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Greater Access to Affordable Pharmaceuticals Act

Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.

Official summary

Version 00 · Introduced in Senate · Jun 10, 2003

Greater Access to Affordable Pharmaceuticals Act - Amends the Federal Food, Drug, and Cosmetic Act to: (1) limit a brand name drug manufacturer to one Food and Drug Administration (FDA) 30-month stay of competition in a patent infringement suit against a generic drug applicant; (2) permit a generic applicant being sued to file a counterclaim to correct or delete patent information; (3) limit damages that a brand name manufacturer may recover in an instance where such manufacturer failed to file certain patent information; (4) permit a generic drug applicant to seek declaratory judgment regarding patent infringement prior to marketing a drug; (5) forfeit the180-day market exclusivity period for a first generic drug applicant to a subsequent generic applicant if the first applicant engages in certain activities which impede such drug's timely marketing; and (6) permit alternative means to determine bioequivalence for drugs that are not absorbed into the bloodstream.

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Who introduced it

Sen. Gregg, Judd [R-NH] · R–NH

Committees

  • Health, Education, Labor, and Pensions Committee
4 cosponsorship records, including any withdrawals

Actions

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  1. Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  3. Introduced in Senate

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

Source last updated: Aug 18, 2025. Consult Congress.gov for the current record.

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