Greater Access to Affordable Pharmaceuticals Act

Summary

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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Timeline

1. 10 June 2003

   Introduced

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

   Source: IntroReferral

2. 10 June 2003

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 11 June 2003

   Reported

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

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 10 June 2003 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 June 2003

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 June 2003

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 10 June 2003

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Gregg, Judd [R-NH] · R · Sponsor
• Sen. Schumer, Charles E. [D-NY] · D · Sponsor
• Sen. McCain, John [R-AZ] · R · Sponsor
• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. Miller, Zell [D-GA] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to → Greater Access to Affordable Pharmaceuticals Act