Can FDA ensure drug safety?

NEWS IN BRIEF — Posted Oct. 23, 2006

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A new analysis of the Food and Drug Administration's capabilities as the nation's drug safety watchdog uncovered numerous problems and urged Congress to step in to provide the agency additional funding and to provide oversight to make sure that changes are made.

The new findings were published in the Oct. 9 Archives of Internal Medicine by five current and former members of the FDA's Drug Safety and Risk Management Advisory Committee. It followed a Sept. 26 report by the Institute of Medicine that also found fault with the agency's ability to approve and monitor drugs for safety.

"Congress has not provided adequate funding and authority to the FDA," said lead author Curt D. Furberg, MD, PhD, professor of public health sciences at Wake Forest University School of Medicine in North Carolina.

Among the problems cited in the Archives analysis: an initial agency approval process that often fails to detect serious adverse drug reactions; the existence of a possible conflict-of-interest situation resulting from the same FDA center that approves drugs having responsibility for taking safety actions; and the FDA's dependence on user fees from drug companies.

Note: This item originally appeared at

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