FDA sets limits to advisers’ ties to industry

The Food and Drug Administration (FDA) announced policies Monday designed to address concerns about its outside advisers’ ties to the pharmaceutical and medical device industries.

“It is imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent,” Randall Lutter, the FDA’s deputy commissioner for policy, said in a statement.

{mosads}The agency’s stated aim with new policies is to reduce real and perceived conflicts of interest and to ensure the objectivity of its influential advisory committees.

Under the new policies, a scientist or other expert would be barred from participating on an FDA advisory committee if he or she or an immediate family member had a $50,000 or greater financial stake in a company or companies up for review by the panel.

A potential committee member with a smaller financial stake would need a waiver from the agency to sit on the panel. Such waivers would be granted only if FDA officials “determine that there is an essential need for the adviser’s particular expertise,” according to a statement by the agency.

FDA advisory committees are composed of researchers and other experts who offer recommendations to the agency on a plethora of weighty matters, such as whether it should approve a new treatment, what warnings need to appear on a product’s label and what types of patients can be prescribed a drug or device.

These panels wield great influence over the FDA’s decision-making, as the agency typically adopts most of their recommendations. Drug and device companies, investors, the press and other interested parties looking for a signal of impending FDA actions turn out in droves to the committees’ meetings, which usually last several days.

Critics, including many lawmakers, question the trustworthiness of the panels’ recommendations because members sometimes have financial stakes in companies under review. Pharmaceutical and device companies draw from the same pool of scientific experts, such as academic researchers, to act as consultants as the FDA does to recruit advisory committee members.

Concurrent with the new financial conflict-of-interest policies, the FDA issued other new rules governing the advisory committee process.

From now on, the FDA will make all materials to be used at the meetings available to the public at least 48 hours before a meeting. Committee members also will vote on recommendations simultaneously, and not sequentially, to avoid members being influenced by the votes cast before their turns. Roll call votes also will be publicly disclosed.

The FDA also issued a draft document seeking to clarify the criteria the agency uses to determine whether it will ask a panel for advice.