WASHINGTON, DC – Today, Reps. Henry A. Waxman and Edward J. Markey, two senior members of the Energy and Commerce Committee, introduced the Fair Access to Clinical Trials (FACT) Act to ensure that patients, clinicians and the public have access to basic clinical trial information about drugs, biologics, and medical devices. Recent news stories have indicated that some pharmaceutical companies are not releasing clinical trial information that raises concerns about their drugs or devices. The lack of mandated full disclosure allows companies to paint a distorted picture of the safety and effectiveness of drugs and medical devices by selectively disclosing trial information.
 

“We cannot continue to allow companies to promote only the positive results of clinical studies and suppress the negative results,” Rep. Waxman said.  “This kind of system can seriously mislead physicians and pose safety hazards for patients.  The Fair Access to Clinical Trials Act creates a publicly accessible clinical trials database and requires that study sponsors use it.”

Rep. Markey said, “Drug companies should not be able to pick and choose which trials they want to disclose and which they want to hide from the public. The medical community deserves to have a complete picture of the safety and effectiveness of drugs and devices.”

The “Fair Access to Clinical Trials Act” would establish a mandatory federal clinical trials database.  This legislation 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;
• Provide for 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;
• Provide for public access to the results of clinical studies, including primary and secondary outcomes and significant adverse events; and
• Give the Secretary authority to impose penalties for noncompliance, including revoking a sponsor’s eligibility for further federal funding and imposing civil money penalties.

H.R. 3149, Bill Text (104.33 KB)
Link to New England Journal of Medicine Editorial on Clinical Trials, June 9, 2005