[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1862 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 1862
To amend the Federal Food, Drug, and Cosmetic Act to provide greater
access to affordable pharmaceuticals.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 16, 2001
Mr. Brown of Ohio (for himself, Mrs. Emerson, Mrs. Thurman, Mr.
Pallone, Mr. Baldacci, Mr. Stupak, Mr. Shows, Mr. Allen, Ms. Kaptur,
Mr. Sanders, and Mr. Frank) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Greater Access to Affordable
Pharmaceuticals Act of 2001''.
SEC. 2. 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 Act 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. 3. ACCELERATED GENERIC DRUG COMPETITION.
(a) In General.--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)(iv), by striking subclause (II) and
inserting the following:
``(II) the earlier of--
``(aa) the date of a final decision of a
court in an action described in clause (iii)
(from which no appeal can or has been taken);
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 patents that are the subject of the
certification are invalid or not infringed;'';
(2) by redesignating subparagraphs (C) and (D) as
subparagraphs (E) and (F), respectively; and
(3) by inserting after subparagraph (B) the following:
``(C) Forfeiture of 180-day period.--
``(i) In general.--The 180-day period
described in subparagraph (B)(iv) shall be
forfeited by the previous applicant and become
available to the next applicant submitting an
application containing a certification
described in paragraph (2)(A)(vii)(IV) if--
``(I) the previous applicant fails
to market the drug within 90 days after
the date on which the approval of the
application for the drug is made effective under subparagraph (B)(iii);
``(II) the previous applicant
withdraws the application;
``(III) the previous applicant
amends the certification from a
certification under subclause (IV) to a
certification under paragraph
(2)(A)(vii)(III), either voluntarily or
as a result of a settlement or defeat
in patent litigation;
``(IV) the previous applicant fails
to get tentative approval of the
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 tentative
approval of the application
imposed after the date on which
the application was filed; or
``(bb) other extraordinary
or unusual circumstances, as
determined by the Secretary;
``(V) in a case in which, after the
date on which the previous application
was submitted under this subsection,
new patent information is submitted for
the drug under subsection (c)(2) for a
patent for which certification is
required under paragraph
(2)(A)(vii)(IV), the previous applicant
fails to challenge the patent that is
the subject of the information within
60 days after the date on which the
patent information is submitted; or
``(VI) the previous applicant is
determined by the Secretary, after a
fair and sufficient hearing and in
consultation with the Federal Trade
Commission, to have engaged in
anticompetitive or collusive conduct,
or any other conduct intended to
unfairly monopolize the commercial
manufacturing of the drug of the
application.
``(ii) Availability.--The 180-day period
described in subparagraph (B)(iv) shall be
available only to--
``(I) the previous applicant
submitting an application for a drug
under this subsection containing a
certification described in paragraph
(2)(A)(vii)(IV) with respect to any
patent; or
``(II) under clause (i), the next
applicant submitting an application for
a drug under this subsection containing
such a certification with respect to
any patent;
even if an application has been submitted for
the drug under this subsection containing such
a certification with respect to a different
patent.
``(iii) Applicability.--The 180-day period
described in subparagraph (B)(iv) shall apply
only if--
``(I) the application contains a
certification described in paragraph
(2)(A)(vii)(IV); and
``(II) an action is brought for
infringement of a patent that is the
subject of the certification or the
applicant brings an action (not later
than 50 days after the date on which
the notice provided under paragraph
(2)(B)(ii) was received), against the
holder of the approved application for
the listed drug.''.
(b) Effective Date.--The amendment made by this section 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))
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.
SEC. 4. BIOEQUIVALENCE TESTING METHODS.
Section 505(j)(8)(B) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(8)(B)) is amended--
(1) in clause (i), by striking ``or'' at the end;
(2) in clause (ii), by striking the period at the end and
inserting ``; or''; and
(3) by adding at the end the following:
``(iii)(I) clauses (i) and (ii) are not applicable,
as determined by the Secretary;
``(II) the effects of the drug and the listed drug
do not show a significant difference based on tests
(other than tests that assess rate and extent of
absorption), including--
``(aa) a bioequivalence study with a
pharmacodynamic endpoint;
``(bb) a bioequivalence study with a
clinical endpoint;
``(cc) in vitro methods; or
``(dd) any other methodology that
demonstrates that no significant differences in
therapeutic effects of active ingredients are
expected; and
``(III) limited confirmatory studies to supplement
the bioequivalence testing are considered necessary by
the Secretary.''.
SEC. 5. CITIZEN PETITIONS.
Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) (as amended by section 3(a)) is amended by inserting
after subparagraph (C) the following:
``(D) Citizen petitions.--
``(i) In general.--Notwithstanding any
other provision of law, any petition submitted
under section 10.30 of title 21, Code of
Federal Regulations (or any successor
regulation), shall include a statement that to
the best knowledge and belief of the
petitioner, the petition--
``(I) includes all information and
views on which the petitioner relies;
``(II) is well grounded in fact and
is warranted by law (including
regulations);
``(III) is not submitted for any
improper purpose, such as to harass or
cause unnecessary delay;
``(IV) does not contain a
materially false, misleading, or
fraudulent statement that the
petitioner has knowingly and willingly
included; and
``(V) includes all representative
data and information known to the
petitioner that is favorable or
unfavorable to the petition.
``(ii) Applicability of criminal
provision.--Section 1001 of title 18, United
States Code, shall apply to a person that
submits a petition under section 10.30 of title
21, Code of Federal Regulations (or any
successor regulation).
``(iii) Investigations.--
``(I) In general.--The Federal
Trade Commission shall investigate, on
receipt of a complaint or upon its own
initiative, any petition submitted
under section 10.30 of title 21, Code
of Federal Regulations (or any
successor regulation), that may have
been submitted for an improper purpose,
such as to delay competition or agency
action.
``(II) Referral.--If the Commission
finds that a petitioner has engaged in
conduct that may be illegal, the
Commission shall refer the petition to
the Antitrust Division of the
Department of Justice for further
action.
``(iv) Notice of receipt of
consideration.--
``(I) In general.--A person that
submits a petition under section 10.30
of title 21, Code of Federal
Regulations (or any successor
regulation), shall provide a written
notice to the Federal Trade Commission
if the person receives any
consideration for submitting the
petition.
``(II) A notice under subclause (I)
shall include--
``(aa) the name of the
person or entity that provided
the consideration;
``(bb) the dollar value of
the consideration, if provided
in cash, or a description of
such consideration;
``(cc) the date on which
the consideration was provided;
and
``(dd) any other
information that the Commission
requires to be disclosed.''.
SEC. 6. PATENT CERTIFICATION.
(a) Abbreviated New Drug Applications.--Section 505(j)(5) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended
by section 3(a)(2)) is amended--
(1) in subparagraph (B), by striking clause (iii) and
inserting the following:
``(iii) Certification that patent is
invalid or will not be infringed.--
``(I) In general.--Except as
provided in subclauses (II) and (III),
if the applicant made a certification
described in paragraph (2)(A)(vii)(IV),
the approval shall be made effective on
the expiration of 45 days after the
date on which the notice provided under
paragraph (2)(B)(ii) was received.
``(II) Action for patent
infringement.--If an action is brought
for infringement of a patent that is
the subject of the certification
before the expiration of the 45-day period beginning on the date on
which the notice provided under paragraph (2)(B)(ii) was received, the
approval shall be made effective on the expiration of the 45-day period
unless 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.
``(III) Patent invalid or not
infringed.--If the court decides that
the patent is invalid or was not
infringed, the approval shall be made
effective on the date of the court
decision.
``(IV) Patent infringed.--If the
court decides that the patent was
infringed, the approval shall be made
effective on such date as the court
orders under section 271(e)(4)(A) of
title 35, United States Code.
``(V) Procedure.--In an action
described in subclause (II)--
``(aa) each of the parties
shall reasonably cooperate in
expediting the action;
``(bb) until the expiration
of 45 days after the date the
notice provided under paragraph
(2)(B)(i) was received, no
civil action may be brought
under section 2201 of title 28,
United States Code, for a
declaratory judgment with
respect to the patent, except
as provided in subparagraph
(H); and
``(cc) any such civil
action shall be brought in the
judicial district in which the
defendant has its principal
place of business or a regular
and established place of
business.''; and
(2) by adding at the end the following:
``(G) Civil action for declaratory judgment.--A
person that files an abbreviated application for a new
drug under this paragraph may bring a civil action
against the holder of an approved application for a
listed drug for a declaratory judgment to determine
whether the patent that claims the listed drug or a
method of using the drug is invalid or will not be
infringed.
``(H) Civil action to determine legal status.--
Notwithstanding any other provision of law, if
information on a patent for a listed drug has been
published under subsection (c)(2) for at least 1 year
after the date on which an abbreviated application for
approval of a new drug was filed under this subsection
in relation to the listed drug, the person that filed
the abbreviated application or the holder of the
approved application for the listed drug may
immediately bring a civil action to determine the legal
status of the patent for the listed drug.''.
(b) New Drug Applications.--Section 505(c)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended by striking
subparagraph (C) and inserting the following:
``(C) Certification that patent is invalid or will
not be infringed.--
``(i) In general.--Except as provided in
clauses (ii) and (iii), if the applicant made a
certification described in subsection
(b)(2)(A)(iv), the approval shall be made
effective on the expiration of 45 days after
the date on which the notice provided under
subsection (b)(3)(B) was received.
``(ii) Action brought before expiration of
45 days.--If an action is brought for
infringement of a patent that is the subject of
the certification before the expiration of the
45-day period beginning on the date the notice
provided under subsection (b)(3)(B) was
received, the approval shall be made effective
on the expiration of the 45-day period unless
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.
``(iii) Patent invalid or not infringed.--
If the court decides that the patent is invalid
or not infringed, the approval shall be made
effective on the date of the court decision.
``(iv) Patent infringed.--If the court
decides that the patent has been infringed, the
approval may be made effective on such date as
the court orders under section 271(e)(4)(A) of
title 35, United States Code.
``(v) Procedure.--In an action described in
clause (ii)--
``(I) each of the parties shall
reasonably cooperate in expediting the
action;
``(II) until the expiration of 45
days after the date the notice provided
under subsection (b)(3)(B) was
received, no civil action may be
brought under section 2201 of title 28,
United States Code, for a declaratory
judgment with respect to the patent,
except as provided in subsection
(j)(5)(H); and
``(III) any such civil action shall
be brought in the judicial district
where the defendant has its principal
place of business or a regular and established place of business.''.
(c) Effective Date.--The amendments made by this section shall not
apply to an application submitted under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) before the date of
enactment of this Act.
SEC. 7. PATENT INFORMATION.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) is amended--
(1) in subsection (b), by striking ``(b)(1) Any person''
and all that follows through paragraph (1) and inserting the
following:
``(b) Applications.--
``(1) In general.--
``(A) Filing.--Any person may file with the
Secretary an application with respect to any drug
subject to subsection (a).
``(B) Contents.--A person that files an application
shall submit to the Secretary as a part of the
application with respect to a drug--
``(i) full reports of investigations that
have been made to show whether or not such drug
is safe for use and whether the drug is
effective in use;
``(ii) a full list of the articles used as
components of the drug;
``(iii) a full statement of the composition
of the drug;
``(iv) a full description of the methods
used in, and the facilities and controls used
for, the manufacture, processing, and packing
of the drug;
``(v) such samples of the drug and of the
articles used as components of the drug as the
Secretary may require; and
``(vi) specimens of the labeling proposed
to be used for the drug.
``(C) Patent information.--
``(i) In general.--The applicant shall file
with the application the patent number and
expiration date of any patent that claims a
drug or method of using a drug and 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 for which the applicant
submitted the application.
``(ii) Amendment of application.--If an
application is filed with respect to a drug and
a patent as described in clause (i) is issued
after the filing date but before approval of
the application, the applicant shall amend the
application to include the information required
by clause (i).
``(iii) Publication of information.--On
approval of the application, the Secretary
shall publish information submitted under
clauses (i) and (ii).
``(D) Guidance.--The Secretary shall, in
consultation with the Director of the National
Institutes of Health and with representatives of the
drug manufacturing industry, review and develop
guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by subparagraph
(B)(i).''; and
(2) in paragraph (2)(A)--
(A) by striking ``which claims'' the first place it
appears and all that follows through ``subsection
and''; and
(B) by striking ``subsection (c)--'' and inserting
``and 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 for which the investigations
were conducted--'';
(3) in the first sentence of subsection (c)(2)--
(A) by inserting ``such patent information'' after
``shall file''; and
(B) by striking ``Secretary,'' and all that follows
and inserting ``Secretary.'';
(4) in subsection (j)(2)(vii), by striking ``which claims
the listed drug'' and all that follows through ``under this
subsection and'' and inserting ``for the listed drug referred
to in clause (i)''; and
(5) by adding at the end the following:
``(o) Patent Information.--
``(1) Applicability.--This subsection applies to a holder
of an approved application under subsection (c) that files a
patent--
``(A) that claims, with regard to a drug of the
application, a drug or method of using a drug; and
``(B) for 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, after the date of approval of the
application.
``(2) Certification.--A holder of a patent described in
paragraph (1) shall--
``(A) inform the Secretary of the filing of the
patent; and
``(B) certify that the information is a complete
and accurate listing of all such patents.
``(3) Secretary.--The Secretary shall list the information
provided under paragraph (2) in accordance with subsection
(j)(7).''.
SEC. 8. 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 Act--
(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.
<all>