This week, the Trump administration followed through on its plans for mass layoffs at health agencies under the US Department of Health & Human Services (HHS).
Per a communiqué issued by the White House last week, layoffs at HHS departments including the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) would total around 10,000. Including voluntary resignations and retirements, the plans to drive governmental efficiency and ‘Make America Healthy Again’ were projected to reduce the total full-time employees under the combined HHS agencies from 82,000 to 62,000.
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Medical device contract research organisation (CRO) NAMSA hosted a webinar on 3 April to discuss the potential impact of the layoffs on the medical device industry.
Addressing the potential impact of the cuts to the FDA’s review and approval process of medical devices, Dr Jeff Shuren, who served as director of the FDA’s Center for Devices and Radiological Health (CDRH) from 2009 until July 2024, said it would “not be surprising” if the cuts resulted in longer device review times, at least in the near term.
“One of the challenges moving forward will be to assure that the FDA’s premarket review programme has the expertise that it needs, and that time and attention is put into recruitment and retention,” said Shuren.
The Trump administration has stated that it wants to be more effective and efficient and to do more with less. Shuren’s view is that various opportunities may exist to meet these aims.
Shuren added: “I don’t know where they’ll go, but there are discussions around using artificial intelligence (AI) tools to help in premarket review…. the centre was already looking at those and starting to invest in tools to leverage AI to make it [the programme] more effective and efficient.
“It’ll be important to continue efforts in areas including data management, taxonomies and tagging to make the best use of the data available.
“And we had an effort underway to do that. But it’s not yet done, so hopefully, if anything, that gets expedited. But some of the people involved in that were also part of the ‘rips’”.
Shuren’s forward-looking hopes are that career staff at the FDA remain part of efficiency-solution efforts and that whatever is done, his hope is that it doesn’t “compromise the rigour” of the evaluations performed by the agency.
“Having robust science to inform decision-making has been the lifeblood for the agency, and patients and providers rely on the FDA to assure those devices are safe and effective,” he added.
Open communication principles
According to Dr Juan Granada, president and CEO of the Cardiovascular Research Foundation (CRF), while no system is perfect, there were no specific issues that needed to be “drastically changed” in the FDA’s collaborations with the CRF and other companies.
And while the CRF is amenable to innovation and change, Granada said there is now a lot of “fear and uncertainty” about how the future may look.
“All these changes are deeply impacting what we do, with international companies left wondering if there is going to continue to be a functional FDA that can help them, and those at a critical point of development left wondering what is going to happen next.”
According to Martin Leon, professor of medicine at Columbia University Irving Medical Center and CRF founder and chairman, the FDA has “evolved dramatically” over the past 15 years, favouring innovation, embracing communication, and developing a commitment to both safety and the efficient approval of new medtech and other technologies that are really meaningful to patients.
In his view, the changes that appear to be occurring are “in the face” of what has been a successful organisation in the recent past.
Leon added that a key part of this has been in the open communication principles Shuren introduced at the agency and highlighted his observation that with the administration’s changes, the FDA no longer has a public-facing interaction capability.
“What we were most proud of was the fact that we had open communication with the agency,” Leon said.
“We could discuss the likes of regulatory science, and brainstorm new ways to improve how we managed certain current approval processes. That dynamic of an open communication process was extremely helpful.
“It’s painful for me to see that a lot of that has been erased very quickly. To the extent that can be restored in a way that preserves the communication would I think be very important going forward.”
As a regulatory agency that is committed to public health, Leon concluded that the FDA does not function “in a vacuum”.
He stated: “If we lose things like communication and, in the ability to improve regulatory science, if we lose things like our strong innovative culture, then I think it is going to have a long or negative impact on the way we interact with patients and on the way in which we develop our healthcare system.”
