Transcript of Device User Fee Meeting
FDA has posted the transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act (MDUFA) program. During the meeting, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the Center’s ability to continue to meet user fee goals. Hahn said without the Covid strain, CDRH staff were already “operating at a breakneck pace. The MDUFA 4 agreement set ambitious review performance goals, and it included a host of infrastructure and process improvement commitments that the Center has worked tirelessly to meet. Yet the size of the device user fee program, and the resources that come with it, are only a fraction of the size of the programs for prescription and generic drug user fees. This makes the program’s success all the more remarkable.”
The next MDUFA program, which doesn’t begin until 10/2022, will be an opportunity, Hahn promised, to make investments in human resources and programs that enhance opportunities for meaningful early and ongoing communication between FDA and device sponsors. “As demonstrated by the Breakthrough Devices program, if structured well, such interactive programs help bring safe and effective devices to patients more quickly than standard premarket reviews,” he said. “It’s also an opportunity to consider, for instance, what further investments can be made in the development and evaluation of real world data from patient registries, electronic health records, and other sources... Finally, it’s an opportunity to consider how we can provide technological, programmatic, and other resources to the device team – resources that enable the FDA to build a program that can continue to sustain its success by investing in our most important resource—our people—throughout the next MDUFA cycle and for years to come.”
The medical device industry, however, said it is not quite on board with potentially paying more for CDRH’s review activities. Medical Device Manufacturers Association (MDMA) Mark Leahy told the meeting that user fee revenue has grown from $144 million under MDUFA 1 to over $1 billion during the current MDUFA 4 (each MDUFA period runs five years).
“So, there have been significant investments that we've made, and throughout the negotiations we've been told multiple times that PDUFA [Prescription Drug User Fee Act) is a more mature program and we are 10 years behind,” Leahy told the meeting. He said the during the first four MDUFA legs industry was told it had to make significant investments, but then the program would move to a “maintenance pathway,” and that was a key selling feature to get industry to agree to the current billion dollar threshold. “And we've created a solid foundation, and now it is making sure that the tools are utilized wisely, that if there are lessons learned from Covid and others we can enhance the process to make it more efficient without compromising patient safety,” he said.
Absent any commitment for companies to pay more user fees, AdvaMed senior executive vice president Janet Trunzo encouraged CDRH to focus on the basics of the review process to advance the principles of consistency, predictability and efficiency. “We have the tools we need with the current infrastructure,” she said, adding that there should be a focus on review process basics from the pre-submission process to the interactive review and then to the final decision. She said AdvaMed looks forward to results from CDRH’s Quality Management Systems program, and other programs such as the improved third-party review program, and the use of real-world evidence to support premarket regulatory decisions.