New FDA Commissioner Agreed to Replace Top Vaccine Regulator Following Private Swearing-In Ceremony
The abrupt resignation of Peter Marks has created unease among scientists and researchers.
TroibNews 
Food and Drug Administration Commissioner Marty Makary approved the removal of top vaccine official Peter Marks shortly after his quiet swearing-in as the agency's new leader late last week, according to four individuals with knowledge of the situation.
This forced departure marked Makary's first major action as commissioner and sent a strong message to a concerned Washington, already apprehensive about the implications of vaccine skepticism in Secretary Robert F. Kennedy Jr.'s Health and Human Services Department. Makary and Kennedy had previously agreed to oust Marks, who had led the FDA’s vaccine division for over eight years, as part of a broader leadership overhaul within HHS.
The decision has raised alarms among lawmakers and the pharmaceutical industry, who view it as a strategic move by Kennedy to reshape the government’s vaccine policy in light of ongoing doubts regarding vaccine efficacy.
While Kennedy made the final decision regarding Marks' exit, this action was contingent on Makary's agreement, as noted by sources who requested anonymity to share details of private discussions. Makary was sworn in late last week, according to several insiders who spoke on condition of anonymity regarding the timeline.
Within the FDA, Makary’s role in the decision was not widely known, and the agency has not officially acknowledged his swearing-in; as of now, Sara Brenner remains listed as the acting commissioner of food and drugs on the FDA's website.
Even Marks seemed unaware of Makary's position on Friday, as he directed his resignation letter to Brenner and used his final remarks to criticize Kennedy. Marks chose not to comment further.
"I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency," Marks wrote. "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."
Makary’s backing for Marks' removal is likely to further disturb pharmaceutical companies and those who support the FDA, as many had hoped that the former Johns Hopkins surgeon and researcher would act as a bulwark against significant changes to the nation’s vaccine policies.
Gaining prominence in recent years as a vocal critic of both the FDA and the government’s approach to the Covid pandemic, Makary has consistently supported vaccines and has never advocated for the discredited theory linking them to autism, a view embraced by Kennedy.
Makary was confirmed by the Senate to lead the FDA last Tuesday, though he was not expected to begin his duties until this week, per multiple sources.
An HHS spokesperson declined to provide comments. The Pink Sheet was the first to report on the timing of Makary's swearing-in.
In his initial weeks, Makary has indicated plans to pursue further changes within the FDA, including potential new leadership at the Center for Tobacco Products, according to three individuals familiar with his intentions.
This anticipated change is in addition to an already tumultuous period for the FDA. Since Trump’s election, top officials overseeing drug and food regulation have resigned, as has the principal deputy commissioner. A substantial reorganization announced by Kennedy last week foresees a workforce reduction of 3,500 at the agency over the coming weeks.
Amid this restructuring, Marks' ouster has sparked significant concern within the FDA and the broader healthcare community. Stocks for vaccine manufacturers Moderna and Novavax dropped sharply when the market opened on Monday.
John Crowley, President and CEO of the Biotechnology Innovation Organization, stated that the loss of leadership at the FDA could undermine scientific standards and hinder the development of new medicines.
“We advocated strongly for Peter’s continued leadership,” Crowley texted.
While sometimes viewed as a polarizing figure at the FDA, Marks is acknowledged for his role in establishing the Operation Warp Speed initiative during President Donald Trump’s first term, which delivered a Covid vaccine within months.
Marks earned the trust of FDA commissioners and legislators from both parties and built a reputation over more than 12 years at the FDA's Center for Biologics Evaluation and Research as a staunch defender of scientific independence and the agency's rigorous vaccine development processes.
“Peter’s commitment to bringing the best science and data to the development and availability of lifesaving biomedical technologies, from gene and cell therapies to the Trump Administration’s Operation Warp Speed, has saved countless lives,” Mark McClellan, a former FDA commissioner during the George W. Bush administration, told PMG. “His decade-long leadership at the FDA is a big reason why the FDA is the gold standard for advancing the most innovative breakthrough medicines."
Robert Califf, a commissioner during the Biden administration, noted last week that Marks' “interest was always with the combination of public health and the special needs of patients.”
"The role of the FDA Commissioner is largely to fend off political interference so that career civil servants without financial conflicts can make decisions based upon the statutes and rules governing these decisions," Califf posted on LinkedIn on Monday.
Sen. Bill Cassidy, a physician who played a pivotal role in supporting Kennedy’s confirmation, remarked in a statement that Makary and Kennedy should “replace him with someone of similar stature and credibility amongst the scientific community,” adding that Marks' departure was “a loss to the FDA.”
Conversely, Kennedy and his supporters — which include prominent anti-vaccine figures — have long exhibited skepticism towards Marks and the FDA’s vaccination policies, often citing unsubstantiated claims of the agency downplaying health risks associated with vaccines.
In a NewsNation interview last week, Kennedy expressed his intention to establish an office within the Centers for Disease Control and Prevention focused on “vaccine injuries.” He also ordered a comprehensive study evaluating any potential links between vaccines and autism, despite a wealth of research disproving such connections.
Kennedy's handling of the measles outbreak has also put him in conflict with Marks, who addressed this in his resignation letter. Kennedy has provided only lukewarm support for the measles vaccine, simultaneously promoting questionable vitamin A supplements as a treatment for the disease.
"Undermining confidence in well-established vaccines that have met 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 wrote.
Following Marks' resignation, an HHS official attributed blame to him for not aligning with Kennedy's objectives, stating he "has no place at FDA under the strong leadership of Secretary Kennedy."
Makary has yet to publicly address Marks' departure.
Debra A Smith for TROIB News
This forced departure marked Makary's first major action as commissioner and sent a strong message to a concerned Washington, already apprehensive about the implications of vaccine skepticism in Secretary Robert F. Kennedy Jr.'s Health and Human Services Department. Makary and Kennedy had previously agreed to oust Marks, who had led the FDA’s vaccine division for over eight years, as part of a broader leadership overhaul within HHS.
The decision has raised alarms among lawmakers and the pharmaceutical industry, who view it as a strategic move by Kennedy to reshape the government’s vaccine policy in light of ongoing doubts regarding vaccine efficacy.
While Kennedy made the final decision regarding Marks' exit, this action was contingent on Makary's agreement, as noted by sources who requested anonymity to share details of private discussions. Makary was sworn in late last week, according to several insiders who spoke on condition of anonymity regarding the timeline.
Within the FDA, Makary’s role in the decision was not widely known, and the agency has not officially acknowledged his swearing-in; as of now, Sara Brenner remains listed as the acting commissioner of food and drugs on the FDA's website.
Even Marks seemed unaware of Makary's position on Friday, as he directed his resignation letter to Brenner and used his final remarks to criticize Kennedy. Marks chose not to comment further.
"I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency," Marks wrote. "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."
Makary’s backing for Marks' removal is likely to further disturb pharmaceutical companies and those who support the FDA, as many had hoped that the former Johns Hopkins surgeon and researcher would act as a bulwark against significant changes to the nation’s vaccine policies.
Gaining prominence in recent years as a vocal critic of both the FDA and the government’s approach to the Covid pandemic, Makary has consistently supported vaccines and has never advocated for the discredited theory linking them to autism, a view embraced by Kennedy.
Makary was confirmed by the Senate to lead the FDA last Tuesday, though he was not expected to begin his duties until this week, per multiple sources.
An HHS spokesperson declined to provide comments. The Pink Sheet was the first to report on the timing of Makary's swearing-in.
In his initial weeks, Makary has indicated plans to pursue further changes within the FDA, including potential new leadership at the Center for Tobacco Products, according to three individuals familiar with his intentions.
This anticipated change is in addition to an already tumultuous period for the FDA. Since Trump’s election, top officials overseeing drug and food regulation have resigned, as has the principal deputy commissioner. A substantial reorganization announced by Kennedy last week foresees a workforce reduction of 3,500 at the agency over the coming weeks.
Amid this restructuring, Marks' ouster has sparked significant concern within the FDA and the broader healthcare community. Stocks for vaccine manufacturers Moderna and Novavax dropped sharply when the market opened on Monday.
John Crowley, President and CEO of the Biotechnology Innovation Organization, stated that the loss of leadership at the FDA could undermine scientific standards and hinder the development of new medicines.
“We advocated strongly for Peter’s continued leadership,” Crowley texted.
While sometimes viewed as a polarizing figure at the FDA, Marks is acknowledged for his role in establishing the Operation Warp Speed initiative during President Donald Trump’s first term, which delivered a Covid vaccine within months.
Marks earned the trust of FDA commissioners and legislators from both parties and built a reputation over more than 12 years at the FDA's Center for Biologics Evaluation and Research as a staunch defender of scientific independence and the agency's rigorous vaccine development processes.
“Peter’s commitment to bringing the best science and data to the development and availability of lifesaving biomedical technologies, from gene and cell therapies to the Trump Administration’s Operation Warp Speed, has saved countless lives,” Mark McClellan, a former FDA commissioner during the George W. Bush administration, told PMG. “His decade-long leadership at the FDA is a big reason why the FDA is the gold standard for advancing the most innovative breakthrough medicines."
Robert Califf, a commissioner during the Biden administration, noted last week that Marks' “interest was always with the combination of public health and the special needs of patients.”
"The role of the FDA Commissioner is largely to fend off political interference so that career civil servants without financial conflicts can make decisions based upon the statutes and rules governing these decisions," Califf posted on LinkedIn on Monday.
Sen. Bill Cassidy, a physician who played a pivotal role in supporting Kennedy’s confirmation, remarked in a statement that Makary and Kennedy should “replace him with someone of similar stature and credibility amongst the scientific community,” adding that Marks' departure was “a loss to the FDA.”
Conversely, Kennedy and his supporters — which include prominent anti-vaccine figures — have long exhibited skepticism towards Marks and the FDA’s vaccination policies, often citing unsubstantiated claims of the agency downplaying health risks associated with vaccines.
In a NewsNation interview last week, Kennedy expressed his intention to establish an office within the Centers for Disease Control and Prevention focused on “vaccine injuries.” He also ordered a comprehensive study evaluating any potential links between vaccines and autism, despite a wealth of research disproving such connections.
Kennedy's handling of the measles outbreak has also put him in conflict with Marks, who addressed this in his resignation letter. Kennedy has provided only lukewarm support for the measles vaccine, simultaneously promoting questionable vitamin A supplements as a treatment for the disease.
"Undermining confidence in well-established vaccines that have met 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 wrote.
Following Marks' resignation, an HHS official attributed blame to him for not aligning with Kennedy's objectives, stating he "has no place at FDA under the strong leadership of Secretary Kennedy."
Makary has yet to publicly address Marks' departure.
Debra A Smith for TROIB News
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