By Josh Nathan-Kazis

When Vera Rosenthal left work at the offices of Food and Drug Administration a week ago, she made sure to take home her Dr. Anthony Fauci bobblehead doll.

Rosenthal had a hunch layoffs were on the way. "I was not letting them keep my Fauci bobblehead," she says.

Rosenthal was right about the layoffs. The email telling her she was out of a job landed in her inbox at 5:14 a.m. on Tuesday morning. She found out about it about an hour later, when her group chat with her co-workers lit up.

Rosenthal had worked in an office that alerted the public about dangerous problems with medicines. As of Tuesday morning, that office is gone.

"If we aren't able to tell you about the good, the bad, and the ugly about what's going on," she says, there is no one to spread the word. "If people don't hear these things, people are going to die."

Massive layoffs passed like a scythe through the FDA this week, part of health secretary Robert F. Kennedy Jr.'s plan to cut as many as 10,000 inside the U.S. Department of Health and Human Services, including 3,500 at FDA.

The FDA's responsibilities range from approving new drugs to inspecting food warehouses. It is the bedrock on which the U.S. biopharma industry rests, and the regulator responsible for keeping medicines, foods, and other products safe.

Now, the question is what the FDA won't be able to do anymore.

"It's kind of like you're in a funeral everyday," one current FDA official told Barron's. "An eight hour funeral. It's sad. You're trying to figure out who is still there, what functions still exist, what you can still do. It's very disjointed. Very chaotic."

As the market collapsed late this week, drug stocks briefly rose on the theory they might provide a haven. The unfolding crisis at the FDA, however, could pose a major threat of its own to the biopharma industry.

Amid the chaos, there is growing worry the FDA no longer intends to keep up with the basic jobs that drugmakers need to keep the industry on track.

On Tuesday, the FDA missed the deadline to act on a request from the drugmaker Novavax to approve its Covid-19 vaccine, which has been available under an emergency use authorization.

FDA deadlines, called PDUFA dates, are set under agreement between the industry and the FDA, and aren't often missed. Last year, the FDA division responsible for approving new drugs hit its PDUFA goal dates 94% of the time.

The missed deadline on the Novavax vaccine review raised concerns about Kennedy, a vaccine skeptic, meddling in the review process. It also raised broader worries the FDA might not be able to meet its PDUFA deadlines in the future.

"It's possible that RFK wanted to raise additional questions about a vaccine application," says David Risinger, an analyst at Leerink Partners. "It's also possible that it may be a sign that PDUFA dates may not be met, given the turmoil at FDA."

If the FDA is unwilling or unable to meet its PDUFA deadlines for decisions on drug approvals, it would mean major trouble for the drug industry, which relies on predictability from the agency.

"What may happen is that, due to both disruption at the FDA and the change in oversight of FDA, that your regular meetings, updates that companies need to have, dialogue between companies and the FDA, just regular activities that are designed to support the process of advancing new drugs and vaccines to patients, are being disrupted," Risinger says.

Yet another new worry emerged late Thursday, when Agency IQ, a trade publication owned by Politico that covers the FDA, reported the mass layoffs risk triggering a law that would require the FDA to repay billions of dollars in fees paid by drugmakers and other companies.

Under a system set up in the 1990s, companies the FDA regulates pay for roughly half of its budget through so-called user fees. To keep the FDA from diverting those user fees, Congress set up a trigger mechanism that requires the FDA to pay the companies back if its spending of Congressionally-appropriated funds falls below a certain level.

The Agency IQ report says that after this week's layoffs, the FDA is getting close to falling below spending levels that would trip the user fee trigger. If the FDA needed to pay back the user fees it has already collected, much of the work of the agency would stop.

HHS didn't respond to a request for comment on the Agency IQ report.

Even without having to repay the user fees, the FDA's capacities today are seriously diminished. Senior leaders are gone, including top vaccines regulator Dr. Peter Marks and Dr. Peter Stein, the former head of the office responsible for reviewing applications for new medicines. But so are countless rank-and-file workers, some of whom now say they are worried about what the agency will stop doing now they are gone.

On Friday, The Wall Street Journal published an interview with Marks in which he said Kennedy's team had asked him for data that doesn't exist on deaths and brain swelling in people who received a measles vaccine.

"I can never give allegiance to anyone else other than to follow the science as we see it," Marks told the Journal.

Rosenthal worked in health communications within the Center for Drug Evaluation and Research, the FDA division responsible for regulating over the counter and prescription drugs.

When counterfeit Botox was making people sick last year, it was the team Rosenthal worked on that put out alerts to warn patients and healthcare professionals. When there was a rash of recalls of over the counter eye drops, it was Rosenthal's team that wrote the warnings and educational materials distributed to the public.

Now Rosenthal's team is gone, along with the rest of the communications staff within CDER, and Rosenthal says there is no one left to warn the public when things go wrong with their medicines.

"No communications are getting out," she says. "We're the front line of letting people know."

Now, that front line is gone.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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April 04, 2025 16:00 ET (20:00 GMT)

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