The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, submitted his resignation on Friday, citing fundamental disagreements with Health and Human Services Secretary Robert F. Kennedy Jr.’s approach to vaccine policy and public health communications.
In his resignation letter to acting FDA Commissioner Sara Brenner, Marks expressed frustration with what he characterized as Kennedy’s promotion of incorrect information about vaccine safety. “It has become evident that the Secretary is not interested in factual accuracy and transparency, but rather seeks validation of his misstatements,” Marks wrote in the letter obtained by BioPharma Dive.
Marks, who will officially depart on April 5, played an instrumental role in the development and authorization of COVID-19 vaccines during the first Trump administration, including helping conceive Operation Warp Speed. His exit leaves another crucial vacancy at the FDA, following the January departure of Patrizia Cavazzoni, who previously led the agency’s other main drug review division.
The resignation comes amid a measles outbreak that has affected 483 individuals across 20 states and resulted in one death, the first U.S. measles fatality 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 failing to strongly endorse established vaccine protocols.
“Weakening public confidence in vaccines that have proven their safety and effectiveness over decades of FDA oversight poses a serious threat to our nation’s public health and security,” Marks stated in his resignation letter.
Industry leaders have expressed concern about the implications of Marks’ departure. John Crowley, who leads the biotechnology industry organization BIO, warned that losing experienced FDA leadership could compromise scientific standards and impede therapeutic development. Former Alnylam Pharmaceuticals CEO John Maraganore echoed these sentiments on social media.
The resignation occurs against a backdrop of broader changes at HHS under the Trump administration. Kennedy recently announced plans to reduce the department’s workforce by approximately 10,000 positions, including 2,400 at the CDC and 3,500 at the FDA. Additional
controversial moves include the temporary postponement of CDC advisory committee meetings and potential changes to vaccine advisory panels.
Former FDA Commissioner Robert Califf, who served under Presidents Obama and Biden, praised Marks’ dedication to public health and patient care, noting that while his decisions sometimes sparked disagreement, his motivations consistently centered on advancing medical technology and protecting public health.
Marks, a physician and hematologist, had led the Center for Biologics Evaluation and Research since 2016, overseeing the regulation of vaccines, blood products, and genetic medicines. During his tenure, he advocated for accelerated development of cell and gene therapies, sometimes drawing controversy for his progressive approach to regulation.
The leadership vacuum at the FDA comes just as Martin Makary received Senate confirmation as the new FDA commissioner, though his official installation remains pending. Neither the FDA nor HHS responded to multiple requests for comment on Marks’ resignation.
In his final message, Marks expressed hope that the current climate of scientific skepticism would eventually give way to a renewed appreciation for medical advancement: “I look forward to a time when our nation can fully embrace the remarkable progress being made in medical science, free from the unprecedented assault on scientific truth that has compromised public health in recent years.”