Amid Mounting Pressure, FDA Commissioner Marty Makary to Resign

This is a developing story. Coverage remains ongoing.

FDA Commissioner Marty Makary, MD, MPH, intends to resign from his position, according to reporting from The New York Times, Politico, and The Associated Press. The resignation caps a turbulent 13-month tenure marked by ambitious regulatory reform efforts and escalating conflict with the White House.^1-3

Makary's plans to step down come after months of turmoil at the agency and after President Donald Trump reportedly signed off last week on a plan to replace him, according to sources from The Wall Street Journal. Kyle Diamantas, JD, the FDA's deputy commissioner for food, is expected to assume the role in an acting capacity.^1-4

An official statement from the FDA or the Department of Health and Human Services has yet to be released. Pharmacy Times reached out to the FDA for comment.

A Tenure Defined by Reform and Controversy

Makary, a surgeon by training, took office in March 2025 after gaining national prominence during the COVID-19 pandemic, when he argued against mask mandates for children and criticized the CDC for its vaccine booster recommendations. Once confirmed, he moved quickly on a sweeping regulatory agenda.⁵

Under Makary's leadership, the FDA initiated efforts to speed up drug approvals and clinical trials, reduce regulatory burdens, crack down on ultraprocessed foods, and phase out artificial food dyes—moves welcomed by food policy advocates within the Make America Healthy Again (MAHA) movement.^6,7,8

However, some actions taken during Makary's tenure divided the MAHA coalition. Vaccine critics lamented that he had not pulled COVID-19 vaccines off the market, despite numerous actions taken to restrict their use, including prioritizing COVID-19 vaccine recommendations for high-risk groups and blocking the publication of FDA-led studies highlighting the vaccines’ safety and efficacy.^9,10

REFERENCES

1. Jewett C. FDA commissioner Marty Makary resigns after weeks of pressure. The New York Times. Updated May 12, 2026. Accessed May 12, 2026. https://www.nytimes.com/2026/05/12/us/politics/trump-fires-fda-commissioner-makary.html

2. Lim D, Gardner L. Makary’s time atop FDA over, Diamantas named acting commissioner. Politico. Updated May 12, 2026. Accessed May 12, 2026. https://www.politico.com/news/2026/05/12/makary-fda-resign-white-house-00916014

3. Perrone M, Min Kim S. Trump FDA chief is leaving after angering pharma CEOs, vaping lobbyists and anti-abortion groups. The Associated Press. Updated May 12, 2026. Accessed May 12, 2026. https://apnews.com/article/fda-trump-makary-kennedy-vaccines-drugs-ef151784342c48cca3b91a829d615b5e

4. Whyte LE, Dawsey J. Trump is planning to fire FDA commissioner Marty Makary. The Wall Street Journal. Updated May 8, 2026. Accessed May 12, 2026. https://www.wsj.com/health/healthcare/trump-planning-to-fire-fda-commissioner-marty-makary-34c072e2

5. Kekatos M, Faulders K, Fishel J. Dr. Marty Makary intends to resign as FDA commissioner: Sources. ABC News. Updated May 12, 2026. Accessed May 12, 2026. https://abcnews.com/Health/dr-marty-makary-intends-resign-fda-commissioner-sources/story?id=132759639

6. McGovern G. FDA awards national priority voucher to teclistamab plus daratumumab in relapsed/refractory multiple myeloma. Pharmacy Times. December 16, 2025. Accessed May 12, 2026. https://www.pharmacytimes.com/view/fda-awards-national-priority-voucher-to-teclistamab-plus-daratumumab-in-relapsed-refractory-multiple-myeloma

7. Valletti D. New federal dietary guidelines emphasize protein and real foods while cutting sugar. Pharmacy Times. January 8, 2026. Accessed May 12, 2026. https://www.pharmacytimes.com/view/new-federal-dietary-guidelines-emphasize-protein-and-real-foods-while-cutting-sugar

8. Bettelheim A. FDA cliffhanger: Makary’s fate in limbo. Axios. May 11, 2026. Accessed May 12, 2026. https://www.axios.com/2026/05/11/fda-cliffhanger-makary-trump-administration

9. Halpern L. FDA to restrict future COVID-19 vaccine recommendations to older adults, high-risk groups. Pharmacy Times. May 21, 2025. Accessed May 12, 2026. https://www.pharmacytimes.com/view/fda-to-restrict-future-covid-19-vaccine-recommendations-to-older-adults-high-risk-groups

10. Ferruggia K. FDA blocks publication of COVID-19 and shingles vaccine safety studies: What pharmacists need to know. Pharmacy Times. May 6, 2026. Accessed May 12, 2026. https://www.pharmacytimes.com/view/fda-blocks-publication-of-covid-19-and-shingles-vaccine-safety-studies-what-pharmacists-need-to-know