Amid Mounting Pressure, FDA Commissioner Marty Makary Resigns

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 J. 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

President Trump seemed to confirm the news while speaking to reporters on the White House lawn on May 12, 2026. When questioned whether he asked Makary to resign or he officially fired Makary, Trump said only, “He’s going to be off…. The deputy is taking over temporarily. Marty is a terrific guy, but he’s going to go on, and he’s going to lead a good life. He was having some difficulty.”⁵

Later, on his Truth Social account, President Trump posted a screenshot of a text he allegedly received from Makary announcing his resignation.⁶

“Please accept my resignation, effective today,” Makary wrote to the president. “It’s been the honor of a lifetime to serve as your FDA commissioner. I am forever grateful.”⁶

An official statement from the FDA or the US Department of Health and Human Services has yet to be released. Pharmacy Times has 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.⁷

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.^8-10

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.^11,12

Drawing the Ire of Key Trump Stakeholders

Most recently, Makary attempted to block agency scientists from approving flavored vapes, which caught the attention of President Trump, who wanted the products approved to appeal to younger voters in his electoral base, according to reporting from The Wall Street Journal. The issue prompted an angry Trump to directly press Makary over the vapes’ decisions, and the FDA subsequently reversed course on flavored e-cigarettes in early May 2026.^13-15

Makary also drew the ire of antiabortion activists, who have applied significant pressure in pushing for the FDA to reverse regulations that allow providers to send the abortion pill mifepristone through the mail. Such a move would have broad repercussions for abortion access nationwide, as the FDA sets the rules for prescribing the drug. Medication accounts for roughly two-thirds of all US pregnancy terminations, which has fueled an overall increase in abortions since the Supreme Court ended nationwide abortion rights protections in the 2023 decision Dobbs v Jackson Women’s Health Organization.^16,17

Makary had reportedly angered the antiabortion community and some Republican lawmakers by slow-walking an FDA safety study on mifepristone. In a widely noted interview with The Wall Street Journal, Makary stated bluntly, "I don't think about the abortion pill," a comment that drew sharp criticism from antiabortion advocates and legislators seeking to further restrict mifepristone.^16,17

Broader Leadership Instability at FDA and HHS

Makary's exit leaves the FDA and the broader HHS with significant leadership vacancies at a critical time. The administration already lacks a permanent director at the CDC and a permanent surgeon general. Makary's departure comes one day before he was set to testify about the FDA's proposed budget before the Senate Appropriations Committee.¹⁶

For pharmacy professionals, the leadership transition carries real stakes. The FDA regulates drug approval timelines; prescribing rules for medications, including mifepristone; and tobacco and nicotine products—all areas where Makary's policies were still in flux at the time of his resignation. How an acting—and ultimately, permanent—commissioner handles those open questions will have direct implications for pharmacy practice and patient care in the months ahead.

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. @CSPAN on X. Posted May 12, 2026, at 2:05 PM. Accessed May 12, 2026. https://x.com/cspan/status/2054261753391812727

6. @realDonaldTrump on Truth Social. Posted May 12, 2026, at 3:27 PM. Accessed May 12, 2026. https://truthsocial.com/@realDonaldTrump/posts/116563249285039587

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Whyte LE, Cooper L. White House pushes for flavored vapes blocked by FDA head. The Wall Street Journal. Updated April 17, 2026. Accessed May 12, 2026. https://www.wsj.com/politics/policy/white-house-pushes-for-flavored-vapes-blocked-by-fda-head-2f8f0138

14. Meyer Z. After Trump pressure, FDA chief OKs some flavored vapes. The Wall Street Journal. Updated May 5, 2026. Accessed May 12, 2026. https://www.wsj.com/politics/policy/after-trump-pressure-fda-chief-oks-some-flavored-vapes-d443b907

15. Halpern L. FDA authorizes first-ever fruit-flavored ENDS products, marking major policy shift. Pharmacy Times. May 6, 2026. Accessed May 12, 2026. https://www.pharmacytimes.com/view/fda-authorizes-first-ever-fruit-flavored-ends-products-marking-major-policy-shift

16. Cancryn A, Owermohle S, Tirrell M. Trump has signed off on ousting FDA chief, senior official says. CNN. Updated May 8, 2026. Accessed May 12, 2026. https://www.cnn.com/2026/05/08/health/makary-fda-commissioner

17. Wegmann P, Whyte LE, Calfas J. The antiabortion movement is turning on Trump. The Wall Street Journal. May 3, 2026. Accessed May 12, 2026. https://www.wsj.com/politics/policy/trump-anti-abortion-movement-76393c1c