The Food and Drug Administration, in response to severe concerns about permitting scientific experts with financial conflicts of interest to participate in advisory committee meetings, has announced draft guidance that would implement a more stringent approach to evaluating such conflicts of interest, determining eligibility for meeting participation, and limiting the nature of such participation. Under the proposed guidance, if an individual has disqualifying financial interests for which the combined value exceed $50,000, that individual would not be considered for participation in an FDA meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, the individual might be recommended to participate in an FDA meeting as a nonvoting member. Under this guidance, the FDA would retain its right to waive these new standards when, in the agency's judgment, a waiver seems justified. Waivers are loopholes, and many critics believe the FDA has used them too frequently under its existing procedures. 

For more information, please visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html.