FDA changes policy on advisory committees

FDA has issued new draft guidelines that set more stringent standards for participation on its advisory committees and are aimed at eliminating potential conflicts of interest among panel members. The proposal, announced on March 21, follows a barrage of recent criticism about the agency's performance from the Institute of Medicine, some members of Congress, and consumer activists. FDA currently screens prospective advisory committee participants before each meeting for potential financial conflicts of interest. But agency officials say they have found it difficult to achieve consistent results because of the complexity of the screening criteria. Under the revised guidelines, if an individual has disqualifying financial interests the combined value of which exceeds $50,000, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. Under the old system, a complicated waiver process was used to determine eligibility. Financial interest in this context means there is potential for gain or loss as a result of FDA's action on a particular drug or medical device. Such interests may include stock ownership or consulting arrangements with a company whose product is being discussed.