FDA to Rule on Outside Advisers' Governmental Influence

WASHINGTON – Outside experts who advise the government on drugs and other regulated products often have financial ties to industry, creating the potential for conflicts of interest.

Bar these scientists from review panels, say some members of Congress and critics of the Food and Drug Administration. Not possible, the agency says, because so many scientists whose expertise the government relies on have ties to industries under FDA regulation.

But pressured by Congress, the agency is trying to bring its decision-making more into the open by spelling out how and why it grants waivers for outside experts that allow them to serve as FDA advisers.

Eventually, new guidelines — plans for which are being announced Monday — should clarify its actions when an expert might have a conflict of interest, said Dr. Scott Gottlieb, the FDA's deputy commissioner for Medical and Scientific Affairs. Few details were available about the proposed guidelines.

The FDA says that simply eliminating all outside reviewers with potential conflicts would deny the FDA access to advisers with the expertise and experience it seeks.

"We probably couldn't recruit department chairmen. It would hinder us from recruiting all but junior faculty members," Gottlieb said.

A congressional critic called that claim "absolutely untrue," adding that anything action short of barring advisers with conflicts would be a "charade."

"It just doesn't make any sense to me. When you have this problem — conflicts of interest on critical panels — the solution is eliminate the conflict. It's simple and easy to do," said Rep. Maurice Hinchey (news, bio, voting record), D-N.Y.

That blanket approach is too restrictive, while the FDA's is too permissive, said Dr. Peter Lurie, author of a recent study on the issue that appeared in The Journal of the American Medical Association.

"They should literally beat the bushes to find people with as few conflicts as possible. One thing is to look harder," Lurie said.

Outside advisers, while independent of the FDA, often have ties to the drug, vaccine, medical device and other industries regulated by the agency.

The FDA turns to its advisory committees for outside advice. The agency is not required to follow the recommendations of its outside advisers but usually does.

In April, a study found that more than one-fourth of the experts relied on for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict.

Only 1 percent of these reviewers were excluded from serving on FDA advisory panels because of those conflicts, which can include tens of thousands of dollars in corporate grants, contracts and consulting fees, according to the study by the consumer advocacy group Public Citizen.

The FDA routinely grants panelists waivers to participate and vote in advisory committee meetings even when they do report conflicts of interest.

Those conflicts typically are minor and often arise because the panelists, many of them academics, either work for universities that have received industry support or supervise others who have, Gottlieb said.

The FDA is moving to clarify when and how it grants waivers, laying out, for instance, whether it would approve panelists with a "scientific" relationship with a company, but not do so when their work filled a more marketing function, Gottlieb said.

The guidelines also could codify how those decisions to grant waivers are made — a process now done on a case-by-case basis.

Gottlieb planned to announce the proposals at a forum convened by the Center for Science in the Public Interest. He and others were expected to debate whether experts with financial ties to corporate interests should serve on panels advising the FDA, the Environmental Protection Agency and the National Academy of Sciences.