FDA Commish: COI Rules Should Remain Intact

FDA Commish: COI Rules Should Remain Intact

February 3rd, 2012 // 1:26 pm @

Six months after telling Congress that the FDA may loosen conflict of interest rules because finding qualified experts to serve on advisory committees has become increasingly difficult, FDA commish Margaret Hamburg has issued an about-face and now says the rules should remain intact. She confessed her change of heart before a House committee hearing yesterday on user fees.

Why the reversal? For months, FDA data has actually shown that the percentage of conflict of interest waivers granted for advisory committee members has remained below targets. At the same time, the FDA vacancy rate for advisory committees has remained low (see here and here). In other words, finding qualified experts is not a problem.

Yet, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, last year was openly pushing to relax the rules, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 (you can read more here). Two years ago, the agency tweaked its procedures for granting waivers (see this).

The effort by FDA officials to roll back the rules, which were passed in 2008 after an arduous campaign to promote greater transparency at the agency, alarmed some consumer advocates, who argue that the concerns expressed by Hamburg and Woodcock have more to do with pressure from the pharmaceutical industry than actual difficulties finding unconflicted experts for panels.

Last fall, three US Senators introduced a bill to reverse FDA regs that bar experts with financial ties to drug or device makers from serving on committees without a waiver. The impetus has been a heated debate over the FDA approval process for devices, although drugmakers share the sentiment. “Our view is there a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts,” Geno Germano, who heads the Pfizer specialty care and oncology unit, told the House Energy & Commerce Committee yesterday.

But in recent months, Hamburg and Woodcock were undermined by their own data, as has been reported more than once (see this and this). Consequently, Hamburg could no longer – at least, not easily – that the FDA was truly having difficulty finding qualified experts.

“At the present time, we are not bumping up against our cap in terms of waivers,” she told the committee. “We don’t, at the moment, see major areas where a legislative fix is required.” Of course, Hamburg would have known this last summer if she had reviewed agency data before issuing her earlier statements.

source


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner