As sweeping changes continue to unfold at federal health agencies, the repercussions of a massive cull of the workforce are becoming more apparent. The restructuring plan, part of the Make America Healthy Again agenda, is set to slash 10,000 staff across HHS, with about 20% of FDA staff facing job cuts. Pink slips have already started arriving for thousands of HHS workers, placing them on administrative leave as part of a “reduction in force” strategy. This adds to the hundreds who have already lost their jobs or resigned since the Trump administration began.
Despite assurances from HHS that the reductions would not affect drug, medical device, or food reviewers, the true impact of these cuts remains uncertain. Former FDA Commissioner Dr. Robert Califf has voiced concerns about the loss of institutional knowledge and experienced leaders, stating that “The FDA as we’ve known it is finished.”
One of the notable departures from the FDA is Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research. Marks, a key figure in the FDA’s COVID-19 vaccine efforts, was forced out of his position over the weekend. His departure has raised concerns in the industry and led to a drop in shares for vaccine makers like Moderna and Pfizer. Dr. Marks criticized HHS Secretary Robert F. Kennedy Jr. for his views on vaccines in his resignation letter.
Another significant loss is Dr. Peter Stein, the director of CDER’s Office of New Drugs, who was fired on Tuesday. Dr. Stein, a respected regulatory leader, had been responsible for overseeing drug development studies and marketing approvals. He declined a reassignment offered to him, calling it a “silly, alternative job.”
Dr. Ross Segan, a top medical device regulator, was among the few hundred FDA employees who were cut in late February. Segan, who oversaw the review process for medical devices and postmarket monitoring, was let go by the Department of Government Efficiency, led by Elon Musk. His departure made headlines as his team was reviewing Musk’s medical device Neurolink.
As these workforce reductions continue to unfold, the future of federal health agencies, particularly the FDA, remains uncertain. The departure of experienced leaders and the loss of institutional knowledge could have far-reaching consequences for drug and medical device regulation in the United States.
The FDA’s office of neurological and physical medicine devices experienced a significant shakeup in February, with about 20 staff members being let go, including Ross Segan who took on the role last September. This restructuring has raised concerns about potential delays in drug and medical device approvals, as the reduced workforce struggles to meet product review deadlines.
In addition to the changes in the neurological and physical medicine devices office, two deputy directors at the FDA who review cancer drugs, Paul Kluetz and Marc Theoret, have plans to leave the agency. Their departures, alongside the layoffs in the medtech division, have sparked worries about the impact on cancer drug development and overall regulatory processes.
Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER), recently announced his resignation, leaving a leadership vacuum in the department. This departure comes on the heels of Dr. Celia Witten leaving her position as CBER’s deputy director in late February. With both key positions now vacant, the future direction of CBER is uncertain.
Another notable resignation was that of Troy Tazbaz, the director of the FDA’s Digital Health Center of Excellence, who announced his immediate resignation in January. Tazbaz played a crucial role in shaping the agency’s policies on AI and software as medical devices. His departure raises questions about the future of regulatory frameworks for AI in the biopharma industry.
Dr. Patrizia Cavazzoni, the former director of the FDA’s Center for Drug Evaluation and Research, also announced her resignation in January. Cavazzoni was a respected leader at the FDA, overseeing drug approvals, safety, and enforcement actions. Her departure, citing a desire to spend more time with her family, adds to the list of key personnel changes within the agency.
Overall, these recent resignations and layoffs within the FDA have created uncertainty about the agency’s ability to efficiently regulate drugs and medical devices. The vacancies in key leadership positions raise concerns about potential delays in approvals and the overall direction of regulatory processes. The FDA will need to navigate these challenges and swiftly fill these crucial roles to maintain its mission of ensuring the safety and effectiveness of medical products.
