The US Food and Drug Administration (FDA) commissioner Marty Makary on Tuesday (local time) resigned from his position, marking the fourth high-profile exit of a member from President Donald Trump's administration this year.
Makary's departure comes several 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, AP reported.
Makary's 13-month tenure was marked by months of criticism from health industry executives, anti-abortion activists, vaping lobbyists, and other allies of Trump.
According to a Bloomberg report, Kyle Diamantas, a lawyer who previously served as the FDA's top food official, is expected to take over the commissioner role in an acting capacity. The Trump administration is also considering additional personnel changes at the agency.
Speaking to reporters, Trump said, "Marty is a terrific guy, but he's going to go on, and he's going to lead a good life. He was having some difficulty," and added, "The assistant, the deputy, is taking over temporarily until we find someone."
Makary rose to prominence during COVID-19
A surgeon and health researcher, Makary came to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox News.
But he struggled to manage the health agency's bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes, and a series of controversies in which the FDA's scientific principles were seemingly overriden by political interests, including those of Health Secretary Robert F. Kennedy Jr.
The FDA commissioner, who leads an agency responsible for regulating billions of dollars worth of consumer goods and medicines, is often tasked with balancing competing priorities that lie at the intersection of science and politics.
According to reports, the former FDA commissioner was tasked with a unique challenge in balancing calls by Trump and other Republicans to bring down red tape at the FDA while also tending to Kennedy's interest in scrutinizing the safety of vaccines, drugs, and food additives.
Turmoil within the FDA
Virtually all of the FDA's senior career officials either resigned, retired, or were forced out during the first year of Trump's second term, triggering a steady stream of media reports highlighting low morale, dysfunction, and frustration within the agency.
Makary's handpicked deputy, Dr. Vinay Prasad, was removed from the agency twice in less than a year after clashing with specialty drugmakers and advocacy groups representing patients with rare diseases. Despite an ongoing pressure campaign urging Trump to dismiss him, Makary appeared likely to survive the controversy.
Criticism mounted against Makary
However, recent months have brought fresh criticisms from other interest groups that the White House considers crucial to Republican chances in November elections.
Anti-abortion groups have slammed Makary for allegedly slow-walking an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target for conservative activists.
Simultaneously, vaping executives told Trump that Makary was blocking approval of their products, including new flavoured e-cigarettes seen as crucial to the industry's survival. According to an NBC report, despite Makary blocking the flavoured e-cigarettes, the FDA announced it has authorised fruit-flavoured vapes for adults in the US, after months of pressure from the industry and the president. Bringing back fruit-flavored vapes and e-cigarettes was a key campaign promise Trump made in 2024.
Makary's tenure marked by high-profile disputes
Marty Makary, a surgical oncologist at 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 had caused more problems for Trump than Makary, citing the FDA's two rejections of Replimune's melanoma therapy.
Makary's tenure was marked by several high-profile disputes involving FDA reviews of vaccines, gene therapies, and other rare-disease treatments. After the second rejection of its drug, Replimune accused the FDA of reversing positions the agency had previously expressed during a meeting in September.
The FDA Commissioner's exit from the Trump administration marks the fourth high-profile firing by the US President this year. Since January, former Homeland Security Secretary Kristi Noem and former Attorney General Pam Bondi have been let go. In April, former Labor Secretary Lori Chavez DeRemer resigned her post amid a misconduct probe.