PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 01 · Reported to Senate with amendment(s) · Jun 20, 2002
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.
People & committees
Sen. Leahy, Patrick J. [D-VT] · D–VT
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
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.
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.
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.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (text: CR S11341-11342)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text: CR S11341-11342)
The committee substitute as amended agreed to by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S11339-11342; text of measure as reported in Senate: CR S11339-11340)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 431.
Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. With written report No. 107-167.
Committee on the Judiciary. Reported by Senator Leahy with an amendment in the nature of a substitute. With written report No. 107-167.
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on the Judiciary.
Sponsor introductory remarks on measure. (CR S3760-3761)
Introduced in Senate
Primary sources
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No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 10, 2026. Consult Congress.gov for the current record.
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