FDA's Leading Vaccine Official, Peter Marks, Forced to Leave
The agency is now facing a gap in senior regulation following Marks' departure.
TroibNews 
Peter Marks, the top vaccine regulator at the FDA, unexpectedly resigned on Friday, as revealed in a copy of his resignation letter obtained by PMG.
Marks' exit came amid pressure from HHS Secretary Robert F. Kennedy Jr., according to two individuals familiar with the situation who spoke on the condition of anonymity. This sudden development raised alarm across Washington and sparked concerns among several pharmaceutical firms.
In recent weeks, Kennedy and his team decided to push Marks out, believing a fresh start was necessary as part of a broader reorganization within the department, said one source familiar with Kennedy’s rationale. This individual noted that there was no single incident that led to Marks' departure.
However, Marks had increasingly expressed worry about Kennedy’s views on vaccines, particularly taking issue with the secretary’s lukewarm response to the Texas measles outbreak.
In his resignation letter, Marks addressed vaccine hesitancy and the ongoing outbreak in West Texas, which has contributed to two deaths and hundreds of cases of a viral disease that was declared eradicated in the U.S. in 2000. Kennedy has made public comments that only mildly support the measles, mumps, and rubella vaccines while advocating for alternative treatments such as vitamin A, which public health experts largely agree do not replace the protection offered by vaccinations.
“Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety and security,” Marks articulated in the letter, which was addressed to acting FDA Commissioner Sara Brenner. Marks’ last day at the FDA is April 5.
“Efforts currently being advanced by some on the adverse health effects of vaccination are concerning,” Marks added, noting, “The history of the potential individual and societal benefits of vaccination is as old as our great nation.”
An HHS official stated to PMG, “If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.”
The departure of Marks, who began working at the FDA in 2012 as the deputy director of the Center for Biologics Evaluation and Research, leaves the agency without yet another senior official. The agency’s top drug regulator, Patrizia Cavazzoni, departed just before President Donald Trump took office, while Jeff Shuren, the longtime head of the devices unit, left last year.
Marks was instrumental in Operation Warp Speed, which focused on developing and distributing a Covid-19 vaccine during the early months of the pandemic.
“Have had two CEOs call me already,” texted a Republican pharmaceutical lobbyist who requested anonymity to discuss Marks' resignation. “Folks are VERY concerned. This is why [Sen. Bill] Cassidy should have voted NO.”
In his letter, Marks expressed his willingness to address the Secretary’s concerns regarding vaccine safety and transparency, mentioning plans for a series of public meetings with the National Academy of Sciences, Engineering and Medicine—one of the nation’s top scientific bodies.
“However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks contended.
On Friday, the day after HHS announced the termination of 3,500 employees at the agency, FDA staff arriving at their offices in White Oak, Maryland, found armored vehicles from the Department of Homeland Security parked outside and an increase in security personnel at the entrance, as reported by two FDA employees who spoke on the condition of anonymity.
Later that day, an email reviewed by PMG informed employees that the FDA would be ending the use of an overflow parking lot initially arranged to accommodate the influx of people returning to the office after the department abandoned work-from-home policies.
“My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science,” Marks concluded in his letter.
Max Fischer for TROIB News
Marks' exit came amid pressure from HHS Secretary Robert F. Kennedy Jr., according to two individuals familiar with the situation who spoke on the condition of anonymity. This sudden development raised alarm across Washington and sparked concerns among several pharmaceutical firms.
In recent weeks, Kennedy and his team decided to push Marks out, believing a fresh start was necessary as part of a broader reorganization within the department, said one source familiar with Kennedy’s rationale. This individual noted that there was no single incident that led to Marks' departure.
However, Marks had increasingly expressed worry about Kennedy’s views on vaccines, particularly taking issue with the secretary’s lukewarm response to the Texas measles outbreak.
In his resignation letter, Marks addressed vaccine hesitancy and the ongoing outbreak in West Texas, which has contributed to two deaths and hundreds of cases of a viral disease that was declared eradicated in the U.S. in 2000. Kennedy has made public comments that only mildly support the measles, mumps, and rubella vaccines while advocating for alternative treatments such as vitamin A, which public health experts largely agree do not replace the protection offered by vaccinations.
“Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety and security,” Marks articulated in the letter, which was addressed to acting FDA Commissioner Sara Brenner. Marks’ last day at the FDA is April 5.
“Efforts currently being advanced by some on the adverse health effects of vaccination are concerning,” Marks added, noting, “The history of the potential individual and societal benefits of vaccination is as old as our great nation.”
An HHS official stated to PMG, “If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.”
The departure of Marks, who began working at the FDA in 2012 as the deputy director of the Center for Biologics Evaluation and Research, leaves the agency without yet another senior official. The agency’s top drug regulator, Patrizia Cavazzoni, departed just before President Donald Trump took office, while Jeff Shuren, the longtime head of the devices unit, left last year.
Marks was instrumental in Operation Warp Speed, which focused on developing and distributing a Covid-19 vaccine during the early months of the pandemic.
“Have had two CEOs call me already,” texted a Republican pharmaceutical lobbyist who requested anonymity to discuss Marks' resignation. “Folks are VERY concerned. This is why [Sen. Bill] Cassidy should have voted NO.”
In his letter, Marks expressed his willingness to address the Secretary’s concerns regarding vaccine safety and transparency, mentioning plans for a series of public meetings with the National Academy of Sciences, Engineering and Medicine—one of the nation’s top scientific bodies.
“However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks contended.
On Friday, the day after HHS announced the termination of 3,500 employees at the agency, FDA staff arriving at their offices in White Oak, Maryland, found armored vehicles from the Department of Homeland Security parked outside and an increase in security personnel at the entrance, as reported by two FDA employees who spoke on the condition of anonymity.
Later that day, an email reviewed by PMG informed employees that the FDA would be ending the use of an overflow parking lot initially arranged to accommodate the influx of people returning to the office after the department abandoned work-from-home policies.
“My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science,” Marks concluded in his letter.
Max Fischer for TROIB News
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