FDA issues guidelines to tighten advisory committee rules

Scientific experts with over $50,000 in financial ties to companies regulated by the FDA would be barred from serving on agency advisory committees under new draft guidelines issued last week. Experts with less than $50,000 in financial interests – such as corporate grants, contracts and consulting fees – can still participate on FDA advisory committees but only as non-voting members of the panel, and only if the need for their services outweighs the potential conflict of interest, under the proposed guidelines. Only individuals with no potential conflicts of interest would be eligible to fully participate in meetings as voting members, the FDA said. “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. “Today’s draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.” The issuance of the draft guidelines comes amid increased scrutiny from Congress and critics over the potential for conflicts of interest among FDA advisory committee members. The FDA maintains that it currently screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under existing law, the FDA may grant a waiver when certain criteria are met, such as when the need for an individual’s expertise outweighs the potential for a conflict of interest. Advisory committees provide the agency with advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices and food. In general, the FDA’s advisory committees are comprised of a chairperson, several members, plus a consumer, industry and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. Although the recommendations of the FDA’s advisory committees are not binding, the agency typically follows the advice of its panels of outside experts. The FDA will accept public comments on the proposed draft guidelines for the next 60 days, with a notice soon to appear in the Federal Register. To submit electronic comments on the draft guidance, visit www.regulations.gov or www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), US Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments must include the docket number 2007D-0101.