Marty Makary, the 27th commissioner of the US Food and Drug Administration, is stepping down after a turbulent tenure marked by internal turmoil, political pressure and mounting criticism from various corners of the healthcare and pharmaceutical sectors.
US President Donald Trump on Tuesday (May 12) confirmed the replacement of Makary as head of the FDA.
“He had some difficulties,” Trump told reporters at the White House.
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Marty Makary has resigned as FDA commissioner amid a turbulent tenure marked by internal turmoil, political pressure and cross-sector criticism. Key issues have included controversies over the approval of vaccines, vaping products and drug approvals, as well as disputes over scientific independence.
Makary’s tenure has been marked by controversies including clashes over vaccine approvals and leadership instability, pressure from anti-abortion groups over the abortion pill mifepristone, and complaints from the vaping industry over product approvals. Internal unrest and high turnover in leadership roles also contributed to the controversy.
Kyle Diamantas is expected to take over as acting FDA commissioner following the resignation of Marty Makary. Diamantas currently leads the FDA’s Human Foods Program.
Before leading the FDA, Marty Makary was a renowned surgeon and professor at the Johns Hopkins University School of Medicine. He was also known for his work on health care transparency and patient safety and as an author and commentator during the COVID-19 pandemic.
Political pressure from various groups, including the Trump administration’s push to reduce regulation and Health Secretary Robert F. Kennedy Jr.’s push for increased scrutiny, has created a challenging environment for Makary. Criticism from conservative activists, anti-abortion groups and vaping lobbyists also contributed to the pressure.
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 head one of the world’s most influential health regulatory agencies.
Renowned surgeon and Johns Hopkins professor
Prior to joining the FDA, Makary built a distinguished career at the Johns Hopkins University School of Medicine, where he served as a surgical oncologist and chief of islet transplant surgery.
After joining the faculty, he was later appointed Endowed Chair of 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 has become widely known in medical and public circles for his research and commentary on health care transparency, patient safety, obesity, cancer care, Alzheimer’s disease, antimicrobial resistance, and vulnerable patient populations.
He also collaborated on the development of the Surgery Checklist system, which is now used in operating theaters around the world.
Author and commentator from the COVID era
Makary has authored more than 300 peer-reviewed medical papers and written several best-selling books on health care, including:
The Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Healthcare
Blind Spots: When Medicine Goes 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 innate immunity and antibody protection.
He has also become a well-known television personality, appearing regularly on cable news, including Fox News, commenting on pandemic policy, vaccines and health care reform.
Rocky tenure at the FDA
Makary joins the FDA at a politically charged time, tasked with balancing the Trump administration’s push for reduced regulation while riding the influence of Health Secretary Robert F. Kennedy Jr., who advocated for increased scrutiny of vaccines, food additives and pharmaceutical oversight.
His tenure quickly became controversial.
FDA staff morale reportedly deteriorated due to layoffs, leadership changes, and repeated clashes over scientific independence. A number of senior FDA officials resigned, retired or were pushed out during the administration’s first year.
Critics accused Makary of allowing political considerations to override longstanding standards of scientific evaluation at the agency.
Vaccine controversy and civil unrest
Much of the controversy has centered around vaccine approval and leadership instability within the FDA’s drug and vaccine divisions.
Makary’s representative, Vinay Prasad, has repeatedly clashed with drug companies and patient advocacy groups. Prasad was pushed out of FDA leadership roles twice in one year.
The FDA also faced backlash after limiting eligibility for updated COVID-19 vaccines and initially refusing to consider the Moderna mRNA flu vaccine before later reversing course.
In one particularly contentious episode, Prasad circulated an internal report alleging links between COVID vaccines and child deaths, although no public evidence was released.
A group of former FDA commissioners has 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 organizations, who accused him of delaying internal reviews of the abortion pill mifepristone.
At the same time, vaping industry leaders complained that the FDA was blocking approval of new flavored e-cigarette products vital 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 around Makary’s leadership.
Leadership changes and agency instability
The FDA Drug Center experienced unusually high turnover during Makary’s tenure, with six different people serving as director in a single year.
Among them was George Tidmarsh, who resigned after allegations of a personal dispute with a former business partner.
Veteran cancer specialist Rick Pazdur later temporarily took over the role, but announced his retirement a few weeks later after reportedly clashing with Makary.
Read also | US FDA Commissioner Marty Makary Resigns Amid Turbulence at Health Agencies
