WASHINGTON — The FDA’s center for approving devices has neither the staff nor the money it needs to fully do its job, said Jeffrey Shuren, MD, JD, at a briefing sponsored by the Alliance for a Stronger FDA on Thursday.
“Are we staffed at the level we need? No,” said Shuren, who is director of the FDA’s Center for Devices and Radiological Health (CDRH). “I don’t think we’re really close to the staff we truly need to carry out our critical public health mission.”
The center has hired almost all of the people it can hire under the Medical Device User Fee Amendments (MDUFA) authorization, “and we really don’t have a lot of other money to be hiring other kinds of folks, although we are looking at using certain carry-over dollars in user fees for some of that,” he said.
“Quite frankly, the big thing is we need to be able to pay more,” Shuren added. “We have to be competitive with the marketplace — we continue to lose good people to the private sector. We even lose people within the agency to those who might be able to pay more and offer better opportunities.”
He lamented that current employees don’t feel as if they have time to take advantage of the professional development opportunities his agency offers. “The job has to be attractive, it’s got to be fulfilling, and it’s got to provide a good work/life balance. If we continue to treat people as if they’re in a sweatshop, quite frankly, it will continue to be difficult to get the best and the brightest.”
More Funds Needed
“So the real answer on the budget — has it kept up with demands? The simple answer is no,” Shuren said. “We still have great needs, and they are much worse with the pandemic, which again shows that we really have very little give or capacity.”
For about a decade, “we haven’t seen any kind of meaningful increases in our appropriations at CDRH,” said Shuren. “When you combine that with the fact that the cost of things continue to go up just from inflation alone, the purchasing power of every dollar we have goes down — so a flat budget.”
He added, however, that starting in 2019 the agency did get some targeted funding increases from Congress. “I have to say a very big thank you to Congress and particularly our appropriators; those dollars have been critically important. And they are making a difference.”
CDRH is “responsible for roughly over 230,000 different types of medical devices with over 20,000 different manufacturers,” he said. “It is a huge responsibility.” Only about 35% of the CDRH budget comes from user fees, with the rest from money appropriated by Congress.
If CDRH is compared with the Center for Drug Evaluation and Research (CDER) — the agency responsible for evaluating new drugs and vaccines — CDER gets eight times or more the user fees that CDRH receives and has about three times the number of people, “and I would not say they have any more work than we do, so when you put that together, the resources are still tough,” said Shuren.
Meeting New Demands
As for new demands on the agency, “they include being able to address the pandemic and try to get back to the ‘new normal,'” said Shuren. “Quite frankly, we’re not well positioned to meet the current needs that we see today, let alone be well positioned to address the technologies that we know will be coming … Many in the public — some in industry, some elsewhere — are just used to us being underfunded and somehow always pulling off a miracle. I will tell you that after having gone through the pandemic and where we are, there are essentially no more rabbits to pull from our hat. That’s the bottom line.”
Shuren also addressed other issues during the briefing, including the successes his agency has had during the COVID-19 pandemic. “We have authorized, either through emergency use authorization or traditional pathways, over 1,500 medical devices for COVID — just a phenomenal number — and we’ve responded to or prevented over two dozen device or device component shortages,” he said. “We had a 1-800 hotline that we staffed 24/7 for many weeks to answer anybody’s questions on COVID and medical devices.”
The COVID workload, on the other hand, has been a real challenge. “It’s a massive workload,” he said. “During this time we’ve received over 7,000 EUA [emergency use authorization] requests and pre-EUA requests, and this is on top of roughly 25,000 traditional premarket submissions … With that and insufficient resources, it has put a tremendous strain on the system.”
Keeping the Team Afloat
On the non-COVID side, “the big success is just the very fact that we kept the ship afloat, and we kept the team together,” Shuren continued. Although CDRH is continuing to try to meet the deadlines set under MDUFA, “we’re anticipating we’ll probably fall off some of those goals, but we’ve continued to put out deliverables under that program.” One issue is having to redirect staffing and other resources to the pandemic — “it’s the equivalent of over 330 people working full time for an entire year just on COVID, and this is in a center that has about 1,900 people, so that’s a big impact.”
Shuren also addressed the lessons learned during COVID-19. “Let me flag two: they are regulatory flexibility and engagement,” he said. CDRH’s use of EUAs “gives us tremendous flexibility in better tailoring our evidentiary and other expectations to the technology, and then quickly adapt as circumstances change, and that allowed us to facilitate, for example, tests being developed, validated, authorized, and deployed within a few weeks rather than traditional months or year long. And I think that kind of flexibility is something that we need all the time, not just in the setting of the public health emergency.”
As for engagement, a key component was the ability “to work with developers, essentially in real or near-real time,” said Shuren. “We are not resourced to do that routinely; it’s unsustainable, but the impact has been enormous.” Companies that worked with CDRH in this way “all say the same thing: ‘We would like to never have to go back to the old way.’ And so we could do that if we have the resources to make it happen.” Shuren added that he’s working on a proposal to put into the MDUFA reauthorization legislation that would allow CDRH to do just that.
Looking to the future, Shuren said CDRH “needs to establish a permanent device shortages program … We have never received dedicated funds for a device shortages program. And that has obviously important ramifications, as we found in the context of the pandemic. So as a result when we hit the pandemic in the beginning, we had to pull people to do work on shortages — we essentially had to reassign, full time or part time, roughly 130 people to do that.”
Cybersecurity will also be an issue needing CDRH’s attention now that more healthcare is being rendered via telehealth and remote monitoring, he added.
Last Updated July 22, 2021