(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

“The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum,” says Randall Lutter, Ph.D., deputy commissioner for policy. “It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent.”

The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days.

Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings. Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings, and contracts with a company that would be affected by the committee’s recommendations. FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting.

Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. As detailed in the final guidance on advisory committee briefing materials, FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA’s web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also recommends a timetable that sponsors should follow when submitting such documents.

The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once. Simultaneous voting avoids “voting momentum” in which some voters may be influenced, even subconsciously, by the votes of those who precede them. The results of the votes will then be announced immediately in the meeting, and FDA intends to post on the FDA website a list indicating how each member voted. Any posted list will be part of the permanent record of the meeting.

For further information, visit www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html.