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FDA To Make Changes To Boost Drug Safety
Key Excerpts from Article on Website of ABC News/Reuters
Posted: February 7th, 2007
http://abcnews.go.com/Health/wireStory?id=2835505
The U.S. Food and Drug Administration said on Tuesday it would make organizational changes to improve internal communication about potential risks that emerge after a new drug reaches the market. The move is part of the agency's response to an Institute of Medicine (IOM) report that sharply criticized the FDA's drug safety oversight and called for more staffing, funding and power to police the drug industry. The September 2006 report also found a "dysfunctional" FDA structure that hindered the agency's ability to protect public health. The IOM experts said they found FDA officials had trouble managing scientific disagreements among staff and downplayed some concerns by safety reviewers who monitor drugs after they win approval. On Tuesday, the agency said it was "making specific organizational and management changes to increase communications among FDA review staff and safety staff." The announcement came as lawmakers prepare to debate critical funding legislation for the agency that could become a vehicle for drug safety reforms. The FDA had requested the IOM report after it came under harsh criticism for its handling of Merck & Co. Inc.'s withdrawn arthritis drug Vioxx and other medicines. Merck pulled Vioxx from the market in 2004, five years after its approval, because of a link to heart attacks and strokes.
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