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WASHINGTON - A Food and Drug Administration official said Friday "we categorically reject" accusations the agency has failed to protect the public against dangerous drugs.
"All the drugs that are on the market have risks," said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.
Appearing on morning television a day after an FDA critic renewed allegations the regulatory agency mishandled the arthritis drug Vioxx, Galson also said that a review is under way of five other medications whose safety was questioned.
In revelatory testimony to the Senate Finance Committee Thursday, senior FDA safety reviewer David Graham had cited Meridia, Crestor, Accutane, Bextra and Serevent as having problems. The manufacturers of these drugs immediately defended the use and safety of their products.
Graham argued that the country is "virtually defenseless" against a repeat of the Vioxx debacle. Galson immediately rejected that, saying it had "no basis in fact."
"What we're concerned about is the sort of hysterical charges that come out, that aren't based on reality," Galson said Friday on NBC's Today show.
"I think the drug industry would be astounded at the charges we're too cozy with them," he said. "I spend a lot of time dealing with complaints from the drug industry."
Merck pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.
The committee chairman, Sen. Charles Grassley, told the hearing he believes an independent board of drug safety may be necessary to ensure the safety of medications after FDA approval.
In Graham's view, the five most worrisome drugs that demand speedy action:
Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it.
Crestor, an anticholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects.
Accutane, an acne drug linked to birth defects. Graham said sales should be restricted immediately.
Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.
Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma.