ARTICLE SUMMARY:
FDA is thinking big, while industry groups are urging restraint for the next round of user fee negotiations, in this report from the editors of Market Pathways.
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The next round of device user fee negotiations is kicking off during an unprecedented time for the FDA and device industry, but, in many ways, the core disagreements the two sides work through every five years won’t be that different in this fifth, MDUFA V, go-around. In short, it will be about resources—FDA wants more as industry pushes for restraint. That underlying thread was evident during FDA’s October 27 public (virtual) stakeholder meeting to officially launch the discussions that will be needed to hatch out a reauthorization plan before the current MDUFA IV program expires in 2022.
The meeting had been postponed twice and couldn’t be held in person due to the pandemic; it was unavoidable that COVID-19 framed the day’s discussions. FDA officials emphasized the tremendous strain the pandemic response has put on its staff, but also underscored the unprecedented speed and flexibility it has displayed in churning out Emergency User Authorizations, review templates, and enforcement discretion guidance documents. Industry speakers similarly praised the agency for its COVID-19 performance.
One striking element of the pandemic has been, despite a doubling or more of overall workload for FDA device reviewers, the agency continues to meet its user-fee program performance goals for non-COVID-19 devices. Other than some dilution and delays in the pre-submissions process, CDRH seemed to be covering its bases. More recently, however, agency officials have been warning that its broader premarket review performance is going to start to show more signs of wear as the pandemic carries on. For instance, in a video posted in advance of the kickoff meeting, Barbara Zimmerman, deputy director of CDRH’s Office of Regulatory Programs, highlighted several early signs of degradation, including aslight slowing of 510(k) and PMA FDA review timelines and a growing backlog of pending PMAs.
“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, but it is also a level of effort that cannot be sustained in perpetuity,” FDA Commissioner Stephen Hahn said in his October 27 remarks.
But Hahn went further than simply highlighting anticipated impacts during the pandemic. He linked the current pressures to broader resource constraints at CDRH even out outside of the public health emergency context. And he started laying the groundwork for a MDUFA V negotiation position by the agency to raise industry user fees.
“Even absent the COVID-19 pandemic, FDA’s medical device team was already operating at a breakneck pace—the MDUFA IV set ambitious review performance goals and it included a host of infrastructure and process improvement commitments that the center has worked tirelessly to meet,” Hahn noted. “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. However, it also causes me concern for the long-term health of the program, and its ability to both protect and promote public health, particularly in light of the ever-accelerating pace of device innovation.”
The case made by Hahn that there is a resource shortfall dovetails with the CDRH’s anticipated push for big underlying reforms in FDA’s review processes, some of which could require more money to FDA, including, potentially, in the form of industry fees.
Even before the pandemic, CDRH Director Jeff Shuren had been urging industry to think broadly about what can be improved, both as part of the core MDUFA V agreement and potentially in legislative reforms that can be accomplished in parallel with the user fee reauthorization. In particular, Shuren has advocated for changes to the agency’s device framework that would allow the center to employ more flexible regulatory building blocks to better address new technologies as they evolve, and stand up new paradigms, such as a nascent pre-certification program for digital health, without having to continually go back to Congress.
The COVID-19 experience has caused CDRH to further rethink its regulatory processes, and Shuren has made the case that it would be “a tragedy” for the center not to adopt for more routine use some of the emergency-era approaches advanced in recent months. These could include more real-time guidance document updates, establishing standardized review templates for an array of devices, and building on the center’s growing “total product lifecycle” focus linking premarket and postmarket activities.
At the MDUFA V stakeholder meeting, Shuren reemphasized these points and linked the opportunities more directly to the oncoming user fee reauthorization process. “We should engage in a dialogue about where we want the medical device ecosystem to be at the end of MDUFA V, and then consider how the user fee program can best be used to support achieving that future state, as well as additional actions that we should take,” he noted.
Industry Urges Moderation
Device companies, on the other hand, are signaling a much smaller appetite for potentially costly MDUFA V changes. Industry groups were aligned at the meeting in recognizing the unprecedented challenges and strains from the ongoing pandemic. But, they noted, the current device review program is fundamentally sound. The next reauthorization, they argue, should build on the existing program and narrowly focus on improving individual areas of weakness.
“Given the satisfactory performance the agency has achieved under MDUFA IV, at this time, we do not anticipate any need for major new programmatic initiatives or major new commitments in MDUFA V,” said Peter Weems, director of policy and strategy for the Medical Imaging & Technology Alliance.
“We have the tools we need with the current infrastructure,” agreed Janet Trunzo, who runs AdvaMed’s regulatory shop, during the meeting. “Now we just need to focus on sharpening those tools and maximizing their use.”
Mark Leahey, president and CEO of the Medical Device Manufacturers Association, compared the approximately $1 billion in total five-year fee collections baked into the current MDUFA IV program to the $144 million total for the first user fee program that started in 2003. “There have been significant investments that we have made,” Leahey noted, arguing for thinking smaller for the next round. “Fundamentally, our members believe that the primary source of funding for the agency should be congressional appropriations.”
Industry groups appear open to adopting some COVID-19-era best practices, but not in the service of achieving big-scale reforms. The trade group speakers placed more attention on ensuring that some MDUFA IV commitments that have fallen through the cracks are followed through on, before pursuing new agendas. For example, both Trunzo and Leahy pointed out that there are about 50 more FDA positions funded by MDUFA IV that have yet to be filled by the agency. They also noted gaps FDA has identified via internal audits on the commitment by reviewers to cite the specific rationales for observations made in each premarket review deficiency letter sent to a company.
Now that the public meeting has taken place, FDA and industry can move toward more detailed negotiations. Those will take place over the next year and a half, a period of likely massive change in the underlying public health, economic, and political dynamics in the US, that will potentially include a new administration in the White House and, hopefully, a subsiding of the pandemic. Nonetheless, much of the discussion could hinge on basic questions of dollars and cents.