(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-
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, for the district in which such person officer,
director, partner, agent, or employee thereof resides or
does business, may order compliance and grant such other
equitable relief as the court in its discretion determines
necessary or appropriate, upon application of the Commis-
sion or the Assistant Attorney General.
SEC. 8. RULEMAKING.
The Commission, with the concurrence of the Assist-
ant Attorney General and by rule in accordance with sec-
tion 553 of title 5, United States Code, consistent with
the purposes of this Act—
(1) may require that the notice of an agreement
described in section 5 of this Act be in such form
and contain such documentary material and infor-
mation 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 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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