I
106TH CONGRESS
2D SESSION
H. R. 5235
To ensure the timely availability of generic drugs through enhancement of
drug approval and antitrust laws enforced by the Food and Drug Admin-
istration and the Federal Trade Commission regarding brand name drugs
and generic drugs.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 20, 2000
Mr. WAXMAN (for himself, Mr. STARK, Mr. BROWN of Ohio, Mr. BERRY, Mr.
COBURN, and Mr. DEUTSCH) introduced the following bill; which was re-
ferred to the Committee on 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 en-
forced 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 Representa-
tives 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 2000’’.
SEC. 2. FINDINGS.
Congress finds that—
(1) prescription drug costs are increasing at an
alarming rate and are a major concern of senior citi-
zens and American families;
(2) there is a potential for drug companies own-
ing 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 Amer-
ican 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 Com-
mission 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 effi-
ciency 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 Ab-
breviated New Drug Application, as defined under
section 505(j) of the Federal Food, Drug and Cos-
metic Act.
(4) BRAND NAME DRUG COMPANY.—The term
‘‘brand name drug company’’ means a person en-
gaged 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 sec-
tion 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 ap-
plicant 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 appli-
cant seeks such a determination of therapeutic equiva-
lence, and which agreement could have the effect of lim-
iting the research, development, manufacture, marketing,
or selling of a generic drug that has been or could be ap-
proved 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 inter-
fere with the production, manufacture, or sale of the ge-
neric 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, direc-
tor, or partner thereof, who fails to comply with any provi-
sion 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 es-
tablished in section 16(a)(1) of the Federal Trade Com-
mission Act (15 U.S.C. 56(a)).
(b) COMPLIANCE AND EQUITABLE RELIEF.—If any
person, or any officer, director, partner, agent, or em-
ployee thereof, fails to comply with the notification re-
quirement 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 deter-
mines 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 Gen-
eral 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 sec-
tion 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 en-
able 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 agree-
ments 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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