House Bills - 109th Congress

H.R. 3196—The Fair Access to Clinical Trials Act (FACT)

On June 30, 2005, Representative Henry Waxman (D-CA) introduced H.R. 3196, the Fair Access to Clinical Trials Act (FACT). The measure would require sponsors of privately and publicly funded studies of drugs, biologics, or medical devices to register using a database that builds on the National Library of Medicine’s www.clinicaltrials.gov. It would provide public access to basic information on studies before they begin, such as the disease or condition with which the trial is concerned, the hypothesis being tested, the sponsor and principal investigator, and the sources of funding. Public access to the results of clinical studies, including primary and secondary outcomes and significant adverse events, would also be permitted under the legislation. H.R. 3196 also would authorize the Secretary of HHS to impose penalties for noncompliance, including revoking a sponsor’s eligibility for further Federal funding and imposing civil money penalties. The bill was referred to the House Committee on Energy and Commerce.

Legislative Update (December 2006): Access to Clinical Trial Information