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 Senator Edward M. Kennedy of Massachusetts, 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.”
“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 drug Vioxx, antidepressants for children, and last week for the painkiller Celebrex.
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.
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. Lester Crawford, the FDA’s acting commissioner, said Friday the agency was 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 Senator Charles E. Grassley, Republican of Iowa, chairman of the Senate Finance Committee, for an investigation of the federal drug agency similar in scale to the 9/11 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. David Graham, FDA drug-safety officer and whistle-blower, said the agency suppressed his research showing apparent dangers in Vioxx.
Speaking later on the same news show, Pfizer chief executive 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 yet the relevance of this new data,” he said.
A company official said yesterday, that direct-to-consumer advertising for Celebrex will be ended.
Graham, who also appeared on “This Week,” said he would not 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. “The fact that the FDA now says that it’s concerned about Celebrex to me is a very serious signal.”
The FDA has lacked a permanent commissioner since March and has had an acting leader for about two-thirds of President Bush’s first term. Yesterday, Kennedy called for the quick nomination of a reform-minded commissioner while Card said acting commissioner Crawford “is doing a very good job.”
Congress has shown growing concern over the FDA’s safety monitoring, and committees in both chambers are involved in investigating the withdrawal of Vioxx and the potential risks from Celebrex. On Friday, the House Energy and Commerce Committee asked Pfizer for scores of documents on Celebrex.