US Food and Drug Administration (FDA) Commissioner Marty Makary resigned from his post on Tuesday (local time), marking the fourth major departure of a member of President Donald Trump’s administration this year.
Makary’s departure comes days after it was reported that the US president was considering removing him after months of dissatisfaction with some of his work at the FDA, the AP reported.
Makary’s 13-month tenure has been marked by months of criticism from health industry executives, anti-abortion activists, vaping lobbyists and other Trump allies.
Kyle Diamantas, a lawyer who previously served as the FDA’s top food official, is expected to take on the acting commissioner’s role, according to a Bloomberg report. The Trump administration is also considering other personnel changes at the agency.
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Speaking to reporters, Trump said, “Marty’s a great guy, but he’s going to go on and lead a good life. He’s had some trouble,” adding, “The assistant, the deputy, is taking over temporarily until we get somebody.”
Makary rose to prominence during COVID-19
Makary, a surgeon and health researcher, rose to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic, appearing frequently on Fox News.
But he struggled to navigate the health agency’s bureaucracy and failed to win the trust of its staff after mass layoffs, leadership changes and a series of controversies in which the FDA’s scientific principles appeared to be overridden by political interests, including those of Health Secretary Robert F. Kennedy Jr.
The FDA commissioner, who leads the agency responsible for regulating billions of dollars in consumer goods and drugs, is often tasked with balancing competing priorities that lie at the intersection of science and politics.
According to reports, the former FDA commissioner has been tasked with the unique task of balancing calls from Trump and other Republicans to cut red tape at the FDA while tending to Kennedy’s interest in reviewing the safety of vaccines, drugs and food additives.
Unrest inside the FDA
Virtually all top career FDA officials have either resigned, retired or been forced out during the first year of Trump’s second term, triggering a steady stream of media reports pointing to low morale, dysfunction and frustration within the agency.
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Makary’s chosen representative, Dr. Vinay Prasad, was removed from the agency twice in less than a year after clashing with specialty drugmakers and interest groups representing rare disease patients. Despite an ongoing pressure campaign calling on Trump to fire him, Makary appeared to survive the dispute.
Criticism mounted against Makary
But recent months have brought fresh criticism from other interest groups that the White House sees as key to Republicans’ chances in the November election.
Anti-abortion groups criticized Makary for allegedly being slow to conduct an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target of conservative activists.
At the same time, vaping executives told Trump that Makary was blocking approval of their products, including new flavored e-cigarettes, which are seen as critical to the industry’s survival. According to an NBC report, despite Makary blocking flavored e-cigarettes, the FDA announced after months of pressure from the industry and the president that it has allowed fruit-flavored vapes in the U.S. for adults. Bringing back fruit-flavored vapes and e-cigarettes was a key campaign promise Trump made in 2024.
Makary’s tenure marked by great controversy
Marty Makary, a surgical oncologist at the Johns Hopkins University School of Medicine, was confirmed by the US Congress as FDA commissioner last March.
One opinion piece published by The Wall Street Journal questioned whether any administration official caused more trouble for Trump than Makary, citing two FDA rejections of the melanoma treatment Replimune.
Makary’s tenure has been marked by several high-profile controversies involving FDA reviews of vaccines, gene therapies and other treatments for rare diseases. After the second rejection of his drug, Replimune, he accused the FDA of reversing positions the agency had previously expressed at a meeting in September.
The departure of the FDA commissioner from the Trump administration is the fourth major dismissal of the US president this year. Since January, former Homeland Security Secretary Kristi Noem and former Attorney General Pam Bondi have been fired. In April, former Labor Secretary Lori Chavez DeRemer resigned from her post amid a misconduct investigation.
