Exclusive-FDA staff struggle to meet product review deadlines after DOGE layoffs

Yahoo

27-03-2025

(Reuters) - Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet deadlines mandated by Congress due to Trump administration layoffs, three scientists working on the projects told Reuters.
Two of the scientists who work at the U.S. Food and Drug Administration said they had been assigned around double the number of new product applications for review since their colleagues were fired. They requested anonymity for fear of professional repercussions.
They said they were instructed to shelve other work, including oversight of other reviewers and providing early feedback on planned product applications before they are submitted for approval review.
One scientist at the FDA's Center for Tobacco Products said the center had delayed starting new applications while staff worked on existing submissions, some with reviews that must be completed within 180 days under U.S. law. Several tobacco-related research projects have also been canceled, he said.
"We have 180 days to complete those (existing) reviews, and we're not going to come anywhere close to that. It's just not going to happen," the scientist said.
A medical device reviewer said they were working to the wire to meet some deadlines.
The FDA did not respond to a request for comment.
The U.S. Department of Government Efficiency - led by billionaire Elon Musk - fired around 1,000 probationary FDA employees last month, mostly from the agency's centers for tobacco, food and medical devices, before bringing some back.
Reuters could not confirm the final number of staff fired. The FDA had more than 20,000 workers earlier this year.
Ameet Sarpatwari, a professor at Harvard Medical School, said the FDA's loss of personnel and institutional experience could lead the agency to spend longer on reviews, resulting in products coming to market later, or spend less time on individual applications, increasing the risk of missing any red flags.
CANCELED MEETINGS
A lawyer specializing in FDA regulation, who spoke on condition of anonymity, said her clients at large medical device companies were deeply concerned that the FDA would start missing deadlines. Medical device industry group AdvaMed said the organization was hearing similar concerns, a spokesperson said.
Eva Temkin, a lawyer at Arnold & Porter who advises clients on medical device applications, said the FDA had canceled some meetings with companies or reverted to providing written responses only.
The FDA last year approved more than 3,000 medical devices, around three-dozen of which were for original, high-risk devices like Medtronic's Affera system to treat atrial fibrillation, and more than 250 applications for tobacco products, according to agency databases.
It is currently reviewing high-profile projects including one from Philip Morris International that seeks approval for a new iteration of its heated tobacco device IQOS. Philip Morris did not respond to a request for comment.
The U.S. Department of Health and Human Services, which oversees the FDA, submitted plans for further layoffs to the Trump administration earlier this month.
The administration had been offering $25,000 buyouts to FDA employees, excluding reviewers, investigators and security personnel, and early retirement ahead of that proposal, according to agency emails viewed by Reuters.
A second scientist in the tobacco division said he had been given more complicated applications to review, which require more in-depth study, after over a dozen people were fired in his office, while simpler submissions assigned to him had been put on pause.
He said he had also been given a regulatory memorandum to work on by himself that would normally be compiled by as many as six scientists.
Some of the probationary workers laid off from the FDA's tobacco center had been recruited last year for their understanding of emerging technologies, such as age verification software for electronic cigarettes, according to the first scientist.
"We needed a greater variety of expertise, and we lost that. And so that has left us scrambling quite a bit," he said.