The U.S. Food and Drug Administration (FDA) has issued a new draft guidance that would toughen rules for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.
"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, PhD, 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 "Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."
This new guidance ( www.fda.gov/oc/advisory/waiver/coiguidedft.html) offers a more streamlined approach for considering who may participate in meetings. It looks specifically at changing rules regarding the financial interests of members, and only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members, FDA said.
FDA is accepting public comments on the proposal. To submit electronic comments on the draft guidance, visit www.regulations.gov or www.fda.gov/dockets/ecomments.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), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number 2007D-0101.