FDA responds to drug safety blueprint

The agency unveiled a plan to enhance its oversight, but congressional action is needed to carry out the broader revamp called for by the Institute of Medicine.

By Susan J. Landers, AMNews staff. Feb. 26, 2007.

Washington -- The Food and Drug Administration's Jan. 30 announcement of planned changes in the way it oversees drug safety was met with yeas, nays and some cautious "time will tell" observations.

The agency announcement came in response to recommendations made last fall in an Institute of Medicine report detailing the FDA's difficulties.

As a result, the agency said it would place increased emphasis on the science of drug safety to identify risky drugs before they reach consumers and to take steps to improve postmarketing surveillance of at least some new products to spot emerging dangers.

The FDA has come under fire in recent years as unsettling information surfaced about delayed warnings of serious side effects from marketed drugs such as COX-2 inhibitors and selective serotonin reuptake inhibitors. Charges were made that public health was taking a back seat in a drug approval system that seemed to cater more strongly to the needs of pharmaceutical companies than to safety.

The fact that changes were needed had been recognized by nearly everyone except, until now, the agency itself, said observers who welcomed the change in attitude.

The FDA's response seemed "conciliatory," said Bruce Psaty, MD, PhD, MPH, professor of medicine and epidemiology at the University of Washington in Seattle and a member of the IOM committee that drafted the 2006 recommendations.

The agency's standard reaction to past criticisms had been that there are no problems, Dr. Psaty said. "The tone here is very different." Still, he cautioned, "I have to see how it plays out. Whether the effect is to improve drug safety remains to be seen."