Witnesses spar over FDA's effectiveness on drug safety

The FDA needs to fundamentally change the way it approves and monitors the safety of drugs, witnesses told the Senate Health, Education, Labor and Pensions Committee Thursday.

But a top FDA official said the agency already is moving to correct lapses that led to the withdrawal of the painkiller Vioxx last year after it was linked to increased risk of heart attack and stroke.

Health, Education, Labor and Pensions Committee Chairman Mike Enzi, R-Wyo., and ranking member Edward Kennedy, D-Mass., are working on legislation regarding FDA's approval process, although aides said there is no timeline for its completion. In the meantime, witnesses had plenty of suggestions.

"I have thought about this a great deal, and I do believe there's a crisis" in the FDA's approval process, testified Raymond Woosley, a professor of medicine and pharmacology at the University of Arizona. "Only 109 scientists monitor the safety data from over 3,000 prescription drugs. Where a complete system of drug safety surveillance is needed, the FDA is forced to rely on its voluntary reporting system for adverse events," he said.

Bruce Psaty, professor of Medicine and Epidemiology at the University of Washington, agreed. "Your committee did good work correcting the drug lag" by passing the Prescription Drug User Fee Act in 1992, which sped up the drug approval process, he said. "But now we have a safety lag."

FDA Acting Deputy Commissioner for Operations Janet Woodcock said agency officials already spend half their time on safety issues, and that new information about drug dangers "is not a cause for dismay" but rather evidence of medical progress.

"Our approval process is the strongest it's ever been," she said. If the agency took only safety into account, "We wouldn't have any drugs because all of them have risks."

Woodcock also said the agency is taking steps to combat allegations of "intellectual bias" that might lead FDA officials who approved a drug to disregard later evidence of safety problems. She said safety boards outside the agency are a bad idea. Surveillance of drugs "is a continuum between pre-market and post-market" activities, she said, and the same people should be involved.

Woodcock also said she is less concerned about direct-to-consumer advertising, which has been blamed for millions of patients taking Vioxx who did not really need it, than about the level of direct-to-physician marketing done by drug companies. "That has more impact on doctors' prescribing practices than direct-to-consumer ads," she said.