To clarify the authority of the Office of Surveillance and Epidemiology with respect to postmarket drug safety pursuant to recommendations by the Institute of Medicine.

TEXT OF AMENDMENTS

SA 1034. Mr. DURBIN (for himself and Mr. Bingaman) submitted an
amendment intended to be proposed by him to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

In title II, strike subtitle D and insert the following:

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, through the Office of Women's
Health, the Office of Orphan Product Development, the Office
of Pediatric Therapeutics, and other offices within the Food
and Drug Administration with relevant expertise, shall
develop and implement strategies on effective outreach to
potential members of advisory committees at universities,
colleges, other academic research centers, professional and
medical societies, and patient and consumer groups. 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 funding from the National Institutes of Health, the
Agency for Healthcare Research and Quality, the Centers for
Disease Control and Prevention, or the Veterans Health
Administration 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.
``(3) Participation of guest expert with financial
interest.--Notwithstanding any other provision of this
section, an individual with a financial interest with respect
to any matter considered by an advisory committee may be
allowed to participate in a meeting of an advisory committee
as a guest expert if the Secretary determines that the
individual has particular expertise required for the meeting.
An individual participating as a guest expert may provide
information and expert opinion, but shall not participate in
the discussion or voting by the members of the advisory
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

[[Page S5606]]

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) Limitations.--
``(A) One waiver per committee meeting.--Notwithstanding
any other provision of this section, with respect to each
advisory committee, the Secretary shall not grant more than 1
waiver under paragraph (3) per committee meeting.
``(B) Scientific work.--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 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.
______

SA 1035. Mr. BURR submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the end of the bill, insert the following:

SEC. __. ADDITION TO PRIORITY LIST CONSIDERATIONS.

Section 409I of the Public Health Service Act (42 U.S.C.
284m), as amended by this Act, is further amended--
(1) by striking subsection (a)(2) and inserting the
following:
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary--
``(A) shall consider--
``(i) 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;
``(ii) 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
``(iii) the adequacy of necessary infrastructure to conduct
pediatric pharmacological research, including research
networks and trained pediatric investigators; and
``(B) may consider the availability of qualified
countermeasures (as defined in section 319F-1) and qualified
pandemic or epidemic products (as defined in section 319F-3)
to address the needs of pediatric populations, in
consultation with the Assistant Secretary for Preparedness
and Response.''; and
(2) in subsection (b), by striking ``subsection (a)'' and
inserting ``paragraphs (1) and (2)(A) of subsection (a)''.

______

SA 1036. Mr. CORKER submitted an amendment intended to be proposed to
amendment SA 990 submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr.
Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor,
Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) to the bill S. 1082,
to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and
amend the prescription drug user fee provisions, and for other
purposes; which was ordered to lie on the table; as follows:

On page 88 of the amendment, strike lines 5 through 7 and
insert the following:
``(B) the packaging, repackaging, labeling, relabeling, or
distribution of a prescription drug.
``(o) Prohibition on Commingling.--
``(1) In general.--A registered importer shall not
commingle a prescription drug imported into the United States
under this section with another prescription drug unless such
other prescription drug is imported from a permitted country.
``(2) Label.--A registered importer (including an Internet
pharmacy) that dispenses a prescription drug imported from a
permitted country shall affix on each dispensed container of
the prescription drug the label required under paragraph (3),
unless such a label is already affixed to the container.
``(3) Requirements.--Each prescription drug imported under
this section shall be in a container that bears a label
stating, in prominent and conspicuous type--
``(A) the lot number of the prescription drug;
``(B) the name, address, and phone number of the exporter
of the drug, regardless of whether the exporter is
registered;
``(C) the following statement: `This drug has been imported
from ______.' with the name of the permitted country from
which the prescription drug has imported in the blank space;
``(D) a unique identifier code provided by the Secretary
that modifies the national drug code of the prescription drug
to indicate that the drug has been imported;
``(E) a statement that discloses the originating country of
the drug; and
``(F) that the container complies with any other applicable
requirement of this Act.''.

______

SA 1037. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place in the amendment, insert the
following:

SEC. __. REQUIRED TESTING OF DRUGS.

Notwithstanding any other provision of this title (and the
amendment made by this title) a prescription drug may only be
imported by a pharmacist, wholesaler, or individual under
this title (or amendments) if

[[Page S5607]]

the importer of such drug complies with subsections (d)(1)
and (e) of section 804 of such Act (21 U.S.C. 384(d)(1) and
(e)), as in effect on the day before the date of enactment of
this Act.
______

SA 1038. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place in the amendment, insert the
following:

SEC. __. REQUIRED FDA APPROVAL OF DRUGS.

Notwithstanding any other provision of this title (and the
amendment made by this title) a prescription drug may only be
imported by a pharmacist, wholesaler, or individual under
this title (or amendments) if--
(1) such drug complies with section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355)(including with
respect to being safe and effective for the intended use of
the prescription drug) and with sections 501 and 502 of such
Act (21 U.S.C. 351 and 352);
(2) the importer of such drug complies with subsections
(d)(1) and (e) of section 804 of such Act (21 U.S.C.
384(d)(1) and (e)), as in effect on the day before the date
of enactment of this Act; and
(3) the drug or importer of such drug complies with any
additional requirements determined by the Secretary of Health
and Human Services to be appropriate as a safeguard to
protect the public health or as a means to facilitate the
importation of prescription drugs.
______

SA 1039. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of subtitle E of title II, insert the following:

SEC. 2_. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND
EPIDEMIOLOGY.

With respect to all actions of the Food and Drug
Administration related to postmarketing drug safety,
including labeling changes, postapproval studies, and
restrictions on distribution or use of drugs with serious
risks, the Office of Surveillance and Epidemiology (or
successor office) of such Administration and the Office of
New Drugs (or successor office) of such Administration shall
make decisions jointly. In the event of a disagreement with
respect to an action related to postmarketing drug safety,
including labeling changes, postapproval studies, and
restrictions on distribution or use of drugs with serious
risks, between such 2 offices, the Commissioner of Food and
Drugs shall make the decision with respect to such action.
______

SA 1040. Mrs. CLINTON (for herself and Mr. Lautenberg) submitted an
amendment intended to be proposed by her to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. JOINT TASK FORCE WITH THE FOOD AND DRUG
ADMINISTRATION AND THE DEPARTMENT OF
AGRICULTURE.

(a) In General.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services, the Commissioner of Food and Drugs, and the
Secretary of Agriculture shall establish a joint task force
concerning foodborne illnesses.
(b) Chairperson.--The Secretary of Health and Human
Services shall serve as the chairperson of the joint task
force established under subsection (a).
(c) Duties.--The joint task force established under
subsection (a) shall--
(1) develop recommendations on how to effectively address
the problem of foodborne illness in the United States;
(2) submit to Congress recommendation for changes in the
law to address the sources of food contamination before
hazards enter the food supply, such as mandatory recall
authority, trace back procedures, and modification to farm
regulations; and
(3) identify measures to be taken at the Federal agency
level to effectively improve internal and external
communication and information sharing with respect to
addressing the problem of foodborne illness.
(d) Participation and Input of Others.--The joint task
force established under subsection (a) shall establish
mechanisms to allow relevant stakeholder, including farmers,
the food industry, consumer groups, and relevant State
agencies, to participate in task force activities and to
provide the task force with input on food safety policy.
______

SA 1041. Mr. OBAMA submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. 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 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.
______

SA 1042. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. LIABILITY OF HEALTHCARE PROVIDERS.

A healthcare provider who prescribes, or who dispenses
pursuant to a prescription, a drug, biologic product, or
medical device approved, licensed, or cleared by the Food and
Drug Administration shall not be named as a party to a
product liability lawsuit involving such drug, biological
product, or medical device and shall not be liable to a
claimant in a class action lawsuit against the manufacturer,
distributor, or seller of such drug, biological product, or
medical device.
______

SA 1043. Mr. REED (for himself and Mr. Dodd) submitted an amendment
intended to be proposed to amendment SA 1035 submitted by Mr. Burr and
intended to be proposed to the bill S. 1082, to amend the Federal Food,
Drug, and Cosmetic Act to reauthorize and amend the prescription drug
user fee provisions, and for other purposes; which was ordered to lie
on the table; as follows:

In lieu of the matter proposed to be inserted, insert the
following:
( ) Addition to Priority List Considerations.--
(1) In general.--Section 409I of the Public Health Service
Act (42 U.S.C. 284m), as amended by this Act, is amended--
(A) by striking subsection (a)(2) and inserting the
following:
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary--
``(A) shall consider--
``(i) 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;
``(ii) 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
``(iii) the adequacy of necessary infrastructure to conduct
pediatric pharmacological research, including research
networks and trained pediatric investigators; and
``(B) may consider the availability of qualified
countermeasures (as defined in section 319F-1) and qualified
pandemic or epidemic products (as defined in section 319F-3)
to address the needs of pediatric populations, in
consultation with the Assistant Secretary for Preparedness
and Response.''; and
(B) in subsection (b), by striking ``subsection (a)'' and
inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
(2) Biomedical advanced research and development
authority.--Section 319L(c)(6) of the Public Health Service
Act (42 U.S.C. 247d-e(c)(6)) is amended by striking ``may
give priority'' and inserting ``shall give priority''.
______

SA 1044. Mr. KOHL submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. 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.

[[Page S5608]]

____________________