FDA adopts new policies for advisory committees

8/4/2008

WASHINGTON The Food and Drug Administration announced Monday that it has adopted several improved policies and procedures to strengthen management of FDA advisory committees.

The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures and improved disclosure processes related to advisory committee members and issues considered at their meetings.

Prior to each meeting, FDA staff will screen advisory committee members for potential financial conflicts of interest, such as grants, stock holdings and contracts with any company the committee’s recommendations would affect. The FDA is instituting a cap of $50,000 as the maximum financial interest an adviser may have in all companies a particular meeting might affect. Advisers with financial interests more than $50,000 will be excluded from the meeting. Advisers with interests of less than $50,000 may receive a waiver, but only if the FDA staff determine a need for their expertise.

The agency will also post briefing materials that committee members receive on the FDA’s Web site at least two days before the meeting.

In another improvement, the agency has issued guidelines regarding how committees vote on issues to avoid even the perception of vote manipulation, recommending that all members vote simultaneously.

The FDA also proposed new criteria to determine when it should refer a matter to a committee. In some instances, the law would require it. In others, the agency would consider the new criteria when deciding whether to refer a matter.

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