FDA's Peter Marks Resigns Amid Vaccine Controversy and Agency Reshuffling

In a significant development for the pharmaceutical industry, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER), has announced his resignation effective April 5, 2025. This move comes amid growing tensions within the agency and broader changes in the U.S. health sector under the second Trump administration.

Marks' Departure and Its Implications

Dr. Marks, who has led CBER since 2016, cited an "unprecedented assault on scientific truth" in his resignation letter, particularly calling out Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. for promoting misinformation about FDA-approved vaccines. The resignation follows reports that HHS officials had given Marks an ultimatum to either resign or face termination.

During his tenure, Marks played a crucial role in the evaluation and approval of vaccines, blood products, and biologics, including cell and gene therapies. He was instrumental in promoting the FDA's accelerated approval pathway for rare diseases and played a significant part in Operation Warp Speed, which expedited COVID-19 vaccine development.

Industry leaders have expressed concern about the potential impact of Marks' departure. John Crowly, CEO of the Biotechnology Innovation Organization (BIO), stated, "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."

Broader Changes at FDA and HHS

Marks' exit is part of a larger shake-up within the FDA and HHS. The agency has seen several high-profile departures since the beginning of the year, including Patrizia Cavazzoni, former head of the Center for Drug Evaluation and Research (CDER), and Hilary Perkins, the FDA's chief counsel.

The Trump administration has announced plans to cut 3,500 full-time FDA staffers and 1,200 NIH workers as part of a broader initiative to eliminate 10,000 jobs across HHS. These changes come as the FDA welcomes a new commissioner, Johns Hopkins surgeon Dr. Marty Makary.

Industry Reactions and Market Impact

The pharmaceutical and biotech sectors are closely watching these developments. Analysts at William Blair suggest that Marks' departure could particularly affect smaller and midsized companies working in vaccines, gene editing, and cell and gene therapy.

Market reactions have been swift, with shares of vaccine and gene therapy players such as Moderna, Pfizer, Novavax, Taysha Gene Therapies, Solid Biosciences, and Sarepta Therapeutics all experiencing declines in premarket trading.

However, analysts at Jefferies offer a more optimistic outlook, suggesting that there may not be immediate regulatory risks for companies already working with the FDA on expedited pathways for rare diseases. They anticipate that existing rare disease programs are unlikely to be dismantled by Marks' successor.

As the industry grapples with these changes, the search for a new CBER director begins, with stakeholders hoping for a candidate who can maintain the delicate balance between innovation and safety in biological product regulation.