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FDA Review Process Short On Manpower

WASHINGTON--The U.S. Food and Drug Administration has been taking its lumps of late for its failure to adequately monitor the generic drug review process. FDA officials, in defending themselves before congressional inquiries, say that financial limitations—on staff and other resources—have hampered the agency’s ability to perform its statutory duties. But it seems that FDA has made its job of regulating the nation’s pharmaceutical industry more difficult by failing to

Charles Marwick

WASHINGTON--The U.S. Food and Drug Administration has been taking its lumps of late for its failure to adequately monitor the generic drug review process. FDA officials, in defending themselves before congressional inquiries, say that financial limitations—on staff and other resources—have hampered the agency’s ability to perform its statutory duties. But it seems that FDA has made its job of regulating the nation’s pharmaceutical industry more difficult by failing to fill at least two new outside committees created to advise it.

The FDA has 19 such committees, which provide it with scientific advice on the approval of new drugs and biologics to combat disease. Their workload has grown in recent years to keep up with the increasing number of products flowing from commercial laboratories. Last year Congress created a new panel, the antiviral drugs advisory committee, that was meant to shoulder some of the burden carried by another panel, on anti-infective...

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