Sweeping changes are underway at federal health agencies, starting with a massive cull of the workforce that has included several prominent leaders. Overall, 10,000 staff across HHS, including about 20% of staff at the FDA, are due to be slashed as part of a far-reaching restructuring plan under the Make America Healthy Again agenda.
Yesterday, pink slips began arriving for thousands of HHS workers announcing they were immediately put on administrative leave as part of a “reduction in force.” The fresh cuts add to the hundreds who’ve already lost their jobs or resigned in the months since the Trump administration took office.
While HHS promised the workforce reductions would not “affect drug, medical device or food reviewers,” the impact and severity of the reductions are still unknown. And at least one former FDA leader is warning that HHS secretary Robert F. Kennedy Jr.’s actions will have consequences.
“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,” Dr. Robert Califf, former FDA commissioner, said in a LinkedIn post yesterday. “I believe that history will see this [as] a huge mistake.”
Amid the changes, HHS has painted a murky picture of what’s happening on the ground floor. Here’s what we know about some of the top leaders and key officials who’ve departed the FDA so far.
Dr. Peter Marks, a top vaccine official
Over the weekend, director of the Center for Biologics Evaluation and Research Dr. Peter Marks was forced out of the agency, offering his resignation to leave the post after an agency official asked him to quit or be fired, the Wall Street Journal first reported. The decision to oust Marks was OK’d by Dr. Marty Makary, who was confirmed as the new FDA commissioner earlier this month, Politico reported.
Marks, who played an important role in the FDA’s efforts to push through COVID-19 vaccines during the first Trump administration, had been with the FDA since 2012 and became known as a top vaccine official. Leading the CBER since 2016, he has helped oversee the regulation of biologics, including vaccines and cell and gene therapies.
Shares for vaccine makers, including Moderna and Pfizer, sank after the news broke, Reuters reported on Monday. Industry groups also voiced concerns regarding Marks’ departure.
“We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people,” John Crowley, president and CEO of BIO, said in a statement.
On his way out, Marks slammed Kennedy for his views on vaccines.
“It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in his resignation letter. His last day at the FDA is April 5.
Dr. Peter Stein, a regulatory leader
One of the highest ranking leaders at the FDA who’s responsible for regulatory oversight of drug development studies and marketing approvals is out. Dr. Peter Stein, director of CDER’s Office of New Drugs, was fired Tuesday, STAT reported.
Stein, an R&D expert, first joined CDER in 2016 after previously serving as vice president for late stage development, diabetes and endocrinology at Merck Research Laboratories, and vice president, head of metabolism development at Janssen. He was reportedly offered a reassignment in patient affairs, which he turned down and called a “silly, alternative job.”
Planning for the layoffs did not originally include CDER or OND leadership, and the dismissals this week will result in the loss of support and review functions of the OND, Stein told BioPharma Dive.
Dr. Ross Segan, a top medical device regulator
Dr. Ross Segan was among a few hundred FDA employees who were cut in late February by the Department of Government Efficiency, led by Elon Musk. He was formerly the director of the medical device center’s Office of Product Evaluation and Quality at the FDA’s medical device center, responsible for overseeing the review process for medical devices and postmarket monitoring.
Segan’s departure made headlines in February because his OPEQ team was reviewing Musk’s medical device Neurolink, an implanted brain-computer device with two FDA-registered trials. In addition to Segan, about 20 people in the FDA’s office of neurological and physical medicine devices were let go in February, Reuters reported.
Segan took on the role last September after serving as a consultant with medical device companies.
Drug and medtech reviewers
Two deputy directors at the FDA who review cancer drugs have plans to leave the FDA, STAT reported last week. Medical reviewers Paul Kluetz and Marc Theoret made their intentions known to colleagues. Both were part of the Oncology Center of Excellence, which aims to speed cancer drug development.
Their departures, alongside those on the medtech side of the agency, have triggered concerns about potential delays in drug and medical device approvals. Some setbacks for devices were reported last week, with staff struggling to meet product review deadlines, according to Reuters. With a reduced workforce, some workers said they were assigned double the amount of new product applications to review.
Dr. Celia Witten, Marks’ deputy
Marks’ resignation this week will leave a vacancy alongside the already open role forCBER’s deputy director — a position Dr. Celia Witten left in late February. The job was listed as “vacant” on FDA’s website as of April 1.
After her departure in February, some health experts expressed “relief” that at least Marks was still in control of CBER. Now, with both the director and deputy director out, the direction of the department is up in the air.
Troy Tazbaz, an AI leader
Soon after the Trump administration took office in January, Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, announced his immediate resignation. Tazbaz held the position for two years and led the agency’s direction and policymaking on AI and software as a medical device during that time.
In the last few years, the agency has begun to build a regulatory framework for the biopharma industry around AI, and published a draft guidance to assess the risk of AI models in drug and biological product development in January.
Dr. Patrizia Cavazzoni, an influential drug reviewer
Even before Trump’s second term began, a handful of FDA officials announced their exit, including Dr. Patrizia Cavazzoni, who was director of the agency’s Center for Drug Evaluation and Research. She left the role on Jan. 18, just days before President Donald Trump’s second term began.
Cavazzoni was considered an influential leader at the FDA, with oversight of drug approvals, drug safety and enforcement actions. In her resignation, Cavazzoni said her desire to spend more time with her family factored into her decision.
