FDA negotiations with the medical device industry over user fees may get a little relief if a bill granting the watchdog agency a boost to its 2012 budget gets the green light from Congress.
As part of a bill from a House/Senate conference negotiation this week, the FDA’s pocketbook would not only avoid getting a trim – the agency would get a $50 million boost over last year’s budget.
Although the FDA’s device arm, the Center for Devices & Radiological Health, would only see a small bump, it could still take a lot of pressure off the agency’s negotiations over the fees industry pays to get its devices reviewed.
“FDA’s position earlier this year was that it wanted substantially greater sums in terms of user fees from industry, because it was concerned about appropriated monies falling off,” Medical Device Daily Washington editor Mark McCarty told MassDevice. “Now that the appropriated levels look like they’re going to jump up even a tiny bit, it gives the FDA a little bit more breathing room to negotiate with industry. And it takes some of the pressure off industry to agree to user fee levels that are greater than it would care to have to pay.”
The proposed bill grants the FDA an extra $50 million dollars, which would bring its total budget to $2.5 billion – a 2 percent bump from fiscal 2011. Most of the extra funding would go to the agency’s food safety and bioterrorism programs.
The bill would also meet CDRH’s $332 million budget and up the ante by $1 million.
Although the 0.03 percent increase is minor, any increase during times of austerity is a boon, McCarty said.
“It is a small increase, but when you look at how compressed the work is, I think an additional million dollars makes a big difference,” he told us. “It might only translate into a couple of additional full-time equivalents, but I guarantee you [CRDRH chief Dr.] Jeff Shuren’s not quibbling about it. He’ll be happy to take it.”
Rumors circulated earlier this year that Shuren’s 2012 bureau could face a 12 percent cut, equivalent to $40 million. Fears over lost funding may have played a role in the agency’s push for a hike in medical device application user fees.
Earlier this week, Shuren faced sharp questions from Sen. Richard Burr (R-N.C.).
Industry has long argued that user fees should stay at current levels until the FDA can make good on promises it made to improve review times, a concern that Burr voiced during a Capitol Hill hearing this week.
"Negotiations suggest that the agency is seeking a more-than 250 percent increase in user fees from current levels," Burr told Shuren. "Let me ask you – would you agree to pay somebody any money at all, much less a 250 percent increase over what they’re currently paying, when the terms of what you’re paying for aren’t being met?"
MDD’s McCarty said the support for this week’s budget proposal came from both sides of the aisle, giving it a fair chance of making it through both the House and Senate, even in a tough fiscal climate.
“You can get support for a better FDA budget from across the political spectrum,” McCarty said. “American citizens really don’t want to see a less effective FDA, they want to see a more effective FDA. If ever there’s an argument to be made for an exception to the rule that everyone’s going to need a haircut, this would be it.”
