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

Patrick Wingrove - Reuters - 27/03
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.
  • Some scientists assigned double the number of new product applications for review
  • Some deadlines for tobacco products will not be met and the start of new applications have been delayed, scientist says
  • FDA staff told to shelve other work, including providing early feedback on planned product applications
March 27 (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.

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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...
[Short citation of 8% of the original article]