By Jeffrey Young
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 groupPublic 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.