There's been an ongoing debate in biopharma circles over the impact a shortage of drug experts is having on the FDA's panel review process. But anyone looking for the agency to welcome changes in the rules governing conflicts of interest--which have been keeping some of the experts at bay--can rule out any support from FDA Commissioner Margaret Hamburg.
In testimony to Congress this week, Hamburg made it crystal clear that the agency isn't supporting any new legislative initiatives to ease the 4-year-old set of rules, despite calls from supporters who say the changes would significantly reduce approval times and enhance innovation in the industry. The FDA has more than enough waivers to use if the agency believes that it needs to get more panelists, says the commissioner.
"At the present time, we are not bumping up against our cap in terms of waivers," Hamburg told a House committee, according to a report in Reuters. "We don't at the moment see major areas where a legislative fix is required."
Patient advocacy groups are likely to cheer that position. But it won't sit well with many on the drug development side of the fence, especially as critics constantly roast the agency over what they see as an unresponsive bureaucracy that moves far too slowly.
"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," noted Geno Germano, president of Pfizer's ($PFE) specialty care and oncology unit, according to Reuters.
Given the difference of opinion, this is one issue not likely to go away anytime soon.
- here's the story from Reuters