Shuren apologizes for MDUFA delay, says FDA will start closing the spigot on new EUAs

Regulatory NewsRegulatory News | 30 March 2022 |  By 

The head of the US Food and Drug Administration’s (FDA) device center was criticized by top House lawmakers for not getting a Medical Device User Fee Amendments (MDUFA V) deal to them for review on time. He apologized for missing the statutory deadline and noted his staff have been slammed due to the COVID-19 pandemic.
On 30 March, the House Energy and Commerce (E&C) subcommittee on health met to discuss renewing FDA’s MDUFA program. At the start of the meeting committee Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-OR), scolded Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), for missing the 15 January deadline to submit a MDUFA V commitment letter. (RELATED: MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more, Regulatory Focus 23 March 2022)
The letter is a tentative deal between FDA and the medtech industry on how much revenue the agency will bring in over the next five years to help pay for reviewing premarket applications while also setting performance goals for reviewers to meet.
“This deadline is not a mere suggestion it's actually the law and the process is important because it allows for the FDA, industry and members of the public to examine what has worked well, and where review programs can be improved through the reauthorization process,” said Pallone. “It also provides Congress with time to thoroughly review these recommendations and reauthorize the program ahead of the funding deadline.”
Pallone noted that FDA and industry were not only delayed two months but since they only got the letter a week ago there hasn’t been enough time for the agency to collect public comments on the deal which he argued has serious unanswered questions on a number of issues. Despite the delay, he said Congress will get the program reauthorized before it expires on 30 September, so that FDA isn’t forced to lay off staff paid through the device user fee program.
“I'm not trying to beat you up Dr. Shuren but the bottom line is we get this two months later, we're going to meet our deadline because we don't want to have the pink slips but I remember a few years ago when the pink slips went out and everybody was saying, 'Well Congress why didn't you do this quicker?'” Pallone said. “Well in this case it's your fault. I don't know how else to put it.”
McMorris Rodgers, also piled on and expressed her disappointment with FDA and industry for missing the deadline and only giving lawmakers a week to review the deal. She also noted that she’s concerned about “the lack of transparency” throughout the MDUFA negotiation process and wrote to then acting FDA Commissioner Janet Woodcock about the agency’s delay in posting meeting minutes.
"To ensure transparency and progress, documentation of meeting outcomes and action items are supposed to be made part of the official record and made publicly available,” she said. “While posting minutes publicly takes no more than two to three weeks, during MDUFA V negotiations we saw delays of 6 months. Even today there are no meeting minutes posted for any meetings that took place after June 30, 2021."
In response to the criticism, Shuren apologized to lawmakers for the delay and noted that his staff have had to put a lot of things on the backburner to prioritize their work on developing guidances and reviewing emergency use authorization (EUA) applications related to the pandemic.
"I want you to know I personally regret that we missed the statutory deadline to deliver our recommendations to congress. I and the entire agency take this obligation very seriously,” he said. “I am pleased to report however that the long deliberations have ultimately produced a strong thoughtful agreement on recommendations to congress that if enacted will continue to advance medical device innovation while maintaining the FDA’s standards to protect patients."
Shuren noted that while the agency met or exceeded its MDUFA obligations at the start of the pandemic, it eventually was overwhelmed and ended up falling short on a number of metrics due to increase in workload for which the agency wasn’t well-funded. He also added that its reviewers received 15 times the number of EUAs that they typically see during a public health emergency (PHE) and overall received 8,000 EUAs of which they’ve authorized 2,200. They are reportedly still receiving about 130 EUA applications a month.
"This has been a perfect storm my center has been battling for two years… with many of my staff burning the midnight oil and burning out in the process," said Shuren.
If Congress fails to reauthorize the MDUFA deal by September, Shuren warned that FDA will have to start laying off staff which could lead to delays in product reviews and the US risks losing its edge in getting medical technologies to market first.
Pallone asked Shuren, what could be done to make the MDUFA negotiation deal better so that the same kind of delay is avoided in another five years when MDUFA VI is being negotiated.
Shuren again noted that this was an unusual situation because FDA was delayed due to the pandemic but suggested adding an additional deadline.
“This was us and industry saying we're getting hammered with COVID, we need more time,” he said. “One thing maybe congress can do is rather than just have the date when you have to come to congress, have the date when we have to sit down and get this started so we have enough lead time to get it done."
McMorris Rodgers pushed on the fact FDA hasn’t provided meeting minutes on negotiations between itself and industry since 30 June and asked Shuren how many meetings have been held since. She noted that the lack of minutes means lawmakers and the public has been left without much context on how the MDUFA deal was developed.
Past reporting has indicated that FDA and industry also suddenly halted public negotiations in late November and then went into overdrive after the 15 January deadline to finally come to an agreement. McMorris Rodgers pressed Shuren on how many meetings were held between FDA and industry in that timeframe.
Shuren noted that while the meeting minutes have not been posted, he estimates FDA and industry met over a dozen times since 30 June to hash out a deal. He explained that MDUFA negotiations are very sensitive like international treaties with a lot of parties involved and all sides were more focused on reaching a deal.
"We put the priority on getting the deal done than the meeting minutes," he said.
Shuren also noted that while there weren’t a lot of in-person meetings between December and January, there were a lot of offline discussions with industry to get to a deal.
Rep. Anna Eshoo (D-CA), chair of the health subcommittee, asked Shuren what FDA’s plan is over the long term to help alleviate the extra burdens caused by the agency’s response to EUAs.
Shuren said the agency is taking steps to narrow their focus to EUA devices that are especially important in the pandemic fight.
"Over the coming months the goal really is to start turning off the spigot on EUAs [because] there's enough product out there," he said.
During the hearing McMorris Rodgers noted that FDA published two draft guidances in December on transitioning EUA products to regular marketing authorization. In response, industry groups have raised concerns that the agency’s proposed guidances don’t give companies enough time to submit a premarket application and make labeling changes.
She asked whether FDA was taking those concerns into account so as not to worsen potential supply chain shortages that could affect patient access to devices, and whether it had the resources needed to handle the influx of applications.
Shuren said that FDA is still reviewing the comments but encouraged manufacturers to not wait for the PHE to be over to transition their products to regular marketing status. He said if device makers know they plan to make that transition they should come to FDA as soon as possible with their data and start the process.
“Also remember the product is already on the market and we're going to focus on new product applications but we're not going to disenfranchise anyone who already has their product on the market,” he added.
A major concern that Shuren and other FDA leadership have raised during the pandemic is they are worried that experienced staff are burning out from their pandemic workload and potentially leaving the agency. The director noted that work flexibility such as being allowed to work from home has helped the agency keep staff and they are seeing better recruitment than ever before. However, one thing he said that could be very helpful in recruiting more people is if Congress gave FDA direct hiring authority that isn’t tied to certain legislation such as the 21st Century Cures Act.
"If we find the right person, let's bring them in as quickly as possible," said Shuren.
Maybe the most contentious issue between FDA and industry during the MDUFA V negotiations was the agency’s wish to create a total product lifecycle advisory program (TAP) that could incorporate external stakeholders such as physicians and insurance providers during the presubmission process. While industry pushed back on the issue stating it didn’t think there was a lot of interest from external stakeholders to participate in the program, FDA argued it could help manufacturers better understand what users and insurers want to see in a product to better inform its development. Ultimately, the two sides agreed to start off with a TAP pilot program to see if it is successful.
Rep. Brett Guthrie (R-KY) asked Shuren what the difference was between the TAP program and FDA’s presubmission program that allows product sponsors to discuss product development before submitting their device for agency review.
Shuren noted that while the presubmission program was immensely popular with sponsors, it’s narrowly structured to address individual questions in a back-and-forth process that can be relatively slow. The TAP program on the other hand according to the director address bigger marketing questions close to real-time.
He said it also addresses a major issue that the medtech industry has long complained about called the “valley of death,” which is the time between when a product gets FDA marketing authorization and when it starts getting reimbursed by insurers based on factors such as clinical meaningfulness.
"If we can solve the challenges before we get the submission, we're not talking about saving days, we're talking about saving months and years in getting to yes more efficiently,” said Shuren. “TAP can be a gamechanger, and this is what we learned from COVID that it really works, it's part of the secret sauce, that got those 2,200 devices out onto the market."
When asked about the fact MDUFA V potentially almost doubles its expected revenue compared to MDUFA IV, Shuren stated that the previous user fee deal was under-resourced, and the agency had no way to adjust it.
By contrast, he added the MDUFA V deal is designed to deal with resource gaps while also allowing the agency to improve its performance goals which includes the TAP pilot program, more funding for analyzing real-world evidence, adopting national and international consensus standards and driving international harmonization, which Shuren characterized as the “next frontier.”
On a separate matter, Eshoo also noted that in June 2021, FDA published a draft guidance that attempts to clarify the different between servicing and remanufacturing. She asked whether the agency needs further clarification of the terms in statute which presumably could be added as an amendment when the reauthorization bill is passed. (RELATED: FDA explains when device 'servicing' becomes 'remanufacturing', Regulatory Focus 17 June 2021)
Shuren said that FDA is still looking over the comments but "there is value in providing greater clarity and maybe even doing so through statute.”
“When we saw reports come in with servicing [adverse events] most of those had to do with remanufacturing, so clarity about what constitutes and what doesn't constitute remanufacturing is important,” he added.


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