S. 470 (109th): FACT Act

Introduced:
Feb 28, 2005 (109th Congress, 2005–2006)
Sponsor:
Sen. Christopher Dodd [D-CT]
Status:
Died (Referred to Committee)
See Instead:
This bill was re-introduced as S. 467 (110th) on Jan 31, 2007.

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on February 28, 2005, in a previous session of Congress, but was not enacted.

Progress
Introduced Jan 26, 2005
Referred to Committee Feb 28, 2005
Cosponsors
7 cosponsors (4D, 3R) (show)
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Full Title

A bill to amend the Public Health Service Act to expand the clinical trials drug data bank.

Summary

No summaries available.

Text

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Last updated Feb 28, 2005.
47 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

2/28/2005--Introduced.
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.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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