FDA ADVISORY COMMITTEE SYSTEM BIASED, GROUP SAYS

The FDA's advisory committee system is slanted toward approval of drugs, even when there are significant concerns about those products' safety, an activist group concludes in an Aug. 28 report.

But a senior FDA official said the report's authors demonstrate a misunderstanding of how the agency uses the advisory committee process.

The agency must overhaul this system to change its culture, ensuring a more evenhanded approach to drug reviews, the National Research Center (NRC) for Women & Families' report, "Are FDA Advisory Committees a Rubber Stamp For Approval?", said. The group found, based on its review of voting patterns and discussions of several drug advisory panels over an eight-year period, that the committees recommended approval for 76 percent of the drugs they reviewed. "It is not possible to know what the rate of approval 'should be,' but the study results are worrisome," Diana Zuckerman, the group's president, said in a release.

NRC is particularly concerned that many drugs were recommended for approval despite members' misgivings about the product's safety and efficacy. The group also alleges that members of these panels are pressured to recommend approval and that members' industry ties influence their decisionmaking.

The FDA is to blame for this problem, the report said. "Many of today's FDA drug and device advisory committees are rubber stamps for approval almost every time they meet."

However, the agency does not usually rely on these committees alone in deciding whether to approve a drug, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said. Instead, these committees are used to advise the agency on the indication a product should be approved for, the proper labeling or the most appropriate postmarket commitments. NRC's conclusions represent a "fundamental misunderstanding about the scope of the value we derive from our advisory committees," he said.

Another expert also said that the report is off-target. Seventy-six percent is an "unbelievably low" approval rate for drugs that have made it to the advisory process, Peter Barton Hutt, senior counsel at Covington & Burling and former FDA general counsel, said. These drugs have been through many stages of approval and are usually the ones the FDA is close to approving.

NRC's argument that the agency is approving too high a percentage of these drugs is unfounded, he said. "These people are just dead wrong." (http://www.fdanews.com/did/5_170/)