The Food and Drug Administration’s leading vaccine expert, Dr. 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 over Kennedy’s approach to vaccine policy and public health messaging. “Truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” wrote Marks, who will officially leave his position on April 5.
Marks, who has directed the FDA’s Center for Biologics Evaluation and Research since 2016, played a crucial role in developing COVID-19 vaccines during the first Trump administration. He was instrumental in conceiving Operation Warp Speed, which accelerated the development and distribution of safe, effective COVID-19 vaccines.
The resignation comes amid an ongoing 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 criticized Kennedy’s response to the outbreak, particularly the Secretary’s promotion of unproven treatments like cod liver oil, which can be harmful in large doses, while failing to strongly endorse established vaccine protocols.
The departure creates additional leadership gaps at the FDA, as both primary drug review offices now lack permanent directors following Patrizia Cavazzoni’s January departure. Multiple agency leaders have either resigned or been terminated in recent months.
Industry leaders have expressed concern about the implications of Marks’ departure. John Crowley, who heads the biotech advocacy group BIO, warned that losing experienced FDA leadership could compromise scientific standards and impede therapeutic development. Former Alnylam Pharmaceuticals CEO John Maraganore also expressed dismay at Marks’ resignation.
Former FDA Commissioner Robert Califf, who served under Presidents Obama and Biden, praised Marks’ dedication to public health and patient care, noting that while some disagreed with certain decisions, Marks consistently prioritized public health concerns.
The resignation coincides with broader changes at HHS under the Trump administration, including Kennedy’s recent announcement of significant staff reductions – approximately 2,400 positions at the CDC and 3,500 at the FDA. These cuts are part of a larger initiative to decrease government workforce and scientific research funding.
In his resignation letter, Marks emphasized the dangers of undermining public confidence in established vaccines that have met rigorous FDA safety and effectiveness standards. He specifically addressed the measles vaccine’s proven 97% effectiveness rate with two doses and its established safety profile, countering long-standing claims about links to autism.
The timing of Marks’ departure follows the Senate’s confirmation of Martin Makary as FDA Commissioner, though it remains unclear whether Makary has officially assumed the role.
Recent developments at HHS have raised additional concerns among public health experts, including the postponement (though later rescheduled) of a CDC advisory committee meeting shortly after Kennedy took office. Reports suggest Kennedy is reviewing the composition of vaccine advisory committees and may remove certain advisers.
Neither the FDA nor HHS responded to multiple requests for comment on Marks’ resignation, which was first reported by The Wall Street Journal. The departure of such a senior official has intensified concerns about the future direction of vaccine policy and public health initiatives under the current administration.