The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration is doing an adequate job overseeing drug safety, and whether the agency needs major reforms. In a preview of the debate to come, White House Chief of Staff Andrew H. Card Jr. said the agency is doing a "spectacular" job and should "continue to do the job they do."
But Sen. Edward M. Kennedy (Mass.), ranking Democrat on the Senate Health, Education, Labor and Pensions Committee, shot back that the FDA's "record on protecting us from harmful prescription drugs is a catastrophic failure."
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The maker of Celebrex, Pfizer Inc., reiterated yesterday that it would not take the drug off the market after a clinical trial showed increased risk of heart attacks and strokes among users. Acting FDA Commissioner Lester Crawford said Friday that the agency is concerned about the finding and left open all possible regulatory responses.
Card made his comments about the FDA during ABC's "This Week," when he was asked whether he supported last week's call by Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, for an investigation of the federal drug agency similar in scale to the Sept. 11 commission. Card responded that "I don't know that we need a commission" and that "I've got great confidence in the FDA." He said news coming out about previously unaddressed safety risks associated with popular drugs on the market is "a testament to the FDA in how they do their job."
In the cases of Vioxx and Celebrex, the agency had little to do with the studies that identified the additional heart attack and stroke risks. According to FDA drug safety officer and whistle-blower David Graham, his research showing apparent dangers in Vioxx was suppressed by the agency."
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http://www.washingtonpost.com/wp-dyn/articles/A11900-2004Dec19.html