PhRMA Act of 2005

Summary

Pharmaceutical Research and Manufacturers Accountability Act of 2005 or the PhRMA Act of 2005 - Sets forth penalties for violations of acts prohibited under the Federal Food, Drug, and Cosmetic Act by an individual employed as the chief executive officer or as a member of the senior executive management group of the manufacturer of a drug, where the violation involves knowing concealment of evidence of a serious adverse drug experience. Requires the Secretary of Health and Human Services to require the chief executive officer of the manufacturer of a Food and Drug Administration (FDA)-approved drug to annually: (1) attest that the manufacturer has disclosed to the Secretary all evidence of any serious adverse drug experience related to the drug; and (2) describe the process by which the manufacturer ensures that such disclosure has occurred. Allows the Secretary to withdraw an approval for such a drug for failure to provide such an attestation. Prohibits a chief executive officer of a manufacturer of such a drug from failing to provide such an attestation. Requires the Secretary to direct a manufacturer or sponsor of a drug to complete any required postmarketing study of that drug by a specified deadline. Allows the Secretary to extend such a deadline. Sets forth penalties for failing to meet such a deadline.

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Timeline

1. 16 February 2005

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 16 February 2005

   Introduced

   Sponsor introductory remarks on measure. (CR E252)

   Source: IntroReferral

3. 16 February 2005

   Introduced

   Introduced in House

   Source: IntroReferral

4. 16 February 2005

   Introduced

   Introduced in House

   Source: IntroReferral

5. 14 March 2005

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 16 February 2005 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 16 February 2005

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 16 February 2005

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 16 February 2005

  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

• Rep. Stark, Fortney Pete [D-CA-13] · D · Sponsor
• Rep. Berry, Marion [D-AR-1] · D · Sponsor
• Rep. Cummings, Elijah E. [D-MD-7] · D · Cosponsor
• Rep. Israel, Steve [D-NY-3] · D · Cosponsor
• Rep. McGovern, James P. [D-MA-2] · D · Cosponsor
• Rep. Woolsey, Lynn C. [D-CA-6] · D · Cosponsor
• Rep. Kucinich, Dennis J. [D-OH-10] · D · Cosponsor
• Rep. Kildee, Dale E. [D-MI-5] · D · Cosponsor
• Rep. McDermott, Jim [D-WA-7] · D · Cosponsor
• Rep. Owens, Major R. [D-NY-11] · D · Cosponsor
• Rep. Jackson Lee, Sheila [D-TX-18] · D · Cosponsor
• Sen. Sanders, Bernard [I-VT] · I · Cosponsor
• Rep. Hinchey, Maurice D. [D-NY-22] · D · Cosponsor
• Rep. Solis, Hilda L. [D-CA-32] · D · Cosponsor
• · hsif00 · Standing

Related records

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