GAAP Act of 2000

Summary

Greater Access to Affordable Pharmaceuticals Act or GAAP Act of 2000 - Amends the Federal Food, Drug, and Cosmetic Act to include in a required abbreviated new drug application information concerning certification of each patent which claims any active ingredient for a listed drug (currently, only the listed drug itself), either alone or in combination with other active ingredients, or which claims the first approved use for such drug for which an applicant is seeking approval. States that the filing of a citizen petition review shall not cause the Secretary of Health and Human Services to delay review and approval of an abbreviated new drug application unless the petition demonstrates through substantial scientific proof that approval would pose a threat to public health and safety. Allows a drug to be considered a bioequivalent to a listed drug if the effects of such drug and the listed drug do not show a significant difference based on certain tests or studies. Provides for an accelerated date of approval of a generic drug application. Expresses the sense of Congress that measures should be taken to effectuate the purpose of the Drug Price Competition and Patent Term Restoration Act of 1984 to make generic drugs more available and accessible, thereby reducing health care costs.

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Timeline

1. 14 September 2000

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S8590)

   Source: IntroReferral

2. 14 September 2000

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 14 September 2000 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 14 September 2000

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 14 September 2000

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in Senate

  summary · EN · 14 September 2000

  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. Schumer, Charles E. [D-NY] · D · Sponsor
• Sen. McCain, John [R-AZ] · R · Sponsor
• Sen. Johnson, Tim [D-SD] · D · Sponsor
• · sshr00 · Standing

Related records

• related to → GAAP Act of 2000