The Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, Peter Marks, submitted his resignation on Friday, citing irreconcilable differences with Health and Human Services Secretary Robert F. Kennedy Jr. over
vaccine-related matters.
In a resignation letter obtained by BioPharma Dive and addressed to acting FDA Commissioner Sara Brenner, Marks expressed his frustration with Kennedy’s approach to vaccine policy and public health messaging. The letter criticized the Secretary’s promotion of what Marks characterized as “misinformation and lies,” despite attempts to address Kennedy’s concerns about vaccine safety and transparency.
Marks, who played a crucial role in the development and approval of COVID-19 vaccines during the first Trump administration, will officially leave his position on April 5. His departure creates a significant leadership vacuum at the FDA, as both major drug review offices will now lack permanent directors following Patrizia Cavazzoni’s earlier departure on January 18.
The resignation comes amid 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 this issue, criticizing Kennedy’s handling of the outbreak and his promotion of unproven treatments like cod liver oil, which can be harmful if taken in excess.
Industry leaders have expressed concern about the implications of Marks’ departure. John Crowley, who heads the biotechnology lobbying organization BIO, warned about potential degradation of scientific standards and its impact on therapeutic development. Former Alnylam Pharmaceuticals CEO John Maraganore also expressed his dismay at the news on social media.
The resignation occurs against a backdrop of broader changes within HHS under the Trump administration. Kennedy recently announced plans to reduce the department’s workforce significantly, including cutting 2,400 positions at the CDC and 3,500 at the FDA. These reductions are part of a larger pattern of downsizing in government scientific research and staffing.
Marks, a hematologist by training, has led the Center for Biologics Evaluation and Research since 2016. His tenure included significant achievements such as helping conceive Operation Warp Speed and advancing the development of cell and gene therapies. Former FDA Commissioner Robert Califf praised Marks’ dedication to public health and patient needs in a social media post.
The departing official expressed particular concern about the undermining of public confidence in established vaccines. In his resignation letter, Marks emphasized that questioning vaccines that have met rigorous safety and effectiveness standards poses a significant threat to national health security. He specifically defended the measles vaccine’s 97% effectiveness rate with two doses, refuting long-standing claims about links to autism.
Kennedy’s brief tenure as HHS Secretary has already sparked
controversy in the scientific community. Reports from Politico indicate his office is reviewing vaccine advisory committees and considering removing certain advisers. A CDC advisory committee meeting was temporarily postponed after Kennedy took office, though it has since been rescheduled.
The Senate recently confirmed Martin Makary as the new FDA
Commissioner, though it remains unclear whether he has officially assumed the role. As the agency faces these significant leadership changes, questions remain about the future direction of vaccine policy and drug regulation under the current administration.