I
106TH CONGRESS
2D SESSION
H. R. 5313
To enhance competition for prescription drugs by increasing the ability of
the Department of Justice and Federal Trade Commission to enforce
existing antitrust laws regarding brand name drugs and generic drugs.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 27, 2000
Mr. ANDREWS introduced the following bill; which was referred to the Com-
mittee 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 enhance competition for prescription drugs by increasing
the ability of the Department of Justice and Federal
Trade Commission to enforce existing antitrust laws re-
garding 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 ‘‘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 worry of senior citi-
zens and American families;
(2) there is a potential for drug companies own-
ing patents on brand-name drugs to enter in 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 Department
of Justice and the Federal Trade Commission re-
garding agreements between companies owning pat-
ents on brand name drugs and companies who could
manufacture generic or bioequivalent versions of
such brand name drugs; and
(2) by providing timely notice, to—
(A) enhance the effectiveness and effi-
ciency of the enforcement of the antitrust laws
of the United States; and
(B) 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 (21 U.S.C 355(j)).
(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 (21 U.S.C. 355(b)).
(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’’
is a product that the Food and Drug Administration
has approved under section 505(j) of the Federal
Food, Drug and Cosmetic Act (221 U.S.C. 355(j)).
(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 (21 U.S.C. 355(j)).
(9) NDA.—The term ‘‘NDA’’ means a New
Drug Application, as defined under section 505(b) of
the Federal Food, Drug and Cosmetic Act (21
U.S.C. 355(b))
SEC. 5. NOTIFICATION OF AGREEMENTS AFFECTING THE
SALE OR MARKETING OF GENERIC DRUGS.
A brand name drug manufacturer and a generic drug
manufacturer that enter into an agreement—
(1) regarding the sale or manufacture of a ge-
neric drug equivalent of a brand name drug that is
manufactured by that brand name manufacturer.
and
(2) which agreement could have the effect of
limiting the research, development, manufacture,
marketing or selling of a generic drug product that
could be approved for sale by the FDA pursuant to
an ANDA,
shall both file with the Commission and the Attorney Gen-
eral a notice that such an agreement has been entered
into, the text of the agreement, an explanation of the pur-
pose 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 Attorney
General and the Commission 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-