[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1530 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 1530
To ensure the timely availability of generic drugs through enhancement
of drug approval and antitrust laws enforced by the Food and Drug
Administration and the Federal Trade Commission regarding brand name
drugs and generic drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 4, 2001
Mr. Waxman (for himself, Mr. Berry, Mr. Stark, Mr. Brown of Ohio, and
Mr. Deutsch) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
the Judiciary, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To ensure the timely availability of generic drugs through enhancement
of drug approval and antitrust laws enforced by the Food and Drug
Administration and the Federal Trade Commission regarding brand name
drugs and generic drugs.
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 ``Prescription Drug Competition Act of
2001''.
SEC. 2. FINDINGS.
Congress finds that--
(1) prescription drug costs are increasing at an alarming
rate and are a major concern of senior citizens and American
families;
(2) there is a potential for drug companies owning patents
on brand-name drugs to enter to private financial deals with
generic drug companies in a manner that could tend to restrain
trade and greatly reduce competition and increase prescription
drug costs for American citizens; and
(3) enhancing competition between generic drug
manufacturers and brand name manufacturers can significantly
reduce prescription drug costs to American families.
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide timely notice to the Food and Drug
Administration and the Federal Trade Commission regarding
agreements between companies owning patents on branded drugs
and companies who could manufacture generic or bioequivalent
versions of such branded drugs; and
(2) by providing timely notice, to--
(A) ensure the prompt availability of safe and
effective generic drugs;
(B) enhance the effectiveness and efficiency of the
enforcement of the antitrust laws of the United States;
and
(C) deter pharmaceutical companies from engaging in
anticompetitive actions or actions that tend to
unfairly restrain trade.
SEC. 4. DEFINITIONS.
In this Act:
(1) Agreement.--The term ``agreement'' means an agreement
under section 1 of the Sherman Act (15 U.S.C. 1) or section 5
of the Federal Trade Commission Act (15 U.S.C. 45).
(2) Antitrust laws.--The term ``antitrust laws'' has the
same meaning as in section 1 of the Clayton Act (15 U.S.C. 12),
except that such term includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent that such section
applies to unfair methods of competition.
(3) ANDA.--The term ``ANDA'' means an Abbreviated New Drug
Application, as defined under section 505(j) of the Federal
Food, Drug and Cosmetic Act.
(4) Brand name drug company.--The term ``brand name drug
company'' means a person engaged in the manufacture or
marketing of a drug approved under section 505(b) of the
Federal Food, Drug and Cosmetic Act.
(5) Commission.--The term ``Commission'' means the Federal
Trade Commission.
(6) FDA.--The term ``FDA'' means the United States Food and
Drug Administration.
(7) Generic drug.--The term ``generic drug'' means a
product that is the subject of an ANDA.
(8) Generic drug applicant.--The term ``generic drug
applicant'' means a person who has filed or received approval
for an ANDA under section 505(j) of the Federal Food, Drug and
Cosmetic Act.
(9) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 5. NOTIFICATION OF AGREEMENTS AFFECTING THE SALE OR MARKETING OF
GENERIC DRUGS.
A brand name drug company and a generic drug applicant that enter
into an agreement regarding the sale or manufacture of a generic drug
that the Secretary has determined is the therapeutic equivalent of a
brand name drug that is manufactured or marketed by that brand name
drug company, or for which the generic drug applicant seeks such a
determination of therapeutic equivalence, and which agreement could
have the effect of limiting the research, development, manufacture,
marketing, or selling of a generic drug that has been or could be
approved for sale by the FDA pursuant to an ANDA, shall file with the
Commission and the Secretary the text of the agreement, an explanation
of the purpose and scope of the agreement, and an explanation of
whether the agreement could delay, restrain, limit, or in any way
interfere with the production, manufacture, or sale of the generic
version of the drug in question.
SEC. 6. FILING DEADLINES.
Any notice, agreement, or other material required to be filed under
section 5 shall be filed with the Commission and the Secretary not
later than 10 business days after the date the agreement is executed.
SEC. 7. ENFORCEMENT.
(a) Civil Fine.--Any person, or any officer, director, or partner
thereof, who fails to comply with any provision of this Act shall be
liable for a civil penalty of not more than $20,000 for each day during
which such person is in violation of this Act. Such penalty may be
recovered in a civil action brought by the United States, or brought by
the Commission in accordance with the procedures established in section
16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
(b) Compliance and Equitable Relief.--If any person, or any
officer, director, partner, agent, or employee thereof, fails to comply
with the notification requirement under section 5 of this Act, the
United States district court may order compliance, and may grant such
other equitable relief as the court in its discretion determines
necessary or appropriate, upon application of the Commission or the
Assistant Attorney General.
SEC. 8. RULEMAKING.
The Commission, in consultation with the Secretary, and with the
concurrence of the Assistant Attorney General and by rule in accordance
with section 553 of title 5, United States Code, consistent with the
purposes of this Act--
(1) may require that the notice described in section 5 of
this Act be in such form and contain such documentary material
and information relevant to the agreement as is necessary and
appropriate to enable the Commission and the Assistant Attorney
General to determine whether such agreement may violate the
antitrust laws;
(2) may define the terms used in this Act;
(3) may exempt classes of persons or agreements from the
requirements of this Act; and
(4) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this Act.
SEC. 9. EFFECTIVE DATES.
This Act shall take effect 90 days after the date of enactment of
this Act.
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