Relaxing conflict-of-interest restrictions for FDA advisory panels will be a top priority for Texas Republican Congressman Michael Burgess during the upcoming reauthorization of device and drug user fee programs, he said Sept. 26.

“This time we will get this done,” Burgess said during a hearing he convened in San Diego to hear complaints from local biotech industry representatives on the impact of FDA oversight on medical innovation. “This is a fight I intend to continue into this year.”

The FDA Amendments Act of 2007, which includes the last user fee reauthorizations, limits the availability of conflict-of-interest waivers for advisory committee members. In particular, the act places a progressively more stringent cap on the number of waivers that may be granted per year across the agency, and requires a determination that the individual receiving the waiver offers “essential expertise.”

Groups including industry and patient organizations have complained that the policies make it more difficult for FDA to recruit the best and most knowledgeable experts, who often are the physicians and clinical investigators involved in company-sponsored research.

Burgess said at the San Diego hearing, conducted with Brian Bilbray, R-Calif., that he was frustrated by the advisory panel conflict-of-interest provisions included in the 2007 act, but was unable to get them changed during debate on that bill.

This time, he suggested, he is more determined to “get things fixed.”

He may have a willing partner in FDA, which has signaled interest in changing policies to make it easier for the agency to recruit well-qualified panel members.

Commissioner Margaret Hamburg expressed openness to reforms during a July 25 speech to the consumer advocacy group Public Citizen, noting complaints coming from a cross-section of interest groups. (See “ Also see "Conflict-Of-Interest Policy Relaxation For FDA Cmtes. Could Be Easy PDUFA Add-on" - Pink Sheet, 1 August, 2011. ” – “The Pink Sheet” Aug. 1, 2011.)

She suggested the need for FDA to work with Congress on the matter.

“Any changes that would happen would no doubt be done both in concert with Congress and would be done through an open notice-and-comment … process where we could get input from all stakeholders,” Hamburg said.

By David Filmore

Rep. Burgess Vows To Fight FDA Panel Conflict-Of-Interest Restrictions

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