Watchdogs bark as FDA relaxes rules on conflicts of interest

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An FDA move to relax conflict-of-interest rules governing advisory panels is meeting with heated opposition from watchdog groups and medical societies.

FDA commissioner Margaret Hamburg recently told Public Citizen that the agency may loosen a three-year-old policy aimed at keeping industry-funded physicians off FDA advisory panels because the resulting vacancies are gumming up the approvals process.

An FDA spokesperson told MM&M: “The new conflict of interest rules have, in some cases, made it more difficult for FDA to find expert advisors. In most cases, FDA has been successful in finding experts to meet our needs. However, in a few cases it has been necessary to delay holding advisory committee meetings in order to allow more time to contact and screen more experts for consideration or to begin the screening process with many more experts. This increases the work requirement for advisory committee preparation.”

As of March, 23% of the agency's advisory committee seats – 138 of them – were vacant.

FDA CDER director Dr. Janet Woodcock said at a conference in May: “There is no doubt it is difficult finding highly experienced people who do not have conflicts.”

Bull, said the Project on Government Oversight (POGO), arguing that the number of conflict-of-interest waivers granted FDA advisory members has never exceeded 5% and that the percentage of seats vacant is falling, having sunk from 30% in 2009.

“These rules do create an additional hurdle, but that is exactly the point,” said POGO head Danielle Brian in a letter to Dr. Hamburg. “We want expert advice that is as free as possible from the influence of industry.”

Like POGO, the National Physicians Alliance pointed to lists of conflict-free physicians.

“We understand and decry the increasing entanglement of many researchers and clinicians with industry and understand that finding reviewers without conflicts can be a challenge,” said National Physicians Alliance president Valerie Arkoosh, MD, who noted that almost half of the cardiologists who develop clinical practice guidelines for the American College of Cardiology and the American Heart Association do not have conflicts of interest.

In the FDA's corner on the topic is House Energy and Commerce Committee chair Rep. Fred Upton (R-MI), who said in July: “The rigid and unrealistic conflict of interest provision has prevented FDA and its advisory committees from utilizing some of science's best minds and left advisory committee slots unfilled,” and suggested that the rules have slowed approvals.

Another voice in favor of relaxing the rules is that of Peter Pitts, an industry PR man and generally pro-industry think tanker who, as FDA associate commissioner, was in charge of advisory committee oversight, in which role he had final say on what would-be panelists with conflicts made the cut and were granted conflict of interest waivers.

“Many did not,” wrote Pitts, “but those who did received their waivers because FDA professional career staff made a strong case that these people weren't just important to the advisory committee but critical. And we should all pay attention to the nomenclature. It's not about ‘conflict of interest' – it's about (as HHS Secretary Sebelius correctly says) ‘interest.' And having an ‘interest' is not necessarily a bad thing as long as you're transparent about it.”

“If we allow FDA adcomms to become the realm of the second best and the almost brightest,” continued Pitts, “What have we done to the advancement of America's health?”
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