FDA slow to respond to drug safety issues

By Trevor Schubert

Published on May 01, 2006

The report filed by the Government Accountability Office found that the FDA does not have well defined policies for addressing drug safety issues and sometimes their best safety experts are excluded from important meetings.

The GAO study was authorized by Congress in 2004 following the sudden withdrawal of Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users.

The FDA was widely criticized at the time for their delayed response in its review of Vioxx's potential health problems. The GAO report takes the criticism one step further and concludes that the agency's entire system for reviewing the safety of drugs already on the market is too limited and broadly flawed.

The study focused on the FDA's handling of four controversial drugs -- Baycol, Bextra, Arava, and Propulsid. Of the four, Arava is the only drug that remains on the market.

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