Strained by Covid, CDRH Wants More MDUFA Money
CDRH will be seeking a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program. During a 10/27 public meeting on reauthorizing the user fees, 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. “It is no exaggeration to say that the work I’ve witnessed from my colleagues over the past eight months has been nothing short of heroic,” he said at the meeting. “But it is also a level of effort that cannot be sustained in perpetuity.”
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.”
Non-Covid submissions have not slowed down, according to Hahn. During the first eight months of 2020, original PMAs, de novo submissions, and 510(k)s submitted exceeded the numbers from a year ago. At the same time, the Center is actively engaged in revamping safety surveillance with the goal of being “consistently first among the world’s regulatory agencies to identify and act upon device safety signals,” he said, through the National Evaluation System for health Technology Coordinating Center (NEST). The public-private partnership NEST will perform active surveillance, efficient post-market safety studies, and develop, test, and apply new methods to detect and evaluate enhanced safety signals, he said.
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 is not quite on board with potentially paying more for CDRH’s review activities. Medical Device Manufacturers Association (MDMA) Mark Leahy told the public 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.
Leahy said a MDMA member survey found that 95% of them “prioritize the quality of the journey over the time of the journey, meaning the more consistently transparent and predictable it was, that was far more important than a day or two on a decision goal, with the understanding that if you have a more well-defined consistent process, that the net output here should be a more efficient review at the end of the day.”
Leahy said that MDMA members believe that the primary source of funding for the agency should be congressional appropriations, and that it was always intended that user fees were supplemental in nature, and not to be the primary source of funding. “We think that's a critical tenet to maintain as we enter the MDUFA 5 discussions as well.
Additionally, Leahy said MDUFA 5 should focus on areas that may have fallen behind a little bit, like a guidance on “software as a medical device” and deficiency letters with improved specificity (those that cite a statute, guidance or regulation). He said an FDA audit in 2019 found that 27% of the deficiency letters that came out actually had that citation with specificity. There has been additional training, and an audit performed this year found that the deficiency letters have improved to 50% with the sought-after specificity, he said.
“I think before we go and look to create new initiatives or priorities, there are some foundational MDUFA 4 commitments we should focus on that were important, and that were previously negotiated, Leahy said. “We need to make sure that was realized before we look too far ahead to try to create a number of number of new initiatives.”
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.