Drug Competition Act of 2003

Summary

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.

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Timeline

1. 29 April 2003

   Introduced

   Read twice and referred to the Committee on the Judiciary.

   Source: IntroReferral

2. 29 April 2003

   Introduced

   Sponsor introductory remarks on measure. (CR S5493-5494)

   Source: IntroReferral

3. 29 April 2003

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 29 April 2003 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 29 April 2003

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 29 April 2003

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 29 April 2003

  Open at official source

Sponsors

• Sen. Leahy, Patrick J. [D-VT] · D · Sponsor
• Chuck Grassley · R · Sponsor
• Richard Durbin · D · Sponsor
• Sen. Feingold, Russell D. [D-WI] · D · Sponsor
• Sen. Kohl, Herb [D-WI] · D · Sponsor
• Charles Schumer · D · Sponsor
• Maria Cantwell · D · Cosponsor
• · ssju00 · Standing

Related records

No cross-record relationships stored yet.