The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration (FDA) is doing an adequate job overseeing drug safety, and whether...
WASHINGTON The Bush administration and some of its critics squared off yesterday over whether the Food and Drug Administration (FDA) is doing an adequate job overseeing drug safety, and whether the agency needs major reforms.
White House Chief of Staff Andrew Card Jr. said the agency is doing a “spectacular” job. But Massachusetts Sen. Edward Kennedy, 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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“Early action on bipartisan FDA reforms is possible in Congress, and I hope that the White House and congressional leadership will not stand in the way,” Kennedy said.
The agency has come under intense scrutiny for its handling of drug-safety questions involving the arthritis drugs Vioxx and Celebrex, and antidepressants for children.
Vioxx was taken off the market by manufacturer Merck & Co. in September; the agency toughened guidelines on pediatric use of antidepressants in October after public and congressional criticism; and the fate of Celebrex remains uncertain.
Pfizer, which makes Celebrex, 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. Card made his comments about the FDA during ABC’s “This Week,” when he was asked whether he supported Senate Finance Committee Chairman Charles Grassley’s call for an investigation of the federal drug agency similar in scale to that done by the 9/11 commission.
“I don’t know that we need a commission,” Card said. “I’ve got great confidence in the FDA.”
He said news about previously unaddressed safety risks associated with popular drugs already 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. FDA drug-safety officer David Graham has said his research showing apparent dangers in Vioxx was suppressed.
Speaking later on the same news show, Pfizer CEO Hank McKinnell defended the decision to keep selling Celebrex. “For many patients, Celebrex is the best option or, in some cases, the last option to live a normal life with the pain and inflammation of arthritis,” he said.
McKinnell said that although one large and well-controlled study had found a significant cardiovascular risk with Celebrex, another large one in progress did not find the risk, and nor have about 50 other clinical studies of the drug. “So I’m not sure we really understand this new data,” he said.
A company official said yesterday, however, that direct-to-consumer advertising for Celebrex will be ended.
FDA’s Graham, who also appeared on “This Week,” said he wouldn’t prescribe Celebrex “to my mother-in-law.”
“The FDA wasn’t concerned about Vioxx, and would not have removed it from the market if Merck hadn’t, yet 100,000 patients had heart attacks because of Vioxx,” Graham said.