S 946
108th Congress
Senate
Commerce
Administrative procedure
Antitrust law
Civil Rights and Liberties, Minority Issues
Civil actions and liability
Drug approvals
Drug industry
Federal Trade Commission
Fines (Penalties)
Freedom of information
Generic drugs
Government Operations and Politics
Government paperwork
Health
Independent regulatory commissions
Injunctions
Law
Marketing
Pharmaceutical research
Research and development
Drug Competition Act of 2003
Introduced: April 29, 2003
See on congress.gov
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 29, 2003
Read twice and referred to the Committee on the Judiciary.
Apr 29, 2003
Sponsor introductory remarks on measure. (CR S5493-5494)
Apr 29, 2003
Introduced in Senate
Plain-English 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.
What's happening now
Read twice and referred to the Committee on the Judiciary.
Committees of jurisdiction
1