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FDA Critic Seeks Revamp of Drug Safety Review

Senator Calls for Independent Drug Safety Office
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WebMD Health News

March 10, 2005 - A key congressional critic of the FDA says he will soon begin an effort to overhaul the way the agency monitors the safety of the nation's prescription drug supply.

His bill is likely to be the first attempt by lawmakers to reform the FDA in the wake of lingering questions over its handling of safety issues, including suicide risk in adolescents taking antidepressants and heart problems with Vioxx and similar drugs.

Sen. Charles E. Grassley (R-Iowa), who leads the Finance Committee, says he will introduce a bill designed to set up within the FDA an independent drug safety office with expanded new powers to police -- and possibly remove -- drugs already on the U.S. market.

The FDA's existing Office of Drug Safety is under the authority of its Office of New Drugs, which is responsible for declaring new drug products safe and clearing them for sale to consumers.

Critics have said that the arrangement intimidates FDA scientists who raise safety questions about already available drugs because they are forced to take their concerns to superiors who have already declared the drugs safe and effective.

New Drug Safety Office, New Power

A current draft of the new bill instead creates an independent drug safety office with the power to force manufacturers to tighten drug warning labels and to order new drug safety trials for products already on the U.S. market.

The bill is also likely to give the new office the power to suspend advertising of suspect drugs and to pull drugs from the market that it determines are unsafe for patients to use, a Senate aide tells WebMD.

"The existing Office of New Drugs is hampered by real and perceived conflicts of interest. An independent drug safety office would more effectively regulate drugs once they're on the market," Grassley said in a speech before the Consumer Federation of America.

"If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drugs on the market in the first place," he said.

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