FACT Act

Summary

Fair Access to Clinical Trials Act of 2004 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of registry information on clinical trials for drugs, biological products, and devices. Requires the principal investigator or a responsible person to submit clinical trial information to the Secretary. Requires the Secretary to: (1) seek a memorandum of understanding with the heads of other Federal agencies to include in the registry clinical trials sponsored by such agencies; and (2) establish procedures to allow voluntary submission of clinical trial information not involving drugs, biological products, or devices. Allows the Secretary to: (1) require that information from such other clinical trials be submitted to the registry in cases in which it is in the interest of public health; and (2) correct any information included in the registry that is factually and substantively inaccurate, false, or misleading. Extends requirements of this Act to clinical trials conducted outside of the United States under certain circumstances. Requires the responsible person for proposals submitted to the Secretary requesting financial assistance to conduct research to submit registry information to the Secretary. Prohibits a responsible person or a manufacturer from performing any act that prohibits, limits, or imposes unreasonable delays on the ability of an individual to discuss or publish the results of a clinical trial. Requires the Secretary to enter into a contract with the Institute of Medicine to study the extent to which data submitted to the registry has impacted the public health.

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Timeline

1. 7 October 2004

   Introduced

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

   Source: IntroReferral

2. 7 October 2004

   Introduced

   Sponsor introductory remarks on measure. (CR S10728-10730)

   Source: IntroReferral

3. 7 October 2004

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 7 October 2004 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 7 October 2004

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 7 October 2004

  ViewDownloadOpen at official source

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  Vertaal document

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• Introduced in Senate

  summary · EN · 7 October 2004

  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. Dodd, Christopher J. [D-CT] · D · Sponsor
• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. Johnson, Tim [D-SD] · D · Sponsor
• Sen. Wyden, Ron [D-OR] · D · Sponsor
• · sshr00 · Standing

Related records

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