FDA Layoffs Continue as Former Commissioner Robert Califf Speaks Out

FDA signage at its headquarters in Maryland

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The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were reportedly underway Tuesday, with CDER Office of New Drugs Director Peter Stein added to the list of casualties.

The Department of Health and Human Services layoffs promised last week are well underway as FDA employees showed up to work on Tuesday only to discover they no longer had a job, according to reporting by Endpoints News.

Witnesses—who requested anonymity—described to Endpoints instances of employees arriving to work at the FDA’s main White Oak campus in Maryland and learning of their firing when their badges wouldn’t work.

These scenes are part of a larger picture that has emerged over the past week. On Thursday, recently installed HHS Secretary Robert F. Kennedy Jr. announced he would cut 10,000 jobs across his department. According to reporting from The Wall Street Journal, this included 3,500 staffers at the FDA, 2,400 employees at the Centers for Disease Control and Prevention, 1,200 at the National Institutes of Health and 300 from the Centers for Medicare and Medicaid Services.

Then, late Friday evening, news broke that Center for Biologics Evaluation and Research head Peter Marks had been forced to resign. Marks, who has helmed CBER since 2016, has been a staunch advocate of vaccines—a viewpoint that reportedly put him at odds with Kennedy.

Another senior leader, Peter Stein, director of the Center for Drug Evaluation and Research’s Office of New Drugs, will also depart, according to Endpoints. Stein was offered a “reassignment” in patient affairs but turned it down. “I declined the offer (as ridiculous) so am on administrative leave,” Stein told the publication.

Reaction to Kennedy’s overhaul has been swift and furious. Analysts expressed their concern as biotech stocks tumble, and former FDA Commissioner Robert Califf took to social media to voice his dismay.

“The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” Califf, who stepped down as FDA commissioner in January, wrote on LinkedIn Tuesday. “I believe that history will see this a huge mistake. I will be glad if I’m proven wrong, but even then there is no good reason to treat people this way.”

In a post later Tuesday morning, Califf referenced a “dark day for public health.”

Marks struck a similarly dire note in his resignation letter. “It has become clear that truth and transparency are not desired by the secretary [Kennedy], but rather he wishes subservient confirmation of his misinformation and lies.”

On Monday following Marks’ resignation, analysts at financial firm Cantor Fitzgerald called for Kennedy himself to get the axe. Josh Schimmer and Eric Schmidt said in a note that Kennedy was “undermining the trusted leadership of health care in this country,” adding that, “HHS cannot be led by an anti-vax, conspiracy theorist with inadequate training.”

Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
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