OK as-is?

Conflict-of-interest rules for FDA not needed, says agency commissioner

Amy Swinderman
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WASHINGTON, D.C.—On Feb. 1, U.S. Food and DrugAdministration (FDA) Commissioner Margaret Hamburg told a U.S. House ofRepresentatives committee that federal lawmakers should not alterconflict-of-interest restrictions on advisory panel members. Hamburg'sstatements surprised many, as six months ago, the FDA told Congress thatloosening conflict-of-interest rules would make it easier for the agency tofind qualified individuals to serve on advisory committees.
The debate over conflict-of-interest rules was ignited lastfall, when three U.S. senators introduced bills seeking to reverse 2007legislation that barred experts with financial ties to drugmakers or toolproviders from serving on committees without waivers. These advisory panelsprovide input to the FDA on new therapies or medical issues before the agencyrenders decisions. Current rules bar individuals from participating in FDA advisorycommittees if they, their spouse or minor children have more than $50,000 inpotentially conflicting financial interests.
At the time, the FDA testified that it can use waivers onsome potential conflicts to place experts on panels, but the number of allowablewaivers has been decreasing. According to the FDA's website, 23 percent of theseats on the FDA's advisory committees weren't filled as of March 2011, with608 positions occupied and 138 vacant.
Now, the agency seems to be changing its tune.
"At the present time, we are not bumping up against our capin terms of waivers," Hamburg told a hearing of the House Energy and CommerceCommittee. "We don't, at the moment, see major areas where a legislative fix isrequired."
The focus on conflict-of-interest rules reflects pressurefrom some lawmakers and companies to increase approval of drugs and devices asa way to promote scientific innovation and job creation.
"I think it will be very hard for us to factor into thisscience-based decision making and how approving or not approving a product willimpact jobs, or impact jobs of a competitor," Hamburg told the committee. "Itwill get very, very complicated and, frankly, I think would be quiteinappropriate. It would not serve the American people well and would not serveindustry well."
Industry representatives voiced their concerns aboutrevising the current rules. Geno Germano, who heads Pfizer Inc.'s specialtycare and oncology unit, told the committee, "Our view is there is a need toimprove the process of the advisory committees, particularly in areas wherethere is a paucity of experts."
Patient and consumer advocate groups were also swift torespond to Hamburg's testimony, contending that loosening the rules couldjeopardize the independence of the panels. Robert Weissman, president of PublicCitizen, argued that conflict-of-interest rules shouldn't be changed becausefinancial interests influence the way products are evaluated.
"We need stronger protection rather than less," hetestified.

Amy Swinderman

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