House Members Introduce Bill To Establish Mandatory Online Clinical Trial Database
Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have announced the introduction of a bill (HR 3196) that would establish a mandatory federal clinical trials database, CQ HealthBeat reports. The Fair Access to Clinical Trials Act seeks to provide patients, clinicians and the public with access to information on the safety and efficacy of prescription drugs and medical devices.
Under the legislation, sponsors of privately and publicly funded trials would have to register results on an online database that would expand on ClinicalTrials.gov, a Web site administered by the National Library of Medicine at NIH. In addition to trial results, the online database would include preliminary information, such as hypotheses, sponsors and investigators.
The bill would provide the HHS secretary with the authority to penalize those who do not comply.
"We cannot continue to allow companies to promote only the positive results of clinical studies and suppress the negative results," Waxman said.
A Pharmaceutical Research and Manufacturers of America spokesperson said that members plan to post information online voluntarily on the safety and efficacy of prescription drugs by October. "There is a sense that more information is always better, but, when you're talking about trailer-truckloads of information, that's not always the case," the PhRMA spokesperson said.
However, Waxman said, "A voluntary program from the drug industry that is unenforceable and full of loopholes doesn't move us forward." He added, "We already know many companies ignore the current law. That is why Congress needs to pass legislation to create a mandatory registry" (CQ HealthBeat, 7/1).