Panel urges FDA overhaul

Institute of Medicine panel seeks major reforms at FDA, including bolstering intramural and extramural research

Ted Agres
Sep 24, 2006
A new report from the National Academy of Sciences' Institute of Medicine (IOM) recommends strengthening the U.S. Food and Drug Administration's science capabilities by substantially increasing intramural and extramural research within the agency and appointing a chief scientist in the commissioner's office responsible for overseeing the agency's research programs. The recommendation is one of 25 measures urged by the IOM in its long-awaited report on the FDA. The report is deeply critical of the agency, stating that it is suffering from a "dysfunctional organizational culture" that funnels resources into reviewing new drugs for market approval at the expense of thorough monitoring of post-market safety.Many of the report's recommendations, which were unanimously endorsed by the 15-member panel of academics and other experts, focus on bolstering the agency's drug safety monitoring and enforcement mechanisms. To strengthen FDA's ability to conduct post-market drug safety assessments, the panel recommends creating a "robust program of...

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