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Article Excerpt
Amid public concern about dangerous drugs, the Government Accountability Office (GAO) recently released a report saying that the FDA "lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues." (Gov't Accountability Office, Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process, GAO-06-402 (Mar. 31, 2006).)
The report found that there was "a lack of criteria for determining what safety actions to take and when to take them" and that, without such criteria, decisions "are often based on the case-by-case judgments of the individuals reviewing the data."
Senate Finance Committee Chairman Charles Grassley (R-Iowa) requested the inquiry in 2004, after the painkiller Vioxx was withdrawn from the market. Since 2000, only 10 drugs have been withdrawn for safety reasons, and their manufacturers withdrew them voluntarily.
James Gotz, a Boston lawyer...
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