FDA Announces Improved Transparency, Public Disclosure Policies

The Food and Drug Administration yesterday announced several improved policies and procedures strengthening its management of FDA 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 policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. FDA announced the availability of the guidance documents in the Aug. 4, 2008 Federal Register; copies of all of the guidances are available on FDA's Web site. 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.

"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. [Yesterday's] announcement strengthens our processes."

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.

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.

For more information, go to www.fda.gov.

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