Convergence: CDRH will continue with MDUFA V plan even with user fee delay

Regulatory NewsRegulatory News | 15 September 2022 |  By 

PHOENIX, AZ – The US Food and Drug Administration’s device center will operate based on the Medical Device User Fee Amendment (MDUFA V) deal negotiated with industry even if Congressional lawmakers fail to pass the legislation on time. The center has enough carryover funds to take it into the new year by when it hopes a bill will be signed into law.
The various medical user fee programs are set to expire at the end of fiscal year 2022 (30 September) if Congress does not reauthorize them. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), told attendees at RAPS Convergence 2022 that his center plans to continue operating on the understanding a reauthorization bill will be law before funding runs out.
“We're hopeful that Congress will reauthorize that by the end of the fiscal year,” Shuren said during a health authority forum focused on CDRH. “If not... we will proceed with the new performance goals, even if MDUFA V is not reauthorized on time, and will continue as if MDUFA V was in place to the extent we can.”
Shuren said his center can perform most of its obligations under MDUFA V using the carryover funds; however, other FDA centers are not situated the same.
Back in August, FDA Commissioner Robert Califf said that the agency would be forced to send layoff  warnings to staff in September if it looked like the reauthorization bill would not be passed on time (Related: Califf seeking Congressional assurance user fees won’t run out, Regulatory Focus, 1 August, 2022).
By statute, the FDA is required to do so 60 days before funding runs out. But in the past few weeks, agency leaders have become more optimistic that would not be needed.
“We cannot comment on our conversations with Congress, but at this time we have a reasonable expectation that the positions supported by user fees will be funded. We will continue to evaluate the situation,” FDA spokesperson Lauren-Jei McCarthy, said in an interview with Focus. “To ensure that we don’t have a budget shortfall, without assurance that we can collect fees beyond September, we would have to begin notifying [prescription drug user fee amendment]-funded staff of impending employment actions in September.”
Touting TAP
During the health authority forum, Shuren and other FDA leaders touted the agency’s total product lifecycle advisory committee program (TAP) which was a major point of contention for industry and the FDA during the MDUFA V negotiations (Related: MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more, Regulatory Focus, 23 March, 2022).
Douglas Kelly, deputy center director for science at CDRH, made the case for the program which he said would help sponsors better prepare products for market. As a former physician venture capitalist at Alloy Ventures in Silicon Valley who helped bring FDA-regulated products market, he said the TAP program would make a big impact on companies looking beyond getting products through the regulatory review process. 
“Poor communication and lack of coordination with external stakeholders required for successful commercialization hides a huge percentage of the risk in medtech development and commercialization, makes the process years longer, and is much more expensive and riskier than it should be,” he said. “The problem is innovators with a single product often think too tactically about just getting through the FDA as fast as possible and often… [don’t] think about the bigger business strategic questions that will certainly be brought up by payers, physicians, professional societies and [hospitals].”
That’s where he said the TAP program would come in by allowing all interested parties to voluntarily sit down and talk about what needs to happen during the product development stage for medical devices and diagnostics to be commercially successful.
When asked about how CDRH’s discussions with industry have evolved especially in terms of pre-submission meetings and other communications, Shuren said there has been a significant shift in the discussions over the years and that is going to “go to a new level” with the TAP program.
“It changes the tenor of the dialogue. I think it also changes the tenor of the relationship,” he said. “And you can see this exemplified in all the different kinds of growing collaborations that we have with industry, patients, providers and other customers.”


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