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FDA is faulted for drug-safety process

Monday, September 25, 2006

The nation's system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the Food and Drug Administration is plagued with poor management and persistent internal squabbling, according to a long-anticipated study of the agency. The study, requested by the FDA, was carried out by the Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues. The report is likely to intensify a debate about the safety of the nation's drug supply and the adequacy of the F.D.A.'s oversight. The debate began in earnest in September 2004 when Merck withdrew its popular arthritis drug, Vioxx. [ Source : New York Times ]

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