Three years after the FDA enacted tougher conflict of interest rules for its advisory committees, a legislative effort is under way to roll back the policy. A trio of US Senators has introduced a bill that would reverse agency regulations that bar experts with financial ties to drug or device makers from serving on the committees without a waiver.
The move comes shortly after FDA commish Margaret Hamburg told Congress that the agency was finding it increasingly difficult to locate qualified experts who do not have financial ties to drug or device makers (read here and here). Current FDA regs include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 (see this).
In particular, the impetus for the proposal is a heated debate over the FDA approval process for devices. Over the past year, device makers have bitterly complained the agency implements inconsistent regulations or simply does not approve devices fast enough. Meanwhile, the US Government Accountability Office says the FDA failed to strengthen its approval and recall procedures (look here).
To remedy the situation, Minnesota Democrat Amy Klobuchar, North Carolina Republican Richard Burr and Colorado Democrat Michael Bennet introduced the Medical Device Regulatory Improvement Act to “streamline” FDA regulation of devices. Minnesota, by the way, is home to Medtronic, one of the largest device makers. In a statement they said this about advisory panel conflicts:
“Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government” (here is the proposed bill).
A companion bill may soon be introduced in the House, according to Reuters. However, some consumer advocates have already begun pushing back, arguing that the FDA is buckling under industry pressure and that finding unconflicted experts for panels is not has difficult as agency officials would have the public believe.
For instance, we wrote two months ago that the Project on Government Oversight watchdog group challenged Hamburg to look harder for qualified panel members and cited data gathered by the agency to debunk recent comments made by agency officials. POGO found the number of conflict of interest waivers granted for FDA panel members never exceeded 5 percent, below the legal cap of 13 percent.
The group also cited published FDA data indicating the vacancy rate for advisory committees fell another 2 percent this year, and has fallen 10 percent overall, from 33 percent in 2009 to the present rate of 23 percent, suggesting the FDA is having fewer problems finding experts without industry ties (read the letter and the FDA data cited by POGO).