Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says

Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews.

“We have to be sure that FDA has subject-matter experts that we need for our important decision making,” Hamburg said, adding that the agency also must “prevent inappropriate influence or distortion of information” that may compromise reviews. Patient-advocacy groups and academic researchers have expressed “valid concerns” about the conflict-of-interest policy, prompting an agency rules review, she said.

Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers.

Representative Fred Upton of Michigan, the chairman of the Energy and Commerce Committee, said this month the conflict-of- interest rules are slowing new product approvals because advisory committees lack sufficient qualified members. Twenty- three percent of the seats on the FDA’s advisory committees weren’t filled as of March, with 608 positions occupied and 138 vacant, according to the agency’s website.

Congressional action on product-review fees has created a “renewed sense of interest” and will provide critics of the policy with an opportunity to petition for fewer restrictions on participation on FDA advisory committees, Hamburg said.

The rules shouldn’t be changed because financial interests influence the way products are evaluated, said Robert Weissman, president of Public Citizen. “We need stronger protection rather than less,” he said after Hamburg’s remarks.

To contact the reporter on this story: Jeffrey Young in Washington at jyoung89@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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