Advisers for FDA face stricter ethics rules

WASHINGTON – The federal government proposed new rules Wednesday that would make it tougher for scientists with industry ties to offer advice about approving new drugs and medical devices.

The Food and Drug Administration said that most scientists with $50,000 or more in stock, consulting fees or other financial links to companies should be barred from making recommendations to the agency about a product. Scientists with smaller financial interests would be allowed to participate in agency advisory meetings but could not vote to approve a new product.

“This will enhance the public’s confidence in the integrity of the process,” said Randall Lutter, the FDA’s acting deputy commissioner for policy.

The proposal is the government’s latest attempt to reduce conflicts of interest among scientists who advise the FDA on whether to approve a new drug or medical device, change its warning label or request its removal from the market for safety reasons. The FDA usually follows the advice of the outside scientists.

But critics have attacked the independence of the advisory committees after a series of reports about conflicts involving committee members. A study published in the Journal of the American Medical Association last year, which looked at FDA advisory panel meetings over a recent three-year period, found that more than half of the panel members had a conflict of interest at 22 percent of the meetings surveyed.

Dr. Peter Lurie, the study’s lead author, said he doubted the new rules would keep many scientists from participating in the advisory panels, since most have financial ties to industry of less than $50,000. But he said the rules were still likely to reduce the influence of scientists with industry ties.

Since 2000, the FDA has been screening its advisers for conflicts before meetings. Yet that effort only led to further criticism of industry taint, because the agency granted waivers that allowed many scientists to continue participating on the panels, citing the need for their expertise.

Peter Pitts, who oversaw advisory committees as an FDA associate commissioner from 2000 to 2002, expressed concern about the loss of so many distinguished experts from the panels.

“The agency should not have to depend on the almost best and the kind of brightest, said Pitts, director of the Center for Medicine in the Public Interest, an industry-supported group. Pitts derided the $50,000 limit as arbitrary and said the FDA should have decided instead to let its staff continue to pick scientists for the panels.