FDA Revamps Process for Safety of Drugs After Approval

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.

"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 R. 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 were 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 medications rather than monitoring those already on the market.

"There was an asymmetry in esteem and funding between these two groups," Charo said. While the changes the FDA announced yesterday to integrate drug safety experts in the process were a start, she said, the agency's drug safety specialists still lacked power.

When FDA safety officials see a problem with a drug, Charo said, the agency is required to discuss proposed warnings, labeling changes or limits on distribution with the manufacturer. What FDA safety officials need, she said, is the power to impose fines and restrictions on companies that do not voluntarily follow the FDA's directives.

Agency officials said some of the changes proposed in the IOM report require congressional action, because they call for new powers. But officials also said they are starting a pilot program to produce report cards on some new drugs 12 to 18 months after their approval -- a process that would bring problems to light.

FDA Commissioner Andrew von Eschenbach and other senior officials said they were largely in agreement with the institute but called its report useful advice, not a blueprint. The agency is taking steps to break down internal walls and strengthen the role of safety specialists on advisory panels, they said.

Referring to the IOM's concern about a "lack of respect" between agency staff who approve new drugs and those who monitor drug safety, Galson said, "We need to improve the way scientific disagreements are handled and resolved."

Besides the "cultural" issues within the agency, officials outlined a number of initiatives to better understand which patients may be susceptible to particular types of side effects, and which patients may be most likely to benefit from a particular drug. "This new science of safety will help us make products safer from the get-go," said Janet Woodcock, the FDA's deputy commissioner for operations.

The agency also said it is seeking alliances with the Department of Veterans Affairs, the Centers for Medicare & Medicaid Services and private insurers to gather better information about problems with using drugs and the challenges that physicians and patients encounter in the everyday use of medications.

Officials also promised greater transparency in how they select experts to serve on influential panels that assess new drugs and devices, as well as policy issues facing the agency. Some of these panel members have come under criticism for having ties to the drug industry.

While greater transparency is a good thing, Charo said, the FDA also ought to limit the overall number of panel members who have conflicts of interest.