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Groups Want a Tougher FDA

Panel Considers Calls for More Agency Power

Companies: We're Improving

Drug company executives said their firms are working with the FDA to improve safety monitoring but warned that giving the agency more power would slow the progress of getting new drugs to market.

"It's not at all clear that the FDA is using the tools it already has in an adequate and effective way," said Geoffrey Levitt, an attorney representing Wyeth Pharmaceuticals. Granting regulators more authority "will undermine public health by depriving patients access to new medicines."

Sidney M. Wolfe, MD, director of the health research group for the FDA watchdog group Public Citizen, told experts that more authority for the FDA was essential. Wolfe listed 13 medications that later showed severe safety problems after being approved by the agency. The drugs including the drugs Rezulin, Baycol, and Propulsid; all had to be from the market because of safety concerns.

"This is certain to continue unless some fundamental changes take place," he said.

The committee is set to conclude its investigation this summer.


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