The Food and Drug Administration has recently announced several revised policies and procedures strengthening its management of FDA advisory committees. The revisions address 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 policies and procedures are described in four final guidance documents available on FDA's website. 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. FDA advisory committees are panels of independent, outside experts who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues.

"The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum," said 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. Today's announcement strengthens our processes."
One change is a cap of $50,000 as the maximum personal financial interest (stocks, grants, and contracts) an adviser may have in all companies that will be affected by a particular meeting. The FDA screens members to determine financial conflict of interest prior to the meetings. According to the new guidelines, if an advisor's personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting. If less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the adviser's particular expertise. Any such waivers will be posted on the FDA's website and include a description of the adviser's personal financial interest and why the need for the expertise was essential.

Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. The 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.

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