FACT Act

Summary

Fair Access to Clinical Trials Act of 2005 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 information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trials results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device. Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug applications; and (2) copies of written consultations on a drug's safety conducted by the Office of Drug Safety. Requires the Secretary to assess civil monetary penalties for failure to comply with the reporting requirements of this Act. Allows the Secretary to correct any information included in the registry or database 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. 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. 26 January 2005

   Introduced

   Sponsor introductory remarks on measure. (CR S538-539)

   Source: IntroReferral

2. 28 February 2005

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1798-1803)

   Source: IntroReferral

3. 28 February 2005

   Introduced

   Sponsor introductory remarks on measure. (CR S1797-1798)

   Source: IntroReferral

4. 28 February 2005

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 28 February 2005 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 28 February 2005

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 28 February 2005

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 28 February 2005

  Open at official source

Sponsors

• Rep. Dodd, Christopher J. [D-CT-2] · D · Sponsor
• Chuck Grassley · R · Sponsor
• Rep. Johnson, Tim [D-SD-At Large] · D · Sponsor
• Ron Wyden · D · Sponsor
• Sen. Chafee, Lincoln [R-RI] · R · Cosponsor
• Richard Durbin · D · Cosponsor
• Rep. Harkin, Tom [D-IA-5] · D · Cosponsor
• Rep. DeWine, Mike [R-OH-7] · R · Cosponsor
• · sshr00 · Standing

Related records

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