Dr. Marty Makary is no longer serving as commissioner of the U.S. Food and Drug Administration (FDA), becoming the fourth high-profile departure from the administration this year. Multiple sources reported that Makary's removal was initiated by President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. The departure follows a tenure marked by policy disputes, internal discord, and criticism from various stakeholders.
Timeline of Departure
Reports indicate that President Trump had decided to remove Makary as early as May 8, 2025, according to anonymous administration sources cited by NBC News, The New York Times, The Wall Street Journal, and The Washington Post. On Tuesday, December 18, 2025, President Trump announced that Makary had left the position. Trump did not clarify whether Makary was fired or asked to resign. A federal health official stated that Makary was expected to resign.
"He's a great doctor and he was having some difficulty, but he's going to go on and he's going to do well."
— President Donald Trump, on Dr. Makary's departure
Trump also referred to Makary as "a great guy" and "a wonderful man."
Appointment and Background
Makary, a former surgical oncologist and health policy researcher at Johns Hopkins University, was confirmed as FDA commissioner on March 25, 2025, with bipartisan support. His confirmation drew criticism due to his previous advocacy for natural immunity against COVID-19 over vaccine-induced immunity, his past role as a Fox News contributor, and his critical stance on the Biden administration's COVID-19 vaccine policy.
Reasons for Departure
A source cited disagreement over authorizing flavored e-cigarettes as a key factor. The FDA authorized fruit-flavored vapes for adults in the U.S. in early December 2025, following industry and presidential pressure. Restoring fruit-flavored vapes and e-cigarettes had been a 2024 campaign promise of Trump.
A senior administration official said the decision was due to a buildup of issues, including abortion politics. Makary faced scrutiny from Republican lawmakers after promising during his confirmation to review the safety of the abortion medication mifepristone. The FDA had not released its review of the abortion pill as of Makary's departure. Bloomberg News reported that Makary asked officials to delay the release until after the midterm elections. The Susan B. Anthony Pro-Life America organization called for his ouster over the FDA's handling of mifepristone.
Tenure and Policy Actions
During his 13-month tenure, Makary:
- Sought to streamline FDA processes, including consolidating reporting systems for adverse events
- Advocated for single pivotal clinical trials to speed drug approvals
- Approved updated mRNA COVID-19 vaccines
- Approved a second generic version of mifepristone
- Removed warnings on certain hormone replacement therapy products without an advisory committee
- Initially rejected then accepted an application for Moderna's mRNA flu shot
- Appointed Dr. Vinay Prasad as director of the Center for Biologics Evaluation and Research (CBER); Prasad faced criticism over decisions on Moderna's flu shot and a Huntington's disease gene therapy
Internal Challenges
Reports indicate Makary faced challenges leading the FDA, including:
- Staff departures and layoffs
- Criticism from healthcare, pharmaceutical, and advocacy groups
- Backlash from drugmakers, physicians, and patient groups over regulatory decisions
- Friction with the White House over the pace of key policy initiatives
- Staff morale decline following layoffs and departures, including cancer regulator Dr. Richard Pazdur
- Senator Ron Johnson announced an investigation into the FDA's rejection of rare disease treatments
Interim and Next Steps
President Trump announced Kyle Diamantas, former top food official at the FDA, as acting commissioner. The administration aims to nominate a permanent replacement in the coming weeks. The pharmaceutical industry is monitoring the leadership change, amid ongoing negotiations on the Prescription Drug User Act Fee reauthorization. Installing a new commissioner may require support from Senator Bill Cassidy.
Context
Makary's departure follows other administration departures: former Homeland Security Secretary Kristi Noem, former Attorney General Pam Bondi, and former Labor Secretary Lori Chavez DeRemer, who resigned amid a misconduct probe.