Earlier this year, FDA commish Margaret Hamburg bemoaned the lack of qualified, unconflicted experts available to participate on advisory committees. And last month, a trio of US Senators introduced a bill that would reverse three-year-old agency regulations that bar experts with financial ties to drug or device makers from serving on those committees without a waiver (seehere and here).
Those regulations, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000, were instituted amid concerns that the FDA was not doing enough to address conflicts. The issue emerged in the wake of various safety scandals and a subsequent clamor for panelists who would be largely divorced from substantive industry influence.
The legislative effort comes amid complaints that the FDA is not approving new devices, in particular, fast enough. As for drugs, the agency recently released data showing 35 new meds were approved over the past 12 months, which is nearly the highest number of approvals in the past decade (see this). Whatever the numbers, the FDA does not appear to have a huge problem filling its advisory committees.
Through the first nine months of the recently ended fiscal year, the vacancy percentage for panelists for the Center for Drug Evaluation and Research remained around 25 percent, which was below the 30 percent reached in 2009, according to the most recent available agency data (see this). Over the same period, the percentage of vacancies on Center for Devices and Radiological Health panels have been declining - from 28 percent in October 2010 to 13 percent this past June (look here).
Meanwhile, the percentage of conflict of interest waivers granted for FDA advisory members has remained far below the 12.78 percent target that was established (read here). And the percentage of vacancies overall has been declining, from 35 percent in July 2010 to 20 percent in June 2011 (look here).
The upshot is that the FDA does not appear to be having much difficulty finding experts without industry ties, despite the protestations from the pols who want the regs loosened - Minnesota Democrat Amy Klobuchar, North Carolina Republican Richard Burr and Colorado Democrat Michael Bennet, who introduced the Medical Device Regulatory Improvement Act to “streamline” FDA regs for devices.
For those who are curious, Klobuchar has received campaign donations from Medtronic (see this), and Burr received contributions from several drug and device makers, including Pfizer, Merck, GlaxoSmithKline and Medtronic (read here), according to the OpenSecrets database run by the Center for Responsive Politics.