To ensure that there is competition in the pharmaceutical industry and increased access to affordable drugs.

TEXT OF AMENDMENTS

SA 936. Mr. NELSON of Florida submitted an amendment intended to be
proposed by him to the bill S. 1, to amend title XVIII of the Social
Security Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table, as follows:

At the end of subtitle C of title II, add the following:

SEC. __. EXTENSION OF DEMONSTRATION FOR ESRD MANAGED CARE.

The Secretary shall extend without interruption, through
December 31, 2007, the approval of the demonstration project,
Contract No. H1021, under the authority of section
2355(b)(1)(B)(iv) of the Deficit Reduction Act of 1984, as
amended by section 13567 of the Omnibus Reconciliation Act of
1993. Such approval shall be subject to the terms and
conditions in effect for the 2002 project year with respect
to eligible participants and covered benefits. The Secretary
shall set the monthly capitation rate for enrollees on the
basis of the reasonable medical and direct administrative
costs of providing those benefits to such participants.
______

SA 937. Mr. NELSON of Florida submitted an amendment intended to be
proposed by him to the bill S. 1, to amend title XVIII of the Social
Security Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table, as follows:

At the end of subtitle B of title IV, add the following:

SEC. __. PROHIBITION OF INCIDENTAL FEES AND REQUIRED PURCHASE
OF NONCOVERED ITEMS OR SERVICES UNDER MEDICARE.

(a) In General.--Section 1842 (42 U.S.C. 1395u) is amended
by adding at the end the following new subsection:
``(u) Prohibition of Incidental Fees or Requiring Purchase
of Noncovered Items or Services.--
``(1) In general.--A physician, practitioner (as described
in section 1842(b)(18)(C)), or other individual may not--
``(A) charge a membership fee or any other incidental fee
to a medicare beneficiary (as defined in section
1802(b)(5)(A)); or
``(B) require a medicare beneficiary (as so defined) to
purchase a noncovered item or service,

as a prerequisite for the provision of a covered item or
service to the beneficiary under this title.
``(2) Construction.--Nothing in this subsection shall be
construed to apply the prohibition under paragraph (1) to a
physician, practitioner, or other individual described in
such subsection who does not accept any funds under this
title.''.

[[Page S8247]]

(b) Effective Date.--The amendment made by subsection (a)
shall apply to membership fees and other charges made, or
purchases of items and services required, on or after the
date of enactment of this Act.
______

SA 938. Mr. NELSON of Florida submitted an amendment intended to be
proposed by him to the bill S. 1, to amend title XVIII of the Social
Security Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

At the end of subtitle B of title IV, add the following:

SEC. __. GAO STUDY AND REPORT ON THE PROPAGATION OF CONCIERGE
CARE.

(a) Study.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on concierge care (as defined in
paragraph (2)) to determine the extent to which such care--
(A) is used by medicare beneficiaries (as defined in
section 1802(b)(5)(A) of the Social Security Act (42 U.S.C.
1395a(b)(5)(A))); and
(B) has impacted upon the access of medicare beneficiaries
(as so defined) to items and services for which reimbursement
is provided under the medicare program under title XVIII of
the Social Security Act (42 U.S.C. 1395 et seq.).
(2) Concierge care.--In this section, the term ``concierge
care'' means an arrangement under which, as a prerequisite
for the provision of a health care item or service to an
individual, a physician, practitioner (as described in
section 1842(b)(18)(C) of the Social Security Act (42 U.S.C.
1395u(b)(18)(C))), or other individual--
(A) charges a membership fee or another incidental fee to
an individual desiring to receive the health care item or
service from such physician, practitioner, or other
individual; or
(B) requires the individual desiring to receive the health
care item or service from such physician, practitioner, or
other individual to purchase an item or service.
(b) Report.--Not later than the date that is 12 months
after the date of enactment of this Act, the Comptroller
General of the United States shall submit to Congress a
report on the study conducted under subsection (a)(1)
together with such recommendations for legislative or
administrative action as the Comptroller General determines
to be appropriate.
______

SA 939. Mr. DASCHLE (for himself, Mr. Nelson of Nebraska, Ms.
Mikulski, and Mr. Johnson) proposed an amendment to the bill S. 1, to
amend title XVIII of the Social Security Act to make improvements in
the medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

On page 103, strike lines 10 though 13 and insert the
following:
``(B) the lesser of--
``(i) the amount by which the monthly plan premium approved
by the Administrator for the plan exceeds the amount of the
monthly national average premium; or
``(ii) in the case of an eligible beneficiary who is
enrolled in a Medicare Prescription Drug plan that provides
standard prescription drug coverage or an actuarially
equivalent prescription drug coverage and does not provide
additional prescription drug coverage pursuant to section
1860D-6(a)(2), an amount equal to 10 percent of the amount of
the monthly national average premium.

On page 77, strike lines 10 through 22 and insert the
following:
``(A) In general.--In the case of an eligible beneficiary
receiving access to qualified prescription drug coverage
through enrollment with an entity with a contract under
paragraph (1)(B), the monthly beneficiary obligation of such
beneficiary for such enrollment shall be an amount equal to
the lesser of--
``(i) the applicable percent (for the area in which the
beneficiary resides, as determined under section 1860D-17(c))
of the monthly national average premium (as computed under
section 1860D-15) for the year as adjusted using the
geographic adjuster under subparagraph (B); or
``(ii) 110 percent of an amount equal to the applicable
percent (as determined under section 1860D-17(c) before any
adjustment under paragraph (2) of such section) of the
monthly national average premium (as computed under section
1860D-15 before any adjustment under subsection (b) of such
section) for the year.
______

SA 940. Mr. KERRY submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

On page 200, between lines 13 and 14, insert the following:

SEC. __. ACCESS TO DISCOUNTED PRESCRIPTION DRUGS.

(a) In General.--From amounts made available under
subsection (c), the Secretary of Health and Human Services
shall award grants to covered entities described in section
340B(a)(4) of the Public Health Service Act (42 U.S.C.
256b(a)(4)) to enable such entities to pay the start-up costs
associated with the establishment of pharmacies to provide
covered drugs under such section 340B.
(b) Application.--To be eligible to receive a grant under
subsection (a), a covered entity shall prepare and submit to
the Secretary of Health and Human Services an application at
such time, in such manner, and containing such information as
the Secretary may require.
(c) Funding.--There shall be made available from the
Prescription Drug Account established under section 1860DD-25
of the Social Security Act, $300,000,000 to carry out this
section. Amounts made available under this subsection shall
remain available until expended.
______

SA 941. Mr. WYDEN (for himself, Mrs. Murray, and Mr. Smith) submitted
an amendment intended to be proposed by him to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; which was ordered to lie on
the table; as follows:

At the end of title IV, add the following:

SEC. __. MEDPAC STUDY ON MEDICARE PAYMENTS AND EFFICIENCIES
IN THE HEALTH CARE SYSTEM.

Not later than 18 months after the date of enactment of
this Act, the Medicare Payment Advisory Commission
established under section 1805 of the Social Security Act (42
U.S.C. 1395b-6) shall provide Congress with recommendations
to recognize and reward, within payment methodologies for
physicians and hospitals established under the medicare
program under title XVIII of the Social Security Act,
efficiencies, and the lower utilization of services created
by the practice of medicine in historically efficient and
low-cost areas. Measures of efficiency recognized in
accordance with the preceding sentence shall include--
(1) shorter hospital stays than the national average;
(2) fewer physician visits than the national average;
(3) fewer laboratory tests than the national average;
(4) a greater utilization of hospice services than the
national average; and
(5) the efficacy of disease management and preventive
health services.
______

SA 942. Ms. CANTWELL submitted an amendment intended to be proposed
by her to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

On page 204, after line 22, insert the following:

SEC. 133. PHARMACY BENEFIT MANAGERS TRANSPARENCY
REQUIREMENTS.

(a) Medicare.--Subpart 3 of part D of title XVIII of the
Social Security Act (as added by section 101) is amended by
adding at the end the following new section:

``pharmacy benefit managers transparency requirements

``Sec. 1860D-27. Notwithstanding any other provision of
law, an eligible entity offering a Medicare Prescription Drug
plan under this part or a MedicareAdvantage organization
offering a MedicareAdvantage plan under part C shall not
enter into a contract with any pharmacy benefit manager (in
this section referred to as a `PBM') to manage the
prescription drug coverage provided under such plan, or to
control the costs of such coverage, unless the PBM satisfies
the following requirements:
``(1) The PBM is not owned by a pharmaceutical
manufacturing company.
``(2) The PBM agrees to pass along any cost savings
negotiated with a pharmacy to the Medicare Prescription Drug
plan or the MedicareAdvantage plan.
``(3) The PBM agrees to make public on an annual basis the
percent of manufacturer's rebates received by the PBM that is
passed back to the Medicare Prescription Drug plan or the
MedicareAdvantage plan on a drug-by-drug basis.
``(4) The PBM agrees to provide, at least annually, the
Medicare Prescription Drug plan or the MedicareAdvantage plan
with all financial and utilization information requested by
the plan relating to the provision of benefits to eligible
beneficiaries through the PBM and all financial and
utilization information relating to services provided to the
plan. A PBM providing information under this paragraph may
designate that information as confidential. Information
designated as confidential by a PBM and provided to a plan
under this paragraph may not be disclosed to any person
without the consent of the PBM.
``(5) The PBM agrees to provide, at least annually, the
Medicare Prescription Drug plan or the MedicareAdvantage plan
with all financial terms and arrangements for remuneration of
any kind that apply between the PBM and any prescription drug
manufacturer or labeler, including formulary management and
drug-switch programs, educational support, claims processing
and

[[Page S8248]]

pharmacy network fees that are charged from retail pharmacies
and data sales fees.
``(6) The PBM agrees to disclose the retail cost of a
prescription drug upon request by a consumer.''.
(b) Employee Retirement Income Security Act of 1974.--
(1) In general.--Subpart B of part 7 of subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.) is amended by adding at the end the
following:

``SEC. 714. PHARMACY BENEFIT MANAGERS TRANSPARENCY
REQUIREMENTS.

``The provisions of section 1860D-27 of the Social Security
Act shall apply to a group health plan, and a health
insurance issuer providing health insurance coverage in
connection with a group health plan, in the same manner as
such provisions apply to an eligible entity offering a
Medicare Prescription Drug plan under part D of title XVIII
of the Social Security Act or to a MedicareAdvantage
organization offering a MedicareAdvantage plan under part C
of title XVIII of that Act.''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 is
amended by inserting after the item relating to section 713
the following:

``Sec. 714. Pharmacy benefit managers transparency requirements.''.

(3) Effective dates.--The amendments made by this
subsection shall apply with respect to plan years beginning
on or after the date of enactment of this Act.
(c) Amendments to the Public Health Service Act Relating to
the Group Market.--
(1) In general.--Subpart 2 of part A of title XXVII of the
Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is
amended by adding at the end the following:

``SEC. 2707. PHARMACY BENEFIT MANAGERS TRANSPARENCY
REQUIREMENTS.

``The provisions of section 1860D-27 of the Social Security
Act shall apply to a group health plan and a health insurance
issuer providing health insurance coverage in connection with
a group health plan, in the same manner as such provisions
apply to an eligible entity offering a Medicare Prescription
Drug plan under part D of title XVIII of the Social Security
Act or to a MedicareAdvantage organization offering a
MedicareAdvantage plan under part C of title XVIII of that
Act.''.
(2) Effective date.--The amendment made by this subsection
shall apply to group health plans and health insurance
issuers in connection with group health plans for plan years
beginning on or after the date of enactment of this Act.
(d) Amendment to the Public Health Service Act Relating to
the Individual Market.--
(1) In general.--The first subpart 3 of part B of title
XXVII of the Public Health Service Act (42 U.S.C. 300gg-51 et
seq.) is amended--
(A) by redesignating such subpart as subpart 2; and
(B) by adding at the end the following:

``SEC. 2753. PHARMACY BENEFIT MANAGERS TRANSPARENCY
REQUIREMENTS.

``The provisions of section 1860D-27 of the Social Security
Act shall apply to health insurance coverage offered by a
health insurance issuer in the individual market in the same
manner as they apply to an eligible entity offering a
Medicare Prescription Drug plan under part D of title XVIII
of the Social Security Act or to a MedicareAdvantage
organization offering a MedicareAdvantage plan under part C
of title XVIII of that Act.''.
(2) Effective date.--The amendment made by subsection
(c)(1)(B) shall apply with respect to health insurance
coverage offered, sold, issued, renewed, in effect, or
operated in the individual market on or after the date of
enactment of this Act.
(e) Amendments to the Internal Revenue Code of 1986.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by inserting after
section 9812 the following:

``SEC. 9813. PHARMACY BENEFIT MANAGERS TRANSPARENCY
REQUIREMENTS.

``The provisions of section 1860D-27 of the Social Security
Act shall apply to a group health plan in the same manner as
they apply to an eligible entity offering a Medicare
Prescription Drug plan under part D of title XVIII of the
Social Security Act or to a MedicareAdvantage organization
offering a MedicareAdvantage plan under part C of title XVIII
of that Act.''.
(2) Clerical Amendment.--The table of contents for chapter
100 of such Code is amended by inserting after the item
relating to section 9812 the following

``Sec. 9813. Required coverage of young adults.''.

(3) Effective date.--The amendments made by this subsection
shall apply with respect to plan years beginning on or after
the date of enactment of this Act.
______

SA 943. Ms. CANTWELL submitted an amendment intended to be proposed
by her to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

On page 516, after line 22, add the following:

SEC. __. INCENTIVE PAYMENT IN MEDICARE HEALTH PROFESSIONAL
SHORTAGE AREAS DEMONSTRATION PROJECT.

Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended by adding at the end the following new
section:

``incentive payments in medicare health professional shortage areas
demonstration project

``Sec. 1897. (a) Establishment.--
``(1) In general.--The Secretary shall establish a
demonstration project under which--
``(A) pursuant to paragraph (3), the Secretary designates
areas in a State selected under paragraph (5) as medicare
health professional shortage areas; and
``(B) an incentive payment is provided under part B to
primary care physicians for each physician's service (as
defined in section 1861(q)) that is furnished in a medicare
health professional shortage area to an individual enrolled
under such part.
``(2) Primary care physician defined.--For purposes of this
section, the term `primary care physician' has the meaning
given such term for purposes of designating health
professional shortage areas under section 332(a) of the
Public Health Service Act (42 U.S.C. 254e(a)).
``(3) Designation of areas.--The Secretary shall designate
an area in a State selected under paragraph (5) as a medicare
health professional shortage area if the Secretary
determines, using the methodology established under
subsection (b)(1)(B), that individuals enrolled under part B
and residing in the area have inadequate access to primary
care physicians.
``(4) Terms and conditions.--
``(A) Incentive payment in addition to payment otherwise
made.--
``(i) In general.--Subject to clause (ii), the incentive
payment made under the demonstration project for a
physician's service shall be in addition to the amount
otherwise made for the service under part B.
``(ii) No payments under the incentive payment program in a
demonstration state during operation of the demonstration
program.--Subject to subparagraph (D), notwithstanding
section 1833(m), during the operation of the demonstration
project in a State selected under paragraph (5), the
Secretary may not make any incentive payment to any physician
under such section for any service furnished in any part of
such State, regardless of--

``(I) whether the physician is eligible for bonus payments
under the demonstration program; and
``(II) where the service was furnished in the State.

``(B) Amount of incentive payment.--The amount of the
incentive payment for a physician's service furnished under
the demonstration project shall be an amount equal to 40
percent of the payment amount for the service under part B.
``(C) No effect on amount of coinsurance an individual is
required to pay.--The amount of any coinsurance that an
individual enrolled under part B is responsible for paying
with respect to a physicians' service furnished to the
individual shall be determined as if this section had not
been enacted.
``(D) No effect on payments to critical access hospitals.--
The amount of payment for outpatient critical access services
of a critical access hospital under section 1834(g) shall be
determined as if this section had not been enacted.
``(5) Demonstration sites.--The Secretary shall conduct the
demonstration project in 5 States selected by the Secretary
as demonstration sites.
``(6) Automation of incentive payments.--
``(A) In general.--Under the demonstration project,
incentive payments under paragraph (1)(B) to a primary care
physician shall be made automatically to the physician rather
than the physician being responsible for determining when a
payment is required to be made under that paragraph.
``(B) Incentive payment based on zip codes.--In order to
comply with subparagraph (A), the Secretary shall establish
procedures in which the amount of payment otherwise made for
a physician's service is automatically increased by the
amount of the incentive payment under the demonstration
project if the service was furnished in any zip code that is
entirely or partially in a designated medicare health
professional shortage area in a State selected under
paragraph (5).
``(7) Duration.--The demonstration project shall be
conducted for a 3-year period. The period for establishing
the methodology under subsection (b) shall not be counted for
purposes determining such 3-year period.
``(b) Establishment of Methodology for Assisting Secretary
in Designating Medicare Health Professional Shortage Areas.--
``(1) In general.--The Secretary shall select 1 or more
Federal rural health research centers within the Health
Resources Services Administration to establish a methodology
to assist the Secretary in designating areas within the
States selected under subsection (a)(5) as medicare health
professional shortage areas pursuant to subsection (a)(3).
``(2) Rules for establishing methodology.--
``(A) In general.--The methodology established under
paragraph (1) shall address--

[[Page S8249]]

``(i) how to measure the percentage of the total population
in an area that consists of individuals enrolled under part
B; and
``(ii) the appropriate ratio of such individuals to primary
care physicians in an area in order to ensure that such
individuals have adequate access to services furnished by
such physicians.
``(B) Methodology may be similar to methodologies used
under the public health service act.--The methodology
established under paragraph (1) may be similar to
methodologies utilized by the Secretary for designating
areas, and population groups within areas, as health
professional shortage areas under section 332(a) of the
Public Health Service Act (42 U.S.C. 254e(a)).
``(C) Consultation.--The Federal rural health research
centers selected under paragraph (1) shall consult with the
State and local medical societies of the States selected
under subsection (a)(5) in establishing the methodology under
paragraph (1).
``(c) No Effect on Designation as a Health Professional
Shortage Area.--Except as provided in subsection
(a)(4)(A)(ii), the designation of an area as a medicare
health professional shortage area under subsection (a)(3)
shall have no effect on the designation of such area as a
health professional shortage area under section 332(a) of the
Public Health Service Act (42 U.S.C. 254e(a)).
``(d) Waiver Authority.--The Secretary may waive such
requirements of title XI and this title as may be necessary
for the purpose of carrying out the demonstration project.
``(e) Report.--
``(1) In general.--Not later than 6 months after the
completion of the demonstration project, the Secretary shall
submit to Congress a report on such project.
``(2) Contents.--The report submitted under paragraph (1)
shall contain--
``(A) an evaluation of whether the demonstration project
has had the effect of stabilizing, maintaining, or increasing
access of individuals enrolled under part B to physicians'
services furnished by primary care physicians, including
whether the amount of the incentive payment is adequate to
stabilize, maintain, or increase such access and if not, then
what amount will;
``(B) a comparison of the effectiveness of the
demonstration project in stabilizing, maintaining, or
increasing such access with the effectiveness of other
Federal, State, and local programs, such as the incentive
program under section 1833(m), that are designed to
stabilize, maintain, or increase such access;
``(C) recommendations for such legislation and
administrative actions as the Secretary considers
appropriate; and
``(D) any other items that the Secretary considers
appropriate.
``(f) Funding.--
``(1) Incentive payments.--The Secretary shall use funds in
the Federal Supplementary Medical Insurance Trust Fund under
section 1841 to make the incentive payments under this
section.
``(2) Establishment of methodology.--
``(A) In general.--There is authorized to be appropriated
$6,000,000 to establish the methodology under subsection
(b)(1).
``(B) Availability.--Any amounts appropriated pursuant to
subparagraph (A) shall remain available until expended.''.
______

SA 944. Mr. ENZI (for Ms. Cantwell) proposed an amendment to
amendment SA 932 proposed by Mr. Enzi (for himself, Mr. Reed, and Mr.
Pryor) to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; as follows:

On page 2 of amendment SA#932 between lines 18 and 19
strike ``.'' and insert the following: ``with the auditor of
the Administrator's choice.''
______

SA 945. Mr. GREGG (for himself, Mr. Schumer, Mr. McCain, Mr. Kennedy,
Mr. Roberts, Mr. Edwards, Ms. Collins, Mr. Leahy, Mr. Johnson, Mr.
Feingold, Mr. Harkin, Mr. Kohl, Mr. Smith, Ms. Stabenow, Mr. Miller,
and Mr. Coleman) proposed an amendment to the bill S. 1, to amend title
XVIII of the Social Security Act to make improvements in the medicare
program, to provide prescription drug coverage under the medicare
program, and for other purposes; as follows:

At the end, add the following:

TITLE __--ACCESS TO AFFORDABLE PHARMACEUTICALS

SEC. __01. SHORT TITLE.

This title may be cited as the ``Greater Access to
Affordable Pharmaceuticals Act''.

SEC. __02. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD.

(a) Abbreviated New Drug Applications.--Section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
is amended--
(1) in paragraph (2), by striking subparagraph (B) and
inserting the following:
``(B) Notice of opinion that patent is invalid or will not
be infringed.--
``(i) Agreement to give notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV) shall
include in the application a statement that the applicant
will give notice as required by this subparagraph.
``(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV) shall
give notice as required under this subparagraph--
``(I) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice
with which the Secretary informs the applicant that the
application has been filed; or
``(II) if the certification is in an amendment or
supplement to the application, at the time at which the
applicant submits the amendment or supplement, regardless of
whether the applicant has already given notice with respect
to another such certification contained in the application or
in an amendment or supplement to the application.
``(iii) Recipients of notice.--An applicant required under
this subparagraph to give notice shall give notice to--
``(I) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
``(II) the holder of the approved application under
subsection (b) for the drug that is claimed by the patent or
a use of which is claimed by the patent (or a representative
of the holder designated to receive such a notice).
``(iv) Contents of notice.--A notice required under this
subparagraph shall--
``(I) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification;
and
``(II) include a detailed statement of the factual and
legal basis of the opinion of the applicant that the patent
is invalid or will not be infringed.''; and
(2) in paragraph (5)--
(A) in subparagraph (B)--
(i) by striking ``under the following'' and inserting ``by
applying the following to each certification made under
paragraph (2)(A)(vii)''; and
(ii) in clause (iii)--

(I) in the first sentence, by striking ``unless'' and all
that follows and inserting ``unless, before the expiration of
45 days after the date on which the notice described in
paragraph (2)(B) is received, an action is brought for
infringement of the patent that is the subject of the
certification and for which information was submitted to the
Secretary under subsection (b)(1) or (c)(2) before the date
on which the application (excluding an amendment or
supplement to the application), which the Secretary later
determines to be substantially complete, was submitted.'';
and
(II) in the second sentence--

(aa) by striking subclause (I) and inserting the following:
``(I) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no
cause of action for patent infringement or invalidity), the
approval shall be made effective on--
``(aa) the date on which the court enters judgment
reflecting the decision; or
``(bb) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;'';
(bb) by striking subclause (II) and inserting the
following:
``(II) if before the expiration of such period the district
court decides that the patent has been infringed--
``(aa) if the judgment of the district court is appealed,
the approval shall be made effective on--

``(AA) the date on which the court of appeals decides that
the patent is invalid or not infringed (including any
substantive determination that there is no cause of action
for patent infringement or invalidity); or
``(BB) the date of a settlement order or consent decree
signed and entered by the court of appeals stating that the
patent that is the subject of the certification is invalid or
not infringed; or

``(bb) if the judgment of the district court is not
appealed or is affirmed, the approval shall be made effective
on the date specified by the district court in a court order
under section 271(e)(4)(A) of title 35, United States
Code;'';
(cc) in subclause (III), by striking ``on the date of such
court decision.'' and inserting ``as provided in subclause
(I); or''; and
(dd) by inserting after subclause (III) the following:
``(IV) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of the
drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent
has been infringed, the approval shall be made effective as
provided in subclause (II).'';
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (E) and (F), respectively; and
(C) by inserting after subparagraph (B) the following:
``(C) Civil action to obtain patent certainty.--

[[Page S8250]]

``(i) Declaratory judgment absent infringement action.--If
an owner of the patent or the holder of the approved
application under subsection (b) for the drug that is claimed
by the patent or a use of which is claimed by the patent does
not bring a civil action against the applicant for
infringement of the patent on or before the date that is 45
days after the date on which the notice given under paragraph
(2)(B) was received, the applicant may bring a civil action
against the owner or holder (but not against any owner or
holder that has brought such a civil action against that
applicant, unless that civil action was dismissed without
prejudice) for a declaratory judgment under section 2201 of
title 28, United States Code, that the patent is invalid or
will not be infringed by the drug for which the applicant
seeks approval.
``(ii) Counterclaim to infringement action.--

``(I) In general.--If an owner of the patent or the holder
of the approved application under subsection (b) for the drug
that is claimed by the patent or a use of which is claimed by
the patent brings a patent infringement action against the
applicant, the applicant may assert a counterclaim seeking an
order requiring the holder to correct or delete the patent
information submitted by the holder under subsection (b) or
(c) on the ground that the patent does not claim either--

``(aa) the drug for which the application was approved; or
``(bb) an approved method of using the drug.

``(II) No independent cause of action.--Subclause (I) does
not authorize the assertion of a claim described in subclause
(I) in any civil action or proceeding other than a
counterclaim described in subclause (I).

``(iii) No damages.--An applicant shall not be entitled to
damages in a civil action under subparagraph (i) or a
counterclaim under subparagraph (ii).''.
(b) Applications Generally.--Section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b), by striking paragraph (3) and
inserting the following:
``(3) Notice of opinion that patent is invalid or will not
be infringed.--
``(A) Agreement to give notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall include
in the application a statement that the applicant will give
notice as required by this paragraph.
``(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall give
notice as required under this paragraph--
``(i) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice
with which the Secretary informs the applicant that the
application has been filed; or
``(ii) if the certification is in an amendment or
supplement to the application, at the time at which the
applicant submits the amendment or supplement, regardless of
whether the applicant has already given notice with respect
to another such certification contained in the application or
in an amendment or supplement to the application.
``(C) Recipients of notice.--An applicant required under
this paragraph to give notice shall give notice to--
``(i) each owner of the patent that is the subject of the
certification (or a representative of the owner designated to
receive such a notice); and
``(ii) the holder of the approved application under this
subsection for the drug that is claimed by the patent or a
use of which is claimed by the patent (or a representative of
the holder designated to receive such a notice).
``(D) Contents of notice.--A notice required under this
paragraph shall--
``(i) state that an application that contains data from
bioavailability or bioequivalence studies has been submitted
under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the
commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification;
and
``(ii) include a detailed statement of the factual and
legal basis of the opinion of the applicant that the patent
is invalid or will not be infringed.''; and
(2) in subsection (c)(3)--
(A) in the first sentence, by striking ``under the
following'' and inserting ``by applying the following to each
certification made under subsection (b)(2)(A)(iv)'';
(B) in subparagraph (C)--
(i) in the first sentence, by striking ``unless'' and all
that follows and inserting ``unless, before the expiration of
45 days after the date on which the notice described in
subsection (b)(3) is received, an action is brought for
infringement of the patent that is the subject of the
certification and for which information was submitted to the
Secretary under paragraph (2) or subsection (b)(1) before the
date on which the application (excluding an amendment or
supplement to the application) was submitted.'';
(ii) in the second sentence--

(I) by striking ``paragraph (3)(B)'' and inserting
``subsection (b)(3)'';
(II) by striking clause (i) and inserting the following:

``(i) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no
cause of action for patent infringement or invalidity), the
approval shall be made effective on--
``(I) the date on which the court enters judgment
reflecting the decision; or
``(II) the date of a settlement order or consent decree
signed and entered by the court stating that the patent that
is the subject of the certification is invalid or not
infringed;'';

(III) by striking clause (ii) and inserting the following:

``(ii) if before the expiration of such period the district
court decides that the patent has been infringed--
``(I) if the judgment of the district court is appealed,
the approval shall be made effective on--

``(aa) the date on which the court of appeals decides that
the patent is invalid or not infringed (including any
substantive determination that there is no cause of action
for patent infringement or invalidity); or
``(bb) the date of a settlement order or consent decree
signed and entered by the court of appeals stating that the
patent that is the subject of the certification is invalid or
not infringed; or

``(II) if the judgment of the district court is not
appealed or is affirmed, the approval shall be made effective
on the date specified by the district court in a court order
under section 271(e)(4)(A) of title 35, United States
Code;'';

(IV) in clause (iii), by striking ``on the date of such
court decision.'' and inserting ``as provided in clause (i);
or''; and
(V) by inserting after clause (iii), the following:

``(iv) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of the
drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent
has been infringed, the approval shall be made effective as
provided in clause (ii).''; and
(iii) in the third sentence, by striking ``paragraph
(3)(B)'' and inserting ``subsection (b)(3)'';
(C) by redesignating subparagraph (D) as subparagraph (E);
and
(D) by inserting after subparagraph (C) the following:
``(D) Civil action to obtain patent certainty.--
``(i) Declaratory judgment absent infringement action.--If
an owner of the patent or the holder of the approved
application under subsection (b) for the drug that is claimed
by the patent or a use of which is claimed by the patent does
not bring a civil action against the applicant for
infringement of the patent on or before the date that is 45
days after the date on which the notice given under
subsection (b)(3) was received, the applicant may bring a
civil action against the owner or holder (but not against any
owner or holder that has brought such a civil action against
that applicant, unless that civil action was dismissed
without prejudice) for a declaratory judgment under section
2201 of title 28, United States Code, that the patent is
invalid or will not be infringed by the drug for which the
applicant seeks approval.
``(ii) Counterclaim to infringement action.--

``(I) In general.--If an owner of the patent or the holder
of the approved application under subsection (b) for the drug
that is claimed by the patent or a use of which is claimed by
the patent brings a patent infringement action against the
applicant, the applicant may assert a counterclaim seeking an
order requiring the holder to correct or delete the patent
information submitted by the holder under subsection (b) or
this subsection on the ground that the patent does not claim
either--

``(aa) the drug for which the application was approved; or
``(bb) an approved method of using the drug.

``(II) No independent cause of action.--Subclause (I) does
not authorize the assertion of a claim described in subclause
(I) in any civil action or proceeding other than a
counterclaim described in subclause (I).

``(iii) No damages.--An applicant shall not be entitled to
damages in a civil action under clause (i) or a counterclaim
under clause (ii).''.
(c) Infringement Actions.--Section 271(e) of title 35,
United States Code, is amended by adding at the end the
following:
``(5) The filing of an application described in paragraph
(2) that includes a certification under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and the
failure of the owner of the patent to bring an action for
infringement of a patent that is the subject of the
certification before the expiration of 45 days after the date
on which the notice given under subsection (b)(3) or
(j)(2)(B) of that section is received, shall establish an
actual controversy between the applicant and the patent owner
sufficient to confer subject matter jurisdiction in the
courts of the United States in any action brought by the
applicant under section 2201 of title 28 for a declaratory
judgment that any patent that is the subject of the
certification is invalid or not infringed.''.
(d) Applicability.--
(1) In general.--Except as provided in paragraphs (2) and
(3), the amendments made by subsections (a), (b), and (c)
apply to any proceeding under section 505 of the Federal

[[Page S8251]]

Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending
on or after the date of enactment of this Act regardless of
the date on which the proceeding was commenced or is
commenced.
(2) Notice of opinion that patent is invalid or will not be
infringed.--The amendments made by subsections (a)(1) and
(b)(1) apply with respect to any certification under
subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
after the date of enactment of this Act in an application
filed under subsection (b)(2) or (j) of that section or in an
amendment or supplement to an application filed under
subsection (b)(2) or (j) of that section.
(3) Effective date of approval.--The amendments made by
subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with
respect to any patent information submitted under subsection
(b)(1) or (c)(2) of section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) made after the date of
enactment of this Act.

SEC. __03. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

(a) In General.--Section 505(j)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by
section __02) is amended--
(1) in subparagraph (B), by striking clause (iv) and
inserting the following:
``(iv) 180-day exclusivity period.--
``(I) Definitions.--In this paragraph:
``(aa) 180-day exclusivity period.--The term `180-day
exclusivity period' means the 180-day period ending on the
day before the date on which an application submitted by an
applicant other than a first applicant could become effective
under this clause.
``(bb) First applicant.--The term `first applicant' means
an applicant that, on the first day on which a substantially
complete application containing a certification described in
paragraph (2)(A)(vii)(IV) is submitted for approval of a
drug, submits a substantially complete application containing
a certification described in paragraph (2)(A)(vii)(IV) for
the drug.
``(cc) Substantially complete application.--As used in this
subsection, the term `substantially complete application'
means an application under this subsection that on its face
is sufficiently complete to permit a substantive review and
contains all the information required by paragraph (2)(A).
``(dd) Tentative approval.--

``(AA) In general.--The term `tentative approval' means
notification to an applicant by the Secretary that an
application under this subsection meets the requirements of
paragraph (2)(A), but cannot receive effective approval
because the application does not meet the requirements of
this subparagraph, there is a period of exclusivity for the
listed drug under subparagraph (E) or section 505A, or there
is a 7-year period of exclusivity for the listed drug under
section 527.
``(BB) Limitation.--A drug that is granted tentative
approval by the Secretary is not an approved drug and shall
not have an effective approval until the Secretary issues an
approval after any necessary additional review of the
application.

``(II) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a certification
described in paragraph (2)(A)(vii)(IV) and is for a drug for
which a first applicant has submitted an application
containing such a certification, the application shall be
made effective on the date that is 180 days after the date of
the first commercial marketing of the drug (including the
commercial marketing of the listed drug) by any first
applicant.''; and
(2) by inserting after subparagraph (C) the following:
``(D) Forfeiture of 180-day exclusivity period.--
``(i) Definition of forfeiture event.--In this
subparagraph, the term `forfeiture event', with respect to an
application under this subsection, means the occurrence of
any of the following:

``(I) Failure to market.--The first applicant fails to
market the drug by the later of--

``(aa) the earlier of the date that is--
``(AA) 75 days after the date on which the approval of the
application of the first applicant is made effective under
subparagraph (B)(iii); or
``(BB) 30 months after the date of submission of the
application of the first applicant; or
``(bb) with respect to the first applicant or any other
applicant (which other applicant has received tentative
approval), the date that is 75 days after the date as of
which, as to each of the patents with respect to which the
first applicant submitted a certification qualifying the
first applicant for the 180-day exclusivity period under
subparagraph (B)(iv), at least 1 of the following has
occurred:
``(AA) In an infringement action brought against that
applicant with respect to the patent or in a declaratory
judgment action brought by that applicant with respect to the
patent, a court enters a final decision from which no appeal
(other than a petition to the Supreme Court for a writ of
certiorari) has been or can be taken that the patent is
invalid or not infringed.
``(BB) In an infringement action or a declaratory judgment
action described in subitem (AA), a court signs a settlement
order or consent decree that enters a final judgment that
includes a finding that the patent is invalid or not
infringed.
``(CC) The patent expires.
``(DD) The patent is withdrawn by the holder of the
application approved under subsection (b).

``(II) Withdrawal of application.--The first applicant
withdraws the application or the Secretary considers the
application to have been withdrawn as a result of a
determination by the Secretary that the application does not
meet the requirements for approval under paragraph (4).
``(III) Amendment of certification.--The first applicant
amends or withdraws the certification for all of the patents
with respect to which that applicant submitted a
certification qualifying the applicant for the 180-day
exclusivity period.
``(IV) Failure to obtain tentative approval.--The first
applicant fails to obtain tentative approval of the
application within 30 months after the date on which the
application is filed, unless the failure is caused by a
change in or a review of the requirements for approval of the
application imposed after the date on which the application
is filed.
``(V) Agreement with another applicant, the listed drug
application holder, or a patent owner.--The first applicant
enters into an agreement with another applicant under this
subsection for the drug, the holder of the application for
the listed drug, or an owner of the patent that is the
subject of the certification under paragraph (2)(A)(vii)(IV),
the Federal Trade Commission or the Attorney General files a
complaint, and there is a final decision of the Federal Trade
Commission or the court with regard to the complaint from
which no appeal (other than a petition to the Supreme Court
for a writ of certiorari) has been or can be taken that the
agreement has violated the antitrust laws (as defined in
section 1 of the Clayton Act (15 U.S.C. 12), except that the
term includes section 5 of the Federal Trade Commission Act
(15 U.S.C. 45) to the extent that that section applies to
unfair methods of competition).
``(VI) Expiration of all patents.--All of the patents as to
which the applicant submitted a certification qualifying it
for the 180-day exclusivity period have expired.

``(ii) Forfeiture.--The 180-day exclusivity period
described in subparagraph (B)(iv) shall be forfeited by a
first applicant if a forfeiture event occurs with respect to
that first applicant.
``(iii) Subsequent applicant.--If all first applicants
forfeit the 180-day exclusivity period under clause (ii)--

``(I) approval of any application containing a
certification described in paragraph (2)(A)(vii)(IV) shall be
made effective in accordance with subparagraph (B)(iii); and
``(II) no applicant shall be eligible for a 180-day
exclusivity period.''.

(b) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendment made by subsection (a) shall be effective only with
respect to an application filed under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after
the date of enactment of this Act for a listed drug for which
no certification under section 505(j)(2)(A)(vii)(IV) of that
Act was made before the date of enactment of this Act.
(2) Collusive agreements.--If a forfeiture event described
in section 505(j)(5)(D)(i)(V) of that Act occurs in the case
of an applicant, the applicant shall forfeit the 180-day
period under section 505(j)(5)(B)(iv) of that Act without
regard to when the first certification under section
505(j)(2)(A)(vii)(IV) of that Act for the listed drug was
made.
(3) Decision of a court when the 180-day exclusivity period
has not been triggered.--With respect to an application filed
before, on, or after the date of enactment of this Act for a
listed drug for which a certification under section
505(j)(2)(A)(vii)(IV) of that Act was made before the date of
enactment of this Act and for which neither of the events
described in subclause (I) or (II) of section
505(j)(5)(B)(iv) of that Act (as in effect on the day before
the date of enactment of this Act) has occurred on or before
the date of enactment of this Act, the term ``decision of a
court'' as used in clause (iv) of section 505(j)(5)(B) of
that Act means a final decision of a court from which no
appeal (other than a petition to the Supreme Court for a writ
of certiorari) has been or can be taken.

SEC. __04. BIOAVAILABILITY AND BIOEQUIVALENCE.

(a) In General.--Section 505(j)(8) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is amended--
(1) by striking subparagraph (A) and inserting the
following:
``(A)(i) The term `bioavailability' means the rate and
extent to which the active ingredient or therapeutic
ingredient is absorbed from a drug and becomes available at
the site of drug action.
``(ii) For a drug that is not intended to be absorbed into
the bloodstream, the Secretary may assess bioavailability by
scientifically valid measurements intended to reflect the
rate and extent to which the active ingredient or therapeutic
ingredient becomes available at the site of drug action.'';
and
(2) by adding at the end the following:
``(C) For a drug that is not intended to be absorbed into
the bloodstream, the Secretary may establish alternative,
scientifically valid methods to show bioequivalence if the
alternative methods are expected to detect a significant
difference between the drug and the listed drug in safety and
therapeutic effect.''.
(b) Effect of Amendment.--The amendment made by subsection
(a) does not alter

[[Page S8252]]

the standards for approval of drugs under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

SEC. __05. REMEDIES FOR INFRINGEMENT.

Section 287 of title 35, United States Code, is amended by
adding at the end the following:
``(d) Consideration.--In making a determination with
respect to remedy brought for infringement of a patent that
claims a drug or a method or using a drug, the court shall
consider whether information on the patent was filed as
required under 21 U.S.C. 355 (b) or (c), and, if such
information was required to be filed but was not, the court
may refuse to award treble damages under section 284.''.

SEC. __06. CONFORMING AMENDMENTS.

Section 505A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355a) is amended--
(1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by
striking ``(j)(5)(D)(ii)'' each place it appears and
inserting ``(j)(5)(F)(ii)'';
(2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by
striking ``(j)(5)(D)'' each place it appears and inserting
``(j)(5)(F)''; and
(3) in subsections (e) and (l), by striking
``505(j)(5)(D)'' each place it appears and inserting
``505(j)(5)(F)''.
______

SA 946. Mr. DORGAN (for himself, Ms. Stabenow, Mr. Jeffords, Ms.
Snowe, Mr. Johnson, Mr. Leahy, Mrs. Boxer, Mr. Pryor, Mr. Feingold, and
Ms. Collins) proposed an amendment to the bill S. 1, to amend title
XVIII of the Social Security Act to make improvements in the medicare
program, to provide prescription drug coverage under the medicare
program, and for other purposes; as follows:

At the end, add the following:

TITLE __--IMPORTATION OF PRESCRIPTION DRUGS

SEC. __01. IMPORTATION OF PRESCRIPTION DRUGS.

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

``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

``(a) Definitions.--In this section:
``(1) Importer.--The term `importer' means a pharmacist or
wholesaler.
``(2) Pharmacist.--The term `pharmacist' means a person
licensed by a State to practice pharmacy, including the
dispensing and selling of prescription drugs.
``(3) Prescription drug.--The term `prescription drug'
means a drug subject to section 503(b), other than--
``(A) a controlled substance (as defined in section 102 of
the Controlled Substances Act (21 U.S.C. 802));
``(B) a biological product (as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262));
``(C) an infused drug (including a peritoneal dialysis
solution);
``(D) an intravenously injected drug; or
``(E) a drug that is inhaled during surgery.
``(4) Qualifying laboratory.--The term `qualifying
laboratory' means a laboratory in the United States that has
been approved by the Secretary for the purposes of this
section.
``(5) Wholesaler.--
``(A) In general.--The term `wholesaler' means a person
licensed as a wholesaler or distributor of prescription drugs
in the United States under section 503(e)(2)(A).
``(B) Exclusion.--The term `wholesaler' does not include a
person authorized to import drugs under section 801(d)(1).
``(b) Regulations.--The Secretary, after consultation with
the United States Trade Representative and the Commissioner
of Customs, shall promulgate regulations permitting
pharmacists and wholesalers to import prescription drugs from
Canada into the United States.
``(c) Limitation.--The regulations under subsection (b)
shall--
``(1) require that safeguards be in place to ensure that
each prescription drug imported under the regulations
complies with section 505 (including with respect to being
safe and effective for the intended use of the prescription
drug), with sections 501 and 502, and with other applicable
requirements of this Act;
``(2) require that an importer of a prescription drug under
the regulations comply with subsections (d)(1) and (e); and
``(3) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the
public health or as a means to facilitate the importation of
prescription drugs.
``(d) Information and Records.--
``(1) In general.--The regulations under subsection (b)
shall require an importer of a prescription drug under
subsection (b) to submit to the Secretary the following
information and documentation:
``(A) The name and quantity of the active ingredient of the
prescription drug.
``(B) A description of the dosage form of the prescription
drug.
``(C) The date on which the prescription drug is shipped.
``(D) The quantity of the prescription drug that is
shipped.
``(E) The point of origin and destination of the
prescription drug.
``(F) The price paid by the importer for the prescription
drug.
``(G) Documentation from the foreign seller specifying--
``(i) the original source of the prescription drug; and
``(ii) the quantity of each lot of the prescription drug
originally received by the seller from that source.
``(H) The lot or control number assigned to the
prescription drug by the manufacturer of the prescription
drug.
``(I) The name, address, telephone number, and professional
license number (if any) of the importer.
``(J)(i) In the case of a prescription drug that is shipped
directly from the first foreign recipient of the prescription
drug from the manufacturer:
``(I) Documentation demonstrating that the prescription
drug was received by the recipient from the manufacturer and
subsequently shipped by the first foreign recipient to the
importer.
``(II) Documentation of the quantity of each lot of the
prescription drug received by the first foreign recipient
demonstrating that the quantity being imported into the
United States is not more than the quantity that was received
by the first foreign recipient.
``(III)(aa) In the case of an initial imported shipment,
documentation demonstrating that each batch of the
prescription drug in the shipment was statistically sampled
and tested for authenticity and degradation.
``(bb) In the case of any subsequent shipment,
documentation demonstrating that a statistically valid sample
of the shipment was tested for authenticity and degradation.
``(ii) In the case of a prescription drug that is not
shipped directly from the first foreign recipient of the
prescription drug from the manufacturer, documentation
demonstrating that each batch in each shipment offered for
importation into the United States was statistically sampled
and tested for authenticity and degradation.
``(K) Certification from the importer or manufacturer of
the prescription drug that the prescription drug--
``(i) is approved for marketing in the United States; and
``(ii) meets all labeling requirements under this Act.
``(L) Laboratory records, including complete data derived
from all tests necessary to ensure that the prescription drug
is in compliance with established specifications and
standards.
``(M) Documentation demonstrating that the testing required
by subparagraphs (J) and (L) was conducted at a qualifying
laboratory.
``(N) Any other information that the Secretary determines
is necessary to ensure the protection of the public health.
``(2) Maintenance by the secretary.--The Secretary shall
maintain information and documentation submitted under
paragraph (1) for such period of time as the Secretary
determines to be necessary.
``(e) Testing.--The regulations under subsection (b) shall
require--
``(1) that testing described in subparagraphs (J) and (L)
of subsection (d)(1) be conducted by the importer or by the
manufacturer of the prescription drug at a qualified
laboratory;
``(2) if the tests are conducted by the importer--
``(A) that information needed to--
``(i) authenticate the prescription drug being tested; and
``(ii) confirm that the labeling of the prescription drug
complies with labeling requirements under this Act;

be supplied by the manufacturer of the prescription drug to
the pharmacist or wholesaler; and
``(B) that the information supplied under subparagraph (A)
be kept in strict confidence and used only for purposes of
testing or otherwise complying with this Act; and
``(3) may include such additional provisions as the
Secretary determines to be appropriate to provide for the
protection of trade secrets and commercial or financial
information that is privileged or confidential.
``(f) Registration of Foreign Sellers.--Any establishment
within Canada engaged in the distribution of a prescription
drug that is imported or offered for importation into the
United States shall register with the Secretary the name and
place of business of the establishment.
``(g) Suspension of Importation.--The Secretary shall
require that importations of a specific prescription drug or
importations by a specific importer under subsection (b) be
immediately suspended on discovery of a pattern of
importation of that specific prescription drug or by that
specific importer of drugs that are counterfeit or in
violation of any requirement under this section, until an
investigation is completed and the Secretary determines that
the public is adequately protected from counterfeit and
violative prescription drugs being imported under subsection
(b).
``(h) Approved Labeling.--The manufacturer of a
prescription drug shall provide an importer written
authorization for the importer to use, at no cost, the
approved labeling for the prescription drug.
``(i) Prohibition of Discrimination.--
``(1) In general.--It shall be unlawful for a manufacturer
of a prescription drug to discriminate against, or cause any
other person to discriminate against, a pharmacist or
wholesaler that purchases or offers to purchase a
prescription drug from the manufacturer or from any person
that distributes a

[[Page S8253]]

prescription drug manufactured by the drug manufacturer.
``(2) Discrimination.--For the purposes of paragraph (1), a
manufacturer of a prescription drug shall be considered to
discriminate against a pharmacist or wholesaler if the
manufacturer enters into a contract for sale of a
prescription drug, places a limit on supply, or employs any
other measure, that has the effect of--
``(A) providing pharmacists or wholesalers access to
prescription drugs on terms or conditions that are less
favorable than the terms or conditions provided to a foreign
purchaser (other than a charitable or humanitarian
organization) of the prescription drug; or
``(B) restricting the access of pharmacists or wholesalers
to a prescription drug that is permitted to be imported into
the United States under this section.
``(j) Charitable Contributions.--Notwithstanding any other
provision of this section, section 801(d)(1) continues to
apply to a prescription drug that is donated or otherwise
supplied at no charge 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.
``(k) Waiver Authority for Importation by Individuals.--
``(1) Declarations.--Congress declares that in the
enforcement against individuals of the prohibition of
importation of prescription drugs and devices, the Secretary
should--
``(A) focus enforcement on cases in which the importation
by an individual poses a significant threat to public health;
and
``(B) exercise discretion to permit individuals to make
such importations in circumstances in which--
``(i) the importation is clearly for personal use; and
``(ii) the prescription drug or device imported does not
appear to present an unreasonable risk to the individual.
``(2) Waiver authority.--
``(A) In general.--The Secretary may grant to individuals,
by regulation or on a case-by-case basis, a waiver of the
prohibition of importation of a prescription drug or device
or class of prescription drugs or devices, under such
conditions as the Secretary determines to be appropriate.
``(B) Guidance on case-by-case waivers.--The Secretary
shall publish, and update as necessary, guidance that
accurately describes circumstances in which the Secretary
will consistently grant waivers on a case-by-case basis under
subparagraph (A), so that individuals may know with the
greatest practicable degree of certainty whether a particular
importation for personal use will be permitted.
``(3) Drugs imported from canada.--In particular, the
Secretary shall by regulation grant individuals a waiver to
permit individuals to import into the United States a
prescription drug that--
``(A) is imported from a licensed pharmacy for personal use
by an individual, not for resale, in quantities that do not
exceed a 90-day supply;
``(B) is accompanied by a copy of a valid prescription;
``(C) is imported from Canada, from a seller registered
with the Secretary;
``(D) is a prescription drug approved by the Secretary
under chapter V;
``(E) is in the form of a final finished dosage that was
manufactured in an establishment registered under section
510; and
``(F) is imported under such other conditions as the
Secretary determines to be necessary to ensure public safety.
``(l) Studies; Reports.--
``(1) By the institute of medicine of the national academy
of sciences.--
``(A) Study.--
``(i) In general.--The Secretary shall request that the
Institute of Medicine of the National Academy of Sciences
conduct a study of--

``(I) importations of prescription drugs made under the
regulations under subsection (b); and
``(II) information and documentation submitted under
subsection (d).

``(ii) Requirements.--In conducting the study, the
Institute of Medicine shall--

``(I) evaluate the compliance of importers with the
regulations under subsection (b);
``(II) compare the number of shipments under the
regulations under subsection (b) during the study period that
are determined to be counterfeit, misbranded, or adulterated,
and compare that number with the number of shipments made
during the study period within the United States that are
determined to be counterfeit, misbranded, or adulterated; and
``(III) consult with the Secretary, the United States Trade
Representative, and the Commissioner of Patents and
Trademarks to evaluate the effect of importations under the
regulations under subsection (b) on trade and patent rights
under Federal law.

``(B) Report.--Not later than 2 years after the effective
date of the regulations under subsection (b), the Institute
of Medicine shall submit to Congress a report describing the
findings of the study under subparagraph (A).
``(2) By the comptroller general.--
``(A) Study.--The Comptroller General of the United States
shall conduct a study to determine the effect of this section
on the price of prescription drugs sold to consumers at
retail.
``(B) Report.--Not later than 18 months after the effective
date of the regulations under subsection (b), the Comptroller
General of the United States shall submit to Congress a
report describing the findings of the study under
subparagraph (A).
``(m) Construction.--Nothing in this section limits the
authority of the Secretary relating to the importation of
prescription drugs, other than with respect to section
801(d)(1) as provided in this section.
``(n) Effectiveness of Section.--
``(1) In general.--If, after the date that is 1 year after
the effective date of the regulations under subsection (b)
and before the date that is 18 months after the effective
date, the Secretary submits to Congress a certification that,
in the opinion of the Secretary, based on substantial
evidence obtained after the effective date, the benefits of
implementation of this section do not outweigh any detriment
of implementation of this section, this section shall cease
to be effective as of the date that is 30 days after the date
on which the Secretary submits the certification.
``(2) Procedure.--The Secretary shall not submit a
certification under paragraph (1) unless, after a hearing on
the record under sections 556 and 557 of title 5, United
States Code, the Secretary--
``(A)(i) determines that it is more likely than not that
implementation of this section would result in an increase in
the risk to the public health and safety;
``(ii) identifies specifically, in qualitative and
quantitative terms, the nature of the increased risk;
``(iii) identifies specifically the causes of the increased
risk; and
``(iv)(I) considers whether any measures can be taken to
avoid, reduce, or mitigate the increased risk; and
``(II) if the Secretary determines that any measures
described in subclause (I) would require additional statutory
authority, submits to Congress a report describing the
legislation that would be required;
``(B) identifies specifically, in qualitative and
quantitative terms, the benefits that would result from
implementation of this section (including the benefit of
reductions in the cost of covered products to consumers in
the United States, allowing consumers to procure needed
medication that consumers might not otherwise be able to
procure without foregoing other necessities of life); and
``(C)(i) compares in specific terms the detriment
identified under subparagraph (A) with the benefits
identified under subparagraph (B); and
``(ii) determines that the benefits do not outweigh the
detriment.
``(o) Authorization of Appropriations.--There are
authorized to be appropriated such sums as are necessary to
carry out this section.''.
(b) Conforming Amendments.--The Federal Food, Drug, and
Cosmetic Act is amended--
(1) in section 301(aa) (21 U.S.C. 331(aa)), by striking
``covered product in violation of section 804'' and inserting
``prescription drug in violation of section 804''; and
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking
``covered product pursuant to section 804(a)'' and inserting
``prescription drug under section 804(b)''.
______

SA 947. Mr. FRIST (for Mr. Cochran (for himself, Mr. Frist, Mr.
Breaux, and Mr. Santorum)) proposed an amendment to amend SA 946
proposed by Mr. Dorgan (for himself, Ms. Stabenow, Mr. Jeffords, Ms.
Snowe, Mr. Johnson, Mr. Leahy, Mrs. Boxer, Mr. Pryor, Mr. Feingold, and
Ms. Collins) to the bill S. 1, to amend title XVIII of the Social
Security Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; as follows:

At the appropriate place, insert the following:
``(  ) Conditions.--this section shall become effective
only if the Secretary of Health and Human Services certifies
to the Congress that the implementation of this section
will--
``(A) pose no additional risk to the public's health and
safety, and
''(B) result in a significant reduction in the cost of
covered products to the American consumer.''.
______

SA 948. Mr. GRAHAM of South Carolina submitted an amendment intended
to be proposed by him to the bill S. 1, to amend title XVIII of the
Social Security Act to make improvements in the medicare program, to
provide prescription drug coverage under the medicare program, and for
other purposes; which was ordered to lie on the table; as follows:

At the appropriate place in title II, insert the following:

Subtitle __--National Bipartisan Commission on Medicare Reform

SEC. __01. MEDICAREADVANTAGE GOAL; ESTABLISHMENT OF
COMMISSION.

(a) Enrollment Goal.--It is the goal of this title that,
not later than January 1, 2010, at least 15 percent of
individuals entitled to, or enrolled for, benefits under part
A of title XVIII of the Social Security Act and enrolled
under part B of such title should be enrolled in a
MedicareAdvantage plan, as determined by the Center for
Medicare Choices.

[[Page S8254]]

(b) Failure to Achieve Goal.--If the goal described in
subsection (a) is not met by January 1, 2012, as determined
by the Center for Medicare Choices, there shall be
established a commission as described in section 2.

SEC. __02 NATIONAL BIPARTISAN COMMISSION ON MEDICARE REFORM.

(a) Establishment.--Upon a determination under section
__01(b) that the enrollment goal has not been met, there
shall be established a commission to be known as the National
Bipartisan Commission on Medicare Reform (in this section
referred to as the ``Commission'').
(b) Duties of the Commission.--The Commission shall--
(1) review and analyze the long-term financial condition of
the medicare program under title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.);
(2) identify problems that threaten the financial integrity
of the Federal Hospital Insurance Trust Fund and the Federal
Supplementary Medical Insurance Trust Fund established under
sections 1817 and 1841 of such Act (42 U.S.C. 1395i and
1395t), including--
(A) the financial impact on the medicare program of the
significant increase in the number of medicare eligible
individuals; and
(B) the ability of the Federal Government to sustain the
program into the future;
(3) analyze potential solutions to the problems identified
under paragraph (2) that will ensure both the financial
integrity of the medicare program and the provision of
appropriate benefits under such program, including methods
used by other nations to respond to comparable demographic
patterns in eligibility for health care benefits for elderly
and disabled individuals and trends in employment-related
health care for retirees;
(4) make recommendations to restore the solvency of the
Federal Hospital Insurance Trust Fund and the financial
integrity of the Federal Supplementary Medical Insurance
Trust Fund;
(5) make recommendations for establishing the appropriate
financial structure of the medicare program as a whole;
(6) make recommendations for establishing the appropriate
balance of benefits covered under, and beneficiary
contributions to, the medicare program;
(7) make recommendations for the time periods during which
the recommendations described in paragraphs (4), (5) and (6)
should be implemented;
(8) make recommendations on the impact of chronic disease
and disability trends on future costs and quality of services
under the current benefit, financing, and delivery system
structure of the medicare program;
(9) make recommendations regarding a comprehensive approach
to preserve the medicare program, including ways to increase
the effectiveness of the MedicareAdvantage program and to
increase MedicareAdvantage enrollment rates; and
(10) review and analyze such other matters as the
Commission determines appropriate.
(c) Membership.--
(1) Number and appointment.--The Commission shall be
composed of 17 members, of whom--
(A) four shall be appointed by the President;
(B) six shall be appointed by the Majority Leader of the
Senate, in consultation with the Minority Leader of the
Senate, of whom not more than 4 shall be of the same
political party;
(C) six shall be appointed by the Speaker of the House of
Representatives, in consultation with the Minority Leader of
the House of Representatives, of whom not more than 4 shall
be of the same political party; and
(D) one, who shall serve as Chairperson of the Commission,
shall be appointed jointly by the President, Majority Leader
of the Senate, and the Speaker of the House of
Representatives.
(2) Deadline for appointment.--Members of the Commission
shall be appointed by not later than April 1, 2012.
(3) Terms of appointment.--The term of any member appointed
under paragraph (1) shall be for the life of the Commission.
(4) Meetings.--The Commission shall meet at the call of the
Chairperson or a majority of its members.
(5) Quorum.--A quorum for purposes of conducting the
business of the Commission shall consist of 8 members of the
Commission, except that 4 members may conduct a hearing under
subsection (e).
(6) Vacancies.--A vacancy in the membership of the
Commission shall be filled, not later than 30 days after the
Commission is given notice of the vacancy, in the same manner
in which the original appointment was made. Such a vacancy
shall not affect the power of the remaining members to carry
out the duties of the Commission.
(7) Compensation.--Members of the Commission shall receive
no additional pay, allowances, or benefits by reason of their
service on the Commission.
(8) Expenses.--Each member of the Commission shall receive
travel expenses and per diem in lieu of subsistence in
accordance with sections 5702 and 5703 of title 5, United
States Code.
(d) Staff and Support Services.--
(1) Executive director.--
(A) Appointment.--The Chairperson shall appoint an
executive director of the Commission.
(B) Compensation.--The executive director shall be paid the
rate of basic pay for level V of the Executive Schedule under
title 5, United States Code.
(2) Staff.--With the approval of the Commission, the
executive director may appoint such personnel as the
executive director considers appropriate.
(3) Applicability of civil service laws.--The staff of the
Commission shall be appointed without regard to the
provisions of title 5, United States Code, governing
appointments in the competitive service, and shall be paid
without regard to the provisions of chapter 51 and subchapter
III of chapter 53 of such title (relating to classification
and General Schedule pay rates).
(4) Experts and consultants.--With the approval of the
Commission, the executive director may procure temporary and
intermittent services under section 3109(b) of title 5,
United States Code.
(5) Physical facilities.--The Administrator of the General
Services Administration shall locate suitable office space
for the operation of the Commission. The facilities shall
serve as the headquarters of the Commission and shall include
all necessary equipment and incidentals required for the
proper functioning of the Commission.
(e) Powers of Commission.--
(1) Hearings and other activities.--The Commission may hold
such hearings and undertake such other activities as the
Commission determines to be necessary to carry out its duties
under this section.
(2) Studies by gao.--Upon the request of the Commission,
the Comptroller General shall conduct such studies or
investigations as the Commission determines to be necessary
to carry out its duties under this section.
(3) Cost estimates by congressional budget office and
office of the chief actuary of the centers for medicare &
medicaid.--
(A) In general.--The Director of the Congressional Budget
Office or the Chief Actuary of the Center for Medicare &
Medicaid Services, or both, shall provide to the Commission,
upon the request of the Commission, such cost estimates as
the Commission determines to be necessary to carry out its
duties under this section.
(B) Reimbursements.--The Commission shall reimburse the
Director of the Congressional Budget Office for expenses
relating to the employment in the office of the Director of
such additional staff as may be necessary for the Director to
comply with requests by the Commission under subparagraph
(A).
(4) Detail of federal employees.--Upon the request of the
Commission, the head of any Federal agency is authorized to
detail, without reimbursement, any of the personnel of such
agency to the Commission to assist the Commission in carrying
out its duties under this section. Any such detail shall not
interrupt or otherwise affect the civil service status or
privileges of the Federal employee.
(5) Technical assistance.--Upon the request of the
Commission, the head of a Federal agency shall provide such
technical assistance to the Commission as the Commission
determines to be necessary to carry out its duties under this
section.
(6) Use of mails.--The Commission may use the United States
mails in the same manner and under the same conditions as
Federal agencies and shall, for purposes of the frank, be
considered a commission of Congress as described in section
3215 of title 39, United States Code.
(7) Obtaining information.--The Commission may secure
directly from any Federal agency information necessary to
enable it to carry out its duties under this section, if the
information may be disclosed under section 552 of title 5,
United States Code. Upon request of the Chairperson of the
Commission, the head of each such agency shall furnish such
information to the Commission.
(8) Administrative support services.--Upon the request of
the Commission, the Administrator of General Services shall
provide to the Commission on a reimbursable basis such
administrative support services as the Commission may
request.
(9) Printing.--For purposes of costs relating to printing
and binding, including the cost of personnel detailed from
the Government Printing Office, the Commission shall be
deemed to be a committee of Congress.
(f) Report.--Not later than October 1, 2012, the Commission
shall submit to the President and Congress a report and an
implementation bill that shall contain a detailed statement
of only those recommendations, findings, and conclusions of
the Commission that receive the approval of at least 11
members of the Commission.
(g) Termination.--The Commission shall terminate on the
date that is 30 days after the date on which the report and
implementation bill is submitted under subsection (f).

SEC. __03 CONGRESSIONAL CONSIDERATION OF REFORM PROPOSALS.

(a) Definitions.--In this section:
(1) Implementation bill.--The term ``implementation bill''
means only a bill that is introduced as provided under
subsection (b), and contains the proposed legislation
included in the report submitted to Congress under section
__02(f), without modification.
(2) Calendar day.--The term ``calendar day'' means a
calendar day other than 1 on which either House is not in
session because of an adjournment of more than 3 days to a
date certain.
(b) Introduction; Referral; and Report or Discharge.--
(1) Introduction.--On the first calendar day on which both
Houses are in session immediately following the date on which
the report is submitted to Congress under section __02(f), a
single implementation bill shall be introduced (by request)--

[[Page S8255]]

(A) in the Senate by the Majority Leader of the Senate, for
himself and the Minority Leader of the Senate, or by Members
of the Senate designated by the Majority Leader and Minority
Leader of the Senate; and
(B) in the House of Representatives by the Speaker of the
House of Representatives, for himself and the Minority Leader
of the House of Representatives, or by Members of the House
of Representatives designated by the Speaker and Minority
Leader of the House of Representatives.
(2) Referral.--The implementation bills introduced under
paragraph (1) shall be referred to any appropriate committee
of jurisdiction in the Senate and any appropriate committee
of jurisdiction in the House of Representatives. A committee
to which an implementation bill is referred under this
paragraph may report such bill to the respective House
without amendment.
(3) Report or discharge.--If a committee to which an
implementation bill is referred has not reported such bill by
the end of the 15th calendar day after the date of the
introduction of such bill, such committee shall be
immediately discharged from further consideration of such
bill, and upon being reported or discharged from the
committee, such bill shall be placed on the appropriate
calendar.
(c) Floor Consideration.--
(1) In general.--When the committee to which an
implementation bill is referred has reported, or has been
discharged under subsection (b)(3), it is at any time
thereafter in order (even though a previous motion to the
same effect has been disagreed to) for any Member of the
respective House to move to proceed to the consideration of
the implementation bill, and all points of order against the
implementation bill (and against consideration of the
implementation bill) are waived. The motion is highly
privileged in the House of Representatives and is privileged
in the Senate and is not debatable. The motion is not subject
to amendment, or to a motion to postpone, or to a motion to
proceed to the consideration of other business. A motion to
reconsider the vote by which the motion is agreed to or
disagreed to shall not be in order. If a motion to proceed to
the consideration of the implementation bill is agreed to,
the implementation bill shall remain the unfinished business
of the respective House until disposed of.
(2) Amendments.--An implementation bill may not be amended
in the Senate or the House of Representatives.
(3) Debate.--Debate on the implementation bill, and on all
debatable motions and appeals in connection therewith, shall
be limited to not more than 20 hours, which shall be divided
equally between those favoring and those opposing the
resolution. A motion further to limit debate is in order and
not debatable. An amendment to, or a motion to postpone, or a
motion to proceed to the consideration of other business, or
a motion to recommit the implementation bill is not in order.
A motion to reconsider the vote by which the implementation
bill is agreed to or disagreed to is not in order.
(4) Vote on final passage.--Immediately following the
conclusion of the debate on an implementation bill, and a
single quorum call at the conclusion of the debate if
requested in accordance with the rules of the appropriate
House, the vote on final passage of the implementation bill
shall occur.
(5) Rulings of the chair on procedure.--Appeals from the
decisions of the Chair relating to the application of the
rules of the Senate or the House of Representatives, as the
case may be, to the procedure relating to an implementation
bill shall be decided without debate.
(d) Coordination With Action by Other House.--If, before
the passage by 1 House of an implementation bill of that
House, that House receives from the other House an
implementation bill, then the following procedures shall
apply:
(1) Nonreferral.--The implementation bill of the other
House shall not be referred to a committee.
(2) Vote on bill of other house.--With respect to an
implementation bill of the House receiving the implementation
bill--
(A) the procedure in that House shall be the same as if no
implementation bill had been received from the other House;
but
(B) the vote on final passage shall be on the
implementation bill of the other House.
(e) Rules of Senate and House of Representatives.--This
section is enacted by Congress--
(1) as an exercise of the rulemaking power of the Senate
and House of Representatives, respectively, and as such it is
deemed a part of the rules of each House, respectively, but
applicable only with respect to the procedure to be followed
in that House in the case of an implementation bill described
in subsection (a), and it supersedes other rules only to the
extent that it is inconsistent with such rules; and
(2) with full recognition of the constitutional right of
either House to change the rules (so far as relating to the
procedure of that House) at any time, in the same manner, and
to the same extent as in the case of any other rule of that
House.

SEC. __04. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated such sums as may be
necessary to carry out this subtitle for each of fiscal years
2012 through 2013.
______

SA 949. Mr. HARKIN submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

At the end of subtitle B of title IV, add the following:

SEC. __. IMPROVED PAYMENT FOR CERTAIN MAMMOGRAPHY SERVICES.

(a) Exclusion From OPD Fee Schedule.--Section
1833(t)(1)(B)(iv) (42 U.S.C. 13951(t)(1)(B)(iv)) is amended
by inserting before the period at the end the following:
``and does not include screening mammography (as defined in
section 1861(jj)) and unilateral and bilateral diagnostic
mammography''.
(b) Adjustment to Technical Component.--For diagnostic
mammography performed on or after January 1, 2004, for which
payment is made under the physician fee schedule under
section 1848 of the Social Security Act (42 U.S.C. 1395w-4),
the Secretary, based on the most recent cost data available,
shall provide for an appropriate adjustment in the payment
amount for the technical component of the diagnostic
mammography.
(c) Effective Date.--The amendment made by subsection (a)
shall apply to mammography performed on or after January 1,
2004.
______

SA 950. Mr. PRYOR submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

At the appropriate place, add the following:

SEC. __. EQUAL ACCESS TO COMPETITIVE GLOBAL PRESCRIPTION
MEDICINE PRICES FOR AMERICAN PURCHASERS.

(a) Definition of Covered Product.--In this section, the
term ``covered product'' has the meaning given the term in
section 804 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 384).
(b) Prohibition.--It shall be unlawful for the manufacturer
of a covered product or any other person that sells a covered
product to refuse to sell to any wholesaler or retailer (or
other purchaser representing a group of wholesalers or
retailers) of covered products in the United States on terms
(including such terms as prompt payment, cash payment, volume
purchase, single-site delivery, the use of formularies by
purchasers, and any other term that effectively reduces the
cost to the manufacturer of supplying the drug) that are not
substantially the same as the most favorable (to the
purchaser) terms on which the person has sold or has agreed
to sell the covered product to any purchaser in Canada.
(c) Enforcement.--The Secretary of Health and Human
Services, or any wholesaler or retailer in the United States
aggrieved by a violation of subsection (b), may bring a civil
action in United States district court against a person that
violates subsection (b) for an order--
(1) enjoining the violation; and
(2) awarding damages in the amount that is equal to 3 times
the amount of the value of the difference between--
(A) the terms on which the person sold a covered product to
the wholesaler or retailer; and
(B) the terms on which the person sold the covered product
to a person in Canada.
(d) Effectiveness of Section.--This section takes effect on
the date that is 2 years after the date of enactment of this
Act, except that this section shall not be in effect during
any period after that date in which there is in effect a
final regulation promulgated by the Secretary of Health and
Human Services permitting the importation or reimportation of
prescription drugs under section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384).

____________________