Trump layoffs begin to erode FDA drug review system

Yahoo

04-04-2025

By Ahmed Aboulenein, Julie Steenhuysen and Maggie Fick
WASHINGTON (Reuters) -The Trump administration's mass firings at the U.S. Food and Drug Administration have removed employees critical to reviewing new medicines, setting back years of effort to bring promising treatments to patients more quickly, former and current FDA sources told Reuters.
The FDA is slated to lose 3,500 employees under Secretary of Health and Human Services Robert F. Kennedy Jr.'s massive restructuring of U.S. health agencies that is part of President Donald Trump's wider campaign to dramatically slash the federal workforce.
Staff began to receive termination notices on Tuesday, but it is unclear how many have been fired so far.
Kennedy said last week that the main goal of the cuts was to centralize support functions such as technology, procurement, human resources and communications. Yet the personnel changes have included the ouster of high-ranking scientists at most major FDA divisions overseeing drugs and vaccines, medical devices, food, veterinary medicine and tobacco products.
"These deep cuts and the loss of experienced leadership at virtually all the major centers that regulate the safety of food, drugs, devices is quite high risk," said Dr. Jesse Goodman, former chief scientist at the FDA and director of Georgetown University's Center on Medical Product Access, Safety and Stewardship.
"If there is a safety issue with blood or a medical product or some vaccines, it's very important that you detect that and respond to it quickly, and it takes people who really understand it to do that," Goodman added.
The firings this week also include all staff responsible for managing records – such as new product applications – at FDA divisions that oversee biotechnology therapies, medical devices, veterinary medicine and tobacco products, three sources said.
The office that arranges travel for FDA inspectors who ensure factory production lines are meeting safety standards also was cut, three sources said.
Employees directly tasked with reviewing new products appear to have been spared the layoffs, but four sources said they were aware of reviewers who were seeking new jobs outside of the agency due to the disruption.
That prompted concerns over not having enough reviewers to participate in already scheduled meetings with pharmaceutical and device companies, as they would be required to recuse themselves from considering new products from an industry in which they might work.
"The FDA will stay focused on ensuring the safety and efficacy of drugs, medical devices, food, and other critical sectors, and we will continue to meet our regulatory obligations with the integrity and urgency that the American people deserve," an HHS spokesperson said.
Former FDA Commissioner Dr. Mark McClellan, now an economist at Duke University, however, said, significant reductions in staff "have the potential to compromise some of the very important FDA capabilities that have been built up over the last couple of decades."
That is especially true of drugs developed with new mechanisms or through innovative approaches such as artificial intelligence or drugs intended for very rare diseases, he said.
"I'm not sure all these reductions are going to stick because of those direct impacts that I don't think were intended," McClellan said.
'NO PLAN'
Calley Means, a Kennedy ally and recently appointed White House adviser, rejected the idea that the layoffs would undermine public health.
"It is insane for you to insinuate that the thing standing between us and better health is more government bureaucrats," Means said at Politico's Health Care Summit.
The Senate Committee on Health, Education, Labor, and Pensions invited Kennedy to attend a hearing next week to explain the firings. The committee is chaired by Republican U.S. Senator Bill Cassidy of Louisiana, whose vote was key to Kennedy's confirmation.
Cassidy initially showed hesitancy to confirm Kennedy, largely over the nominee's decades promoting theories on the dangers of vaccines contrary to scientific evidence. He said he ultimately agreed to vote for Kennedy after receiving assurances that existing vaccination programs would be protected.
Asked by reporters on Wednesday whether Kennedy appears to be backsliding on his vaccine promises, Cassidy said: "We're in dialogue about that."
Industry groups PhRMA and the Association for Affordable Medicines, which represent makers of branded and generic drugs, respectively, warned that dismissing key officials could hinder the availability of treatments to patients and stressed the importance of maintaining the FDA's expertise.
Some FDA staffers questioned whether any of the firings were in error. Last month, medical device reviewers fired by Elon Musk's DOGE cost-cutting task force were quickly re-hired after the potential impact of their departures on product reviews became apparent.
"They took all of the leadership out with no plan," said a recently terminated official in the FDA animal health division whose work involved addressing the threats of bird flu and antimicrobial resistance, among other functions.
"My most optimistic theory is that some people in DOGE had no idea what they were cutting and they will ask us to come back in a couple of days," the official said.
HHS said on Thursday that some laid off health agency employees will be asked to work remotely until June 2, when their administrative leave expires, while Kennedy said others may be reinstated, without providing details.