Marty Makary, the 27th Commissioner of the U.S. Food and Drug Administration, is stepping down after a turbulent tenure marked by internal upheaval, political pressure, and mounting criticism from multiple corners of the healthcare and pharmaceutical sectors.
US President Donald Trump confirmed on Tuesday (May 12) that Makary was being replaced as head of the FDA.
“He was having some difficulty,” Trump told reporters at the White House.
Makary’s departure comes just over a year after he was confirmed by the US Senate on March 25, 2025, in a bipartisan vote to lead one of the world’s most influential health regulatory agencies.
Renowned surgeon and Johns Hopkins professor
Before joining the FDA, Makary built a high-profile career at Johns Hopkins University School of Medicine, where he worked as a surgical oncologist and chief of Islet Transplant Surgery.
After joining the faculty, he was later appointed an endowed chair in gastrointestinal surgery and promoted to full professor with tenure. He also taught at the Johns Hopkins Carey Business School and founded the Johns Hopkins Center for Surgical Trials and Outcomes Research.
Makary became widely known in medical and public policy circles for his research and commentary on healthcare transparency, patient safety, obesity, cancer care, Alzheimer’s disease, antimicrobial resistance, and vulnerable patient populations.
He also co-developed the Surgery Checklist system now used in operating rooms worldwide.
Author and COVID-era commentator
Makary authored more than 300 peer-reviewed medical papers and wrote several bestselling healthcare books, including:
Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care
Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health
During the COVID-19 pandemic, Makary gained national attention for research conducted with Johns Hopkins colleagues on natural immunity and antibody protection.
He also became a familiar television figure, regularly appearing on cable news, including Fox News, where he commented on pandemic policy, vaccines, and healthcare reform.
Rocky tenure at the FDA
Makary entered the FDA at a politically charged moment, tasked with balancing the Trump administration’s push to reduce regulation while also navigating the influence of Health Secretary Robert F. Kennedy Jr., who has advocated increased scrutiny of vaccines, food additives, and pharmaceutical oversight.
His tenure quickly became controversial.
FDA staff morale reportedly deteriorated amid layoffs, leadership reshuffles, and repeated clashes over scientific independence. Numerous senior FDA officials resigned, retired, or were pushed out during the administration’s first year.
Critics accused Makary of allowing political considerations to override long-standing scientific review standards at the agency.
Vaccine controversies and internal turmoil
Much of the controversy centered around vaccine approvals and leadership instability inside the FDA’s drug and vaccine divisions.
Makary’s deputy, Vinay Prasad, repeatedly clashed with pharmaceutical companies and patient advocacy groups. Prasad was twice forced out of FDA leadership roles within a year.
The FDA also faced backlash after restricting eligibility for updated COVID-19 vaccines and initially refusing to consider a Moderna mRNA flu shot application before later reversing course.
In one particularly contentious episode, Prasad circulated an internal memo alleging links between COVID vaccines and child deaths, though no public evidence was released.
A group of former FDA commissioners publicly condemned the proposed vaccine overhaul, warning it could “undermine the public interest.”
Pressure from anti-abortion and vaping groups
Makary also faced criticism from conservative anti-abortion organisations, which accused him of delaying internal reviews of the abortion pill mifepristone.
At the same time, vaping industry executives complained that the FDA was blocking approval of new flavored e-cigarette products important to the industry’s survival.
The agency later reversed course and approved certain fruit-flavored vaping products, but the move reportedly failed to ease political pressure surrounding Makary’s leadership.
Leadership changes and agency instability
The FDA’s drug center experienced unusually high turnover during Makary’s tenure, with six different people serving as director within a single year.
Among them was George Tidmarsh, who resigned following allegations involving a personal dispute with a former business associate.
Veteran cancer specialist Rick Pazdur later took over the role temporarily but announced retirement weeks later after reportedly clashing with Makary.
