S. 2933 (108th): FACT Act

Oct 07, 2004 (108th Congress, 2003–2004)
Died (Referred to Committee)
Christopher Dodd
Senator from Connecticut
Read Text »
Last Updated
Oct 07, 2004
41 pages
Related Bills
S. 470 (109th) was a re-introduction of this bill in a later Congress.

Referred to Committee
Last Action: Feb 28, 2005


This bill was introduced on October 7, 2004, in a previous session of Congress, but was not enacted.

Introduced Oct 07, 2004
Referred to Committee Oct 07, 2004
Full Title

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


No summaries available.

3 cosponsors (3D) (show)

Senate Health, Education, Labor, and Pensions

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Primary Source

THOMAS.gov (The Library of Congress)

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S. stands for Senate bill.

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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.

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.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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