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Health - Clinical Trials Fair Access to Clinical Trials Act Based on concerns about reports indicating that pharmaceutical companies often refuse to release information from clinical trials of their drugs and devices, Reps. Waxman and Markey (D-MA) introduced the Fair Access to Clinical Trials (FACT) Act (H.R. 3196). Without mandated full disclosure of clinical trial information, companies are free to selectively publish clinical trial data and paint a distorted picture of the safety and effectiveness of drugs and medical devices. The FACT Act would fix this very serious problem. By establishing a mandatory federal clinical trials database, the FACT Act will ensure that patients, clinicians, and the public have access to basic clinical trial information about drugs, biologics, and medical devices. This legislation would mandate public access to basic information on studies, including the disease or condition with which the trial is concerned, the hypothesis being tested, the sponsor and principal investigator, and the sources of funding. The FACT Act would also authorize the Secretary of HHS to impose penalties for a company’s noncompliance, including revoking a sponsor’s eligibility for further federal funding and imposing civil money penalties. |
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