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New Policies Proposed by FDA to Eliminate Conflicts Among Advisory Panelists

FDA advisory panel members will vote simultaneously, rather than one after the other as is done now, the agency announced on Nov. 15. This is just one of several initiatives the FDA has introduced in the last few months as part of a broader effort to ensure that advisory panel votes are made independently and are free of influence.

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Dr. Karl Kieburtz: “Voting en bloc makes some sense as folks may not be swayed by the votes of others, although I am not certain how much that happens.”

Advisory panel members currently vote in a variety of ways, said FDA Senior Policy Advisor and Counselor Jill Hartzler Warner. Often, members announce their votes in turn and when doing so, explain why they are voting that way.

Warner said the agency does not have evidence that this process has influenced the way someone has voted. But she said studies commissioned by the FDA have reported a possibility that comments made by other panel members could affect the deliberations of those yet to vote, or could alter the meaning or interpretation of the question that is being decided. “This is a proactive measure to avoid those risks,” Warner said.

“Voting en bloc makes some sense as folks may not be swayed by the votes of others, although I am not certain how much that happens,” said Karl Kieburtz, MD, chair of the FDA Peripheral and Central Nervous System Drugs Advisory Committee.

In other policy changes, the FDA announced last March that panel members will not be allowed to have more than $50,000 in ties to companies that the agency regulates. Members with financial ties less than that amount might be allowed to participate in panel discussions but could not vote. However, exceptions will be allowed in some cases.

According to another policy announced in the Federal Register in October, advisory members will from now on need to fill out forms disclosing their or their immediate family members' ties to companies regulated by the FDA. If the agency approves these waivers, the discloser forms will be posted on the FDA Web site at least 15 days before any committee meetings.

Under the current system, the FDA commissioner may grant waivers; these are usually announced at panel meetings and posted on the FDA Web site. However, the disclosure documents are not always released.

Warner said the new policies are in keeping with the Food and Drug Administration Amendments Act of 2007, signed into law last September, which states that the agency may grant a waiver only “if necessary to afford the advisory committee essential expertise.” The bill also places a cap on the number of waivers that the agency issues. As a result, “the number of waivers that we issue will be steadily decreasing over a five-year period,” Warner said.