S 754
107th 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
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Independent regulatory commissions
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Research and development
Drug Competition Act of 2002
Introduced: April 6, 2001
See on congress.gov
Everywhere this bill has been
14 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 22, 2002
Referred to the Subcommittee on Health.
Nov 19, 2002
Message on Senate action sent to the House.
Nov 19, 2002
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Nov 19, 2002
Received in the House.
Nov 18, 2002
The committee substitute as amended agreed to by Unanimous Consent.
Nov 18, 2002
Passed Senate with an amendment by Unanimous Consent. (text: CR S11341-11342)
Nov 18, 2002
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text: CR S11341-11342)
Nov 18, 2002
Measure laid before Senate by unanimous consent. (consideration: CR S11339-11342; text of measure as reported in Senate: CR S11339-11340)
Jun 20, 2002
Placed on Senate Legislative Calendar under General Orders. Calendar No. 431.
Jun 20, 2002
Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. With written report No. 107-167.
Oct 18, 2001
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Apr 6, 2001
Introduced in Senate
Apr 6, 2001
Read twice and referred to the Committee on the Judiciary.
Apr 6, 2001
Sponsor introductory remarks on measure. (CR S3760-3761)
Plain-English summary
Drug Competition Act of 2001 - Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA), and a brand name drug company, that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding 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, to each 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 the U.S. district court to order compliance and grant equitable relief, including rendering an agreement unenforceable for the period during which it was not filed as required.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
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