Clinical Trials Information Bill Introduced in the House of Representatives

June 30, 2005—Representatives Henry Waxman (D-CA) and Edward Markey (D-MA) reintroduced the “Fair Access to Clinical Trails Act” (HR 3196) in the House of Representatives. Intended to increase access regarding the safety and efficacy of prescription drugs and medical devises, the bill would expand on the NIH National Library of Medicine’s clinicaltrials.gov database and require online registration of both publicly and privately funded clinical trials. Online information about each trial’s hypotheses, sponsors, investigators, and results would be included. Penalties for non-compliance are included in the bill, which Rep. Waxman cited as important to insuring both positive and negative clinical trial data is readily available to all consumers. Additional information regarding clinical trial reporting is available at the NIH Clinical Trials Web site.