11/16/2006

The Right Legislation Can Strengthen FDA’s Oversight Authority Without Slowing Approval of Lifesaving Medications

Washington, D.C.—Diane E. Thompson, vice president of the Elizabeth Glaser Pediatric AIDS Foundation, testified today at a Senate Health, Education, Labor, and Pension Committee hearing on the role of the Food and Drug Administration (FDA) in ensuring drug safety. Representing the Alliance for Drug Safety and Access (ADSA), a coalition of patient and provider advocacy groups, Thompson urged the Committee to continue the timely review and approval of new therapies while strengthening the oversight of drugs already on the market.

“We do not accept that any patient should have to choose between safety and speedy access to new medications,” said Thompson. “Patients want to know that someone is looking out for the safety of the products already in their medicine cabinet. The bill proposed by Senators Enzi and Kennedy would give the FDA the necessary oversight tools so that pulling a drug from the market is a last resort and not the only option.”

Thompson’s testimony highlighted ADSA’s support for many provisions in S. 3807, the bill introduced by Senators Kennedy and Enzi, but recommended the following in order to fully meet the needs of patients:

• Establish mechanisms for patient and provider input into the risk evaluation and management process;
• Adopt an Institute of Medicine (IOM) recommendation that the Office of Surveillance and Epidemiology be given a greater role in drug review and the development of safety plans;
• Clarify that the authority of the FDA to require studies of post-market safety concerns is not confined to on-label uses of the drug;
• Strengthen the clinical trials database by including Phase II trials, device clinical trials, and already-completed trials;
• Increase the civil money penalties and expand their application to the clinical trials database;
• Adopt the IOM’s recommendation that safety-related performance goals be added to the Prescription Drug User Fee Act; and
• Provide increased resources to the FDA to carry out these new and expanded safety activities through both user fees and appropriations.