FDA Proposes Public Disclosure of Advisory Panel Members' Conflicts of Interest
Originally published by Reuters Health, February 12, 2002
WASHINGTON (Reuters Health) — The US Food and Drug Administration (FDA) has issued a draft guidance aimed at expanding its current policy regarding financial interest disclosure by members of the agency's advisory committees.
In a talk paper released on Tuesday, the agency said the new policy is aimed at increasing transparency regarding the members' financial interests in the products they are asked to review or in competing products.
Members of the advisory committees are considered "special government employees" and are required to provide disclosure of potential financial conflicts of interest to the FDA. The new policy establishes that, in situations in which a member is allowed to remain on a committee despite disclosing a financial interest, information will be made available to the public regarding "the nature and magnitude" of that interest.
The policy, which applies only to members of advisory committees that discuss product-specific issues, will make public information about an advisory committee member's relevant stock holdings, employment (or spouse's employment), consulting fees, contracts and grants, and teaching, speaking and writing fees if the member has disclosed such information to the FDA but has been granted a waiver to remain on the committee.
The information will be read into the record at the start of the advisory committee meeting, the FDA said.
The agency noted that, in order to obtain the necessary level of expertise for its committees, it must sometimes enlist the services of people who have potential conflicts of interest.
The new draft guide follows media attention regarding advisory committee members' potential conflicts of interest in reviewing product applications.
FDA spokesperson Susan Cruzan told Reuters Health that the guidance was based on a recently-obtained opinion from the Department of Justice's Office of Legal Counsel suggesting that this further disclosure would be consistent with the Food and Drug Modernization Act of 1997.
Cruzan said panel members were also surveyed and agreed that further disclosure would be acceptable.
