The director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, submitted his resignation on Friday, citing fundamental disagreements with Health and Human Services Secretary Robert F. Kennedy Jr.’s stance on vaccine-related matters.
In his resignation letter to acting FDA Commissioner Sara Brenner, Marks expressed frustration with Kennedy’s approach to vaccine safety and transparency. The letter, which BioPharma Dive obtained, revealed Marks’ concern that Kennedy was more interested in promoting misleading narratives than pursuing scientific truth.
Marks, who has led CBER since 2016 and played a crucial role in developing COVID-19 vaccines during the first Trump administration, will officially leave his position on April 5. His departure creates a significant leadership void at the FDA, as both major drug review offices will now lack permanent directors following Patrizia Cavazzoni’s earlier departure in January.
The timing of Marks’ resignation coincides with a concerning measles outbreak that has affected 483 individuals across 20 states and resulted in the first U.S. measles death in a decade. In his letter, Marks specifically addressed Kennedy’s handling of the outbreak, criticizing the promotion of unproven treatments like cod liver oil while questioning established vaccine safety.
Industry leaders have expressed alarm over Marks’ departure. John Crowley, who heads the biotechnology advocacy group BIO, warned about the potential deterioration of scientific standards and its impact on therapeutic development. Former Alnylam Pharmaceuticals CEO John Maraganore also expressed dismay at the news.
The resignation comes amid broader changes at HHS under Kennedy’s leadership. The department recently announced plans to reduce its workforce by 10,000 employees, including 2,400 from the CDC and 3,500 from the FDA. These cuts align with the Trump administration’s broader efforts to decrease government workforce and scientific research funding.
During his tenure, Marks was instrumental in conceiving Operation Warp Speed, which accelerated the development and distribution of COVID-19 vaccines. He also advocated for expedited development of cell and gene therapies, though some of his positions on faster approval pathways generated controversy.
Former FDA Commissioner Robert Califf, who served under Presidents Obama and Biden, praised Marks’ dedication to public health and patient needs, acknowledging that while some disagreed with certain decisions, Marks’ commitment to public health was unwavering.
The resignation letter highlighted Marks’ concerns about the undermining of vaccine confidence, particularly regarding
well-established vaccines with proven safety and efficacy records. He emphasized that such actions pose significant risks to national health security.
Other concerning developments under Kennedy’s leadership include the temporary postponement of a CDC advisory committee meeting and reported plans to remove certain advisers from vaccine advisory panels, according to Politico’s reporting.
The pharmaceutical industry has maintained a cautious approach in responding to recent Trump administration actions affecting HHS and the FDA. This latest development occurs as Martin Makary, Trump’s nominee for FDA commissioner, received Senate confirmation, though his official assumption of duties remains unclear.
The Wall Street Journal first reported Marks’ resignation. Neither HHS nor the FDA responded to BioPharma Dive’s multiple requests for comment on the matter.