S. 946 (108th): Drug Competition Act of 2003

Introduced:
Apr 29, 2003 (108th Congress, 2003–2004)
Sponsor:
Sen. Patrick Leahy [D-VT]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on April 29, 2003, in a previous session of Congress, but was not enacted.

Progress
Introduced Apr 29, 2003
Referred to Committee Apr 29, 2003
Cosponsors
6 cosponsors (5D, 1R) (show)
Committees

Senate Judiciary

The committee chair determines whether a bill will move past the committee stage.

Full Title

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.

Summary

No summaries available.

Text

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Last updated Apr 29, 2003.
9 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

4/29/2003--Introduced.
Drug Competition Act of 2003 - Sets filing requirements for a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, before a drug enters the market, regarding:
(1) the manufacture, marketing, or sale of the brand name or the generic drug; or
(2) the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug.
Requires each such party to file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts.
Requires such agreements to be filed not later than ten business days after the date they are executed.
Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.
Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.

House Republican Conference Summary

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House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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