Senate Bills - 109th Congress

S. 470—The Fair Access to Clinical Trials (FACT) Act

On February 28, 2005, Senator Christopher Dodd (D-CT) introduced S. 470, the Fair Access to Clinical Trials (FACT) Act. The measure would require the FDA to expand the clinicaltrials.gov database to create a publicly accessible national data bank of information comprised of a clinical trial registry and a clinical trial results database. The database would include a clinical trial registry accessible to patients and health care practitioners seeking information related to ongoing clinical trials for serious or life-threatening diseases and conditions. Also required would be a database of all publicly and privately funded clinical trial results, regardless of outcome, which would be accessible to the scientific community, health care practitioners, and members of the public. S. 470 would further require the FDA to make internal drug approval and safety reviews publicly available. The clinicaltrials.gov website would continue to be run by the NLM with assistance from the FDA. Provisions of the FACT Act would apply to clinical trials for drugs, biologics, and medical devices, and would require all trials to be registered in the database in order to obtain approval from a U.S. Institutional Review Board. S. 470 was cosponsored by Senators Charles Grassley (R-IA), Chairman, Senate Finance Committee, Ron Wyden (D-OR), and Tim Johnson (D-SD). The bill was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP).

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