Some members of congress are calling for the FDA to provide quarterly reports on the agency’s progress toward meeting the goals set forth in the recent medical device user fee agreement.
Reps Erik Paulsen (R-Minn.) and Anna Eshoo (D-Calif.) sent a letter to the federal watchdog agency in late August asking the FDA to provide Congress with quarterly reports on whether or not they’re meeting specific goals and milestones set forth in the recently passed re-authorization of Medical Device User Fee & Modernization Act, Paulsen told MassDevice.com this week.
Paulsen told us the goal of the request is to continue to hold the FDA’s feet to the fire.
"We thought it was important that, given all the work we did with the re-authorization work, that we should have some follow up," he said.
The Minnesota lawmaker said he hasn’t received a formal response from the FDA but is intent on following up with the agency to make sure they’re in compliance. Specifically, Paulsen wants the agency to inform legislators if they’re going to miss any of the benchmarks set forth in the agreement.
The med-tech industry and the FDA spent months hashing out the terms of the deal, which ultimately boosted the user fees from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals. The deal was signed into law after the user fee bill had passed nearly unanimously in initial rounds in both houses of Congress, on a 387-5 vote in the House and on a 96-1 vote in the Senate.
At the time of the deal, Rep. Joe Pitts (R-Penn.) told MassDevice.com that lawmakers expected results.
"We’re going to follow up with real oversight on the FDA as to what they’ve committed," Pitts told us. "We’re going to make sure they really deliver on what they’ve promised."