S. 2933 · 108th Congress
Fair Access to Clinical Trials Act of 2004
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 108th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
DoddSponsor3 cosponsors · 3 D
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Oct 7, 2004
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Fair Access to Clinical Trials Act of 2004
Also known as: FACT Act
Latest action (Oct 7, 2004): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Oct 7, 2004
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.