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COPYRIGHT 2004 International Medical News Group
WASHINGTON -- The Food and Drug Administration needs a more independent office for assessing postmarketing drug safety. Senate Finance Committee Chairman Charles Grassley (R-Iowa) said at a Senate hearing on drug safety monitoring and the events leading up to the withdrawal of Vioxx in September.
Currently, the Office of Drug Safety has to convince the Office of New Drugs--which approves products--that there is a problem before there can be any sanctions on a drug, explained David J. Graham, M.D., associate director of the Office of Drug Safety.
Thus the same office that approves drugs is also responsible for taking regulatory actions against manufacturers once the drug is on the market, added Dr. Graham, calling the arrangement "an inherent conflict of interest."
Dr. Graham surprised attendees at the hearing by claiming that at least five drugs on the market should be withdrawn or restricted. The drugs--Meridia, Crestor, Accutane, Bextra, and Serevent--have been linked to alarming rates of adverse events, he said.
After the hearing. Steven Galson, M.D., acting...
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