WASHINGTON -- The Food and Drug Administration on Tuesday said it is making changes in how it operates to prevent the kind of drug-safety controversies that have dogged the agency in recent years.
Officials outlined plans to monitor safety problems better after drugs are approved and to make internal changes to raise the profile of agency scientists who raise red flags about drugs. The steps were announced in response toa report last year by theCongressionally-chartered Institute of Medicine that called for an overhaul of FDA's culture and structure following safety controversies over drugs such as the painkiller Vioxx.
Officials said the steps will restore the trust and confidence of Congress and the public. They also pledged a renewed commitment to good science as the best way to counter critics who say the agency is too cozy with drug companies.
"We will fight back against those perceptions and that cynicism," said Steven Galson, head of the agency's Center for Drug Evaluation and Research, the division that evaluates new drugs and that has been at the center of the maelstrom.
A member of the Institute of Medicine panel said the FDA had taken steps in the right direction but had fallen short.
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"In a number of cases, the FDA does not go as far as the IOM recommendations, but they are first steps and in the right direction," said Alta Charo, a professor of law and bioethics at the University of Wisconsin.
A central contention of the IOM report was that the agency did not focus enough on monitoring drugs once they are approved. Most approvals are based on clinical trials involving a few hundred or a few thousand patients, and many uncommon side effects do not emerge until a drug is being used by millions.
The IOM report said FDA officials who monitor drug safety were being ignored, because top officials were focused on approving new drugs rather than monitoring drugs already on the market.
"There was an asymmetry in esteem and funding between these two groups," Charo said. While the changes announced by FDA to integrate drug safety experts in the process of drug approval were a start, she said the agency's drug safety specialists still lacked power.
Agency officials said some of the changes proposed in the IOM report require congressional action, since they call for new powers. But officials also said they were launching a pilot program to produce report cards on some new drugs 12-18 months after their approval -- a process that would bring to light any emerging problems with the drugs.
