[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 812 Engrossed in Senate (ES)]
107th CONGRESS
2d Session
S. 812
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
TITLE I--GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS
SEC. 101. SHORT TITLE.
This title may be cited as the ``Greater Access to Affordable
Pharmaceuticals Act of 2002''.
SEC. 102. FINDINGS; PURPOSES.
(a) Findings.--Congress finds that--
(1) prescription drug costs are increasing at an alarming
rate and are a major worry of American families and senior
citizens;
(2) enhancing competition between generic drug
manufacturers and brand-name manufacturers can significantly
reduce prescription drug costs for American families;
(3) the pharmaceutical market has become increasingly
competitive during the last decade because of the increasing
availability and accessibility of generic pharmaceuticals, but
competition must be further stimulated and strengthened;
(4) the Federal Trade Commission has discovered that there
are increasing opportunities for drug companies owning patents
on brand-name drugs and generic drug companies to enter into
private financial deals in a manner that could restrain trade
and greatly reduce competition and increase prescription drug
costs for consumers;
(5) generic pharmaceuticals are approved by the Food and
Drug Administration on the basis of scientific testing and
other information establishing that pharmaceuticals are
therapeutically equivalent to brand-name pharmaceuticals,
ensuring consumers a safe, efficacious, and cost-effective
alternative to brand-name innovator pharmaceuticals;
(6) the Congressional Budget Office estimates that--
(A) the use of generic pharmaceuticals for brand-
name pharmaceuticals could save purchasers of
pharmaceuticals between $8,000,000,000 and
$10,000,000,000 each year; and
(B) generic pharmaceuticals cost between 25 percent
and 60 percent less than brand-name pharmaceuticals,
resulting in an estimated average savings of $15 to $30
on each prescription;
(7) generic pharmaceuticals are widely accepted by
consumers and the medical profession, as the market share held
by generic pharmaceuticals compared to brand-name
pharmaceuticals has more than doubled during the last decade,
from approximately 19 percent to 43 percent, according to the
Congressional Budget Office;
(8) expanding access to generic pharmaceuticals can help
consumers, especially senior citizens and the uninsured, have
access to more affordable prescription drugs;
(9) Congress should ensure that measures are taken to
effectuate the amendments made by the Drug Price Competition
and Patent Term Restoration Act of 1984 (98 Stat. 1585)
(referred to in this section as the ``Hatch-Waxman Act'') to
make generic drugs more accessible, and thus reduce health care
costs; and
(10) it would be in the public interest if patents on drugs
for which applications are approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) were
extended only through the patent extension procedure provided
under the Hatch-Waxman Act rather than through the attachment
of riders to bills in Congress.
(b) Purposes.--The purposes of this title are--
(1) to increase competition, thereby helping all Americans,
especially seniors and the uninsured, to have access to more
affordable medication; and
(2) to ensure fair marketplace practices and deter
pharmaceutical companies (including generic companies) from
engaging in anticompetitive action or actions that tend to
unfairly restrain trade.
SEC. 103. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG
ADMINISTRATION.
(a) Filing After Approval of an Application.--
(1) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) (as amended by section
9(a)(2)(B)(ii)) is amended in subsection (c) by striking
paragraph (2) and inserting the following:
``(2) Patent information.--
``(A) In general.--Not later than the date that is
30 days after the date of an order approving an
application under subsection (b) (unless the Secretary
extends the date because of extraordinary or unusual
circumstances), the holder of the application shall
file with the Secretary the patent information
described in subparagraph (C) with respect to any
patent--
``(i)(I) that claims the drug for which the
application was approved; or
``(II) that claims an approved method of
using the drug; and
``(ii) with respect to which a claim of
patent infringement could reasonably be
asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the
drug.
``(B) Subsequently issued patents.--In a case in
which a patent described in subparagraph (A) is issued
after the date of an order approving an application
under subsection (b), the holder of the application
shall file with the Secretary the patent information
described in subparagraph (C) not later than the date
that is 30 days after the date on which the patent is
issued (unless the Secretary extends the date because
of extraordinary or unusual circumstances).
``(C) Patent information.--The patent information
required to be filed under subparagraph (A) or (B)
includes--
``(i) the patent number;
``(ii) the expiration date of the patent;
``(iii) with respect to each claim of the
patent--
``(I) whether the patent claims the
drug or claims a method of using the
drug; and
``(II) whether the claim covers--
``(aa) a drug substance;
``(bb) a drug formulation;
``(cc) a drug composition;
or
``(dd) a method of use;
``(iv) if the patent claims a method of
use, the approved use covered by the claim;
``(v) the identity of the owner of the
patent (including the identity of any agent of
the patent owner); and
``(vi) a declaration that the applicant, as
of the date of the filing, has provided
complete and accurate patent information for
all patents described in subparagraph (A).
``(D) Publication.--On filing of patent information
required under subparagraph (A) or (B), the Secretary
shall--
``(i) immediately publish the information
described in clauses (i) through (iv) of
subparagraph (C); and
``(ii) make the information described in
clauses (v) and (vi) of subparagraph (C)
available to the public on request.
``(E) Civil action for correction or deletion of
patent information.--
``(i) In general.--A person that has filed
an application under subsection (b)(2) or (j)
for a drug may bring a civil action against the
holder of the approved application for the drug
seeking an order requiring that the holder of
the application amend the application--
``(I) to correct patent information
filed under subparagraph (A); or
``(II) to delete the patent
information in its entirety for the
reason that--
``(aa) the patent does not
claim the drug for which the
application was approved; or
``(bb) the patent does not
claim an approved method of
using the drug.
``(ii) Limitations.--Clause (i) does not
authorize--
``(I) a civil action to correct
patent information filed under
subparagraph (B); or
``(II) an award of damages in a
civil action under clause (i).
``(F) No claim for patent infringement.--An owner
of a patent with respect to which a holder of an
application fails to file information on or before the
date required under subparagraph (A) or (B) shall be
barred from bringing a civil action for infringement of
the patent against a person that--
``(i) has filed an application under
subsection (b)(2) or (j); or
``(ii) manufactures, uses, offers to sell,
or sells a drug approved under an application
under subsection (b)(2) or (j).''.
(2) Transition provision.--
(A) Filing of patent information.--Each holder of
an application for approval of a new drug under section
505(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)) that has been approved before the date
of enactment of this Act shall amend the application to
include the patent information required under the
amendment made by paragraph (1) not later than the date
that is 30 days after the date of enactment of this Act
(unless the Secretary of Health and Human Services
extends the date because of extraordinary or unusual
circumstances).
(B) No claim for patent infringement.--An owner of
a patent with respect to which a holder of an
application under subsection (b) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
fails to file information on or before the date
required under subparagraph (A) shall be barred from
bringing a civil action for infringement of the patent
against a person that--
(i) has filed an application under
subsection (b)(2) or (j) of that section; or
(ii) manufactures, uses, offers to sell, or
sells a drug approved under an application
under subsection (b)(2) or (j) of that section.
(b) Filing With an Application.--Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following:
``(C) with respect to a patent that claims both the
drug and a method of using the drug or claims more than
1 method of using the drug for which the application is
filed--
``(i) a certification under subparagraph
(A)(iv) on a claim-by-claim basis; and
``(ii) a statement under subparagraph (B)
regarding the method of use claim.''; and
(2) in subsection (j)(2)(A), by inserting after clause
(viii) the following:
``With respect to a patent that claims both the drug and a method of
using the drug or claims more than 1 method of using the drug for which
the application is filed, the application shall contain a certification
under clause (vii)(IV) on a claim-by-claim basis and a statement under
clause (viii) regarding the method of use claim.''.
SEC. 104. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.
(a) Abbreviated New Drug Applications.--Section 505(j)(5) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B)--
(A) in clause (iii)--
(i) by striking ``(iii) If the applicant
made a certification described in subclause
(IV) of paragraph (2)(A)(vii),'' and inserting
the following:
``(iii) Subclause (iv) certification with
respect to certain patents.--If the applicant
made a certification described in paragraph
(2)(A)(vii)(IV) with respect to a patent (other
than a patent that claims a process for
manufacturing the listed drug) for which patent
information was filed with the Secretary under
subsection (c)(2)(A),''; and
(ii) by adding at the end the following:
``The 30-month period provided under the second
sentence of this clause shall not apply to a
certification under paragraph (2)(A)(vii)(IV)
made with respect to a patent for which patent
information was filed with the Secretary under
subsection (c)(2)(B).'';
(B) by redesignating clause (iv) as clause (v); and
(C) by inserting after clause (iii) the following:
``(iv) Subclause (iv) certification with
respect to other patents.--
``(I) In general.--If the applicant
made a certification described in
paragraph (2)(A)(vii)(IV) with respect
to a patent not described in clause
(iii) for which patent information was
published by the Secretary under
subsection (c)(2)(D), the approval
shall be made effective on the date
that is 45 days after the date on which
the notice provided under paragraph
(2)(B) was received, unless a civil
action for infringement of the patent,
accompanied by a motion for preliminary
injunction to enjoin the applicant from
engaging in the commercial manufacture
or sale of the drug, was filed on or
before the date that is 45 days after
the date on which the notice was
received, in which case the approval
shall be made effective--
``(aa) on the date of a
court action declining to grant
a preliminary injunction; or
``(bb) if the court has
granted a preliminary
injunction prohibiting the
applicant from engaging in the
commercial manufacture or sale
of the drug--
``(AA) on issuance
by a court of a
determination that the
patent is invalid or is
not infringed;
``(BB) on issuance
by a court of an order
revoking the
preliminary injunction
or permitting the
applicant to engage in
the commercial
manufacture or sale of
the drug; or
``(CC) on the date
specified in a court
order under section
271(e)(4)(A) of title
35, United States Code,
if the court determines
that the patent is
infringed.
``(II) Cooperation.--Each of the
parties shall reasonably cooperate in
expediting a civil action under
subclause (I).
``(III) Expedited notification.--If
the notice under paragraph (2)(B)
contains an address for the receipt of
expedited notification of a civil
action under subclause (I), the
plaintiff shall, on the date on which
the complaint is filed, simultaneously
cause a notification of the civil
action to be delivered to that address
by the next business day.''; and
(2) by inserting after subparagraph (B) the following:
``(C) Failure to bring infringement action.--If, in
connection with an application under this subsection,
the applicant provides an owner of a patent notice
under paragraph (2)(B) with respect to the patent, and
the owner of the patent fails to 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 is received, the owner of the patent
shall be barred from bringing a civil action for
infringement of the patent in connection with the
development, manufacture, use, offer to sell, or sale
of the drug for which the application was filed or
approved under this subsection.''.
(b) Other Applications.--Section 505(c)) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(c)) (as amended by section
9(a)(3)(A)(iii)) is amended--
(1) in paragraph (3)--
(A) in subparagraph (C)--
(i) by striking ``(C) If the applicant made
a certification described in clause (iv) of
subsection (b)(2)(A),'' and inserting the
following:
``(C) Clause (iv) certification with respect to
certain patents.--If the applicant made a certification
described in subsection (b)(2)(A)(iv) with respect to a
patent (other than a patent that claims a process for
manufacturing the listed drug) for which patent
information was filed with the Secretary under
paragraph (2)(A),''; and
(ii) by adding at the end the following:
``The 30-month period provided under the second
sentence of this subparagraph shall not apply
to a certification under subsection
(b)(2)(A)(iv) made with respect to a patent for
which patent information was filed with the
Secretary under paragraph (2)(B).''; and
(B) by inserting after subparagraph (C) the
following:
``(D) Clause (iv) certification with respect to
other patents.--
``(i) In general.--If the applicant made a
certification described in subsection
(b)(2)(A)(iv) with respect to a patent not
described in subparagraph (C) for which patent
information was published by the Secretary
under paragraph (2)(D), the approval shall be
made effective on the date that is 45 days
after the date on which the notice provided
under subsection (b)(3) was received, unless a
civil action for infringement of the patent,
accompanied by a motion for preliminary
injunction to enjoin the applicant from
engaging in the commercial manufacture or sale
of the drug, was filed on or before the date
that is 45 days after the date on which the
notice was received, in which case the approval
shall be made effective--
``(I) on the date of a court action
declining to grant a preliminary
injunction; or
``(II) if the court has granted a
preliminary injunction prohibiting the
applicant from engaging in the
commercial manufacture or sale of the
drug--
``(aa) on issuance by a
court of a determination that
the patent is invalid or is not
infringed;
``(bb) on issuance by a
court of an order revoking the
preliminary injunction or
permitting the applicant to
engage in the commercial
manufacture or sale of the
drug; or
``(cc) on the date
specified in a court order
under section 271(e)(4)(A) of
title 35, United States Code,
if the court determines that
the patent is infringed.
``(ii) Cooperation.--Each of the parties
shall reasonably cooperate in expediting a
civil action under clause (i).
``(iii) Expedited notification.--If the
notice under subsection (b)(3) contains an
address for the receipt of expedited
notification of a civil action under clause
(i), the plaintiff shall, on the date on which
the complaint is filed, simultaneously cause a
notification of the civil action to be
delivered to that address by the next business
day.''; and
(2) by inserting after paragraph (3) the following:
``(4) Failure to bring infringement action.--If, in
connection with an application under subsection (b)(2), the
applicant provides an owner of a patent notice under subsection
(b)(3) with respect to the patent, and the owner of the patent
fails to 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 is received, the owner
of the patent shall be barred from bringing a civil action for
infringement of the patent in connection with the development,
manufacture, use, offer to sell, or sale of the drug for which
the application was filed or approved under subsection
(b)(2).''.
(c) Effective Date.--
(1) In general.--The amendments made by subsections (a) and
(b) shall be effective 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)
made after the date of enactment of this Act in an application
filed under subsection (b)(2) or (j) of that section.
(2) Transition provision.--In the case of applications
under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) filed before the date of enactment of
this Act--
(A) a patent (other than a patent that claims a
process for manufacturing a listed drug) for which
information was submitted to the Secretary of Health
and Human Services under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act (as in effect on
the day before the date of enactment of this Act) shall
be subject to subsections (c)(3)(C) and (j)(5)(B)(iii)
of section 505 of the Federal Food, Drug, and Cosmetic
Act (as amended by this section); and
(B) any other patent (including a patent for which
information was submitted to the Secretary under
section 505(c)(2) of that Act (as in effect on the day
before the date of enactment of this Act)) shall be
subject to subsections (c)(3)(D) and (j)(5)(B)(iv) of
section 505 of the Federal Food, Drug, and Cosmetic Act
(as amended by this section).
SEC. 105. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.
(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 4(a)) is
amended--
(1) in subparagraph (B)(v), by striking subclause (II) and
inserting the following:
``(II) the earlier of--
``(aa) the date of a final
decision of a court (from which
no appeal has been or can be
taken, other than a petition to
the Supreme Court for a writ of
certiorari) holding that the
patent that is the subject of
the certification is invalid or
not infringed; or
``(bb) the date of a
settlement order or consent
decree signed by a Federal
judge that enters a final
judgment and includes a finding
that the patent that is the
subject of the certification is
invalid or not infringed;'';
and
(2) by inserting after subparagraph (C) the following:
``(D) Forfeiture of 180-day period.--
``(i) Definitions.--In this subparagraph:
``(I) Application.--The term
`application' means an application for
approval of a drug under this
subsection containing a certification
under paragraph (2)(A)(vii)(IV) with
respect to a patent.
``(II) First application.--The term
`first application' means the first
application to be filed for approval of
the drug.
``(III) Forfeiture event.--The term
`forfeiture event', with respect to an
application under this subsection,
means the occurrence of any of the
following:
``(aa) Failure to market.--
The applicant fails to market
the drug by the later of--
``(AA) the date
that is 60 days after
the date on which the
approval of the
application for the
drug is made effective
under clause (iii) or
(iv) of subparagraph
(B) (unless the
Secretary extends the
date because of
extraordinary or
unusual circumstances);
or
``(BB) if 1 or more
civil actions have been
brought against the
applicant for
infringement of a
patent subject to a
certification under
paragraph
(2)(A)(vii)(IV) or 1 or
more civil actions have
been brought by the
applicant for a
declaratory judgment
that such a patent is
invalid or not
infringed, the date
that is 60 days after
the date of a final
decision (from which no
appeal has been or can
be taken, other than a
petition to the Supreme
Court for a writ of
certiorari) in the last
of those civil actions
to be decided (unless
the Secretary extends
the date because of
extraordinary or
unusual circumstances).
``(bb) Withdrawal of
application.--The applicant
withdraws the application.
``(cc) Amendment of
certification.--The applicant,
voluntarily or as a result of a
settlement or defeat in patent
litigation, amends the
certification from a
certification under paragraph
(2)(A)(vii)(IV) to a
certification under paragraph
(2)(A)(vii)(III).
``(dd) Failure to obtain
approval.--The applicant fails
to obtain tentative approval of
an application within 30 months
after the date on which the
application is filed, unless
the failure is caused by--
``(AA) a change in
the requirements for
approval of the
application imposed
after the date on which
the application is
filed; or
``(BB) other
extraordinary
circumstances
warranting an
exception, as
determined by the
Secretary.
``(ee) Failure to challenge
patent.--In a case in which,
after the date on which the
applicant submitted the
application, new patent
information is submitted under
subsection (c)(2) for the
listed drug for a patent for
which certification is required
under paragraph (2)(A), the
applicant fails to submit, not
later than the date that is 60
days after the date on which
the Secretary publishes the new
patent information under
paragraph (7)(A)(iii) (unless
the Secretary extends the date
because of extraordinary or
unusual circumstances)--
``(AA) a
certification described
in paragraph
(2)(A)(vii)(IV) with
respect to the patent
to which the new patent
information relates; or
``(BB) a statement
that any method of use
claim of that patent
does not claim a use
for which the applicant
is seeking approval
under this subsection
in accordance with
paragraph (2)(A)(viii).
``(ff) Unlawful conduct.--
The Federal Trade Commission
determines that the applicant
engaged in unlawful conduct
with respect to the application
in violation of section 1 of
the Sherman Act (15 U.S.C. 1).
``(IV) Subsequent application.--The
term `subsequent application' means an
application for approval of a drug that
is filed subsequent to the filing of a
first application for approval of that
drug.
``(ii) Forfeiture of 180-day period.--
``(I) In general.--Except as
provided in subclause (II), if a
forfeiture event occurs with respect to
a first application--
``(aa) the 180-day period
under subparagraph (B)(v) shall
be forfeited by the first
applicant; and
``(bb) any subsequent
application shall become
effective as provided under
clause (i), (ii), (iii), or
(iv) of subparagraph (B), and
clause (v) of subparagraph (B)
shall not apply to the
subsequent application.
``(II) Forfeiture to first
subsequent applicant.--If the
subsequent application that is the
first to be made effective under
subclause (I) was the first among a
number of subsequent applications to be
filed--
``(aa) that first
subsequent application shall be
treated as the first
application under this
subparagraph (including
subclause (I)) and as the
previous application under
subparagraph (B)(v); and
``(bb) any other subsequent
applications shall become
effective as provided under
clause (i), (ii), (iii), or
(iv) of subparagraph (B), but
clause (v) of subparagraph (B)
shall apply to any such
subsequent application.
``(iii) Availability.--The 180-day period
under subparagraph (B)(v) shall be available to
a first applicant submitting an application for
a drug with respect to any patent without
regard to whether an application has been
submitted for the drug under this subsection
containing such a certification with respect to
a different patent.
``(iv) Applicability.--The 180-day period
described in subparagraph (B)(v) shall apply to
an application only if a civil action is
brought against the applicant for infringement
of a patent that is the subject of the
certification.''.
(b) Applicability.--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, except that if a forfeiture
event described in section 505(j)(5)(D)(i)(III)(ff) of that Act occurs
in the case of an applicant, the applicant shall forfeit the 180-day
period under section 505(j)(5)(B)(v) of that Act without regard to when
the applicant made a certification under section 505(j)(2)(A)(vii)(IV)
of that Act.
SEC. 106. FAIR TREATMENT FOR INNOVATORS.
(a) Basis for Application.--Section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(3)(B), by striking the second
sentence and inserting ``The notice shall include a detailed
statement of the factual and legal basis of the applicant's
opinion that, as of the date of the notice, the patent is not
valid or is not infringed, and shall include, as appropriate
for the relevant patent, a description of the applicant's
proposed drug substance, drug formulation, drug composition, or
method of use. All information disclosed under this
subparagraph shall be treated as confidential and may be used
only for purposes relating to patent adjudication. Nothing in
this subparagraph precludes the applicant from amending the
factual or legal basis on which the applicant relies in patent
litigation.''; and
(2) in subsection (j)(2)(B)(ii), by striking the second
sentence and inserting ``The notice shall include a detailed
statement of the factual and legal basis of the opinion of the
applicant that, as of the date of the notice, the patent is not
valid or is not infringed, and shall include, as appropriate
for the relevant patent, a description of the applicant's
proposed drug substance, drug formulation, drug composition, or
method of use. All information disclosed under this
subparagraph shall be treated as confidential and may be used
only for purposes relating to patent adjudication. Nothing in
this subparagraph precludes the applicant from amending the
factual or legal basis on which the applicant relies in patent
litigation.''.
(b) Injunctive Relief.--Section 505(j)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) (as amended by section
4(a)(1)) is amended--
(1) in clause (iii), by adding at the end the following:
``A court shall not regard the extent of the ability of an
applicant to pay monetary damages as a whole or partial basis
on which to deny a preliminary or permanent injunction under
this clause.''; and
(2) in clause (iv), by adding at the end the following:
``(IV) Injunctive relief.--A court shall not regard
the extent of the ability of an applicant to pay
monetary damages as a whole or partial basis on which
to deny a preliminary or permanent injunction under
this clause.''.
SEC. 107. BIOEQUIVALENCE.
(a) In General.--The amendments to part 320 of title 21, Code of
Federal Regulations, promulgated by the Commissioner of Food and Drugs
on July 17, 1991 (57 Fed. Reg. 17997 (April 28, 1992)), shall continue
in effect as an exercise of authorities under sections 501, 502, 505,
and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351,
352, 355, 371).
(b) Effect.--Subsection (a) does not affect the authority of the
Commissioner of Food and Drugs to amend part 320 of title 21, Code of
Federal Regulations.
(c) Effect of Section.--This section shall not be construed to
alter the authority of the Secretary of Health and Human Services to
regulate biological products under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.). Any such authority shall be exercised
under that Act as in effect on the day before the date of enactment of
this Act.
SEC. 108. REPORT.
(a) In General.--Not later than the date that is 5 years after the
date of enactment of this Act, the Federal Trade Commission shall
submit to Congress a report describing the extent to which
implementation of the amendments made by this title--
(1) has enabled products to come to market in a fair and
expeditious manner, consistent with the rights of patent owners
under intellectual property law; and
(2) has promoted lower prices of drugs and greater access
to drugs through price competition.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000.
SEC. 109. CONFORMING AND TECHNICAL AMENDMENTS.
(a) Section 505.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (a), by striking ``(a) No person'' and
inserting ``(a) In General.--No person'';
(2) in subsection (b)--
(A) by striking ``(b)(1) Any person'' and inserting
the following:
``(b) Applications.--
``(1) Requirements.--
``(A) In general.--Any person'';
(B) in paragraph (1)--
(i) in the second sentence--
(I) by redesignating subparagraphs
(A) through (F) as clauses (i) through
(vi), respectively, and adjusting the
margins appropriately;
(II) by striking ``Such persons''
and inserting the following:
``(B) Information to be submitted with
application.--A person that submits an application
under subparagraph (A)''; and
(III) by striking ``application''
and inserting ``application--'';
(ii) by striking the third through fifth
sentences; and
(iii) in the sixth sentence--
(I) by striking ``The Secretary''
and inserting the following:
``(C) Guidance.--The Secretary''; and
(II) by striking ``clause (A)'' and
inserting ``subparagraph (B)(i)''; and
(C) in paragraph (2)--
(i) by striking ``clause (A) of such
paragraph'' and inserting ``paragraph
(1)(B)(i)'';
(ii) in subparagraphs (A) and (B), by
striking ``paragraph (1) or''; and
(iii) in subparagraph (B)--
(I) by striking ``paragraph
(1)(A)'' and inserting ``paragraph
(1)(B)(i)''; and
(II) by striking ``patent'' each
place it appears and inserting
``claim''; and
(3) in subsection (c)--
(A) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``(A) If the
applicant'' and inserting the
following:
``(A) Clause (i) or (ii) certification.--If the
applicant''; and
(II) by striking ``may'' and
inserting ``shall'';
(ii) in subparagraph (B)--
(I) by striking ``(B) If the
applicant'' and inserting the
following:
``(B) Clause (iii) certification.--If the
applicant''; and
(II) by striking ``may'' and
inserting ``shall'';
(iii) by redesignating subparagraph (D) as
subparagraph (E); and
(iv) in subparagraph (E) (as redesignated
by clause (iii)), by striking ``clause (A) of
subsection (b)(1)'' each place it appears and
inserting ``subsection (b)(1)(B)(i)''; and
(B) by redesignating paragraph (4) as paragraph
(5); and
(4) in subsection (j)--
(A) in paragraph (2)(A)--
(i) in clause (vi), by striking ``clauses
(B) through ((F)'' and inserting ``subclauses
(ii) through (vi) of subsection (b)(1)'';
(ii) in clause (vii), by striking ``(b)
or''; and
(iii) in clause (viii)--
(I) by striking ``(b) or''; and
(II) by striking ``patent'' each
place it appears and inserting
``claim''; and
(B) in paragraph (5)--
(i) in subparagraph (B)--
(I) in clause (i)--
(aa) by striking ``(i) If
the applicant'' and inserting
the following:
``(i) Subclause (i) or (ii)
certification.--If the applicant''; and
(bb) by striking ``may''
and inserting ``shall'';
(II) in clause (ii)--
(aa) by striking ``(ii) If
the applicant'' and inserting
the following:
``(i) Subclause (iii) certification.--If
the applicant''; and
(bb) by striking ``may''
and inserting ``shall'';
(III) in clause (iii), by striking
``(2)(B)(i)'' each place it appears and
inserting ``(2)(B)''; and
(IV) in clause (v) (as redesignated
by section 4(a)(1)(B)), by striking
``continuing'' and inserting
``containing''; and
(ii) by redesignating subparagraphs (C) and
(D) as subparagraphs (E) and (F), respectively.
(b) Section 505A.--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)--
(A) by striking ``(c)(3)(D)(ii)'' each place it
appears and inserting ``(c)(3)(E)(ii)''; and
(B) 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)--
(A) by striking ``(c)(3)(D)'' each place it appears
and inserting ``(c)(3)(E)''; and
(B) by striking ``(j)(5)(D)'' each place it appears
and inserting ``(j)(5)(F)'';
(3) in subsections (e) and (l)--
(A) by striking ``505(c)(3)(D)'' each place it
appears and inserting ``505(c)(3)(E)''; and
(B) by striking ``505(j)(5)(D)'' each place it
appears and inserting ``505(j)(5)(F)''; and
(4) in subsection (k), by striking ``505(j)(5)(B)(iv)'' and
inserting ``505(j)(5)(B)(v)''.
(c) Section 527.--Section 527(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the second sentence by
striking ``505(c)(2)'' and inserting ``505(c)(1)(B)''.
TITLE II--IMPORTATION OF PRESCRIPTION DRUGS
SEC. 201. 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 the prescription drugs or by
the importer that is counterfeit or in violation of any requirement
under this section or poses an additional risk to the public health,
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 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) Authorization of Appropriations.--There are authorized to be
appropriated such sums as are necessary to carry out this section.
``(o) 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.''.
(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)''.
SEC. 202. CLARIFICATION OF STATE AUTHORITY RELATING TO MEDICAID DRUG
REBATE AGREEMENTS.
Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) is
amended by adding at the end the following:
``(l) Rule of Construction.--Nothing in this section shall be
construed as prohibiting a State from--
``(1) directly entering into rebate agreements (on the
State's own initiative or under a section 1115 waiver approved
by the Secretary before, on, or after the date of enactment of
this subsection) that are similar to a rebate agreement
described in subsection (b) with a manufacturer for purposes of
ensuring the affordability of outpatient prescription drugs in
order to provide access to such drugs by residents of a State
who are not otherwise eligible for medical assistance under
this title; or
``(2) making prior authorization (that satisfies the
requirements of subsection (d) and that does not violate any
requirements of this title that are designed to ensure access
to medically necessary prescribed drugs for individuals
enrolled in the State program under this title) a condition of
not participating in such a similar rebate agreement.''.
SEC. 203. TEMPORARY STATE FISCAL RELIEF.
(a) Temporary Increase of Medicaid FMAP.--
(1) Permitting maintenance of fiscal year 2001 fmap for
last 2 calendar quarters of fiscal year 2002.--Notwithstanding
any other provision of law, but subject to paragraph (5), if
the FMAP determined without regard to this subsection for a
State for fiscal year 2002 is less than the FMAP as so
determined for fiscal year 2001, the FMAP for the State for
fiscal year 2001 shall be substituted for the State's FMAP for
the third and fourth calendar quarters of fiscal year 2002,
before the application of this subsection.
(2) Permitting maintenance of fiscal year 2002 fmap for
fiscal year 2003.--Notwithstanding any other provision of law,
but subject to paragraph (5), if the FMAP determined without
regard to this subsection for a State for fiscal year 2003 is
less than the FMAP as so determined for fiscal year 2002, the
FMAP for the State for fiscal year 2002 shall be substituted
for the State's FMAP for each calendar quarter of fiscal year
2003, before the application of this subsection.
(3) General 1.35 percentage points increase for last 2
calendar quarters of fiscal year 2002 and fiscal year 2003.--
Notwithstanding any other provision of law, but subject to
paragraphs (5) and (6), for each State for the third and fourth
calendar quarters of fiscal year 2002 and each calendar quarter
of fiscal year 2003, the FMAP (taking into account the
application of paragraphs (1) and (2)) shall be increased by
1.35 percentage points.
(4) Increase in cap on medicaid payments to territories.--
Notwithstanding any other provision of law, but subject to
paragraph (6), with respect to the third and fourth calendar
quarters of fiscal year 2002 and each calendar quarter of
fiscal year 2003, the amounts otherwise determined for Puerto
Rico, the Virgin Islands, Guam, the Northern Mariana Islands,
and American Samoa under subsections (f) and (g) of section
1108 of the Social Security Act (42 U.S.C. 1308) shall each be
increased by an amount equal to 2.7 percent of such amounts.
(5) Scope of application.--The increases in the FMAP for a
State under this subsection shall apply only for purposes of
title XIX of the Social Security Act and shall not apply with
respect to--
(A) disproportionate share hospital payments
described in section 1923 of such Act (42 U.S.C. 1396r-
4); or
(B) payments under title IV or XXI of such Act (42
U.S.C. 601 et seq. and 1397aa et seq.).
(6) State eligibility.--
(A) In general.--Subject to subparagraph (B), a
State is eligible for an increase in its FMAP under
paragraph (3) or an increase in a cap amount under
paragraph (4) only if the eligibility under its State
plan under title XIX of the Social Security Act
(including any waiver under such title or under section
1115 of such Act (42 U.S.C. 1315)) is no more
restrictive than the eligibility under such plan (or
waiver) as in effect on January 1, 2002.
(B) State reinstatement of eligibility permitted.--
A State that has restricted eligibility under its State
plan under title XIX of the Social Security Act
(including any waiver under such title or under section
1115 of such Act (42 U.S.C. 1315)) after January 1,
2002, but prior to the date of enactment of this Act is
eligible for an increase in its FMAP under paragraph
(3) or an increase in a cap amount under paragraph (4)
in the first calendar quarter (and subsequent calendar
quarters) in which the State has reinstated eligibility
that is no more restrictive than the eligibility under
such plan (or waiver) as in effect on January 1, 2002.
(C) Rule of construction.--Nothing in subparagraph
(A) or (B) shall be construed as affecting a State's
flexibility with respect to benefits offered under the
State medicaid program under title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.) (including any
waiver under such title or under section 1115 of such
Act (42 U.S.C. 1315)).
(7) Definitions.--In this subsection:
(A) FMAP.--The term ``FMAP'' means the Federal
medical assistance percentage, as defined in section
1905(b) of the Social Security Act (42 U.S.C.
1396d(b)).
(B) State.--The term ``State'' has the meaning
given such term for purposes of title XIX of the Social
Security Act (42 U.S.C. 1396 et seq.).
(8) Repeal.--Effective as of October 1, 2003, this
subsection is repealed.
(b) Additional Temporary State Fiscal Relief.--
(1) In general.--Title XX of the Social Security Act (42
U.S.C. 1397-1397f) is amended by adding at the end the
following:
``SEC. 2008. ADDITIONAL TEMPORARY GRANTS FOR STATE FISCAL RELIEF.
``(a) In General.--For the purpose of providing State fiscal relief
allotments to States under this section, there are hereby appropriated,
out of any funds in the Treasury not otherwise appropriated,
$3,000,000,000. Such funds shall be available for obligation by the
State through June 30, 2004, and for expenditure by the State through
September 30, 2004. This section constitutes budget authority in
advance of appropriations Acts and represents the obligation of the
Federal Government to provide for the payment to States of amounts
provided under this section.
``(b) Allotment.--Funds appropriated under subsection (a) shall be
allotted by the Secretary among the States in accordance with the
following table:
------------------------------------------------------------------------
``State Allotment (in dollars)
------------------------------------------------------------------------
Alabama $33,918,100
Alaska $8,488,200
Amer. Samoa $88,600
Arizona $47,601,600
Arkansas $27,941,800
California $314,653,900
Colorado $27,906,200
Connecticut $41,551,200
Delaware $8,306,000
District of Columbia $12,374,400
Florida $128,271,100
Georgia $69,106,600
Guam $135,900
Hawaii $9,914,700
Idaho $10,293,600
Illinois $102,577,900
Indiana $50,659,800
Iowa $27,799,700
Kansas $21,414,300
Kentucky $44,508,400
Louisiana $50,974,000
Maine $17,841,100
Maryland $44,228,800
Massachusetts $100,770,700
Michigan $91,196,800
Minnesota $57,515,400
Mississippi $35,978,500
Missouri $62,189,600
Montana $8,242,000
Nebraska $16,671,600
Nevada $10,979,700
New Hampshire $10,549,400
New Jersey $87,577,300
New Mexico $21,807,600
New York $461,401,900
North Carolina $79,538,300
North Dakota $5,716,900
N. Mariana Islands $50,000
Ohio $116,367,800
Oklahoma $30,941,800
Oregon $34,327,200
Pennsylvania $159,089,700
Puerto Rico $3,991,900
Rhode Island $16,594,100
South Carolina $38,238,000
South Dakota $6,293,700
Tennessee $81,120,000
Texas $159,779,800
Utah $12,551,700
Vermont $8,003,800
Virgin Islands $128,800
Virginia $44,288,300
Washington $66,662,200
West Virginia $19,884,400
Wisconsin $47,218,900
Wyoming $3,776,400
------------------------------------------------------------------------
Total $3,000,000,000
------------------------------------------------------------------------
``(c) Use of Funds.--Funds appropriated under this section may be
used by a State for services directed at the goals set forth in section
2001, subject to the requirements of this title.
``(d) Payment to States.--Not later than 30 days after amounts are
appropriated under subsection (a), in addition to any payment made
under section 2002 or 2007, the Secretary shall make a lump sum payment
to a State of the total amount of the allotment for the State as
specified in subsection (b).
``(e) Definition.--For purposes of this section, the term `State'
means the 50 States, the District of Columbia, and the territories
contained in the list under subsection (b).''.
(2) Repeal.--Effective as of January 1, 2005, section 2008
of the Social Security Act, as added by paragraph (1), is
repealed.
(c) Emergency Designation.--The entire amount necessary to carry
out this section is designated by Congress as an emergency requirement
pursuant to section 252(e) of the Balanced Budget and Emergency Deficit
Control Act of 1985 (2 U.S.C. 902(e)).
Passed the Senate July 31, 2002.
Attest:
Secretary.
107th CONGRESS
2d Session
S. 812
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.