abroad to prevent harm to United States patients
and patients around the world.
(b) Sense of the Senate.--It is the sense of the Senate that--
(1) the United States Trade Representative should use all
the tools at the disposal of the Trade Representative to
address violations and other concerns with intellectual
property, including through--
(A) bilateral engagement with United States trading
partners;
(B) transparency and balance of the annual
``Special 301'' review and reviews of compliance with
the intellectual property requirements of countries
with respect to which the United States grants trade
preferences;
(C) negotiation of responsible and fair
intellectual property provisions as part of bilateral
and regional trade agreements; and
(D) multilateral engagement through the World Trade
Organization (WTO); and
(2) the United States Trade Representative should develop
and submit to Congress a strategic plan to address the problem
of countries that infringe upon American pharmaceutical
intellectual property rights and the problem of countries that
engage in price manipulation.

SEC. 517. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD
PRODUCTS.

The Commissioner of Food and Drugs shall consult with the Assistant
Administrator of the National Marine Fisheries Service of the National
Oceanic and Atmospheric Administration to produce a report on any
environmental risks associated with genetically engineered seafood
products, including the impact on wild fish stocks.

SEC. 518. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS.

Not later than 30 days after the date of enactment of this Act, the
Secretary of Health and Human Services, in consultation with the
Secretary of Commerce, shall submit to the Health, Education, Labor,
and Pensions Committee and the Committee on Commerce, Science, and
Transportation of the Senate, a report on the differences between
taxonomy of species of lobster in the subfamily Nephropinae, and
species of langostino, specifically from the infraorder Caridea or
Anomura. This report shall also describe the differences in consumer
perception of such species, including such factors as taste, quality,
and value of the species.

SEC. 519. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.

(a) Civil Penalties.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the
following:
``(g)(1) Any applicant (as such term is used in section 505(o)) who
disseminates a direct-to-consumer advertisement for a prescription drug
that is false or misleading and a violation of section 502(n) shall be
liable to the United States for a civil penalty in an amount not to
exceed $150,000 for the first such violation in any 3-year period, and
not to exceed $300,000 for each subsequent violation committed after
the applicant has been penalized under this paragraph any time in the
preceding 3-year period. For the purposes of this paragraph, repeated
dissemination of the same or similar advertisement prior to the receipt
of the written notice referred to in paragraph (2) for such
advertisements shall be considered as 1 violation.
``(2) A civil penalty under paragraph (1) shall be assessed by the
Secretary by an order made on the record after providing written notice
to the applicant to be assessed a civil penalty and an opportunity for
a hearing in accordance with this paragraph and section 554 of title 5,
United States Code. If upon receipt of the written notice, the
applicant to be assessed a civil penalty objects and requests a
hearing, then in the course of any investigation related to such
hearing, the Secretary may issue subpoenas requiring the attendance and
testimony of witnesses and the production of evidence that relates to
the matter under investigation, including information pertaining to the
factors described in paragraph (3).
``(3) Upon the request of the applicant to be assessed a civil
penalty, the Secretary, in determining the amount of a civil penalty,
shall take into account the nature, circumstances, extent, and gravity
of the violation or violations, including the following factors:
``(A) Whether the applicant submitted the advertisement or
a similar advertisement for review under section 736A.
``(B) Whether the applicant submitted the advertisement for
prereview if required under section 505(o)(5)(D).
``(C) Whether, after submission of the advertisement as
described in subparagraph (A) or (B), the applicant
disseminated the advertisement before the end of the 45-day
comment period.
``(D) Whether the applicant failed to incorporate any
comments made by the Secretary with regard to the advertisement
or a similar advertisement into the advertisement prior to its
dissemination.
``(E) Whether the applicant ceased distribution of the
advertisement upon receipt of the written notice referred to in
paragraph (2) for such advertisement.
``(F) Whether the applicant had the advertisement reviewed
by qualified medical, regulatory, and legal reviewers prior to
its dissemination.
``(G) Whether the violations were material.
``(H) Whether the applicant who created the advertisement
acted in good faith.
``(I) Whether the applicant who created the advertisement
has been assessed a civil penalty under this provision within
the previous 1-year period.
``(J) The scope and extent of any voluntary, subsequent
remedial action by the applicant.
``(K) Such other matters, as justice may require.
``(4)(A) Subject to subparagraph (B), no applicant shall be
required to pay a civil penalty under paragraph (1) if the applicant
submitted the advertisement to the Secretary and disseminated such
advertisement after incorporating any comment received from the
Secretary.
``(B) The Secretary may retract or modify any prior comments the
Secretary has provided to an advertisement submitted to the Secretary
based on new information or changed circumstances, so long as the
Secretary provides written notice to the applicant of the new views of
the Secretary on the advertisement and provides a reasonable time for
modification or correction of the advertisement prior to seeking any
civil penalty under paragraph (1).
``(5) The Secretary may compromise, modify, remit, with or without
conditions, any civil penalty which may be assessed under paragraph
(1). The amount of such penalty, when finally determined, or the amount
charged upon in compromise, may be deducted from any sums owned by the
United States to the applicant charged.
``(6) Any applicant who requested, in accordance with paragraph
(2), a hearing with respect to the assessment of a civil penalty and
who is aggrieved by an order assessing a civil penalty, may file a
petition for de novo judicial review of such order with the United
States Court of Appeals for the District of Columbia Circuit or for any
other circuit in which such applicant resides or transacts business.
Such a petition may only be filed within the 60-day period beginning on
the date the order making such assessments was issued.
``(7) If any applicant fails to pay an assessment of a civil
penalty--
``(A) after the order making the assessment becomes final,
and if such applicant does not file a petition for judicial
review of the order in accordance with paragraph (6); or
``(B) after a court in an action brought under paragraph
(6) has entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the
60-day period referred to in paragraph (6) or date of such final
judgment, as the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be subject to
review.''.
(b) Direct-to-Consumer Advertisement.--
(1) In general.--Section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting
after the first sentence the following: ``In the case of an
advertisement for a prescription drug presented directly to
consumers in television or radio format that states the name of
the drug and its conditions of use, the major statement
relating to side effects, contraindications, and effectiveness
referred to in the previous sentence shall be stated in a clear
and conspicuous (neutral) manner.''.
(2) Regulations to determine neutral manner.--The Secretary
of Health and Human Services shall by regulation establish
standards for determining whether a major statement, relating
to side effects, contraindications, and effectiveness of a
drug, described in section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph
(1)) is presented in the manner required under such section.

SEC. 520. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING
INFORMATION ON THE RELATIONSHIP BETWEEN THE USE OF INDOOR
TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER
SKIN DAMAGE.

(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs, shall determine--
(1) whether the labeling requirements for indoor tanning
devices, including the positioning requirements, provide
sufficient information to consumers regarding the risks that
the use of such devices pose for the development of
irreversible damage to the eyes and skin, including skin
cancer; and
(2)(A) whether modifying the warning label required on
tanning beds to read, ``Ultraviolet radiation can cause skin
cancer'', or any other additional warning, would communicate
the risks of indoor tanning more effectively; or
(B) whether there is no warning that would be capable of
adequately communicating such risks.
(b) Consumer Testing.--In making the determinations under
subsection (a), the Secretary shall conduct appropriate consumer
testing, using the best available methods for determining consumer
understanding of label warnings.
(c) Public Hearings; Public Comment.--The Secretary shall hold
public hearings and solicit comments from the public in making the
determinations under subsection (a).
(d) Report.--Not later than 1 year after the date of the enactment
of this Act, the Secretary shall submit to the Congress a report that
provides the determinations under subsection (a). In addition, the
Secretary shall include in the report the measures being implemented by
the Secretary to significantly reduce the risks associated with indoor
tanning devices.

TITLE VI--FOOD SAFETY

SEC. 601. FINDINGS.

(a) Findings.--Congress finds that--
(1) the safety and integrity of the United States food
supply is vital to the public health, to public confidence in
the food supply, and to the success of the food sector of the
Nation's economy;
(2) illnesses and deaths of individuals and companion
animals caused by contaminated food--
(A) have contributed to a loss of public confidence
in food safety; and
(B) have caused significant economic losses to
manufacturers and producers not responsible for
contaminated food items;
(3) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and
the ability to detect all forms of contamination; and
(B) an increasing volume of imported food from a
wide variety of countries; and
(C) a shortage of adequate resources for monitoring
and inspection;
(4) the United States is increasing the amount of food that
it imports such that--
(A) from 2003 to the present, the value of food
imports has increased from $45,600,000,000 to
$64,000,000,000; and
(B) imported food accounts for 13 percent of the
average Americans diet including 31 percent of fruits,
juices, and nuts, 9.5 percent of red meat and 78.6
percent of fish and shellfish; and
(5) the number of full time equivalent Food and Drug
Administration employees conducting inspections has decreased
from 2003 to 2007.

SEC. 602. ENSURING THE SAFETY OF PET FOOD.

(a) Processing and Ingredient Standards.--Not later than 18 months
after the date of enactment of this Act, the Secretary of Health and
Human Services (referred to in this title as the ``Secretary''), in
consultation with the Association of American Feed Control Officials,
and other relevant stakeholder groups, including veterinary medical
associations, animal health organizations, and pet food manufacturers,
shall by regulation establish--
(1) processing and ingredient standards with respect to pet
food, animal waste, and ingredient definitions; and
(2) updated standards for the labeling of pet food that
includes nutritional information and ingredient information.
(b) Early Warning Surveillance Systems and Notification During Pet
Food Recalls.--Not later than 180 days after the date of enactment of
this Act, the Secretary shall by regulation establish an early warning
and surveillance system to identify adulteration of the pet food supply
and outbreaks of illness associated with pet food. In establishing such
system, the Secretary shall--
(1) use surveillance and monitoring mechanisms similar to,
or in coordination with, those mechanisms used by the Centers
for Disease Control and Prevention to monitor human health,
such as the Foodborne Diseases Active Surveillance Network
(FoodNet) and PulseNet;
(2) consult with relevant professional associations and
private sector veterinary hospitals; and
(3) work with the Health Alert Network and other
notification networks to inform veterinarians and relevant
stakeholders during any recall of pet food.

SEC. 603. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A
RECALL.

The Secretary shall, during an ongoing recall of human or pet
food--
(1) work with companies, relevant professional
associations, and other organizations to collect and aggregate
information pertaining to the recall;
(2) use existing networks of communication including
electronic forms of information dissemination to enhance the
quality and speed of communication with the public; and
(3) post information regarding recalled products on the
Internet website of the Food and Drug Administration in a
consolidated, searchable form that is easily accessed and
understood by the public.

SEC. 604. STATE AND FEDERAL COOPERATION.

(a) In General.--The Secretary shall work with the States in
undertaking activities and programs that assist in improving the safety
of fresh and processed produce so that State food safety programs
involving the safety of fresh and processed produce and activities
conducted by the Secretaries function in a coordinated and cost-
effective manner. With the assistance provided under subsection (b),
the Secretary shall encourage States to--
(1) establish, continue, or strengthen State food safety
programs, especially with respect to the regulation of retail
commercial food establishments; and
(2) establish procedures and requirements for ensuring that
processed produce under the jurisdiction of the State food
safety programs is not unsafe for human consumption.
(b) Assistance.--The Secretary may provide to a State, for
planning, developing, and implementing such a food safety program--
(1) advisory assistance;
(2) technical assistance, training, and laboratory
assistance (including necessary materials and equipment); and
(3) financial and other assistance.
(c) Service Agreements.--The Secretary may, under an agreement
entered into with a Federal, State, or local agency, use, on a
reimbursable basis or otherwise, the personnel, services, and
facilities of the agency to carry out the responsibilities of the
agency under this section. An agreement entered into with a State
agency under this subsection may provide for training of State
employees.

SEC. 605. ADULTERATED FOOD REGISTRY.

(a) Findings.--Congress makes the following findings:
(1) In 1994, Congress passed the Dietary Supplement Health
and Education Act (P.L. 103-417) to provide the Food and Drug
Administration with the legal framework to ensure that dietary
supplements are safe and properly labeled foods.
(2) In 2006, Congress passed the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (P.L. 109-462) to
establish a mandatory reporting system of serious adverse
events for non-prescription drugs and dietary supplements sold
and consumed in the United States.
(3) The adverse event reporting system created under the
Dietary Supplement and Nonprescription Drug Consumer Protection
Act will serve as the early warning system for any potential
public health issues associated with the use of these food
products.
(4) A reliable mechanism to track patterns of adulteration
in food would support efforts by the Food and Drug
Administration to effectively target limited inspection
resources to protect the public health.
(b) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:

``SEC. 417. ADULTERATED FOOD REGISTRY.

``(a) Definitions.--In this section:
``(1) Importer.--The term `importer', with respect to an
article of food, means the person who submitted the notice with
respect to such article of food under section 801(m).
``(2) Responsible party.--The term `responsible party',
with respect to an article of food, means any registered food
facility under section 415(a), including those responsible for
the manufacturing, processing, packaging or holding of such
food for consumption in the United States.
``(3) Reportable adulterated food.--The term `reportable
adulterated food' for purposes of this section means a food
that is adulterated or--
``(A) presents a situation in which there is a
reasonable probability that the use of, or exposure to,
a violative product will cause serious adverse health
consequences or death as defined in section 7.3(m)(1)
of title, Code of Federal Regulations (or any successor
regulations); or
``(B) meets the threshold established in section
304(h).
``(b) Establishment.--
``(1) In general.--Not later than 180 days after the date
of enactment of this section, the Secretary shall establish
within the Food and Drug Administration an Adulterated Food
Registry to which instances of reportable adulterated food may
be submitted by the Food and Drug Administration after receipt
of reports of adulteration, via an electronic portal, from--
``(A) Federal, State, and local public health
officials;
``(B) an importer;
``(C) a responsible party; or
``(D) a consumer or other individual.
``(2) Review by secretary.--The Secretary shall review and
determine the validity of the information submitted under
paragraph (1) for the purposes of identifying adulterated food,
submitting entries to the Adulterated Food Registry, acting
under subsection (c), and exercising other existing food safety
authorities under the Act to protect the public health.
``(c) Issuance of an Alert by the Secretary.--
``(1) In general.--The Secretary shall issue an alert with
respect to an adulterated food if the Adulterated Food Registry
shows that the food--
``(A) has been associated with repeated and
separate outbreaks of illness or has been repeatedly
determined to be adulterated; or
``(B) is a reportable adulterated food.
``(2) Scope of alert.--An alert under paragraph (1) may
apply to a particular food or to food from a particular
producer, manufacturer, shipper, growing area, or country, to
the extent that elements in subparagraph (A) or (B) of
paragraph (1) are associated with the particular food,
producer, manufacturer, shipper, growing area, or country.
``(d) Submission by a Consumer or Other Individual.--A consumer or
other individual may submit a report to the Food and Drug
Administration using the electronic portal data elements described in
subsection (e). Such reports shall be evaluated by the Secretary as
specified in subsection (b)(2).
``(e) Notification and Reporting of Adulteration.--
``(1) Determination by responsible party or importer.--If a
responsible party or importer determines that an article of
food it produced, processed, manufactured, distributed, or
otherwise handled is a reportable adulterated food, the
responsible party shall provide the notifications described
under paragraph (2).
``(2) Notification of adulteration.--
``(A) In general.--Not later than 5 days after a
responsible party or importer receives a notification,
the responsible party or importer, as applicable, shall
review whether the food referenced in the report
described in paragraph (1) is a reportable adulterated
food.
``(B) Notification.--If a determination is made by
such responsible party or importer that the food is a
reportable adulterated food, such responsible party or
importer shall, no later than 2 days after such
determination is made, notify other responsible parties
directly linked in the supply chain to which and from
which the article of reportable adulterated food was
transferred.
``(3) Submission of reports to the food and drug
administration by a responsible party or importer.--The
responsible party or importer, as applicable, shall submit a
report to the Food and Drug Administration through the
electronic portal using the data elements described in
subsection (f) not later than 2 days after a responsible party
or importer--
``(A) makes a notification under paragraph (2)(B);
or
``(B) determines that an article of food it
produced, processed, manufactured, distributed,
imported, or otherwise handled is a reportable
adulterated food, except that if such adulteration was
initiated with such responsible party or importer, was
detected prior to any transfer of such article of food,
and was destroyed, no report is necessary.
``(f) Data Elements in the Registry.--A report submitted to the
Food and Drug Administration electronic portal under subsection (e)
shall include the following data elements:
``(1) Contact information for the individual or entity
submitting the report.
``(2) The date on which an article of food was determined
to be adulterated or suspected of being adulterated.
``(3) A description of the article of food including the
quantity or amount.
``(4) The extent and nature of the adulteration.
``(5) The disposition of the article.
``(6) Product information typically found on packaging
including product codes, use by dates, and names of
manufactures or distributors.
``(7) Information about the place of purchase or process by
which the consumer or other individual acquired the article of
adulterated food.
``(8) In the case of a responsible party or an importer,
the elements required for the registration of food facilities
under section 415(a).
``(9) The contact information for parties directly linked
in the supply chain and notified under subsection (e)(2).
``(10) In the case of an importer, the elements required
for the prior notice of imported food shipments under section
801(m).
``(g) Maintenance and Inspection of Records.--The responsible
person or importer shall maintain records related to each report
received, notification made, and report submitted to the Food and Drug
Administration under this section and permit inspection of such records
as provided for in section 414. Such records shall also be made
available during an inspection under section 704.
``(h) Request for Information.--Section 552 of title 5, United
States Code, shall apply to any request for information regarding a
record in the Adulterated Food Registry.
``(i) Homeland Security Notification.--If, after receiving a report
under subsection (e), the Secretary suspects such food may have been
deliberately adulterated, the Secretary shall immediately notify the
Secretary of Homeland Security. The Secretary shall make the data in
the Adulterated Imported Food Registry available to the Secretary of
Homeland Security.''.
(c) Definition.--Section 201(ff) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ``section
201(g)'' and inserting ``sections 201(g) and 417''.
(d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by this Act, is further
amended by adding at the end the following:
``(kk) The failure to provide a report as required under section
417(e)(3).
``(ll) The falsification a report as required under section
417(e)(3).''.
(e) Suspected Food Adulteration Regulations.--The Secretary shall,
within 180 days of enactment of this Act, promulgate regulations that
establish standards and thresholds by which importers and responsible
parties shall be required and consumers may be able to, under section
417 of the Federal Food, Drug, and Cosmetic Act (as added by this
section)--
(1) report instances of suspected reportable adulteration
of food to the Food and Drug Administration for possible
inclusion in the Adulterated Food Registry after evaluation of
such report; and
(2) notify, in keeping with subsection (e)(2) of such
section 417, other responsible parties directly linked in the
supply chain, including establishments as defined in section
415(b) of such Act.
(f) Effective Date.--The requirements of section 417(e) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall
become effective 180 days after the date of enactment of this Act.

SEC. 606. SENSE OF THE SENATE.

It is the sense of the Senate that--
(1) it is vital for Congress to provide the Food and Drug
Administration with additional resources, authorities, and
direction with respect to ensuring the safety of the food
supply of the United States;
(2) additional inspectors are required to improve the Food
and Drug Administration's ability to safeguard the food supply
of the United States;
(3) because of the increasing volume of international trade
in food products the Secretary of Health and Human Services
should make it a priority to enter into agreements with the
trading partners of the United States with respect to food
safety; and
(4) the Senate should work to develop a comprehensive
response to the issue of food safety.

SEC. 607. ANNUAL REPORT TO CONGRESS.

The Secretary shall, on an annual basis, submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and Commerce
and the Committee on Appropriations of the House of Representatives a
report that includes, with respect to the preceding 1-year period--
(1) the number and amount of food products regulated by the
Food and Drug Administration imported into the United States,
aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration
inspectors of imported food products referenced in paragraph
(1) and the number of Food and Drug Administration inspections
performed on such products; and
(3) aggregated data on the findings of such inspections,
including data related to violations of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement
actions used to follow-up on such findings and violations.

SEC. 608. RULE OF CONSTRUCTION.

Nothing in this title (or an amendment made by this title) shall be
construed to affect--
(1) the regulation of dietary supplements under the Dietary
Supplement Health and Education Act; or
(2) the adverse event reporting system for dietary
supplements created under the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.

SEC. 609. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated to carry out this title
(and the amendments made by this title) such sums as may be necessary.

TITLE VII--DOMESTIC PET TURTLE MARKET ACCESS

SEC. 701. SHORT TITLE.

This title may be cited as the ``Domestic Pet Turtle Market Access
Act of 2007''.

SEC. 702. FINDINGS.

Congress makes the following findings:
(1) Pet turtles less than 10.2 centimeters in diameter have
been banned for sale in the United States by the Food and Drug
Administration since 1975 due to health concerns.
(2) The Food and Drug Administration does not ban the sale
of iguanas or other lizards, snakes, frogs, or other amphibians
or reptiles that are sold as pets in the United States that
also carry salmonella bacteria. The Food and Drug
Administration also does not require that these animals be
treated for salmonella bacteria before being sold as pets.
(3) The technology to treat turtles for salmonella, and
make them safe for sale, has greatly advanced since 1975.
Treatments exist that can nearly eradicate salmonella from
turtles, and individuals are more aware of the causes of
salmonella, how to treat salmonella poisoning, and the
seriousness associated with salmonella poisoning.
(4) University research has shown that these turtles can be
treated in such a way that they can be raised, shipped, and
distributed without having a recolonization of salmonella.
(5) University research has also shown that pet owners can
be equipped with a treatment regiment that allows the turtle to
be maintained safe from salmonella.
(6) The Food and Drug Administration should allow the sale
of turtles less than 10.2 centimeters in diameter as pets as
long as the sellers are required to use proven methods to treat
these turtles for salmonella.

SEC. 703. SALE OF BABY TURTLES.

Notwithstanding any other provision of law, the Food and Drug
Administration shall not restrict the sale by a turtle farmer,
wholesaler, or commercial retail seller of a turtle that is less than
10.2 centimeters in diameter as a pet if--
(1) the State or territory in which such farmer is located
has developed a regulatory process by which pet turtle farmers
are required to have a State license to breed, hatch,
propagate, raise, grow, receive, ship, transport, export, or
sell pet turtles or pet turtle eggs;
(2) such State or territory requires certification of
sanitization that is signed by a veterinarian who is licensed
in the State or territory, and approved by the State or
territory agency in charge of regulating the sale of pet
turtles;
(3) the certification of sanitization requires each turtle
to be sanitized or treated for diseases, including salmonella,
and is dependant upon using the Siebeling method, or other such
proven non-antibiotic method, to make the turtle salmonella-
free; and
(4) the turtle farmer or commercial retail seller includes,
with the sale of such a turtle, a disclosure to the buyer that
includes--
(A) information regarding--
(i) the possibility that salmonella can re-
colonize in turtles;
(ii) the dangers, including possible severe
illness or death, especially for at-risk people
who may be susceptible to salmonella poisoning,
such as children, pregnant women, and others
who may have weak immune systems, that could
result if the turtle is not properly handled
and safely maintained;
(iii) the proper handling of the turtle,
including an explanation of proper hygiene such
as handwashing after handling a turtle; and
(iv) the proven methods of treatment that,
if properly applied, keep the turtle safe from
salmonella;
(B) a detailed explanation of how to properly treat
the turtle to keep it safe from salmonella, using the
proven methods of treatment referred to under
subparagraph (A), and how the buyer can continue to
purchase the tools, treatments, or any other required
item to continually treat the turtle; and
(C) a statement that buyers of pet turtles should
not abandon the turtle or abandon it outside, as the
turtle may become an invasive species to the local
community, but should instead return them to a
commercial retail pet seller or other organization that
would accept turtles no longer wanted as pets.

SEC. 704. FDA REVIEW OF STATE PROTECTIONS.

The Commissioner of Food and Drugs may, after providing an
opportunity for the affected State to respond, restrict the sale of a
turtle only if the Secretary of Health and Human Services determines
that the actual implementation of State health protections described in
this title are insufficient to protect consumers against infectious
diseases acquired from such turtle at the time of sale.

TITLE VIII--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 801. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Market Access and
Drug Safety Act of 2007''.

SEC. 802. FINDINGS.

Congress finds that--
(1) Americans unjustly pay up to 5 times more to fill their
prescriptions than consumers in other countries;
(2) the United States is the largest market for
pharmaceuticals in the world, yet American consumers pay the
highest prices for brand pharmaceuticals in the world;
(3) a prescription drug is neither safe nor effective to an
individual who cannot afford it;
(4) allowing and structuring the importation of
prescription drugs to ensure access to safe and affordable
drugs approved by the Food and Drug Administration will provide
a level of safety to American consumers that they do not
currently enjoy;
(5) American spend more than $200,000,000,000 on
prescription drugs every year;
(6) the Congressional Budget Office has found that the cost
of prescription drugs are between 35 to 55 percent less in
other highly-developed countries than in the United States; and
(7) promoting competitive market pricing would both
contribute to health care savings and allow greater access to
therapy, improving health and saving lives.

SEC. 803. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF
PRESCRIPTION DRUGS.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.) is amended by striking section 804.

SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT
RESTRICTIONS.

(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 803, is
further amended by inserting after section 803 the following:

``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.

``(a) Importation of Prescription Drugs.--
``(1) In general.--In the case of qualifying drugs imported
or offered for import into the United States from registered
exporters or by registered importers--
``(A) the limitation on importation that is
established in section 801(d)(1) is waived; and
``(B) the standards referred to in section 801(a)
regarding admission of the drugs are subject to
subsection (g) of this section (including with respect
to qualifying drugs to which section 801(d)(1) does not
apply).
``(2) Importers.--A qualifying drug may not be imported
under paragraph (1) unless--
``(A) the drug is imported by a pharmacy, group of
pharmacies, or a wholesaler that is a registered
importer; or
``(B) the drug is imported by an individual for
personal use or for the use of a family member of the
individual (not for resale) from a registered exporter.
``(3) Rule of construction.--This section shall apply only
with respect to a drug that is imported or offered for import
into the United States--
``(A) by a registered importer; or
``(B) from a registered exporter to an individual.
``(4) Definitions.--
``(A) Registered exporter; registered importer.--
For purposes of this section:
``(i) The term `registered exporter' means
an exporter for which a registration under
subsection (b) has been approved and is in
effect.
``(ii) The term `registered importer' means
a pharmacy, group of pharmacies, or a
wholesaler for which a registration under
subsection (b) has been approved and is in
effect.
``(iii) The term `registration condition'
means a condition that must exist for a
registration under subsection (b) to be
approved.
``(B) Qualifying drug.--For purposes of this
section, the term `qualifying drug' means a drug for
which there is a corresponding U.S. label drug.
``(C) U.S. label drug.--For purposes of this
section, the term `U.S. label drug' means a
prescription drug that--
``(i) with respect to a qualifying drug,
has the same active ingredient or ingredients,
route of administration, dosage form, and
strength as the qualifying drug;
``(ii) with respect to the qualifying drug,
is manufactured by or for the person that
manufactures the qualifying drug;
``(iii) is approved under section 505(c);
and
``(iv) is not--
``(I) a controlled substance, as
defined in section 102 of the
Controlled Substances Act (21 U.S.C.
802);
``(II) a biological product, as
defined in section 351 of the Public
Health Service Act (42 U.S.C. 262),
including--
``(aa) a therapeutic DNA
plasmid product;
``(bb) a therapeutic
synthetic peptide product;
``(cc) a monoclonal
antibody product for in vivo
use; and
``(dd) a therapeutic
recombinant DNA-derived
product;
``(III) an infused drug, including
a peritoneal dialysis solution;
``(IV) an injected drug;
``(V) a drug that is inhaled during
surgery;
``(VI) a drug that is the listed
drug referred to in 2 or more
abbreviated new drug applications under
which the drug is commercially
marketed; or
``(VII) a sterile opthlamic drug
intended for topical use on or in the
eye.
``(D) Other definitions.--For purposes of this
section:
``(i)(I) The term `exporter' means a person
that is in the business of exporting a drug to
individuals in the United States from Canada or
from a permitted country designated by the
Secretary under subclause (II), or that,
pursuant to submitting a registration under
subsection (b), seeks to be in such business.
``(II) The Secretary shall designate a
permitted country under subparagraph (E) (other
than Canada) as a country from which an
exporter may export a drug to individuals in
the United States if the Secretary determines
that--
``(aa) the country has statutory or
regulatory standards that are
equivalent to the standards in the
United States and Canada with respect
to--
``(AA) the training of
pharmacists;
``(BB) the practice of
pharmacy; and
``(CC) the protection of
the privacy of personal medical
information; and
``(bb) the importation of drugs to
individuals in the United States from
the country will not adversely affect
public health.
``(ii) The term `importer' means a
pharmacy, a group of pharmacies, or a
wholesaler that is in the business of importing
a drug into the United States or that, pursuant
to submitting a registration under subsection
(b), seeks to be in such business.
``(iii) The term `pharmacist' means a
person licensed by a State to practice
pharmacy, including the dispensing and selling
of prescription drugs.
``(iv) The term `pharmacy' means a person
that--
``(I) is licensed by a State to
engage in the business of selling
prescription drugs at retail; and
``(II) employs 1 or more
pharmacists.
``(v) The term `prescription drug' means a
drug that is described in section 503(b)(1).
``(vi) The term `wholesaler'--
``(I) means a person licensed as a
wholesaler or distributor of
prescription drugs in the United States
under section 503(e)(2)(A); and
``(II) does not include a person
authorized to import drugs under
section 801(d)(1).
``(E) Permitted country.--The term `permitted
country' means--
``(i) Australia;
``(ii) Canada;
``(iii) a member country of the European
Union, but does not include a member country
with respect to which--
``(I) the country's Annex to the
Treaty of Accession to the European
Union 2003 includes a transitional
measure for the regulation of human
pharmaceutical products that has not
expired; or
``(II) the Secretary determines
that the requirements described in
subclauses (I) and (II) of clause (vii)
will not be met by the date on which
such transitional measure for the
regulation of human pharmaceutical
products expires;
``(iv) Japan;
``(v) New Zealand;
``(vi) Switzerland; and
``(vii) a country in which the Secretary
determines the following requirements are met:
``(I) The country has statutory or
regulatory requirements--
``(aa) that require the
review of drugs for safety and
effectiveness by an entity of
the government of the country;
``(bb) that authorize the
approval of only those drugs
that have been determined to be
safe and effective by experts
employed by or acting on behalf
of such entity and qualified by
scientific training and
experience to evaluate the
safety and effectiveness of
drugs on the basis of adequate
and well-controlled
investigations, including
clinical investigations,
conducted by experts qualified
by scientific training and
experience to evaluate the
safety and effectiveness of
drugs;
``(cc) that require the
methods used in, and the
facilities and controls used
for the manufacture,
processing, and packing of
drugs in the country to be
adequate to preserve their
identity, quality, purity, and
strength;
``(dd) for the reporting of
adverse reactions to drugs and
procedures to withdraw approval
and remove drugs found not to
be safe or effective; and
``(ee) that require the
labeling and promotion of drugs
to be in accordance with the
approval of the drug.
``(II) The valid marketing
authorization system in the country is
equivalent to the systems in the
countries described in clauses (i)
through (vi).
``(III) The importation of drugs to
the United States from the country will
not adversely affect public health.
``(b) Registration of Importers and Exporters.--
``(1) Registration of importers and exporters.--A
registration condition is that the importer or exporter
involved (referred to in this subsection as a `registrant')
submits to the Secretary a registration containing the
following:
``(A)(i) In the case of an exporter, the name of
the exporter and an identification of all places of
business of the exporter that relate to qualifying
drugs, including each warehouse or other facility owned
or controlled by, or operated for, the exporter.
``(ii) In the case of an importer, the name of the
importer and an identification of the places of
business of the importer at which the importer
initially receives a qualifying drug after importation
(which shall not exceed 3 places of business except by
permission of the Secretary).
``(B) Such information as the Secretary determines
to be necessary to demonstrate that the registrant is
in compliance with registration conditions under--
``(i) in the case of an importer,
subsections (c), (d), (e), (g), and (j)
(relating to the sources of imported qualifying
drugs; the inspection of facilities of the
importer; the payment of fees; compliance with
the standards referred to in section 801(a);
and maintenance of records and samples); or
``(ii) in the case of an exporter,
subsections (c), (d), (f), (g), (h), (i), and
(j) (relating to the sources of exported
qualifying drugs; the inspection of facilities
of the exporter and the marking of compliant
shipments; the payment of fees; and compliance
with the standards referred to in section
801(a); being licensed as a pharmacist;
conditions for individual importation; and
maintenance of records and samples).
``(C) An agreement by the registrant that the
registrant will not under subsection (a) import or
export any drug that is not a qualifying drug.
``(D) An agreement by the registrant to--
``(i) notify the Secretary of a recall or
withdrawal of a qualifying drug distributed in
a permitted country that the registrant has
exported or imported, or intends to export or
import, to the United States under subsection
(a);
``(ii) provide for the return to the
registrant of such drug; and
``(iii) cease, or not begin, the
exportation or importation of such drug unless
the Secretary has notified the registrant that
exportation or importation of such drug may
proceed.
``(E) An agreement by the registrant to ensure and
monitor compliance with each registration condition, to
promptly correct any noncompliance with such a
condition, and to promptly report to the Secretary any
such noncompliance.
``(F) A plan describing the manner in which the
registrant will comply with the agreement under
subparagraph (E).
``(G) An agreement by the registrant to enforce a
contract under subsection (c)(3)(B) against a party in
the chain of custody of a qualifying drug with respect
to the authority of the Secretary under clauses (ii)
and (iii) of that subsection.
``(H) An agreement by the registrant to notify the
Secretary not more than 30 days before the registrant
intends to make the change, of--
``(i) any change that the registrant
intends to make regarding information provided
under subparagraph (A) or (B); and
``(ii) any change that the registrant
intends to make in the compliance plan under
subparagraph (F).
``(I) In the case of an exporter--
``(i) An agreement by the exporter that a
qualifying drug will not under subsection (a)
be exported to any individual not authorized
pursuant to subsection (a)(2)(B) to be an
importer of such drug.
``(ii) An agreement to post a bond, payable
to the Treasury of the United States that is
equal in value to the lesser of--
``(I) the value of drugs exported
by the exporter to the United States in
a typical 4-week period over the course
of a year under this section; or
``(II) $1,000,000;
``(iii) An agreement by the exporter to
comply with applicable provisions of Canadian
law, or the law of the permitted country
designated under subsection (a)(4)(D)(i)(II) in
which the exporter is located, that protect the
privacy of personal information with respect to
each individual importing a prescription drug
from the exporter under subsection (a)(2)(B).
``(iv) An agreement by the exporter to
report to the Secretary--
``(I) not later than August 1 of
each fiscal year, the total price and
the total volume of drugs exported to
the United States by the exporter
during the 6-month period from January
1 through June 30 of that year; and
``(II) not later than January 1 of
each fiscal year, the total price and
the total volume of drugs exported to
the United States by the exporter
during the previous fiscal year.
``(J) In the case of an importer, an agreement by
the importer to report to the Secretary--
``(i) not later than August 1 of each
fiscal year, the total price and the total
volume of drugs imported to the United States
by the importer during the 6-month period from
January 1 through June 30 of that fiscal year;
and
``(ii) not later than January 1 of each
fiscal year, the total price and the total
volume of drugs imported to the United States
by the importer during the previous fiscal
year.
``(K) Such other provisions as the Secretary may
require by regulation to protect the public health
while permitting--
``(i) the importation by pharmacies, groups
of pharmacies, and wholesalers as registered
importers of qualifying drugs under subsection
(a); and
``(ii) importation by individuals of
qualifying drugs under subsection (a).
``(2) Approval or disapproval of registration.--
``(A) In general.--Not later than 90 days after the
date on which a registrant submits to the Secretary a
registration under paragraph (1), the Secretary shall
notify the registrant whether the registration is
approved or is disapproved. The Secretary shall
disapprove a registration if there is reason to believe
that the registrant is not in compliance with one or
more registration conditions, and shall notify the
registrant of such reason. In the case of a disapproved
registration, the Secretary shall subsequently notify
the registrant that the registration is approved if the
Secretary determines that the registrant is in
compliance with such conditions.
``(B) Changes in registration information.--Not
later than 30 days after receiving a notice under
paragraph (1)(H) from a registrant, the Secretary shall
determine whether the change involved affects the
approval of the registration of the registrant under
paragraph (1), and shall inform the registrant of the
determination.
``(3) Publication of contact information for registered
exporters.--Through the Internet website of the Food and Drug
Administration and a toll-free telephone number, the Secretary
shall make readily available to the public a list of registered
exporters, including contact information for the exporters.
Promptly after the approval of a registration submitted under
paragraph (1), the Secretary shall update the Internet website
and the information provided through the toll-free telephone
number accordingly.
``(4) Suspension and termination.--
``(A) Suspension.--With respect to the
effectiveness of a registration submitted under
paragraph (1):
``(i) Subject to clause (ii), the Secretary
may suspend the registration if the Secretary
determines, after notice and opportunity for a
hearing, that the registrant has failed to
maintain substantial compliance with a
registration condition.
``(ii) If the Secretary determines that,
under color of the registration, the exporter
has exported a drug or the importer has
imported a drug that is not a qualifying drug,
or a drug that does not comply with subsection
(g)(2)(A) or (g)(4), or has exported a
qualifying drug to an individual in violation
of subsection (i)(2)(F), the Secretary shall
immediately suspend the registration. A
suspension under the preceding sentence is not
subject to the provision by the Secretary of
prior notice, and the Secretary shall provide
to the registrant an opportunity for a hearing
not later than 10 days after the date on which
the registration is suspended.
``(iii) The Secretary may reinstate the
registration, whether suspended under clause
(i) or (ii), if the Secretary determines that
the registrant has demonstrated that further
violations of registration conditions will not
occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the
registration under paragraph (1) of a registrant if the
Secretary determines that the registrant has engaged in
a pattern or practice of violating 1 or more
registration conditions, or if on 1 or more occasions
the Secretary has under subparagraph (A)(ii) suspended
the registration of the registrant. The Secretary may
make the termination permanent, or for a fixed period
of not less than 1 year. During the period in which the
registration is terminated, any registration submitted
under paragraph (1) by the registrant, or a person that
is a partner in the export or import enterprise, or a
principal officer in such enterprise, and any
registration prepared with the assistance of the
registrant or such a person, has no legal effect under
this section.
``(5) Default of bond.--A bond required to be posted by an
exporter under paragraph (1)(I)(ii) shall be defaulted and paid
to the Treasury of the United States if, after opportunity for
an informal hearing, the Secretary determines that the exporter
has--
``(A) exported a drug to the United States that is
not a qualifying drug or that is not in compliance with
subsection (g)(2)(A), (g)(4), or (i); or
``(B) failed to permit the Secretary to conduct an
inspection described under subsection (d).
``(c) Sources of Qualifying Drugs.--A registration condition is
that the exporter or importer involved agrees that a qualifying drug
will under subsection (a) be exported or imported into the United
States only if there is compliance with the following:
``(1) The drug was manufactured in an establishment--
``(A) required to register under subsection (h) or
(i) of section 510; and
``(B)(i) inspected by the Secretary; or
``(ii) for which the Secretary has elected to rely
on a satisfactory report of a good manufacturing
practice inspection of the establishment from a
permitted country whose regulatory system the Secretary
recognizes as equivalent under a mutual recognition
agreement, as provided for under section 510(i)(3),
section 803, or part 26 of title 21, Code of Federal
Regulations (or any corresponding successor rule or
regulation).
``(2) The establishment is located in any country, and the
establishment manufactured the drug for distribution in the
United States or for distribution in 1 or more of the permitted
countries (without regard to whether in addition the drug is
manufactured for distribution in a foreign country that is not
a permitted country).
``(3) The exporter or importer obtained the drug--
``(A) directly from the establishment; or
``(B) directly from an entity that, by contract
with the exporter or importer--
``(i) provides to the exporter or importer
a statement (in such form and containing such
information as the Secretary may require) that,
for the chain of custody from the
establishment, identifies each prior sale,
purchase, or trade of the drug (including the
date of the transaction and the names and
addresses of all parties to the transaction);
``(ii) agrees to permit the Secretary to
inspect such statements and related records to
determine their accuracy;
``(iii) agrees, with respect to the
qualifying drugs involved, to permit the
Secretary to inspect warehouses and other
facilities, including records, of the entity
for purposes of determining whether the
facilities are in compliance with any standards
under this Act that are applicable to
facilities of that type in the United States;
and
``(iv) has ensured, through such
contractual relationships as may be necessary,
that the Secretary has the same authority
regarding other parties in the chain of custody
from the establishment that the Secretary has
under clauses (ii) and (iii) regarding such
entity.
``(4)(A) The foreign country from which the importer will
import the drug is a permitted country; or
``(B) The foreign country from which the exporter will
export the drug is the permitted country in which the exporter
is located.
``(5) During any period in which the drug was not in the
control of the manufacturer of the drug, the drug did not enter
any country that is not a permitted country.
``(6) The exporter or importer retains a sample of each lot
of the drug for testing by the Secretary.
``(d) Inspection of Facilities; Marking of Shipments.--
``(1) Inspection of facilities.--A registration condition
is that, for the purpose of assisting the Secretary in
determining whether the exporter involved is in compliance with
all other registration conditions--
``(A) the exporter agrees to permit the Secretary--
``(i) to conduct onsite inspections,
including monitoring on a day-to-day basis, of
places of business of the exporter that relate
to qualifying drugs, including each warehouse
or other facility owned or controlled by, or
operated for, the exporter;
``(ii) to have access, including on a day-
to-day basis, to--
``(I) records of the exporter that
relate to the export of such drugs,
including financial records; and
``(II) samples of such drugs;
``(iii) to carry out the duties described
in paragraph (3); and
``(iv) to carry out any other functions
determined by the Secretary to be necessary
regarding the compliance of the exporter; and
``(B) the Secretary has assigned 1 or more
employees of the Secretary to carry out the functions
described in this subsection for the Secretary
randomly, but not less than 12 times annually, on the
premises of places of businesses referred to in
subparagraph (A)(i), and such an assignment remains in
effect on a continuous basis.
``(2) Marking of compliant shipments.--A registration
condition is that the exporter involved agrees to affix to each
shipping container of qualifying drugs exported under
subsection (a) such markings as the Secretary determines to be
necessary to identify the shipment as being in compliance with
all registration conditions. Markings under the preceding
sentence shall--
``(A) be designed to prevent affixation of the
markings to any shipping container that is not
authorized to bear the markings; and
``(B) include anticounterfeiting or track-and-trace
technologies, taking into account the economic and
technical feasibility of those technologies.
``(3) Certain duties relating to exporters.--Duties of the
Secretary with respect to an exporter include the following:
``(A) Inspecting, randomly, but not less than 12
times annually, the places of business of the exporter
at which qualifying drugs are stored and from which
qualifying drugs are shipped.
``(B) During the inspections under subparagraph
(A), verifying the chain of custody of a statistically
significant sample of qualifying drugs from the
establishment in which the drug was manufactured to the
exporter, which shall be accomplished or supplemented
by the use of anticounterfeiting or track-and-trace
technologies, taking into account the economic and
technical feasibility of those technologies, except
that a drug that lacks such technologies from the point
of manufacture shall not for that reason be excluded
from importation by an exporter.
``(C) Randomly reviewing records of exports to
individuals for the purpose of determining whether the
drugs are being imported by the individuals in
accordance with the conditions under subsection (i).
Such reviews shall be conducted in a manner that will
result in a statistically significant determination of
compliance with all such conditions.
``(D) Monitoring the affixing of markings under
paragraph (2).
``(E) Inspecting as the Secretary determines is
necessary the warehouses and other facilities,
including records, of other parties in the chain of
custody of qualifying drugs.
``(F) Determining whether the exporter is in
compliance with all other registration conditions.
``(4) Prior notice of shipments.--A registration condition
is that, not less than 8 hours and not more than 5 days in
advance of the time of the importation of a shipment of
qualifying drugs, the importer involved agrees to submit to the
Secretary a notice with respect to the shipment of drugs to be
imported or offered for import into the United States under
subsection (a). A notice under the preceding sentence shall
include--
``(A) the name and complete contact information of
the person submitting the notice;
``(B) the name and complete contact information of
the importer involved;
``(C) the identity of the drug, including the
established name of the drug, the quantity of the drug,
and the lot number assigned by the manufacturer;
``(D) the identity of the manufacturer of the drug,
including the identity of the establishment at which
the drug was manufactured;
``(E) the country from which the drug is shipped;
``(F) the name and complete contact information for
the shipper of the drug;
``(G) anticipated arrival information, including
the port of arrival and crossing location within that
port, and the date and time;
``(H) a summary of the chain of custody of the drug
from the establishment in which the drug was
manufactured to the importer;
``(I) a declaration as to whether the Secretary has
ordered that importation of the drug from the permitted
country cease under subsection (g)(2)(C) or (D); and
``(J) such other information as the Secretary may
require by regulation.
``(5) Marking of compliant shipments.--A registration
condition is that the importer involved agrees, before
wholesale distribution (as defined in section 503(e)) of a
qualifying drug that has been imported under subsection (a), to
affix to each container of such drug such markings or other
technology as the Secretary determines necessary to identify
the shipment as being in compliance with all registration
conditions, except that the markings or other technology shall
not be required on a drug that bears comparable, compatible
markings or technology from the manufacturer of the drug.
Markings or other technology under the preceding sentence
shall--
``(A) be designed to prevent affixation of the
markings or other technology to any container that is
not authorized to bear the markings; and
``(B) shall include anticounterfeiting or track-
and-trace technologies, taking into account the
economic and technical feasibility of such
technologies.
``(6) Certain duties relating to importers.--Duties of the
Secretary with respect to an importer include the following:
``(A) Inspecting, randomly, but not less than 12
times annually, the places of business of the importer
at which a qualifying drug is initially received after
importation.
``(B) During the inspections under subparagraph
(A), verifying the chain of custody of a statistically
significant sample of qualifying drugs from the
establishment in which the drug was manufactured to the
importer, which shall be accomplished or supplemented
by the use of anticounterfeiting or track-and-trace
technologies, taking into account the economic and
technical feasibility of those technologies, except
that a drug that lacks such technologies from the point
of manufacture shall not for that reason be excluded
from importation by an importer.
``(C) Reviewing notices under paragraph (4).
``(D) Inspecting as the Secretary determines is
necessary the warehouses and other facilities,
including records of other parties in the chain of
custody of qualifying drugs.
``(E) Determining whether the importer is in
compliance with all other registration conditions.
``(e) Importer Fees.--
``(1) Registration fee.--A registration condition is that
the importer involved pays to the Secretary a fee of $10,000
due on the date on which the importer first submits the
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
importer involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30
days before the start of each fiscal year, the
Secretary, in consultation with the Secretary of
Homeland Security and the Secretary of the Treasury,
shall establish an aggregate total of fees to be
collected under paragraph (2) for importers for that
fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
importers, including the costs associated with--
``(i) inspecting the facilities of
registered importers, and of other entities in
the chain of custody of a qualifying drug as
necessary, under subsection (d)(6);
``(ii) developing, implementing, and
operating under such subsection an electronic
system for submission and review of the notices
required under subsection (d)(4) with respect
to shipments of qualifying drugs under
subsection (a) to assess compliance with all
registration conditions when such shipments are
offered for import into the United States; and
``(iii) inspecting such shipments as
necessary, when offered for import into the
United States to determine if such a shipment
should be refused admission under subsection
(g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2)
for a fiscal year shall not exceed 2.5 percent of the
total price of qualifying drugs imported during that
fiscal year into the United States by registered
importers under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of
complying with the limitation described in
subparagraph (B) when establishing under
subparagraph (A) the aggregate total of fees to
be collected under paragraph (2) for a fiscal
year, the Secretary shall estimate the total
price of qualifying drugs imported into the
United States by registered importers during
that fiscal year by adding the total price of
qualifying drugs imported by each registered
importer during the 6-month period from January
1 through June 30 of the previous fiscal year,
as reported to the Secretary by each registered
importer under subsection (b)(1)(J).
``(ii) Calculation.--Not later than March 1
of the fiscal year that follows the fiscal year
for which the estimate under clause (i) is
made, the Secretary shall calculate the total
price of qualifying drugs imported into the
United States by registered importers during
that fiscal year by adding the total price of
qualifying drugs imported by each registered
importer during that fiscal year, as reported
to the Secretary by each registered importer
under subsection (b)(1)(J).
``(iii) Adjustment.--If the total price of
qualifying drugs imported into the United
States by registered importers during a fiscal
year as calculated under clause (ii) is less
than the aggregate total of fees collected
under paragraph (2) for that fiscal year, the
Secretary shall provide for a pro-rata
reduction in the fee due from each registered
importer on April 1 of the subsequent fiscal
year so that the limitation described in
subparagraph (B) is observed.
``(D) Individual importer fee.--Subject to the
limitation described in subparagraph (B), the fee under
paragraph (2) to be paid on October 1 and April 1 by an
importer shall be an amount that is proportional to a
reasonable estimate by the Secretary of the semiannual
share of the importer of the volume of qualifying drugs
imported by importers under subsection (a).
``(4) Use of fees.--
``(A) In general.--Subject to appropriations Acts,
fees collected by the Secretary under paragraphs (1)
and (2) shall be credited to the appropriation account
for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year
limitation), and the Secretary may, in consultation
with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of
such fees to the appropriation account for salaries and
expenses of the Bureau of Customs and Border Protection
until expended (without fiscal year limitation).
``(B) Sole purpose.--Fees collected by the
Secretary under paragraphs (1) and (2) are only
available to the Secretary and, if transferred, to the
Secretary of Homeland Security, and are for the sole
purpose of paying the costs referred to in paragraph
(3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph (1)
or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(f) Exporter Fees.--
``(1) Registration fee.--A registration condition is that
the exporter involved pays to the Secretary a fee of $10,000
due on the date on which the exporter first submits that
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
exporter involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30
days before the start of each fiscal year, the
Secretary, in consultation with the Secretary of
Homeland Security and the Secretary of the Treasury,
shall establish an aggregate total of fees to be
collected under paragraph (2) for exporters for that
fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
exporters, including the costs associated with--
``(i) inspecting the facilities of
registered exporters, and of other entities in
the chain of custody of a qualifying drug as
necessary, under subsection (d)(3);
``(ii) developing, implementing, and
operating under such subsection a system to
screen marks on shipments of qualifying drugs
under subsection (a) that indicate compliance
with all registration conditions, when such
shipments are offered for import into the
United States; and
``(iii) screening such markings, and
inspecting such shipments as necessary, when
offered for import into the United States to
determine if such a shipment should be refused
admission under subsection (g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2)
for a fiscal year shall not exceed 2.5 percent of the
total price of qualifying drugs imported during that
fiscal year into the United States by registered
exporters under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of
complying with the limitation described in
subparagraph (B) when establishing under
subparagraph (A) the aggregate total of fees to
be collected under paragraph (2) for a fiscal
year, the Secretary shall estimate the total
price of qualifying drugs imported into the
United States by registered exporters during
that fiscal year by adding the total price of
qualifying drugs exported by each registered
exporter during the 6-month period from January
1 through June 30 of the previous fiscal year,
as reported to the Secretary by each registered
exporter under subsection (b)(1)(I)(iv).
``(ii) Calculation.--Not later than March 1
of the fiscal year that follows the fiscal year
for which the estimate under clause (i) is
made, the Secretary shall calculate the total
price of qualifying drugs imported into the
United States by registered exporters during
that fiscal year by adding the total price of
qualifying drugs exported by each registered
exporter during that fiscal year, as reported
to the Secretary by each registered exporter
under subsection (b)(1)(I)(iv).
``(iii) Adjustment.--If the total price of
qualifying drugs imported into the United
States by registered exporters during a fiscal
year as calculated under clause (ii) is less
than the aggregate total of fees collected
under paragraph (2) for that fiscal year, the
Secretary shall provide for a pro-rata
reduction in the fee due from each registered
exporter on April 1 of the subsequent fiscal
year so that the limitation described in
subparagraph (B) is observed.
``(D) Individual exporter fee.--Subject to the
limitation described in subparagraph (B), the fee under
paragraph (2) to be paid on October 1 and April 1 by an
exporter shall be an amount that is proportional to a
reasonable estimate by the Secretary of the semiannual
share of the exporter of the volume of qualifying drugs
exported by exporters under subsection (a).
``(4) Use of fees.--
``(A) In general.--Subject to appropriations Acts,
fees collected by the Secretary under paragraphs (1)
and (2) shall be credited to the appropriation account
for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year
limitation), and the Secretary may, in consultation
with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of
such fees to the appropriation account for salaries and
expenses of the Bureau of Customs and Border Protection
until expended (without fiscal year limitation).
``(B) Sole purpose.--Fees collected by the
Secretary under paragraphs (1) and (2) are only
available to the Secretary and, if transferred, to the
Secretary of Homeland Security, and are for the sole
purpose of paying the costs referred to in paragraph
(3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph (1)
or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(g) Compliance With Section 801(a).--
``(1) In general.--A registration condition is that each
qualifying drug exported under subsection (a) by the registered
exporter involved or imported under subsection (a) by the
registered importer involved is in compliance with the
standards referred to in section 801(a) regarding admission of
the drug into the United States, subject to paragraphs (2),
(3), and (4).
``(2) Section 505; approval status.--
``(A) In general.--A qualifying drug that is
imported or offered for import under subsection (a)
shall comply with the conditions established in the
approved application under section 505(b) for the U.S.
label drug as described under this subsection.
``(B) Notice by manufacturer; general provisions.--
``(i) In general.--The person that
manufactures a qualifying drug that is, or will
be, introduced for commercial distribution in a
permitted country shall in accordance with this
paragraph submit to the Secretary a notice
that--
``(I) includes each difference in
the qualifying drug from a condition
established in the approved application
for the U.S. label drug beyond--
``(aa) the variations
provided for in the
application; and
``(bb) any difference in
labeling (except ingredient
labeling); or
``(II) states that there is no
difference in the qualifying drug from
a condition established in the approved
application for the U.S. label drug
beyond--
``(aa) the variations
provided for in the
application; and
``(bb) any difference in
labeling (except ingredient
labeling).
``(ii) Information in notice.--A notice
under clause (i)(I) shall include the
information that the Secretary may require
under section 506A, any additional information
the Secretary may require (which may include
data on bioequivalence if such data are not
required under section 506A), and, with respect
to the permitted country that approved the
qualifying drug for commercial distribution, or
with respect to which such approval is sought,
include the following:
``(I) The date on which the
qualifying drug with such difference
was, or will be, introduced for
commercial distribution in the
permitted country.
``(II) Information demonstrating
that the person submitting the notice
has also notified the government of the
permitted country in writing that the
person is submitting to the Secretary a
notice under clause (i)(I), which
notice describes the difference in the
qualifying drug from a condition
established in the approved application
for the U.S. label drug.
``(III) The information that the
person submitted or will submit to the
government of the permitted country for
purposes of obtaining approval for
commercial distribution of the drug in
the country which, if in a language
other than English, shall be
accompanied by an English translation
verified to be complete and accurate,
with the name, address, and a brief
statement of the qualifications of the
person that made the translation.
``(iii) Certifications.--The chief
executive officer and the chief medical officer
of the manufacturer involved shall each certify
in the notice under clause (i) that--
``(I) the information provided in
the notice is complete and true; and
``(II) a copy of the notice has
been provided to the Federal Trade
Commission and to the State attorneys
general.
``(iv) Fee.--If a notice submitted under
clause (i) includes a difference that would,
under section 506A, require the submission of a
supplemental application if made as a change to
the U.S. label drug, the person that submits
the notice shall pay to the Secretary a fee in
the same amount as would apply if the person
were paying a fee pursuant to section
736(a)(1)(A)(ii). Subject to appropriations
Acts, fees collected by the Secretary under the
preceding sentence are available only to the
Secretary and are for the sole purpose of
paying the costs of reviewing notices submitted
under clause (i).
``(v) Timing of submission of notices.--
``(I) Prior approval notices.--A
notice under clause (i) to which
subparagraph (C) applies shall be
submitted to the Secretary not later
than 120 days before the qualifying
drug with the difference is introduced
for commercial distribution in a
permitted country, unless the country
requires that distribution of the
qualifying drug with the difference
begin less than 120 days after the
country requires the difference.
``(II) Other approval notices.--A
notice under clause (i) to which
subparagraph (D) applies shall be
submitted to the Secretary not later
than the day on which the qualifying
drug with the difference is introduced
for commercial distribution in a
permitted country.
``(III) Other notices.--A notice
under clause (i) to which subparagraph
(E) applies shall be submitted to the
Secretary on the date that the
qualifying drug is first introduced for
commercial distribution in a permitted
country and annually thereafter.
``(vi) Review by secretary.--
``(I) In general.--In this
paragraph, the difference in a
qualifying drug that is submitted in a
notice under clause (i) from the U.S.
label drug shall be treated by the
Secretary as if it were a manufacturing
change to the U.S. label drug under
section 506A.
``(II) Standard of review.--Except
as provided in subclause (III), the
Secretary shall review and approve or
disapprove the difference in a notice
submitted under clause (i), if required
under section 506A, using the safe and
effective standard for approving or
disapproving a manufacturing change
under section 506A.
``(III) Bioequivalence.--If the
Secretary would approve the difference
in a notice submitted under clause (i)
using the safe and effective standard
under section 506A and if the Secretary
determines that the qualifying drug is
not bioequivalent to the U.S. label
drug, the Secretary shall--
``(aa) include in the
labeling provided under
paragraph (3) a prominent
advisory that the qualifying
drug is safe and effective but
is not bioequivalent to the
U.S. label drug if the
Secretary determines that such
an advisory is necessary for
health care practitioners and
patients to use the qualifying
drug safely and effectively; or
``(bb) decline to approve
the difference if the Secretary
determines that the
availability of both the
qualifying drug and the U.S.
label drug would pose a threat
to the public health.
``(IV) Review by the secretary.--
The Secretary shall review and approve
or disapprove the difference in a
notice submitted under clause (i), if
required under section 506A, not later
than 120 days after the date on which
the notice is submitted.
``(V) Establishment inspection.--If
review of such difference would require
an inspection of the establishment in
which the qualifying drug is
manufactured--
``(aa) such inspection by
the Secretary shall be
authorized; and
``(bb) the Secretary may
rely on a satisfactory report
of a good manufacturing
practice inspection of the
establishment from a permitted
country whose regulatory system
the Secretary recognizes as
equivalent under a mutual
recognition agreement, as
provided under section
510(i)(3), section 803, or part
26 of title 21, Code of Federal
Regulations (or any
corresponding successor rule or
regulation).
``(vii) Publication of information on
notices.--
``(I) In general.--Through the
Internet website of the Food and Drug
Administration and a toll-free
telephone number, the Secretary shall
readily make available to the public a
list of notices submitted under clause
(i).
``(II) Contents.--The list under
subclause (I) shall include the date on
which a notice is submitted and
whether--
``(aa) a notice is under
review;
``(bb) the Secretary has
ordered that importation of the
qualifying drug from a
permitted country cease; or
``(cc) the importation of
the drug is permitted under
subsection (a).
``(III) Update.--The Secretary
shall promptly update the Internet
website with any changes to the list.
``(C) Notice; drug difference requiring prior
approval.--In the case of a notice under subparagraph
(B)(i) that includes a difference that would, under
section 506A(c) or (d)(3)(B)(i), require the approval
of a supplemental application before the difference
could be made to the U.S. label drug the following
shall occur:
``(i) Promptly after the notice is
submitted, the Secretary shall notify
registered exporters, registered importers, the
Federal Trade Commission, and the State
attorneys general that the notice has been
submitted with respect to the qualifying drug
involved.
``(ii) If the Secretary has not made a
determination whether such a supplemental
application regarding the U.S. label drug would
be approved or disapproved by the date on which
the qualifying drug involved is to be
introduced for commercial distribution in a
permitted country, the Secretary shall--
``(I) order that the importation of
the qualifying drug involved from the
permitted country not begin until the
Secretary completes review of the
notice; and
``(II) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the State
attorneys general of the order.
``(iii) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would not be approved, the
Secretary shall--
``(I) order that the importation of
the qualifying drug involved from the
permitted country cease, or provide
that an order under clause (ii), if
any, remains in effect;
``(II) notify the permitted country
that approved the qualifying drug for
commercial distribution of the
determination; and
``(III) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the State
attorneys general of the determination.
``(iv) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would be approved, the
Secretary shall--
``(I) vacate the order under clause
(ii), if any;
``(II) consider the difference to
be a variation provided for in the
approved application for the U.S. label
drug;
``(III) permit importation of the
qualifying drug under subsection (a);
and
``(IV) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the State
attorneys general of the determination.
``(D) Notice; drug difference not requiring prior
approval.--In the case of a notice under subparagraph
(B)(i) that includes a difference that would, under
section 506A(d)(3)(B)(ii), not require the approval of
a supplemental application before the difference could
be made to the U.S. label drug the following shall
occur:
``(i) During the period in which the notice
is being reviewed by the Secretary, the
authority under this subsection to import the
qualifying drug involved continues in effect.
``(ii) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would not be approved, the
Secretary shall--
``(I) order that the importation of
the qualifying drug involved from the
permitted country cease;
``(II) notify the permitted country
that approved the qualifying drug for
commercial distribution of the
determination; and
``(III) promptly notify registered
exporters, registered importers, the
Federal Trade Commission, and the State
attorneys general of the determination.
``(iii) If the Secretary determines that
such a supplemental application regarding the
U.S. label drug would be approved, the
difference shall be considered to be a
variation provided for in the approved
application for the U.S. label drug.
``(E) Notice; drug difference not requiring
approval; no difference.--In the case of a notice under
subparagraph (B)(i) that includes a difference for
which, under section 506A(d)(1)(A), a supplemental
application would not be required for the difference to
be made to the U.S. label drug, or that states that
there is no difference, the Secretary--
``(i) shall consider such difference to be
a variation provided for in the approved
application for the U.S. label drug;
``(ii) may not order that the importation
of the qualifying drug involved cease; and
``(iii) shall promptly notify registered
exporters and registered importers.
``(F) Differences in active ingredient, route of
administration, dosage form, or strength.--
``(i) In general.--A person who
manufactures a drug approved under section
505(b) shall submit an application under
section 505(b) for approval of another drug
that is manufactured for distribution in a
permitted country by or for the person that
manufactures the drug approved under section
505(b) if--
``(I) there is no qualifying drug
in commercial distribution in permitted
countries whose combined population
represents at least 50 percent of the
total population of all permitted
countries with the same active
ingredient or ingredients, route of
administration, dosage form, and
strength as the drug approved under
section 505(b); and
``(II) each active ingredient of
the other drug is related to an active
ingredient of the drug approved under
section 505(b), as defined in clause
(v).
``(ii) Application under section 505(b).--
The application under section 505(b) required
under clause (i) shall--
``(I) request approval of the other
drug for the indication or indications
for which the drug approved under
section 505(b) is labeled;
``(II) include the information that
the person submitted to the government
of the permitted country for purposes
of obtaining approval for commercial
distribution of the other drug in that
country, which if in a language other
than English, shall be accompanied by
an English translation verified to be
complete and accurate, with the name,
address, and a brief statement of the
qualifications of the person that made
the translation;
``(III) include a right of
reference to the application for the
drug approved under section 505(b); and
``(IV) include such additional
information as the Secretary may
require.
``(iii) Timing of submission of
application.--An application under section
505(b) required under clause (i) shall be
submitted to the Secretary not later than the
day on which the information referred to in
clause (ii)(II) is submitted to the government
of the permitted country.
``(iv) Notice of decision on application.--
The Secretary shall promptly notify registered
exporters, registered importers, the Federal
Trade Commission, and the State attorneys
general of a determination to approve or to
disapprove an application under section 505(b)
required under clause (i).
``(v) Related active ingredients.--For
purposes of clause (i)(II), 2 active
ingredients are related if they are--
``(I) the same; or
``(II) different salts, esters, or
complexes of the same moiety.
``(3) Section 502; labeling.--
``(A) Importation by registered importer.--
``(i) In general.--In the case of a
qualifying drug that is imported or offered for
import by a registered importer, such drug
shall be considered to be in compliance with
section 502 and the labeling requirements under
the approved application for the U.S. label
drug if the qualifying drug bears--
``(I) a copy of the labeling
approved for the U.S. label drug under
section 505, without regard to whether
the copy bears any trademark involved;
``(II) the name of the manufacturer
and location of the manufacturer;
``(III) the lot number assigned by
the manufacturer;
``(IV) the name, location, and
registration number of the importer;
and
``(V) the National Drug Code number
assigned to the qualifying drug by the
Secretary.
``(ii) Request for copy of the labeling.--
The Secretary shall provide such copy to the
registered importer involved, upon request of
the importer.
``(iii) Requested labeling.--The labeling
provided by the Secretary under clause (ii)
shall--
``(I) include the established name,
as defined in section 502(e)(3), for
each active ingredient in the
qualifying drug;
``(II) not include the proprietary
name of the U.S. label drug or any
active ingredient thereof;
``(III) if required under paragraph
(2)(B)(vi)(III), a prominent advisory
that the qualifying drug is safe and
effective but not bioequivalent to the
U.S. label drug; and
``(IV) if the inactive ingredients
of the qualifying drug are different
from the inactive ingredients for the
U.S. label drug, include--
``(aa) a prominent notice
that the ingredients of the
qualifying drug differ from the
ingredients of the U.S. label
drug and that the qualifying
drug must be dispensed with an
advisory to people with
allergies about this difference
and a list of ingredients; and
``(bb) a list of the
ingredients of the qualifying
drug as would be required under
section 502(e).
``(B) Importation by individual.--
``(i) In general.--In the case of a
qualifying drug that is imported or offered for
import by a registered exporter to an
individual, such drug shall be considered to be
in compliance with section 502 and the labeling
requirements under the approved application for
the U.S. label drug if the packaging and
labeling of the qualifying drug complies with
all applicable regulations promulgated under
sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.)
and the labeling of the qualifying drug
includes--
``(I) directions for use by the
consumer;
``(II) the lot number assigned by
the manufacturer;
``(III) the name and registration
number of the exporter;
``(IV) if required under paragraph
(2)(B)(vi)(III), a prominent advisory
that the drug is safe and effective but
not bioequivalent to the U.S. label
drug;
``(V) if the inactive ingredients
of the drug are different from the
inactive ingredients for the U.S. label
drug--
``(aa) a prominent advisory
that persons with an allergy
should check the ingredient
list of the drug because the
ingredients of the drug differ
from the ingredients of the
U.S. label drug; and
``(bb) a list of the
ingredients of the drug as
would be required under section
502(e); and
``(VI) a copy of any special
labeling that would be required by the
Secretary had the U.S. label drug been
dispensed by a pharmacist in the United
States, without regard to whether the
special labeling bears any trademark
involved.
``(ii) Packaging.--A qualifying drug
offered for import to an individual by an
exporter under this section that is packaged in
a unit-of-use container (as those items are
defined in the United States Pharmacopeia and
National Formulary) shall not be repackaged,
provided that--
``(I) the packaging complies with
all applicable regulations under
sections 3 and 4 of the Poison
Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.); or
``(II) the consumer consents to
waive the requirements of such Act,
after being informed that the packaging
does not comply with such Act and that
the exporter will provide the drug in
packaging that is compliant at no
additional cost.
``(iii) Request for copy of special
labeling and ingredient list.--The Secretary
shall provide to the registered exporter
involved a copy of the special labeling, the
advisory, and the ingredient list described
under clause (i), upon request of the exporter.
``(iv) Requested labeling and ingredient
list.--The labeling and ingredient list
provided by the Secretary under clause (iii)
shall--
``(I) include the established name,
as defined in section 502(e)(3), for
each active ingredient in the drug; and
``(II) not include the proprietary
name of the U.S. label drug or any
active ingredient thereof.
``(4) Section 501; adulteration.--A qualifying drug that is
imported or offered for import under subsection (a) shall be
considered to be in compliance with section 501 if the drug is
in compliance with subsection (c).
``(5) Standards for refusing admission.--A drug exported
under subsection (a) from a registered exporter or imported by
a registered importer may be refused admission into the United
States if 1 or more of the following applies:
``(A) The drug is not a qualifying drug.
``(B) A notice for the drug required under
paragraph (2)(B) has not been submitted to the
Secretary.
``(C) The Secretary has ordered that importation of
the drug from the permitted country cease under
paragraph (2) (C) or (D).
``(D) The drug does not comply with paragraph (3)
or (4).
``(E) The shipping container appears damaged in a
way that may affect the strength, quality, or purity of
the drug.
``(F) The Secretary becomes aware that--
``(i) the drug may be counterfeit;
``(ii) the drug may have been prepared,
packed, or held under insanitary conditions; or
``(iii) the methods used in, or the
facilities or controls used for, the
manufacturing, processing, packing, or holding
of the drug do not conform to good
manufacturing practice.
``(G) The Secretary has obtained an injunction
under section 302 that prohibits the distribution of
the drug in interstate commerce.
``(H) The Secretary has under section 505(e)
withdrawn approval of the drug.
``(I) The manufacturer of the drug has instituted a
recall of the drug.
``(J) If the drug is imported or offered for import
by a registered importer without submission of a notice
in accordance with subsection (d)(4).
``(K) If the drug is imported or offered for import
from a registered exporter to an individual and 1 or
more of the following applies:
``(i) The shipping container for such drug
does not bear the markings required under
subsection (d)(2).
``(ii) The markings on the shipping
container appear to be counterfeit.
``(iii) The shipping container or markings
appear to have been tampered with.
``(h) Exporter Licensure in Permitted Country.--A registration
condition is that the exporter involved agrees that a qualifying drug
will be exported to an individual only if the Secretary has verified
that--
``(1) the exporter is authorized under the law of the
permitted country in which the exporter is located to dispense
prescription drugs; and
``(2) the exporter employs persons that are licensed under
the law of the permitted country in which the exporter is
located to dispense prescription drugs in sufficient number to
dispense safely the drugs exported by the exporter to
individuals, and the exporter assigns to those persons
responsibility for dispensing such drugs to individuals.
``(i) Individuals; Conditions for Importation.--
``(1) In general.--For purposes of subsection (a)(2)(B),
the importation of a qualifying drug by an individual is in
accordance with this subsection if the following conditions are
met:
``(A) The drug is accompanied by a copy of a
prescription for the drug, which prescription--
``(i) is valid under applicable Federal and
State laws; and
``(ii) was issued by a practitioner who,
under the law of a State of which the
individual is a resident, or in which the
individual receives care from the practitioner
who issues the prescription, is authorized to
administer prescription drugs.
``(B) The drug is accompanied by a copy of the
documentation that was required under the law or
regulations of the permitted country in which the
exporter is located, as a condition of dispensing the
drug to the individual.
``(C) The copies referred to in subparagraphs
(A)(i) and (B) are marked in a manner sufficient--
``(i) to indicate that the prescription,
and the equivalent document in the permitted
country in which the exporter is located, have
been filled; and
``(ii) to prevent a duplicative filling by
another pharmacist.
``(D) The individual has provided to the registered
exporter a complete list of all drugs used by the
individual for review by the individuals who dispense
the drug.
``(E) The quantity of the drug does not exceed a
90-day supply.
``(F) The drug is not an ineligible subpart H drug.
For purposes of this section, a prescription drug is an
`ineligible subpart H drug' if the drug was approved by
the Secretary under subpart H of part 314 of title 21,
Code of Federal Regulations (relating to accelerated
approval), with restrictions under section 520 of such
part to assure safe use, and the Secretary has
published in the Federal Register a notice that the
Secretary has determined that good cause exists to
prohibit the drug from being imported pursuant to this
subsection.
``(2) Notice regarding drug refused admission.--If a
registered exporter ships a drug to an individual pursuant to
subsection (a)(2)(B) and the drug is refused admission to the
United States, a written notice shall be sent to the individual
and to the exporter that informs the individual and the
exporter of such refusal and the reason for the refusal.
``(j) Maintenance of Records and Samples.--
``(1) In general.--A registration condition is that the
importer or exporter involved shall--
``(A) maintain records required under this section
for not less than 2 years; and
``(B) maintain samples of each lot of a qualifying
drug required under this section for not more than 2
years.
``(2) Place of record maintenance.--The records described
under paragraph (1) shall be maintained--
``(A) in the case of an importer, at the place of
business of the importer at which the importer
initially receives the qualifying drug after
importation; or
``(B) in the case of an exporter, at the facility
from which the exporter ships the qualifying drug to
the United States.
``(k) Drug Recalls.--
``(1) Manufacturers.--A person that manufactures a
qualifying drug imported from a permitted country under this
section shall promptly inform the Secretary--
``(A) if the drug is recalled or withdrawn from the
market in a permitted country;
``(B) how the drug may be identified, including lot
number; and
``(C) the reason for the recall or withdrawal.
``(2) Secretary.--With respect to each permitted country,
the Secretary shall--
``(A) enter into an agreement with the government
of the country to receive information about recalls and
withdrawals of qualifying drugs in the country; or
``(B) monitor recalls and withdrawals of qualifying
drugs in the country using any information that is
available to the public in any media.
``(3) Notice.--The Secretary may notify, as appropriate,
registered exporters, registered importers, wholesalers,
pharmacies, or the public of a recall or withdrawal of a
qualifying drug in a permitted country.
``(l) Drug Labeling and Packaging.--
``(1) In general.--When a qualifying drug that is imported
into the United States by an importer under subsection (a) is
dispensed by a pharmacist to an individual, the pharmacist
shall provide that the packaging and labeling of the drug
complies with all applicable regulations promulgated under
sections 3 and 4 of the Poison Prevention Packaging Act of 1970
(15 U.S.C. 1471 et seq.) and shall include with any other
labeling provided to the individual the following:
``(A) The lot number assigned by the manufacturer.
``(B) The name and registration number of the
importer.
``(C) If required under paragraph (2)(B)(vi)(III)
of subsection (g), a prominent advisory that the drug
is safe and effective but not bioequivalent to the U.S.
label drug.
``(D) If the inactive ingredients of the drug are
different from the inactive ingredients for the U.S.
label drug--
``(i) a prominent advisory that persons
with allergies should check the ingredient list
of the drug because the ingredients of the drug
differ from the ingredients of the U.S. label
drug; and
``(ii) a list of the ingredients of the
drug as would be required under section 502(e).
``(2) Packaging.--A qualifying drug that is packaged in a
unit-of-use container (as those terms are defined in the United
States Pharmacopeia and National Formulary) shall not be
repackaged, provided that--
``(A) the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.); or
``(B) the consumer consents to waive the
requirements of such Act, after being informed that the
packaging does not comply with such Act and that the
pharmacist will provide the drug in packaging that is
compliant at no additional cost.
``(m) Charitable Contributions.--Notwithstanding any other
provision of this section, this section does not authorize the
importation into the United States of a qualifying drug donated or
otherwise supplied for free or at nominal cost by the manufacturer of
the drug to a charitable or humanitarian organization, including the
United Nations and affiliates, or to a government of a foreign country.
``(n) Unfair and Discriminatory Acts and Practices.--
``(1) In general.--It is unlawful for a manufacturer,
directly or indirectly (including by being a party to a
licensing agreement or other agreement), to--
``(A) discriminate by charging a higher price for a
prescription drug sold to a registered exporter or
other person in a permitted country that exports a
qualifying drug to the United States under this section
than the price that is charged, inclusive of rebates or
other incentives to the permitted country or other
person, to another person that is in the same country
and that does not export a qualifying drug into the
United States under this section;
``(B) discriminate by charging a higher price for a
prescription drug sold to a registered importer or
other person that distributes, sells, or uses a
qualifying drug imported into the United States under
this section than the price that is charged to another
person in the United States that does not import a
qualifying drug under this section, or that does not
distribute, sell, or use such a drug;
``(C) discriminate by denying, restricting, or
delaying supplies of a prescription drug to a
registered exporter or other person in a permitted
country that exports a qualifying drug to the United
States under this section or to a registered importer
or other person that distributes, sells, or uses a
qualifying drug imported into the United States under
this section;
``(D) discriminate by publicly, privately, or
otherwise refusing to do business with a registered
exporter or other person in a permitted country that
exports a qualifying drug to the United States under
this section or with a registered importer or other
person that distributes, sells, or uses a qualifying
drug imported into the United States under this
section;
``(E) knowingly fail to submit a notice under
subsection (g)(2)(B)(i), knowingly fail to submit such
a notice on or before the date specified in subsection
(g)(2)(B)(v) or as otherwise required under subsection
(e) (3), (4), and (5) of section 4 of the
Pharmaceutical Market Access and Drug Safety Act of
2007, knowingly submit such a notice that makes a
materially false, fictitious, or fraudulent statement,
or knowingly fail to provide promptly any information
requested by the Secretary to review such a notice;
``(F) knowingly fail to submit an application
required under subsection (g)(2)(F), knowingly fail to
submit such an application on or before the date
specified in subsection (g)(2)(F)(ii), knowingly submit
such an application that makes a materially false,
fictitious, or fraudulent statement, or knowingly fail
to provide promptly any information requested by the
Secretary to review such an application;
``(G) cause there to be a difference (including a
difference in active ingredient, route of
administration, dosage form, strength, formulation,
manufacturing establishment, manufacturing process, or
person that manufactures the drug) between a
prescription drug for distribution in the United States
and the drug for distribution in a permitted country;
``(H) refuse to allow an inspection authorized
under this section of an establishment that
manufactures a qualifying drug that is, or will be,
introduced for commercial distribution in a permitted
country;
``(I) fail to conform to the methods used in, or
the facilities used for, the manufacturing, processing,
packing, or holding of a qualifying drug that is, or
will be, introduced for commercial distribution in a
permitted country to good manufacturing practice under
this Act;
``(J) become a party to a licensing agreement or
other agreement related to a qualifying drug that fails
to provide for compliance with all requirements of this
section with respect to such drug;
``(K) enter into a contract that restricts,
prohibits, or delays the importation of a qualifying
drug under this section;
``(L) engage in any other action to restrict,
prohibit, or delay the importation of a qualifying drug
under this section; or
``(M) engage in any other action that the Federal
Trade Commission determines to discriminate against a
person that engages or attempts to engage in the
importation of a qualifying drug under this section.
``(2) Referral of potential violations.--The Secretary
shall promptly refer to the Federal Trade Commission each
potential violation of subparagraph (E), (F), (G), (H), or (I)
of paragraph (1) that becomes known to the Secretary.
``(3) Affirmative defense.--
``(A) Discrimination.--It shall be an affirmative
defense to a charge that a manufacturer has
discriminated under subparagraph (A), (B), (C), (D), or
(M) of paragraph (1) that the higher price charged for
a prescription drug sold to a person, the denial,
restriction, or delay of supplies of a prescription
drug to a person, the refusal to do business with a
person, or other discriminatory activity against a
person, is not based, in whole or in part, on--
``(i) the person exporting or importing a
qualifying drug into the United States under
this section; or
``(ii) the person distributing, selling, or
using a qualifying drug imported into the
United States under this section.
``(B) Drug differences.--It shall be an affirmative
defense to a charge that a manufacturer has caused
there to be a difference described in subparagraph (G)
of paragraph (1) that--
``(i) the difference was required by the
country in which the drug is distributed;
``(ii) the Secretary has determined that
the difference was necessary to improve the
safety or effectiveness of the drug;
``(iii) the person manufacturing the drug
for distribution in the United States has given
notice to the Secretary under subsection
(g)(2)(B)(i) that the drug for distribution in
the United States is not different from a drug
for distribution in permitted countries whose
combined population represents at least 50
percent of the total population of all
permitted countries; or
``(iv) the difference was not caused, in
whole or in part, for the purpose of
restricting importation of the drug into the
United States under this section.
``(4) Effect of subsection.--
``(A) Sales in other countries.--This subsection
applies only to the sale or distribution of a
prescription drug in a country if the manufacturer of
the drug chooses to sell or distribute the drug in the
country. Nothing in this subsection shall be construed
to compel the manufacturer of a drug to distribute or
sell the drug in a country.
``(B) Discounts to insurers, health plans, pharmacy
benefit managers, and covered entities.--Nothing in
this subsection shall be construed to--
``(i) prevent or restrict a manufacturer of
a prescription drug from providing discounts to
an insurer, health plan, pharmacy benefit
manager in the United States, or covered entity
in the drug discount program under section 340B
of the Public Health Service Act (42 U.S.C.
256b) in return for inclusion of the drug on a
formulary;
``(ii) require that such discounts be made
available to other purchasers of the
prescription drug; or
``(iii) prevent or restrict any other
measures taken by an insurer, health plan, or
pharmacy benefit manager to encourage
consumption of such prescription drug.
``(C) Charitable contributions.--Nothing in this
subsection shall be construed to--
``(i) prevent a manufacturer from donating
a prescription drug, or supplying a
prescription drug at nominal cost, to a
charitable or humanitarian organization,
including the United Nations and affiliates, or
to a government of a foreign country; or
``(ii) apply to such donations or supplying
of a prescription drug.
``(5) Enforcement.--
``(A) Unfair or deceptive act or practice.--A
violation of this subsection shall be treated as a
violation of a rule defining an unfair or deceptive act
or practice prescribed under section 18(a)(1)(B) of the
Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
``(B) Actions by the commission.--The Federal Trade
Commission--
``(i) shall enforce this subsection in the
same manner, by the same means, and with the
same jurisdiction, powers, and duties as though
all applicable terms and provisions of the
Federal Trade Commission Act (15 U.S.C. 41 et
seq.) were incorporated into and made a part of
this section; and
``(ii) may seek monetary relief threefold
the damages sustained, in addition to any other
remedy available to the Federal Trade
Commission under the Federal Trade Commission
Act (15 U.S.C. 41 et seq.).
``(6) Actions by states.--
``(A) In general.--
``(i) Civil actions.--In any case in which
the attorney general of a State has reason to
believe that an interest of the residents of
that State have been adversely affected by any
manufacturer that violates paragraph (1), the
attorney general of a State may bring a civil
action on behalf of the residents of the State,
and persons doing business in the State, in a
district court of the United States of
appropriate jurisdiction to--
``(I) enjoin that practice;
``(II) enforce compliance with this
subsection;
``(III) obtain damages,
restitution, or other compensation on
behalf of residents of the State and
persons doing business in the State,
including threefold the damages; or
``(IV) obtain such other relief as
the court may consider to be
appropriate.
``(ii) Notice.--
``(I) In general.--Before filing an
action under clause (i), the attorney
general of the State involved shall
provide to the Federal Trade
Commission--
``(aa) written notice of
that action; and
``(bb) a copy of the
complaint for that action.
``(II) Exemption.--Subclause (I)
shall not apply with respect to the
filing of an action by an attorney
general of a State under this
paragraph, if the attorney general
determines that it is not feasible to
provide the notice described in that
subclause before filing of the action.
In such case, the attorney general of a
State shall provide notice and a copy
of the complaint to the Federal Trade
Commission at the same time as the
attorney general files the action.
``(B) Intervention.--
``(i) In general.--On receiving notice
under subparagraph (A)(ii), the Federal Trade
Commission shall have the right to intervene in
the action that is the subject of the notice.
``(ii) Effect of intervention.--If the
Federal Trade Commission intervenes in an
action under subparagraph (A), it shall have
the right--
``(I) to be heard with respect to
any matter that arises in that action;
and
``(II) to file a petition for
appeal.
``(C) Construction.--For purposes of bringing any
civil action under subparagraph (A), nothing in this
subsection shall be construed to prevent an attorney
general of a State from exercising the powers conferred
on the attorney general by the laws of that State to--
``(i) conduct investigations;
``(ii) administer oaths or affirmations; or
``(iii) compel the attendance of witnesses
or the production of documentary and other
evidence.
``(D) Actions by the commission.--In any case in
which an action is instituted by or on behalf of the
Federal Trade Commission for a violation of paragraph
(1), a State may not, during the pendency of that
action, institute an action under subparagraph (A) for
the same violation against any defendant named in the
complaint in that action.
``(E) Venue.--Any action brought under subparagraph
(A) may be brought in the district court of the United
States that meets applicable requirements relating to
venue under section 1391 of title 28, United States
Code.
``(F) Service of process.--In an action brought
under subparagraph (A), process may be served in any
district in which the defendant--
``(i) is an inhabitant; or
``(ii) may be found.
``(G) Measurement of damages.--In any action under
this paragraph to enforce a cause of action under this
subsection in which there has been a determination that
a defendant has violated a provision of this
subsection, damages may be proved and assessed in the
aggregate by statistical or sampling methods, by the
computation of illegal overcharges or by such other
reasonable system of estimating aggregate damages as
the court in its discretion may permit without the
necessity of separately proving the individual claim
of, or amount of damage to, persons on whose behalf the
suit was brought.
``(H) Exclusion on duplicative relief.--The
district court shall exclude from the amount of
monetary relief awarded in an action under this
paragraph brought by the attorney general of a State
any amount of monetary relief which duplicates amounts
which have been awarded for the same injury.
``(7) Effect on antitrust laws.--Nothing in this subsection
shall be construed to modify, impair, or supersede the
operation of the antitrust laws. For the purpose of this
subsection, the term `antitrust laws' has the meaning given it
in the first section of the Clayton Act, except that it
includes section 5 of the Federal Trade Commission Act to the
extent that such section 5 applies to unfair methods of
competition.
``(8) Manufacturer.--In this subsection, the term
`manufacturer' means any entity, including any affiliate or
licensee of that entity, that is engaged in--
``(A) the production, preparation, propagation,
compounding, conversion, or processing of a
prescription drug, either directly or indirectly by
extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis; or
``(B) the packaging, repackaging, labeling,
relabeling, or distribution of a prescription drug.''.
(b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic Act is
amended--
(1) in section 301 (21 U.S.C. 331), by striking paragraph
(aa) and inserting the following:
``(aa)(1) The sale or trade by a pharmacist, or by a business
organization of which the pharmacist is a part, of a qualifying drug
that under section 804(a)(2)(A) was imported by the pharmacist, other
than--
``(A) a sale at retail made pursuant to dispensing the drug
to a customer of the pharmacist or organization; or
``(B) a sale or trade of the drug to a pharmacy or a
wholesaler registered to import drugs under section 804.
``(2) The sale or trade by an individual of a qualifying drug that
under section 804(a)(2)(B) was imported by the individual.
``(3) The making of a materially false, fictitious, or fraudulent
statement or representation, or a material omission, in a notice under
clause (i) of section 804(g)(2)(B) or in an application required under
section 804(g)(2)(F), or the failure to submit such a notice or
application.
``(4) The importation of a drug in violation of a registration
condition or other requirement under section 804, the falsification of
any record required to be maintained, or provided to the Secretary,
under such section, or the violation of any registration condition or
other requirement under such section.''; and
(2) in section 303(a) (21 U.S.C. 333(a)), by striking
paragraph (6) and inserting the following:
``(6) Notwithstanding subsection (a), any person that knowingly
violates section 301(i) (2) or (3) or section 301(aa)(4) shall be
imprisoned not more than 10 years, or fined in accordance with title
18, United States Code, or both.''.
(c) Amendment of Certain Provisions.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by striking subsection
(g) and inserting the following:
``(g) With respect to a prescription drug that is imported or
offered for import into the United States by an individual who is not
in the business of such importation, that is not shipped by a
registered exporter under section 804, and that is refused admission
under subsection (a), the Secretary shall notify the individual that--
``(1) the drug has been refused admission because the drug
was not a lawful import under section 804;
``(2) the drug is not otherwise subject to a waiver of the
requirements of subsection (a);
``(3) the individual may under section 804 lawfully import
certain prescription drugs from exporters registered with the
Secretary under section 804; and
``(4) the individual can find information about such
importation, including a list of registered exporters, on the
Internet website of the Food and Drug Administration or through
a toll-free telephone number required under section 804.''.
(2) Establishment registration.--Section 510(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is
amended in paragraph (1) by inserting after ``import into the
United States'' the following: ``, including a drug that is, or
may be, imported or offered for import into the United States
under section 804,''.
(3) Effective date.--The amendments made by this subsection
shall take effect on the date that is 90 days after the date of
enactment of this title.
(d) Exhaustion.--
(1) In general.--Section 271 of title 35, United States
Code, is amended--
(A) by redesignating subsections (h) and (i) as (i)
and (j), respectively; and
(B) by inserting after subsection (g) the
following:
``(h) It shall not be an act of infringement to use, offer to sell,
or sell within the United States or to import into the United States
any patented invention under section 804 of the Federal Food, Drug, and
Cosmetic Act that was first sold abroad by or under authority of the
owner or licensee of such patent.''.
(2) Rule of construction.--Nothing in the amendment made by
paragraph (1) shall be construed to affect the ability of a
patent owner or licensee to enforce their patent, subject to
such amendment.
(e) Effect of Section 804.--
(1) In general.--Section 804 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall permit the
importation of qualifying drugs (as defined in such section
804) into the United States without regard to the status of the
issuance of implementing regulations--
(A) from exporters registered under such section
804 on the date that is 90 days after the date of
enactment of this title; and
(B) from permitted countries, as defined in such
section 804, by importers registered under such section
804 on the date that is 1 year after the date of
enactment of this title.
(2) Review of registration by certain exporters.--
(A) Review priority.--In the review of
registrations submitted under subsection (b) of such
section 804, registrations submitted by entities in
Canada that are significant exporters of prescription
drugs to individuals in the United States as of the
date of enactment of this title will have priority
during the 90 day period that begins on such date of
enactment.
(B) Period for review.--During such 90-day period,
the reference in subsection (b)(2)(A) of such section
804 to 90 days (relating to approval or disapproval of
registrations) is, as applied to such entities, deemed
to be 30 days.
(C) Limitation.--That an exporter in Canada
exports, or has exported, prescription drugs to
individuals in the United States on or before the date
that is 90 days after the date of enactment of this
title shall not serve as a basis, in whole or in part,
for disapproving a registration under such section 804
from the exporter.
(D) First year limit on number of exporters.--
During the 1-year period beginning on the date of
enactment of this title, the Secretary of Health and
Human Services (referred to in this section as the
``Secretary'') may limit the number of registered
exporters under such section 804 to not less than 50,
so long as the Secretary gives priority to those
exporters with demonstrated ability to process a high
volume of shipments of drugs to individuals in the
United States.
(E) Second year limit on number of exporters.--
During the 1-year period beginning on the date that is
1 year after the date of enactment of this title, the
Secretary may limit the number of registered exporters
under such section 804 to not less than 100, so long as
the Secretary gives priority to those exporters with
demonstrated ability to process a high volume of
shipments of drugs to individuals in the United States.
(F) Further limit on number of exporters.--During
any 1-year period beginning on a date that is 2 or more
years after the date of enactment of this title, the
Secretary may limit the number of registered exporters
under such section 804 to not less than 25 more than
the number of such exporters during the previous 1-year
period, so long as the Secretary gives priority to
those exporters with demonstrated ability to process a
high volume of shipments of drugs to individuals in the
United States.
(3) Limits on number of importers.--
(A) First year limit on number of importers.--
During the 1-year period beginning on the date that is
1 year after the date of enactment of this title, the
Secretary may limit the number of registered importers
under such section 804 to not less than 100 (of which
at least a significant number shall be groups of
pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with
demonstrated ability to process a high volume of
shipments of drugs imported into the United States.
(B) Second year limit on number of importers.--
During the 1-year period beginning on the date that is
2 years after the date of enactment of this title, the
Secretary may limit the number of registered importers
under such section 804 to not less than 200 (of which
at least a significant number shall be groups of
pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with
demonstrated ability to process a high volume of
shipments of drugs into the United States.
(C) Further limit on number of importers.--During
any 1-year period beginning on a date that is 3 or more
years after the date of enactment of this title, the
Secretary may limit the number of registered importers
under such section 804 to not less than 50 more (of
which at least a significant number shall be groups of
pharmacies, to the extent feasible given the
applications submitted by such groups) than the number
of such importers during the previous 1-year period, so
long as the Secretary gives priority to those importers
with demonstrated ability to process a high volume of
shipments of drugs to the United States.
(4) Notices for drugs for import from canada.--The notice
with respect to a qualifying drug introduced for commercial
distribution in Canada as of the date of enactment of this
title that is required under subsection (g)(2)(B)(i) of such
section 804 shall be submitted to the Secretary not later than
30 days after the date of enactment of this title if--
(A) the U.S. label drug (as defined in such section
804) for the qualifying drug is 1 of the 100
prescription drugs with the highest dollar volume of
sales in the United States based on the 12 calendar
month period most recently completed before the date of
enactment of this Act; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(5) Notice for drugs for import from other countries.--The
notice with respect to a qualifying drug introduced for
commercial distribution in a permitted country other than
Canada as of the date of enactment of this title that is
required under subsection (g)(2)(B)(i) of such section 804
shall be submitted to the Secretary not later than 180 days
after the date of enactment of this title if--
(A) the U.S. label drug for the qualifying drug is
1 of the 100 prescription drugs with the highest dollar
volume of sales in the United States based on the 12
calendar month period that is first completed on the
date that is 120 days after the date of enactment of
this title; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(6) Notice for other drugs for import.--
(A) Guidance on submission dates.--The Secretary
shall by guidance establish a series of submission
dates for the notices under subsection (g)(2)(B)(i) of
such section 804 with respect to qualifying drugs
introduced for commercial distribution as of the date
of enactment of this title and that are not required to
be submitted under paragraph (4) or (5).
(B) Consistent and efficient use of resources.--The
Secretary shall establish the dates described under
subparagraph (A) so that such notices described under
subparagraph (A) are submitted and reviewed at a rate
that allows consistent and efficient use of the
resources and staff available to the Secretary for such
reviews. The Secretary may condition the requirement to
submit such a notice, and the review of such a notice,
on the submission by a registered exporter or a
registered importer to the Secretary of a notice that
such exporter or importer intends to import such
qualifying drug to the United States under such section
804.
(C) Priority for drugs with higher sales.--The
Secretary shall establish the dates described under
subparagraph (A) so that the Secretary reviews the
notices described under such subparagraph with respect
to qualifying drugs with higher dollar volume of sales
in the United States before the notices with respect to
drugs with lower sales in the United States.
(7) Notices for drugs approved after effective date.--The
notice required under subsection (g)(2)(B)(i) of such section
804 for a qualifying drug first introduced for commercial
distribution in a permitted country (as defined in such section
804) after the date of enactment of this title shall be
submitted to and reviewed by the Secretary as provided under
subsection (g)(2)(B) of such section 804, without regard to
paragraph (4), (5), or (6).
(8) Report.--Beginning with the first full fiscal year
after the date of enactment of this title, not later than 90
days after the end of each fiscal year during which the
Secretary reviews a notice referred to in paragraph (4), (5),
or (6), the Secretary shall submit a report to Congress
concerning the progress of the Food and Drug Administration in
reviewing the notices referred to in paragraphs (4), (5), and
(6).
(9) User fees.--
(A) Exporters.--When establishing an aggregate
total of fees to be collected from exporters under
subsection (f)(2) of such section 804, the Secretary
shall, under subsection (f)(3)(C)(i) of such section
804, estimate the total price of drugs imported under
subsection (a) of such section 804 into the United
States by registered exporters during the first fiscal
year in which this title takes effect to be an amount
equal to the amount which bears the same ratio to
$1,000,000,000 as the number of days in such fiscal
year during which this title is effective bears to 365.
(B) Importers.--When establishing an aggregate
total of fees to be collected from importers under
subsection (e)(2) of such section 804, the Secretary
shall, under subsection (e)(3)(C)(i) of such section
804, estimate the total price of drugs imported under
subsection (a) of such section 804 into the United
States by registered importers during--
(i) the first fiscal year in which this
title takes effect to be an amount equal to the
amount which bears the same ratio to
$1,000,000,000 as the number of days in such
fiscal year during which this title is
effective bears to 365; and
(ii) the second fiscal year in which this
title is in effect to be $3,000,000,000.
(C) Second year adjustment.--
(i) Reports.--Not later than February 20 of
the second fiscal year in which this title is
in effect, registered importers shall report to
the Secretary the total price and the total
volume of drugs imported to the United States
by the importer during the 4-month period from
October 1 through January 31 of such fiscal
year.
(ii) Reestimate.--Notwithstanding
subsection (e)(3)(C)(ii) of such section 804 or
subparagraph (B), the Secretary shall
reestimate the total price of qualifying drugs
imported under subsection (a) of such section
804 into the United States by registered
importers during the second fiscal year in
which this title is in effect. Such reestimate
shall be equal to--
(I) the total price of qualifying
drugs imported by each importer as
reported under clause (i); multiplied
by
(II) 3.
(iii) Adjustment.--The Secretary shall
adjust the fee due on April 1 of the second
fiscal year in which this title is in effect,
from each importer so that the aggregate total
of fees collected under subsection (e)(2) for
such fiscal year does not exceed the total
price of qualifying drugs imported under
subsection (a) of such section 804 into the
United States by registered importers during
such fiscal year as reestimated under clause
(ii).
(D) Failure to pay fees.--Notwithstanding any other
provision of this section, the Secretary may prohibit a
registered importer or exporter that is required to pay
user fees under subsection (e) or (f) of such section
804 and that fails to pay such fees within 30 days
after the date on which it is due, from importing or
offering for importation a qualifying drug under such
section 804 until such fee is paid.
(E) Annual report.--
(i) Food and drug administration.--Not
later than 180 days after the end of each
fiscal year during which fees are collected
under subsection (e), (f), or (g)(2)(B)(iv) of
such section 804, the Secretary shall prepare
and submit to the House of Representatives and
the Senate a report on the implementation of
the authority for such fees during such fiscal
year and the use, by the Food and Drug
Administration, of the fees collected for the
fiscal year for which the report is made and
credited to the Food and Drug Administration.
(ii) Customs and border control.--Not later
than 180 days after the end of each fiscal year
during which fees are collected under
subsection (e) or (f) of such section 804, the
Secretary of Homeland Security, in consultation
with the Secretary of the Treasury, shall
prepare and submit to the House of
Representatives and the Senate a report on the
use, by the Bureau of Customs and Border
Protection, of the fees, if any, transferred by
the Secretary to the Bureau of Customs and
Border Protection for the fiscal year for which
the report is made.
(10) Special rule regarding importation by individuals.--
(A) In general.--Notwithstanding any provision of
this title (or an amendment made by this title), the
Secretary shall expedite the designation of any
additional countries from which an individual may
import a qualifying drug into the United States under
such section 804 if any action implemented by the
Government of Canada has the effect of limiting or
prohibiting the importation of qualifying drugs into
the United States from Canada.
(B) Timing and criteria.--The Secretary shall
designate such additional countries under subparagraph
(A)--
(i) not later than 6 months after the date
of the action by the Government of Canada
described under such subparagraph; and
(ii) using the criteria described under
subsection (a)(4)(D)(i)(II) of such section
804.
(f) Implementation of Section 804.--
(1) Interim rule.--The Secretary may promulgate an interim
rule for implementing section 804 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a) of this section.
(2) No notice of proposed rulemaking.--The interim rule
described under paragraph (1) may be developed and promulgated
by the Secretary without providing general notice of proposed
rulemaking.
(3) Final rule.--Not later than 1 year after the date on
which the Secretary promulgates an interim rule under paragraph
(1), the Secretary shall, in accordance with procedures under
section 553 of title 5, United States Code, promulgate a final
rule for implementing such section 804, which may incorporate
by reference provisions of the interim rule provided for under
paragraph (1), to the extent that such provisions are not
modified.
(g) Consumer Education.--The Secretary shall carry out activities
that educate consumers--
(1) with regard to the availability of qualifying drugs for
import for personal use from an exporter registered with and
approved by the Food and Drug Administration under section 804
of the Federal Food, Drug, and Cosmetic Act, as added by this
section, including information on how to verify whether an
exporter is registered and approved by use of the Internet
website of the Food and Drug Administration and the toll-free
telephone number required by this title;
(2) that drugs that consumers attempt to import from an
exporter that is not registered with and approved by the Food
and Drug Administration can be seized by the United States
Customs Service and destroyed, and that such drugs may be
counterfeit, unapproved, unsafe, or ineffective;
(3) with regard to the suspension and termination of any
registration of a registered importer or exporter under such
section 804; and
(4) with regard to the availability at domestic retail
pharmacies of qualifying drugs imported under such section 804
by domestic wholesalers and pharmacies registered with and
approved by the Food and Drug Administration.
(h) Effect on Administration Practices.--Notwithstanding any
provision of this title (and the amendments made by this title), the
practices and policies of the Food and Drug Administration and Bureau
of Customs and Border Protection, in effect on January 1, 2004, with
respect to the importation of prescription drugs into the United States
by an individual, on the person of such individual, for personal use,
shall remain in effect.
(i) Report to Congress.--The Federal Trade Commission shall, on an
annual basis, submit to Congress a report that describes any action
taken during the period for which the report is being prepared to
enforce the provisions of section 804(n) of the Federal Food, Drug, and
Cosmetic Act (as added by this title), including any pending
investigations or civil actions under such section.

SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED
STATES.

(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 804, is
further amended by adding at the end the following section:

``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

``(a) In General.--The Secretary of Homeland Security shall deliver
to the Secretary a shipment of drugs that is imported or offered for
import into the United States if--
``(1) the shipment has a declared value of less than
$10,000; and
``(2)(A) the shipping container for such drugs does not
bear the markings required under section 804(d)(2); or
``(B) the Secretary has requested delivery of such shipment
of drugs.
``(b) No Bond or Export.--Section 801(b) does not authorize the
delivery to the owner or consignee of drugs delivered to the Secretary
under subsection (a) pursuant to the execution of a bond, and such
drugs may not be exported.
``(c) Destruction of Violative Shipment.--The Secretary shall
destroy a shipment of drugs delivered by the Secretary of Homeland
Security to the Secretary under subsection (a) if--
``(1) in the case of drugs that are imported or offered for
import from a registered exporter under section 804, the drugs
are in violation of any standard described in section
804(g)(5); or
``(2) in the case of drugs that are not imported or offered
for import from a registered exporter under section 804, the
drugs are in violation of a standard referred to in section
801(a) or 801(d)(1).
``(d) Certain Procedures.--
``(1) In general.--The delivery and destruction of drugs
under this section may be carried out without notice to the
importer, owner, or consignee of the drugs except as required
by section 801(g) or section 804(i)(2). The issuance of
receipts for the drugs, and recordkeeping activities regarding
the drugs, may be carried out on a summary basis.
``(2) Objective of procedures.--Procedures promulgated
under paragraph (1) shall be designed toward the objective of
ensuring that, with respect to efficiently utilizing Federal
resources available for carrying out this section, a
substantial majority of shipments of drugs subject to described
in subsection (c) are identified and destroyed.
``(e) Evidence Exception.--Drugs may not be destroyed under
subsection (c) to the extent that the Attorney General of the United
States determines that the drugs should be preserved as evidence or
potential evidence with respect to an offense against the United
States.
``(f) Rule of Construction.--This section may not be construed as
having any legal effect on applicable law with respect to a shipment of
drugs that is imported or offered for import into the United States and
has a declared value equal to or greater than $10,000.''.
(b) Procedures.--Procedures for carrying out section 805 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall
be established not later than 90 days after the date of the enactment
of this title.
(c) Effective Date.--The amendments made by this section shall take
effect on the date that is 90 days after the date of enactment of this
title.

SEC. 806. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS REGARDING PRIOR
SALE, PURCHASE, OR TRADE.

(a) Striking of Exemptions; Applicability to Registered
Exporters.--Section 503(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(e)) is amended--
(1) in paragraph (1)--
(A) by striking ``and who is not the manufacturer
or an authorized distributor of record of such drug'';
(B) by striking ``to an authorized distributor of
record or''; and
(C) by striking subparagraph (B) and inserting the
following:
``(B) The fact that a drug subject to subsection (b) is exported
from the United States does not with respect to such drug exempt any
person that is engaged in the business of the wholesale distribution of
the drug from providing the statement described in subparagraph (A) to
the person that receives the drug pursuant to the export of the drug.
``(C)(i) The Secretary shall by regulation establish requirements
that supersede subparagraph (A) (referred to in this subparagraph as
`alternative requirements') to identify the chain of custody of a drug
subject to subsection (b) from the manufacturer of the drug throughout
the wholesale distribution of the drug to a pharmacist who intends to
sell the drug at retail if the Secretary determines that the
alternative requirements, which may include standardized anti-
counterfeiting or track-and-trace technologies, will identify such
chain of custody or the identity of the discrete package of the drug
from which the drug is dispensed with equal or greater certainty to the
requirements of subparagraph (A), and that the alternative requirements
are economically and technically feasible.
``(ii) When the Secretary promulgates a final rule to establish
such alternative requirements, the final rule in addition shall, with
respect to the registration condition established in clause (i) of
section 804(c)(3)(B), establish a condition equivalent to the
alternative requirements, and such equivalent condition may be met in
lieu of the registration condition established in such clause (i).'';
(2) in paragraph (2)(A), by adding at the end the
following: ``The preceding sentence may not be construed as
having any applicability with respect to a registered exporter
under section 804.''; and
(3) in paragraph (3), by striking ``and subsection (d)--''
in the matter preceding subparagraph (A) and all that follows
through ``the term `wholesale distribution' means'' in
subparagraph (B) and inserting the following: ``and subsection
(d), the term `wholesale distribution' means''.
(b) Conforming Amendment.--Section 503(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by adding at the
end the following:
``(4) Each manufacturer of a drug subject to subsection (b) shall
maintain at its corporate offices a current list of the authorized
distributors of record of such drug.
``(5) For purposes of this subsection, the term `authorized
distributors of record' means those distributors with whom a
manufacturer has established an ongoing relationship to distribute such
manufacturer's products.''.
(c) Effective Date.--
(1) In general.--The amendments made by paragraphs (1) and
(3) of subsection (a) and by subsection (b) shall take effect
on January 1, 2010.
(2) Drugs imported by registered importers under section
804.--Notwithstanding paragraph (1), the amendments made by
paragraphs (1) and (3) of subsection (a) and by subsection (b)
shall take effect on the date that is 90 days after the date of
enactment of this title with respect to qualifying drugs
imported under section 804 of the Federal Food, Drug, and
Cosmetic Act, as added by section 804.
(3) Effect with respect to registered exporters.--The
amendment made by subsection (a)(2) shall take effect on the
date that is 90 days after the date of enactment of this title.
(4) Alternative requirements.--The Secretary shall issue
regulations to establish the alternative requirements, referred
to in the amendment made by subsection (a)(1), that take effect
not later than January 1, 2010.
(5) Intermediate requirements.--The Secretary shall by
regulation require the use of standardized anti-counterfeiting
or track-and-trace technologies on prescription drugs at the
case and pallet level effective not later than 1 year after the
date of enactment of this title.
(6) Additional requirements.--
(A) In general.--Notwithstanding any other
provision of this section, the Secretary shall, not
later than 18 months after the date of enactment of
this title, require that the packaging of any
prescription drug incorporates--
(i) a standardized numerical identifier
unique to each package of such drug, applied at
the point of manufacturing and repackaging (in
which case the numerical identifier shall be
linked to the numerical identifier applied at
the point of manufacturing); and
(ii)(I) overt optically variable
counterfeit-resistant technologies that--
(aa) are visible to the naked eye,
providing for visual identification of
product authenticity without the need
for readers, microscopes, lighting
devices, or scanners;
(bb) are similar to that used by
the Bureau of Engraving and Printing to
secure United States currency;
(cc) are manufactured and
distributed in a highly secure, tightly
controlled environment; and
(dd) incorporate additional layers
of nonvisible convert security features
up to and including forensic
capability, as described in
subparagraph (B); or
(II) technologies that have a function of
security comparable to that described in
subclause (I), as determined by the Secretary.
(B) Standards for packaging.--For the purpose of
making it more difficult to counterfeit the packaging
of drugs subject to this paragraph, the manufacturers
of such drugs shall incorporate the technologies
described in subparagraph (A) into at least 1
additional element of the physical packaging of the
drugs, including blister packs, shrink wrap, package
labels, package seals, bottles, and boxes.

SEC. 807. INTERNET SALES OF PRESCRIPTION DRUGS.

(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A
the following:

``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

``(a) Requirements Regarding Information on Internet Site.--
``(1) In general.--A person may not dispense a prescription
drug pursuant to a sale of the drug by such person if--
``(A) the purchaser of the drug submitted the
purchase order for the drug, or conducted any other
part of the sales transaction for the drug, through an
Internet site;
``(B) the person dispenses the drug to the
purchaser by mailing or shipping the drug to the
purchaser; and
``(C) such site, or any other Internet site used by
such person for purposes of sales of a prescription
drug, fails to meet each of the requirements specified
in paragraph (2), other than a site or pages on a site
that--
``(i) are not intended to be accessed by
purchasers or prospective purchasers; or
``(ii) provide an Internet information
location tool within the meaning of section
231(e)(5) of the Communications Act of 1934 (47
U.S.C. 231(e)(5)).
``(2) Requirements.--With respect to an Internet site, the
requirements referred to in subparagraph (C) of paragraph (1)
for a person to whom such paragraph applies are as follows:
``(A) Each page of the site shall include either
the following information or a link to a page that
provides the following information:
``(i) The name of such person.
``(ii) Each State in which the person is
authorized by law to dispense prescription
drugs.
``(iii) The address and telephone number of
each place of business of the person with
respect to sales of prescription drugs through
the Internet, other than a place of business
that does not mail or ship prescription drugs
to purchasers.
``(iv) The name of each individual who
serves as a pharmacist for prescription drugs
that are mailed or shipped pursuant to the
site, and each State in which the individual is
authorized by law to dispense prescription
drugs.
``(v) If the person provides for medical
consultations through the site for purposes of
providing prescriptions, the name of each
individual who provides such consultations;
each State in which the individual is licensed
or otherwise authorized by law to provide such
consultations or practice medicine; and the
type or types of health professions for which
the individual holds such licenses or other
authorizations.
``(B) A link to which paragraph (1) applies shall
be displayed in a clear and prominent place and manner,
and shall include in the caption for the link the words
`licensing and contact information'.
``(b) Internet Sales Without Appropriate Medical Relationships.--
``(1) In general.--Except as provided in paragraph (2), a
person may not dispense a prescription drug, or sell such a
drug, if--
``(A) for purposes of such dispensing or sale, the
purchaser communicated with the person through the
Internet;
``(B) the patient for whom the drug was dispensed
or purchased did not, when such communications began,
have a prescription for the drug that is valid in the
United States;
``(C) pursuant to such communications, the person
provided for the involvement of a practitioner, or an
individual represented by the person as a practitioner,
and the practitioner or such individual issued a
prescription for the drug that was purchased;
``(D) the person knew, or had reason to know, that
the practitioner or the individual referred to in
subparagraph (C) did not, when issuing the
prescription, have a qualifying medical relationship
with the patient; and
``(E) the person received payment for the
dispensing or sale of the drug.
For purposes of subparagraph (E), payment is received if money
or other valuable consideration is received.
``(2) Exceptions.--Paragraph (1) does not apply to--
``(A) the dispensing or selling of a prescription
drug pursuant to telemedicine practices sponsored by--
``(i) a hospital that has in effect a
provider agreement under title XVIII of the
Social Security Act (relating to the Medicare
program); or
``(ii) a group practice that has not fewer
than 100 physicians who have in effect provider
agreements under such title; or
``(B) the dispensing or selling of a prescription
drug pursuant to practices that promote the public
health, as determined by the Secretary by regulation.
``(3) Qualifying medical relationship.--
``(A) In general.--With respect to issuing a
prescription for a drug for a patient, a practitioner
has a qualifying medical relationship with the patient
for purposes of this section if--
``(i) at least one in-person medical
evaluation of the patient has been conducted by
the practitioner; or
``(ii) the practitioner conducts a medical
evaluation of the patient as a covering
practitioner.
``(B) In-person medical evaluation.--A medical
evaluation by a practitioner is an in-person medical
evaluation for purposes of this section if the
practitioner is in the physical presence of the patient
as part of conducting the evaluation, without regard to
whether portions of the evaluation are conducted by
other health professionals.
``(C) Covering practitioner.--With respect to a
patient, a practitioner is a covering practitioner for
purposes of this section if the practitioner conducts a
medical evaluation of the patient at the request of a
practitioner who has conducted at least one in-person
medical evaluation of the patient and is temporarily
unavailable to conduct the evaluation of the patient. A
practitioner is a covering practitioner without regard
to whether the practitioner has conducted any in-person
medical evaluation of the patient involved.
``(4) Rules of construction.--
``(A) Individuals represented as practitioners.--A
person who is not a practitioner (as defined in
subsection (e)(1)) lacks legal capacity under this
section to have a qualifying medical relationship with
any patient.
``(B) Standard practice of pharmacy.--Paragraph (1)
may not be construed as prohibiting any conduct that is
a standard practice in the practice of pharmacy.
``(C) Applicability of requirements.--Paragraph (3)
may not be construed as having any applicability beyond
this section, and does not affect any State law, or
interpretation of State law, concerning the practice of
medicine.
``(c) Actions by States.--
``(1) In general.--Whenever an attorney general of any
State has reason to believe that the interests of the residents
of that State have been or are being threatened or adversely
affected because any person has engaged or is engaging in a
pattern or practice that violates section 301(l), the State may
bring a civil action on behalf of its residents in an
appropriate district court of the United States to enjoin such
practice, to enforce compliance with such section (including a
nationwide injunction), to obtain damages, restitution, or
other compensation on behalf of residents of such State, to
obtain reasonable attorneys fees and costs if the State
prevails in the civil action, or to obtain such further and
other relief as the court may deem appropriate.
``(2) Notice.--The State shall serve prior written notice
of any civil action under paragraph (1) or (5)(B) upon the
Secretary and provide the Secretary with a copy of its
complaint, except that if it is not feasible for the State to
provide such prior notice, the State shall serve such notice
immediately upon instituting such action. Upon receiving a
notice respecting a civil action, the Secretary shall have the
right--
``(A) to intervene in such action;
``(B) upon so intervening, to be heard on all
matters arising therein; and
``(C) to file petitions for appeal.
``(3) Construction.--For purposes of bringing any civil
action under paragraph (1), nothing in this chapter shall
prevent an attorney general of a State from exercising the
powers conferred on the attorney general by the laws of such
State to conduct investigations or to administer oaths or
affirmations or to compel the attendance of witnesses or the
production of documentary and other evidence.
``(4) Venue; service of process.--Any civil action brought
under paragraph (1) in a district court of the United States
may be brought in the district in which the defendant is found,
is an inhabitant, or transacts business or wherever venue is
proper under section 1391 of title 28, United States Code.
Process in such an action may be served in any district in
which the defendant is an inhabitant or in which the defendant
may be found.
``(5) Actions by other state officials.--
``(A) Nothing contained in this section shall
prohibit an authorized State official from proceeding
in State court on the basis of an alleged violation of
any civil or criminal statute of such State.
``(B) In addition to actions brought by an attorney
general of a State under paragraph (1), such an action
may be brought by officers of such State who are
authorized by the State to bring actions in such State
on behalf of its residents.
``(d) Effect of Section.--This section shall not apply to a person
that is a registered exporter under section 804.
``(e) General Definitions.--For purposes of this section:
``(1) The term `practitioner' means a practitioner referred
to in section 503(b)(1) with respect to issuing a written or
oral prescription.
``(2) The term `prescription drug' means a drug that is
described in section 503(b)(1).
``(3) The term `qualifying medical relationship', with
respect to a practitioner and a patient, has the meaning
indicated for such term in subsection (b).
``(f) Internet-Related Definitions.--
``(1) In general.--For purposes of this section:
``(A) The term `Internet' means collectively the
myriad of computer and telecommunications facilities,
including equipment and operating software, which
comprise the interconnected world-wide network of
networks that employ the transmission control protocol/
internet protocol, or any predecessor or successor
protocols to such protocol, to communicate information
of all kinds by wire or radio.
``(B) The term `link', with respect to the
Internet, means one or more letters, words, numbers,
symbols, or graphic items that appear on a page of an
Internet site for the purpose of serving, when
activated, as a method for executing an electronic
command--
``(i) to move from viewing one portion of a
page on such site to another portion of the
page;
``(ii) to move from viewing one page on
such site to another page on such site; or
``(iii) to move from viewing a page on one
Internet site to a page on another Internet
site.
``(C) The term `page', with respect to the
Internet, means a document or other file accessed at an
Internet site.
``(D)(i) The terms `site' and `address', with
respect to the Internet, mean a specific location on
the Internet that is determined by Internet Protocol
numbers. Such term includes the domain name, if any.
``(ii) The term `domain name' means a method of
representing an Internet address without direct
reference to the Internet Protocol numbers for the
address, including methods that use designations such
as `.com', `.edu', `.gov', `.net', or `.org'.
``(iii) The term `Internet Protocol numbers'
includes any successor protocol for determining a
specific location on the Internet.
``(2) Authority of secretary.--The Secretary may by
regulation modify any definition under paragraph (1) to take
into account changes in technology.
``(g) Interactive Computer Service; Advertising.--No provider of an
interactive computer service, as defined in section 230(f)(2) of the
Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising
services shall be liable under this section for dispensing or selling
prescription drugs in violation of this section on account of another
person's selling or dispensing such drugs, provided that the provider
of the interactive computer service or of advertising services does not
own or exercise corporate control over such person.''.
(b) Inclusion as Prohibited Act.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after
paragraph (k) the following:
``(l) The dispensing or selling of a prescription drug in violation
of section 503B.''.
(c) Internet Sales of Prescription Drugs; Consideration by
Secretary of Practices and Procedures for Certification of Legitimate
Businesses.--In carrying out section 503B of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (a) of this section), the
Secretary of Health and Human Services shall take into consideration
the practices and procedures of public or private entities that certify
that businesses selling prescription drugs through Internet sites are
legitimate businesses, including practices and procedures regarding
disclosure formats and verification programs.
(d) Reports Regarding Internet-Related Violations of Federal and
State Laws on Dispensing of Drugs.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall,
pursuant to the submission of an application meeting the
criteria of the Secretary, make an award of a grant or contract
to the National Clearinghouse on Internet Prescribing (operated
by the Federation of State Medical Boards) for the purpose of--
(A) identifying Internet sites that appear to be in
violation of Federal or State laws concerning the
dispensing of drugs;
(B) reporting such sites to State medical licensing
boards and State pharmacy licensing boards, and to the
Attorney General and the Secretary, for further
investigation; and
(C) submitting, for each fiscal year for which the
award under this subsection is made, a report to the
Secretary describing investigations undertaken with
respect to violations described in subparagraph (A).
(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there is authorized to be
appropriated $100,000 for each of the first 3 fiscal years in
which this section is in effect.
(e) Effective Date.--The amendments made by subsections (a) and (b)
take effect 90 days after the date of enactment of this title, without
regard to whether a final rule to implement such amendments has been
promulgated by the Secretary of Health and Human Services under section
701(a) of the Federal Food, Drug, and Cosmetic Act. The preceding
sentence may not be construed as affecting the authority of such
Secretary to promulgate such a final rule.

SEC. 808. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN PHARMACIES.

(a) In General.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the
following:
``(g) Restricted Transactions.--
``(1) In general.--The introduction of restricted
transactions into a payment system or the completion of
restricted transactions using a payment system is prohibited.
``(2) Payment system.--
``(A) In general.--The term `payment system' means
a system used by a person described in subparagraph (B)
to effect a credit transaction, electronic fund
transfer, or money transmitting service that may be
used in connection with, or to facilitate, a restricted
transaction, and includes--
``(i) a credit card system;
``(ii) an international, national,
regional, or local network used to effect a
credit transaction, an electronic fund
transfer, or a money transmitting service; and
``(iii) any other system that is centrally
managed and is primarily engaged in the
transmission and settlement of credit
transactions, electronic fund transfers, or
money transmitting services.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which
an electronic fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international,
national, regional, or local network used to
effect a credit transaction, electronic fund
transfer, or money transmitting service.
``(3) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of
an individual who places an unlawful drug importation request
to any person engaged in the operation of an unregistered
foreign pharmacy, of--
``(A) credit, or the proceeds of credit, extended
to or on behalf of the individual for the purpose of
the unlawful drug importation request (including credit
extended through the use of a credit card);
``(B) an electronic fund transfer or funds
transmitted by or through a money transmitting
business, or the proceeds of an electronic fund
transfer or money transmitting service, from or on
behalf of the individual for the purpose of the
unlawful drug importation request;
``(C) a check, draft, or similar instrument which
is drawn by or on behalf of the individual for the
purpose of the unlawful drug importation request and is
drawn on or payable at or through any financial
institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Board by regulation)
that involves a financial institution as a payor or
financial intermediary on behalf of or for the benefit
of the individual for the purpose of the unlawful drug
importation request.
``(4) Unlawful drug importation request.--The term
`unlawful drug importation request' means the request, or
transmittal of a request, made to an unregistered foreign
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, phone, or electronic mail, or by a means
that involves the use, in whole or in part, of the Internet.
``(5) Unregistered foreign pharmacy.--The term
`unregistered foreign pharmacy' means a person in a country
other than the United States that is not a registered exporter
under section 804.
``(6) Other definitions.--
``(A) Credit; creditor; credit card.--The terms
`credit', `creditor', and `credit card' have the
meanings given the terms in section 103 of the Truth in
Lending Act (15 U.S.C. 1602).
``(B) Access device; electronic fund transfer.--The
terms `access device' and `electronic fund transfer'--
``(i) have the meaning given the term in
section 903 of the Electronic Fund Transfer Act
(15 U.S.C. 1693a); and
``(ii) the term `electronic fund transfer'
also includes any fund transfer covered under
Article 4A of the Uniform Commercial Code, as
in effect in any State.
``(C) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in
section 903 of the Electronic Transfer Fund Act
(15 U.S.C. 1693a); and
``(ii) includes a financial institution (as
defined in section 509 of the Gramm-Leach-
Bliley Act (15 U.S.C. 6809)).
``(D) Money transmitting business; money
transmitting service.--The terms `money transmitting
business' and `money transmitting service' have the
meaning given the terms in section 5330(d) of title 31,
United States Code.
``(E) Board.--The term `Board' means the Board of
Governors of the Federal Reserve System.
``(7) Policies and procedures required to prevent
restricted transactions.--
``(A) Regulations.--The Board shall promulgate
regulations requiring--
``(i) an operator of a credit card system;
``(ii) an operator of an international,
national, regional, or local network used to
effect a credit transaction, an electronic fund
transfer, or a money transmitting service;
``(iii) an operator of any other payment
system that is centrally managed and is
primarily engaged in the transmission and
settlement of credit transactions, electronic
transfers or money transmitting services where
at least one party to the transaction or
transfer is an individual; and
``(iv) any other person described in
paragraph (2)(B) and specified by the Board in
such regulations,
to establish policies and procedures that are
reasonably designed to prevent the introduction of a
restricted transaction into a payment system or the
completion of a restricted transaction using a payment
system
``(B) Requirements for policies and procedures.--In
promulgating regulations under subparagraph (A), the
Board shall--
``(i) identify types of policies and
procedures, including nonexclusive examples,
that shall be considered to be reasonably
designed to prevent the introduction of
restricted transactions into a payment system
or the completion of restricted transactions
using a payment system; and
``(ii) to the extent practicable, permit
any payment system, or person described in
paragraph (2)(B), as applicable, to choose
among alternative means of preventing the
introduction or completion of restricted
transactions.
``(C) No liability for blocking or refusing to
honor restricted transaction.--
``(i) In general.--A payment system, or a
person described in paragraph (2)(B) that is
subject to a regulation issued under this
subsection, and any participant in such payment
system that prevents or otherwise refuses to
honor transactions in an effort to implement
the policies and procedures required under this
subsection or to otherwise comply with this
subsection shall not be liable to any party for
such action.
``(ii) Compliance.--A person described in
paragraph (2)(B) meets the requirements of this
subsection if the person relies on and complies
with the policies and procedures of a payment
system of which the person is a member or in
which the person is a participant, and such
policies and procedures of the payment system
comply with the requirements of the regulations
promulgated under subparagraph (A).
``(D) Enforcement.--
``(i) In general.--This section shall be
enforced by the Federal functional regulators
and the Federal Trade Commission under
applicable law in the manner provided in
section 505(a) of the Gramm-Leach-Bliley Act
(15 U.S.C. 6805(a)).
``(ii) Factors to be considered.--In
considering any enforcement action under this
subsection against a payment system or person
described in paragraph (2)(B), the Federal
functional regulators and the Federal Trade
Commission shall consider the following
factors:
``(I) The extent to which the
payment system or person knowingly
permits restricted transactions.
``(II) The history of the payment
system or person in connection with
permitting restricted transactions.
``(III) The extent to which the
payment system or person has
established and is maintaining policies
and procedures in compliance with
regulations prescribed under this
subsection.
``(8) Transactions permitted.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, is authorized to
engage in transactions with foreign pharmacies in connection
with investigating violations or potential violations of any
rule or requirement adopted by the payment system or person in
connection with complying with paragraph (7). A payment system,
or such a person, and its agents and employees shall not be
found to be in violation of, or liable under, any Federal,
State or other law by virtue of engaging in any such
transaction.
``(9) Relation to state laws.--No requirement, prohibition,
or liability may be imposed on a payment system, or a person
described in paragraph (2)(B) that is subject to a regulation
issued under this subsection, under the laws of any state with
respect to any payment transaction by an individual because the
payment transaction involves a payment to a foreign pharmacy.
``(10) Timing of requirements.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, must adopt policies
and procedures reasonably designed to comply with any
regulations required under paragraph (7) within 60 days after
such regulations are issued in final form.''.
(b) Effective Date.--The amendment made by this section shall take
effect on the day that is 90 days after the date of enactment of this
Act.
(c) Implementation.--The Board of Governors of the Federal Reserve
System shall promulgate regulations as required by subsection (g)(7) of
section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333), as added by subsection (a), not later than 90 days after the date
of enactment of this title.

SEC. 809. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES IMPORT AND
EXPORT ACT.

Section 1006(a)(2) of the Controlled Substances Import and Export
Act (21 U.S.C. 956(a)(2)) is amended by striking ``not import the
controlled substance into the United States in an amount that exceeds
50 dosage units of the controlled substance.'' and inserting ``import
into the United States not more than 10 dosage units combined of all
such controlled substances.''.

SEC. 810. SEVERABILITY.

If any provision of this title, an amendment by this title, or the
application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this
title, the amendments made by this title, and the application of the
provisions of such to any person or circumstance shall not affected
thereby.

SEC. 811. PROTECTION OF HEALTH AND SAFETY.

This title, and the amendments made by this title, shall become
effective only if the Secretary of Health and Human Services certifies
to Congress that the implementation of this title (and amendments)
will--
(1) pose no additional risk to the public's health and
safety; and
(2) result in a significant reduction in the cost of
covered products to the American consumer.

Passed the Senate May 9, 2007.

Attest:

Secretary.
110th CONGRESS

1st Session

S. 1082

_______________________________________________________________________

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to reauthorize drug and device user fees and ensure the
safety of medical products, and for other purposes.