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Fair Access to Clinical Trials Act

Introduced: October 7, 2004 Introduced by: Markey, Edward J. Democratic · Massachusetts See on congress.gov
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 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 11, 2004
Sponsor introductory remarks on measure. (CR E1882-1883)
Oct 8, 2004
Referred to the Subcommittee on Health.
Oct 7, 2004
Referred to the House Committee on Energy and Commerce.
Oct 7, 2004
Introduced in House
 Plain-English summary Congressional Research Service

Fair Access to Clinical Trials Act - Amends the Public Health Service Act to prohibit an entity from receiving an award of a grant, contract, or cooperative agreement to conduct a clinical trial to determine the safety or effectiveness of a use of a drug or device unless the entity agrees to: (1) register the trial; (2) provide the results of such trial to the Secretary of Health and Human Services; (3) disclose specified information regarding the trial to the public; and (4) be subject to audits.

Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and operate a databank of such clinical trial information provided to the Secretary. Requires the Director to assign to the National Library of Medicine the primary responsibility for operating such databank.

Requires the Secretary to: (1) identify false or misleading information in the databank, correct such information, and make appropriate public notifications; and (2) amend regulations to require institutional review boards to determine the safety or effectiveness of products registered under this Act and deny approval for trials that are not registered.

Specifies information required for registration of clinical trials, including information important to clinicians or researchers.

Sets forth provisions regarding periodic updates of databank information, submission of results of clinical trials, public disclosure of databank information, and violations of this Act.

Amends the Federal Food, Drug and Cosmetic Act to allow exemptions for clinical investigational use of drugs or devices only if such drugs are registered in accordance with this Act.

What's happening now October 11, 2004

Sponsor introductory remarks on measure. (CR E1882-1883)

 Committees of jurisdiction 2
 Cosponsors 1
All 1 Democratic 1