Makary Resigns as FDA Commissioner After 13 Months Via Screenshot

In a screenshot via Truth Social released by President Donald Trump, Marty Makary, MD, PhD, resigned as FDA commissioner after 13 months leading the agency. Kyle Diamantas, JD, who previously worked as a top official at the agency, will be in an acting capacity for the FDA.¹

“I want to thank Dr. Marty Makary for having done a great job at the FDA,” Trump wrote in a post.² “So much was accomplished under his leadership. He was a hard worker, who was respected by all, and will go on to have an outstanding career in medicine. Kyle Diamantas, a very talented person, will be put in the acting position.”

The decision comes after reports on May 8, 2026, that President Donald Trump was considering firing Makary. However, the decision was subject to change. In the new report, Politico³ said that this decision was “months in the making.”

According to CNN,⁴ the decision to potentially fire Makary follows criticism over controversial drug approval decisions and the handling of further limiting mifepristone access. However, Makary still has public appearances scheduled and was quoted in agency press releases as of the morning of May 12, 2026.

Controversy in the FDA Under Makary

According to NBC News, various disagreements have led to Makary parting ways with the FDA. During his confirmation process, Makary promised to release a safety bill of mifepristone, which has not been released over a year later.⁵

Further, the FDA has faced pushback due to the rejection of rare disease drugs, such as a gene therapy for Huntington disease. This decision also led Vinay Prasad, MD, MPH, to step down from his position at the agency. Previously, the FDA also declined to review Moderna’s application for an mRNA flu vaccine, but the decision was reversed a week later.

On May 5, 2026, the Wall Street Journal⁶ reported that Trump was frustrated with Makary over not approving flavored vapes and nicotine products quickly enough, which was a promise made during Trump’s 2024 presidential election campaign. That same day, the FDA announced the first authorization of fruit-flavored vapes.

A Brief Look at Makary’s Time as Commissioner

Makary positioned himself as a key leader in the Make America Healthy Again movement alongside Secretary of Health and Human Services Robert F. Kennedy Jr.

Kennedy announced in June 2025 that the 17 members of the CDC’s Advisory Committee for Immunization Practices would be retired and replaced, citing concerns about conflicts of interest among members. This decision followed the announcement to update COVID-19 recommendations, announced on X by Kennedy, Makary, and National Institutes of Health Director Jay Bhattacharya, MD, PhD, which removed the COVID-19 vaccine as a recommendation for healthy children and healthy pregnant women.⁷

Following that decision, ACIP recommended against influenza vaccines containing the preservative thimerosal, citing concerns over autism or other neurodevelopment conditions. Thimerosal is a mercury-containing compound that has been used widely as a preservative in some biologics and drug products.⁸

Vaccines continued to be a topic of discussion in December 2025, when an email circulated stating that Prasad would “acknowledge that COVID-19 vaccines have killed American children,” according to PBS NewsHour. Makary added further details, such as vowing to reestablish vaccine development in the US, in an interview with Fox News.⁸

Makary also led an FDA panel to discuss the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy.⁹

“Some estimates have that nearly 1 in 4 middle-aged women are on an antidepressant,” Makary said in the opening remarks of the panel.¹⁰ “Up to 5% of women in pregnancy are [taking] an antidepressant.”

Makary added that although antidepressants can be an effective treatment for depression, the US is “losing the broader battle of addressing mental health,” and in some instances is even going backwards.

“SSRIs may be unique because serotonin may have an interaction with the physiology of a woman and a woman who is pregnant,” Makary said.¹⁰ “Serotonin may play a crucial role in the development of organs of a baby in utero, specifically the heart, brain, and even the gut. SSRIs have also been implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension, and cognitive downstream effects in the baby, as well as cardiac birth defects.”

REFERENCES

1. President Donald Trump. Truth social. https://truthsocial.com/@realDonaldTrump/posts/116563249285039587

2. President Donald Trump. I want to thank Dr. Marty Makary for having done a great job at the FDA. So much was accomplished under his leadership. He was a hard worker, who was respected by all, and will go on to have an outstanding career in Medicine. Kyle Diamantas, a very talented person, will be put in the Acting position. President DONALD J. TRUMP. Truth social. https://truthsocial.com/@realDonaldTrump/posts/116563252057470018

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

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

5. Lovelace B, Alba M. Trump weighs firing Dr. Marty Mkary as FDA chief. NBC News. May 8, 2026. Accessed May 12, 2026. https://www.nbcnews.com/health/health-news/trump-weighs-firing-dr-marty-makary-fda-chief-rcna344274

6. Whyte LE, Andrews N. Trump pressures FDA commissioner to approve flavored vapes. May 5, 2026. Accessed May 12, 2026. https://www.wsj.com/politics/policy/trump-pressures-fda-commissioner-to-approve-flavored-vapes-9dad81ee

7. Gallagher A. RFK Jr. Removes All Members of CDC’s Advisory Committee for Immunization Practices. Drug Topics. June 10, 2025. Accessed May 12, 2026. https://www.drugtopics.com/view/rfk-jr-removes-all-members-of-cdc-s-advisory-committee-for-immunization-practices

8. Gallagher A. ACIP Votes Against Thimerosal Vaccines for Prevention of Influenza. Drug Topics. June 27, 2026. https://www.drugtopics.com/view/acip-votes-against-thimerosal-vaccines-for-prevention-of-influenza

9. Nowosielski B. FDA Enforces Stricter Vaccine Development, Linking COVID Vaccine to Pediatric Deaths. Drug Topics. December 1, 2026. Accessed May 12, 2026. https://www.drugtopics.com/view/fda-enforces-stricter-vaccine-development-linking-covid-vaccine-to-pediatric-deaths

10. Gallagher A. FDA Panel Weighs Risks, Benefits of SSRI Use During Pregnancy. Drug Topics. July 24, 2026. Accessed May 12, 2026. https://www.drugtopics.com/view/fda-panel-weighs-risks-benefits-of-ssri-use-during-pregnancy