GAO calls for expansion of FDA's postmarketing authority

NEWS IN BRIEF — Posted May 15, 2006

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The Food and Drug Administration's system for monitoring drug safety after approval is inadequate, according to a report issued last month by the Government Accountability Office. In addition, the report concluded that the steps the agency has taken to improve it will not be able to address all of its failings and that Congress should consider expanding the agency's authority to require drug companies to complete postmarketing studies.

The GAO initiated its review of the FDA's postmarketing drug safety system in the wake of several high-profile drug-safety cases that raised concerns about the agency's ability to monitor and regulate medications after they hit the market. The agency has taken several steps to address this issue, including establishing a Drug Safety Oversight Board, increasing communication between its Office of New Drugs and the Office of Drug Safety, and working to identify new ways to detect safety problems. The GAO, however, did not find that these efforts went far enough and called for legislative action to expand the agency's regulatory ability.

The FDA responded that the GAO conclusions were reasonable.

Note: This item originally appeared at

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