Feds Release Guidance Against Conflict of Interest - Pharmaceutical Executive

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Feds Release Guidance Against Conflict of Interest


PharmExec Direct

In an effort to curb conflict-of-interest problems, FDA announced new policy prohibiting advisory committee members to take part in meetings if they have more than $50,000 invested in the company being reviewed. Also, if the advisor is the principal investigator of said product, he or she will not be allowed to participate in that meeting.

"FDA's advisory committees provide important, expert, scientific, and technical advice in public to FDA on important regulatory decisions," said Randall Lutter, deputy commissioner for policy, FDA. "While FDA makes final decisions, advisory committees meet to ensure we get the best available advice on important decisions that affect the health and safety of the public."

If an advisor has a smaller than $50,000 stake in the company being reviewed, and his or her expertise is deemed essential to a meeting, they can be provided a waiver. However, experts can be denied a waiver, even if the potential conflict of interest is below the financial cap. In addition, all circumstances behind advisor waivers will be posted online for public viewing. Lutter said that the agency will also be finalizing guidance to post meetings briefings on the Web no later than eight hours after the event, making it easier for the public to gather information. Finally, all committee members will have to vote at the same time to avoid the perception that early votes could have undo influence on members voting later.

"These policies go well beyond the legal requirements enacted recently by Congress," Lutter said.

FDA also proposed that guidance be written to state when a committee should be called. For example, all first in class drugs for human use will be referred to advisory group prior to being approved, or there must be a rationale posted for it not being presented.

The conflict of interest guidance will go into effect within the next four months, so it won't impact reviews currently in progress. The other policies are effective immediately.

"We are now going to apply this test of making sure that an advisor has extensive expertise for the advisory committee before we grant them a waiver," said Jill Hartzler Warner, senior policy advisory and counselor, FDA.

When asked if the new policies could hinder the already difficult task of recruiting experts, Hartzler Warner said, "We see recruitment of advisors with minimal or no conflicts as a very important primary goal, and we have stepped up recruitment to a significant degree."

She also said that in the past year, FDA has contacted 280 professional organizations to recruit new members, published six federal register notices calling for nominations of new members, and emailed almost 400 communications seeking new nominees. "We are very much looking at recruitment to meet our goals and reduce the number of waivers that we grant."

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