[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 946 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 946
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 SENATE OF THE UNITED STATES
April 29, 2003
Mr. Leahy (for himself, Mr. Grassley, Mr. Durbin, Mr. Feingold, Mr.
Kohl, and Mr. Schumer) introduced the following bill; which was
read twice and referred to the Committee on the JudiciaryYYYYYY
_______________________________________________________________________
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 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 ``Drug Competition Act of 2003''.
SEC. 2. FINDINGS.
Congress finds that--
(1) prescription drug prices are increasing at an alarming
rate and are a major worry of many senior citizens and American
families;
(2) there is a potential for companies with patent rights
regarding brand name drugs and companies which could
manufacture generic versions of such drugs to enter into
financial deals that could tend to restrain trade and greatly
reduce competition and increase prescription drug expenditures
for American citizens; and
(3) enhancing competition among these companies can
significantly reduce prescription drug expenditures for
Americans.
SEC. 3. PURPOSES.
The purposes of this Act are--
(1) to provide timely notice to the Department of Justice
and the Federal Trade Commission regarding agreements between
companies with patent rights regarding brand name drugs and
companies which could manufacture generic versions of such
drugs; and
(2) by providing timely notice, to enhance the
effectiveness and efficiency of the enforcement of the
antitrust and competition laws of the United States.
SEC. 4. DEFINITIONS.
In this Act:
(1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug
Application, as defined under section 201(aa) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
(2) Assistant attorney general.--The term ``Assistant
Attorney General'' means the Assistant Attorney General in
charge of the Antitrust Division of the Department of Justice.
(3) Brand name drug.--The term ``brand name drug'' means a
drug approved under section 505(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(c)).
(4) Brand name drug company.--The term ``brand name drug
company'' means the party that received Food and Drug
Administration approval to market a brand name drug pursuant to
an NDA, where that drug is the subject of an ANDA, or a party
owning or controlling enforcement of any patent listed in the
Approved Drug Products With Therapeutic Equivalence Evaluations
of the Food and Drug Administration for that drug, 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) Generic drug.--The term ``generic drug'' means a
product that the Food and Drug Administration has approved
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)).
(7) 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 (21 U.S.C. 355(j)).
(8) NDA.--The term ``NDA'' means a New Drug Application, as
defined under section 505(b) et seq. of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b) et seq.)
SEC. 5. NOTIFICATION OF AGREEMENTS.
(a) In General.--
(1) Requirement.--A generic drug applicant that has
submitted an ANDA containing a certification under section
505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug company
that enter into an agreement described in paragraph (2), prior
to the generic drug that is the subject of the application
entering the market, shall each file the agreement as required by
subsection (b).
(2) Definition.--An agreement described in this paragraph
is an agreement regarding--
(A) the manufacture, marketing or sale of the brand
name drug that is the subject of the generic drug
applicant's ANDA;
(B) the manufacture, marketing or sale of the
generic drug that is the subject of the generic drug
applicant's ANDA; or
(C) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) as it applies
to such ANDA or to any other ANDA based on the same
brand name drug.
(b) Filing.--
(1) Agreement.--The generic drug applicant and the brand
name drug company entering into an agreement described in
subsection (a)(2) shall file with the Assistant Attorney
General and the Commission the text of any such agreement,
except that the generic drug applicant and the brand-name drug
company shall not be required to file an agreement that solely
concerns--
(A) purchase orders for raw material supplies;
(B) equipment and facility contracts;
(C) employment or consulting contracts; or
(D) packaging and labeling contracts.
(2) Other agreements.--The generic drug applicant and the
brand name drug company entering into an agreement described in
subsection (a)(2) shall file with the Assistant Attorney
General and the Commission the text of any other agreements not
described in subsection (a)(2) between the generic drug
applicant and the brand name drug company which are contingent
upon, provide a contingent condition for, or are otherwise
related to an agreement which must be filed under this Act.
(3) Description.--In the event that any agreement required
to be filed by paragraph (1) or (2) has not been reduced to
text, both the generic drug applicant and the brand name drug
company shall file written descriptions of the non-textual
agreement or agreements that must be filed sufficient to reveal
all of the terms of the agreement or agreements.
SEC. 6. FILING DEADLINES.
Any filing required under section 5 shall be filed with the
Assistant Attorney General and the Commission not later than 10
business days after the date the agreements are executed.
SEC. 7. DISCLOSURE EXEMPTION.
Any information or documentary material filed with the Assistant
Attorney General or the Commission pursuant to this Act shall be exempt
from disclosure under section 552 of title 5, and no such information
or documentary material may be made public, except as may be relevant
to any administrative or judicial action or proceeding. Nothing in this
section is intended to prevent disclosure to either body of Congress or
to any duly authorized committee or subcommittee of the Congress.
SEC. 8. ENFORCEMENT.
(a) Civil Penalty.--Any brand name drug company or generic drug
applicant which fails to comply with any provision of this Act shall be
liable for a civil penalty of not more than $11,000, for each day
during which such entity 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 brand name drug
company or generic drug applicant fails to comply with any provision 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 Assistant
Attorney General or the Commission.
SEC. 9. RULEMAKING.
The Commission, 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 define the terms used in this Act;
(2) may exempt classes of persons or agreements from the
requirements of this Act; and
(3) may prescribe such other rules as may be necessary and
appropriate to carry out the purposes of this Act.
SEC. 10. SAVINGS CLAUSE.
Any action taken by the Assistant Attorney General or the
Commission, or any failure of the Assistant Attorney General or the
Commission to take action, under this Act shall not bar any proceeding
or any action with respect to any agreement between a brand name drug
company and a generic drug applicant at any time under any other
provision of law, nor shall any filing under this Act constitute or
create a presumption of any violation of any antitrust or competition
laws.
SEC. 11. EFFECTIVE DATE.
This Act shall--
(1) take effect 30 days after the date of enactment of this
Act; and
(2) shall apply to agreements described in section 5 that
are entered into 30 days after the date of enactment of this
Act.
<all>