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DeLauro Calls on FDA Head to Reconsider Position on Drug Safety

Date: April 24, 2006
Location: Washington, DC
Issues: Drugs


DeLauro Calls on FDA Head to Reconsider Position on Drug Safety

- GAO report echoes concerns raised by ranking member, discounted by agency-

Responding to a government study released today on drug safety problems within the Food and Drug Administration (FDA), Congresswoman Rosa L. DeLauro (Conn.-3) said FDA Acting Commissioner Dr. Andrew von Eschenbach should reconsider the agency's position on drug safety. When asked about authority and management of drug safety within the agency and whether or not Congress should provide more legal authority, Dr. von Eschenbach has said the process the agency already has in place is effective.

Yet according to a study released today by the General Accounting Office (GAO), the FDA "lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues." The report went on to say that "FDA does not have broad authority to require that a drug sponsor conduct an observational study or clinical trial for the purpose of investigating a specific postmarket safety concern." In fact, one senior FDA official and several outside drug safety experts told the GAO that FDA needs greater authority to require such studies.

"This study validates concerns I have raised repeatedly with Dr. von Eschenbach," said DeLauro. "At a time when 65% of post-market studies are pending, when a period of 14 months passed before the label on Vioxx changed, and when withdrawal of an animal antibiotic took five years because of the company's challenge, it is clear that the system FDA has in place is broken and must be fixed.

"I hope this study encourages Dr. von Eschenbach to reconsider his position on the FDA's need for additional mandatory authority," said DeLauro. "Many in Congress are willing to give this agency the legal authority it needs to increase oversight of drug safety and uphold public health. After this GAO study, I hope he will reconsider his position and work with those of us who believe this authority is needed."

http://www.house.gov/delauro/press/2006/April/FDA_drug_safety_4_24_06.html

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