WASHINGTON — The Food and Drug Administration pledged Tuesday to make major changes in the nation's drug safety system, responding to a blue-ribbon panel that last fall found the agency's priorities skewed toward approving new medications without adequate follow-up to identify rare but risky side effects.
FDA Commissioner Andrew C. von Eschenbach said the improvements would help the agency regain the "trust and confidence" of doctors and patients after a series of highly publicized safety lapses, including the withdrawal from the market of Vioxx, a previously approved and popular painkiller found to cause heart attacks.
But the FDA's internal fixes stopped short of addressing key issues such as increased funding and broad new legal powers for the drug safety program -- reforms that depend on congressional action that may come this year. And some critics said the agency had not done enough to bring safety officials into the drug approval process.
Von Eschenbach conceded that more remained to be done, saying, "The initiatives we announce today are not the whole story, and they are not the final chapter in the story."
The changes recognized the need to address safety over the entire lifecycle of a drug, from development to use by patients. They included measures to improve the scientific underpinnings of the safety system, increase monitoring for hazardous side effects, expand communication with patients and doctors, and address long-standing turf battles among FDA scientists that have gotten in the way of alerting the public to safety problems.
A pilot program also will be established to assess the safety record of new drugs 18 months after approval. It will be tried initially with a small number of medications, and results will be reported to the public.
Consumer groups dismissed the FDA's initiative as too little, too late, but members of the panel of medical, legal and policy experts that spent more than a year investigating the drug safety program called it a respectable first step.
"It was a thoughtful and engaged response," said Dr. Bruce M. Psaty, a professor of medicine and epidemiology at the University of Washington in Seattle and a member of the panel that studied shortcomings in the FDA's safety program.
"It looks like they are launching a number of initiatives to address drug safety. Many of them are new, so the degree to which they will improve safety remains to be seen, but I think it's a fairly comprehensive response," he said.
