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OK as-is?
March 2012
by Amy Swinderman  |  Email the author
EDIT CONNECT

SHARING OPTIONS:

WASHINGTON, D.C.—On Feb. 1, U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg told a U.S. House of Representatives committee that federal lawmakers should not alter conflict-of-interest restrictions on advisory panel members. Hamburg's statements surprised many, as six months ago, the FDA told Congress that loosening conflict-of-interest rules would make it easier for the agency to find qualified individuals to serve on advisory committees.  
 
The debate over conflict-of-interest rules was ignited last fall, when three U.S. senators introduced bills seeking to reverse 2007 legislation that barred experts with financial ties to drugmakers or tool providers from serving on committees without waivers. These advisory panels provide input to the FDA on new therapies or medical issues before the agency renders decisions. Current rules bar individuals from participating in FDA advisory committees if they, their spouse or minor children have more than $50,000 in potentially conflicting financial interests.  
 
At the time, the FDA testified that it can use waivers on some potential conflicts to place experts on panels, but the number of allowable waivers has been decreasing. According to the FDA's website, 23 percent of the seats on the FDA's advisory committees weren't filled as of March 2011, with 608 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 cap in terms of waivers," Hamburg told a hearing of the House Energy and Commerce Committee. "We don't, at the moment, see major areas where a legislative fix is required."  
 
The focus on conflict-of-interest rules reflects pressure from some lawmakers and companies to increase approval of drugs and devices as a way to promote scientific innovation and job creation.
 
"I think it will be very hard for us to factor into this science-based decision making and how approving or not approving a product will impact jobs, or impact jobs of a competitor," Hamburg told the committee. "It will get very, very complicated and, frankly, I think would be quite inappropriate. It would not serve the American people well and would not serve industry well."  
 
Industry representatives voiced their concerns about revising the current rules. Geno Germano, who heads Pfizer Inc.'s specialty care and oncology unit, told the committee, "Our view is there is a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts."
 
Patient and consumer advocate groups were also swift to respond to Hamburg's testimony, contending that loosening the rules could jeopardize the independence of the panels. Robert Weissman, president of Public Citizen, argued that conflict-of-interest rules shouldn't be changed because financial interests influence the way products are evaluated.  
 
"We need stronger protection rather than less," he testified.
 
Code: E031227

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