Study Questions FDA Approvals of Cardiac Devices

Dec. 30 -- TUESDAY, Dec. 29 (HealthDay News) -- The U.S. Food and Drug Administration may not be as stringent in evaluating devices as it is in approving drugs.

According to a report in the Dec. 23/30 issue of the Journal of the American Medical Association, approval of cardiovascular devices often sails through based on studies that are not randomized or blinded, and sometimes even on the basis of one study alone.

"While we did not expect that all studies would be or should be randomized and blinded, we were surprised that the numbers of such studies were as low as they were and that there were many devices approved on the basis of a single study," said study senior author Dr. Rita Redberg, a professor of medicine at the University of California, San Francisco.

Redberg is also a member of the FDA Circulatory System Devices Panel, which advises the FDA on regulatory issues pertaining to these kinds of devices.

For its part, the FDA on Tuesday issued a statement in which it said the study presented an "inaccurate picture" of the clinical trials used in the agency's heart device review process, noting that devices and drugs are not the same thing and require different processes for approval.

One outside expert agreed that the researchers' conclusions were too harsh.

"I have been through the [device approval] process often enough with the FDA to know that these types of criticism don't reflect the typical standard of FDA behavior," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City.

The problem with this study, Garratt pointed out, may be that the authors tried to look at too many different types of devices, not all of which have the same impact on the patient and not all of which can be randomized or blinded.

Still, there might be room for improvement, another expert added.

"The FDA has a tough job, and they do a pretty good job," added Dr. Charles Lowenstein, head of cardiology at the University of Rochester Medical Center. "This article is concerning because the results suggest that the FDA sometimes accepts studies that aren't as rigorous as possible. . . The FDA should rely on the best studies possible, not the best studies available."