Greater Access to Affordable Pharmaceuticals Act of 2003

Summary

Greater Access to Affordable Pharmaceuticals Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability. Requires applicants (pharmaceutical companies) to register their patents with the Food and Drug Administration (FDA) within 30 days of approval (or issuance for subsequently issued patents). Makes failure to timely register a bar to civil actions for patent infringement. Requires applications for new drugs (NDA) or abbreviated new drug applications (ANDA) which rely upon investigations not conducted by or for the applicant and which concern a patent that claims both the drug and a method of use or more than one method of use to include a certification on a claim-by-claim basis that the patent is invalid or will not be infringed (known as a Paragraph IV filing/certification) by the new drug's (generic) manufacture and a statement regarding the method(s) of use claim. Prohibits (for subsequently issued patents) an extension of the 30 month stay of FDA approval for any new drug where an ANDA or NDA contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer. Makes failure to timely file a civil action for infringement a bar to later action. Requires the first generic applicant with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors (forfeiture events) which delay or prevent the marketing of the generic drug. Revises notice requirements for Paragraph IV filings to include and protect certain proposed formulation, composition, or method of use information. Excludes an applicants's ability to pay damages from a court's consideration of whether or not to provide injunctive relief before the expiration of the 30 month stay of approval period.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 7 January 2003

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S55-58)

   Source: IntroReferral

2. 7 January 2003

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 7 January 2003 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 7 January 2003

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 7 January 2003

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in Senate

  summary · EN · 7 January 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. Schumer, Charles E. [D-NY] · D · Sponsor
• Sen. McCain, John [R-AZ] · R · Sponsor
• Sen. Edwards, John [D-NC] · D · Sponsor
• Sen. Collins, Susan M. [R-ME] · R · Sponsor
• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. Miller, Zell [D-GA] · D · Sponsor
• Sen. Johnson, Tim [D-SD] · D · Sponsor
• Sen. Clinton, Hillary Rodham [D-NY] · D · Sponsor
• Sen. Kohl, Herb [D-WI] · D · Sponsor
• Sen. Feingold, Russell D. [D-WI] · D · Sponsor
• Sen. Stabenow, Debbie [D-MI] · D · Sponsor
• Sen. Daschle, Thomas A. [D-SD] · D · Sponsor
• Sen. Nelson, Bill [D-FL] · D · Sponsor
• Sen. Rockefeller, John D., IV [D-WV] · D · Sponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Sponsor
• Sen. Reed, Jack [D-RI] · D · Sponsor
• Sen. Pryor, Mark L. [D-AR] · D · Sponsor
• Sen. Durbin, Richard J. [D-IL] · D · Sponsor
• Sen. Dorgan, Byron L. [D-ND] · D · Sponsor
• Sen. Landrieu, Mary L. [D-LA] · D · Cosponsor
• Sen. Bingaman, Jeff [D-NM] · D · Cosponsor
• Sen. Dayton, Mark [D-MN] · D · Cosponsor
• · sshr00 · Standing

Related records

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