Martin A. Makary Becomes New FDA Commissioner

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FDA announced on April 1, 2025 that Martin A. Makary, MD, has been sworn in as the agency’s new commission after a bipartisan confirmation by the US Senate. Makary, a graduate of Bucknell University, Thomas Jefferson University, and the Harvard School of Public Health, completed his residency at Georgetown University and surgical oncology fellowship at Johns Hopkins.

He founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and led cross-disciplinary research on cancer, obesity, Alzheimer’s, adverse event monitoring, and antimicrobial resistance. He is a member of the National Academy of Medicine and co-developer of the Surgery Checklist.

“I am honored and humbled to assume this role at the FDA under the leadership of President Trump and Secretary Kennedy,” said FDA Commissioner Martin A. Makary, in the press release (1). “I look forward to working with this Administration and the FDA workforce to advance our shared goals in meeting the agency’s public health mission. As Commissioner, I hope to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense so that we can Make America Healthy Again.”

“I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and Drug Administration,” said HHS Secretary Robert F. Kennedy, Jr., in the release. “He is a national leader in medicine with impeccable credentials. His extensive research, clinical experience, and national leadership make him uniquely qualified to lead the FDA as we work together to Make America Healthy Again.”

Back in January 2025, FDA leaders, Commissioner Robert Califf and the Director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, resigned their posts (2–4). And in March 2025, Peter Marks, director of the Center for Biologics Evaluation and Research resigned (5).

Califf warned of misinformation on his way out of office. "We are currently losing the battle due to the intersection of social media and cultural changes, which threatens the foundation of public health," Califf said. “A lot of people died who would not have died if they had gotten a free vaccine and not been misled [about the safety of vaccines]” (3).

The concern over misinformation was also on the mind of Marks, who stated the following in his resignation letter (6):

“Over the past 13 years, I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said. “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

References

1. FDA. Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner. Press Release. April 1, 2025.
2. Herper, M. Leaving FDA, Califf is Unapologetic—and Warns of Staff Departures. STAT. Jan. 8, 2025.
3. Eglovitch, J. S. Goodbye Message: Califf Says FDA Needs Help in Battling Misinformation, Has Deep Talent Pool to Mitigate Departures. RAPS.org. Jan. 17, 2025.
4. Haigney, S. Cavazzoni Retires as CDER Director. PharmTech.com. Jan. 10, 2025. https://www.pharmtech.com/view/cavazzoni-retires-as-cder-director
5. Haigney, S. FDA CBER Director Peter Marks Resigns. PharmTech.com. March 31, 2025.
6. Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by The New York Times.