Drug Competition Act of 2003

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 108th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

D LeahySponsor

6 cosponsors · 5 D, 1 R

5 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

What it does: CRS summary · Introduced in Senate · Apr 29, 2003

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Drug Competition Act of 2003

Latest action (Apr 29, 2003): Read twice and referred to the Committee on the Judiciary.

Policy area: Commerce · Origin: Senate · Introduced: Apr 29, 2003

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.