Makary to Resign as FDA Commissioner

The tenure of Marty Makary, MD, MPH, as FDA commissioner has come to a close, according to reports that he is resigning today.¹ Rumors of his anticipated exit first surfaced Friday afternoon, with STAT and Politico attributing his purported firing by President Donald J. Trump to discord between the FDA and White House on issues including drug approvals, vapes, and abortion pills.^2,3

Makary was one of a trio of doctors nominated to lead key federal health positions in Trump’s second term, alongside former Rep Dave Weldon, MD (R, Florida), for the CDC, and Janette Nesheiwat, MD, as Surgeon General,⁴ but the only one to be confirmed. The CDC is currently being led by National Institutes of Health Director Jay Bhattacharya, MD, in an acting capacity, and the Surgeon General‘s post is vacant.

Makary’s time as FDA head brought a series of moves designed to speed up the regulatory process and bring greater transparency to the pathway to approval. In February, Makary and top deputy Vinay Prasad, MD, MPH, announced that the agency’s historic reliance on 2 clinical trials would end and only 1 pivotal trial will be needed for approval.⁵

“The FDA’s historical reliance on 2 clinical trials rather than 1 was intended to provide credible causal evidence that a therapy could improve clinical outcomes with acceptable safety in a world where biologic understanding was more limited than it is today,” the officials wrote. “Two trials should be seen as just 1 of many interlocking facets of clinical credibility, and in 2026, there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

In April, the FDA sent letters calling on drug manufacturers, medical device makers, and researchers to publish trial data on ClinicalTrials.gov, as they are legally required to do but do not always adhere to.⁶ These actions suggested an aim of bringing transparency to the research process, but the FDA’s transparency in its own decisions had been criticized amid the agency’s downsizing of personnel and delays in issuing decisions.

Days before Makary’s resignation, STAT reported that Sanofi requested to exclude its type 1 diabetes drug teplizumab from the agency’s National Priority Voucher pilot program after a reported disagreement on its expanded approval caused the FDA to miss its April 21 goal date for a decision.⁷ The pilot aims to fast-track selected drugs whose uptake could support national interests, but the drugmaker appeared to lose confidence in the agency’s ability or willingness to issue these decisions quickly.

Experts have cast the staff upheaval within the FDA as responsible for the delays, with former FDA Commissioner Scott Gottlieb, MD, stating at a CNBC event in March, “When you lose the folks who have been doing this a long time, as they have, and they’re continuing to lose that caliber of personnel, it starts to impact review decisions.”⁸

Observers have also noted unusual processes in the review of vaccines under Makary’s leadership, with STAT reporting in February that Prasad intervened to dismiss Moderna’s application for an mRNA vaccine against influenza.⁹ The reported overruling took place despite a team of career scientists, including the head of the agency’s vaccine process, assessing the application as suitable to be reviewed.

Officials told Politico that Kyle Diamantas, JD, the deputy commissioner for food, will lead the FDA in an acting capacity until a new commissioner is confirmed.¹

The White House was reportedly unhappy with Makary’s recent attempts to block the approval of flavored vape products.^2,3 The agency also took heat from anti-abortion lawmakers and advocates amid the approval last October of a second generic mifepristone pill, used to terminate pregnancy.¹⁰

It’s currently unclear whether his priorities as commissioner, such as the voucher program, will be maintained by his successor. However, a text message screenshot posted by Trump purporting to show Makary’s resignation letter makes reference to key accomplishments during his tenure: reducing drug review times, introducing guidance for advancing psychedelic agents, and smoothing the rare disease approval pathway, among others.¹¹

References

1. 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

2. Lawrence L. Trump reportedly plans to fire FDA Commissioner Makary. STAT. May 8, 2026. Accessed May 8, 2026. https://www.statnews.com/2026/05/08/fda-commissioner-marty-makary-exit-controversial-tenure

3. Lim D. Makary to leave as FDA commissioner after tumultuous year, White House source says. Politico. May 8, 2026. Accessed May 8, 2026. https://www.politico.com/news/2026/05/08/makary-leave-as-fda-commissioner-white-house-source-00911981

4. Shaw ML. Trio of doctors nominated for CDC, FDA, Surgeon General. AJMC. November 25, 2024. Accessed May 8, 2026. https://www.ajmc.com/view/trio-of-doctors-nominated-for-cdc-fda-surgeon-general

5. Bonavitacola J. FDA will require only 1 study to approve new drugs, speeding up process. AJMC. February 19, 2026. Accessed May 8, 2026. https://www.ajmc.com/view/fda-will-require-only-1-study-to-approve-new-drugs-speeding-up-process

6. Blum D. F.D.A. calls on drug developers to publish missing data from thousands of trials. The New York Times. April 13, 2026. Accessed May 8, 2026. https://www.nytimes.com/2026/04/13/well/fda-clinical-trials.html

7. Lawrence L. Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review. STAT. May 6, 2026. Accessed May 8, 2026. https://www.statnews.com/2026/05/06/sanofi-asks-to-pull-diabetes-drug-teplizumab-makary-fda-voucher-program/

8. Thomas I. FDA watchers warn of ‘chaos’ inside agency, as regulatory delays, staff hemorrhaging risk America’s health. CNBC. March 3, 2026. Accessed May 8, 2026. https://www.cnbc.com/2026/03/03/fda-watchers-warn-agency-chaos-drug-approval-delays-health-risks.html

9. Lawrence L. Prasad overruled FDA staff to reject Moderna’s flu vaccine application. STAT. February 11, 2026. Accessed May 8, 2026. https://www.statnews.com/2026/02/11/moderna-flu-vaccine-application-rejected-by-prasad-overruling-fda-staff/

10. Mattina C. FDA approves second generic mifepristone pill for abortion. AJMC. October 3, 2025. Accessed May 8, 2026. https://www.ajmc.com/view/fda-approves-second-generic-mifepristone-pill-for-abortion

11. @realDonaldTrump. Truth Social. May 12, 2026. Accessed May 12, 2026. https://truthsocial.com/@realDonaldTrump/116563249285039587