FDA to tighten advisory committee rules

WASHINGTON, March 21 (UPI) -- The U.S. Food and Drug Administration has issued draft guidelines for avoiding conflicts of interest among its advisory committee members.

"FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees," said Randall Lutter, the FDA's acting deputy commissioner for policy.

The proposal, which would replace complex guidance issued in 2000 on FDA waiver criteria, is designed to tighten the policy for considering eligibility for participation.

Under the proposal, if an individual has disqualifying financial interests, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, the individual might be recommended as a non-voting member.

Only people with no potential conflicts would be eligible to participate in meetings as voting members.

The FDA said "financial interest" means the potential for gain or loss to a person, their family or outside affiliations as a result of FDA action on a particular topic. Financial interests include stock ownership, as well as related research and consulting arrangements.