After Makary: What the FDA's Leadership Shake-Up Means for Pharmacy

Marty Makary, MD, MPH, has resigned as FDA commissioner following months of turbulence at the agency and amid disagreements with myriad stakeholders throughout the regulatory and health care spaces. The abrupt exit sets off a period of significant uncertainty at an agency that was already stretched thin from budget and staffing cuts. For pharmacists, the questions left in Makary's wake are anything but abstract: they touch on how drugs are approved, how they are dispensed, and who, ultimately, decides which medications patients can access without a prescription.^1,2

“The resignation raises concerns for pharmacists, as while the FDA review capacity is being preserved in some areas, the reduced policy and guidance output and question of leadership could lead to delays in products and confusion on policies,” Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPS (AQ-Cardiology), and CACP, a cardiovascular clinical pharmacist with Baptist Health System and the University of Kentucky College of Pharmacy, told Pharmacy Times. “This will [mean] pharmacists [need] to be more informed and engaged.”

The Circumstances of the Exit

Makary's departure follows reports of conflict and tension over the FDA's agenda. A flashpoint emerged when the FDA approved some flavored e-cigarettes from Glas Inc., a move that, according to The Wall Street Journal (WSJ), came only after President Donald Trump pressured Makary to approve the fruit-flavored varieties, which Makary had been refusing to do.^3,4

According to a source close to Department of Health and Human Services (HHS) leadership and reporting from outlets such as NBC News and WSJ, that pressure was ultimately what prompted Makary's decision to resign. Notably, the resignation occurred ahead of scheduled congressional testimony Wednesday, where Makary would have been questioned and had to defend a position he did not support.^5,6

Makary's own account of his legacy, shared via a resignation text that Trump posted to Truth Social, struck a different tone than the chaos projected in the media. In the message, Makary credited his tenure with reducing drug review times from roughly a year to 1-2 months, developing new guidance to advance psychedelics research, and introducing a "plausible mechanism" pathway for rare disease drugs. Whether those claims hold up to scrutiny, or whether the reforms he set in motion will outlast him, is now the central question facing the agency.¹

An Acting Commissioner With a Food Background

President Trump announced that Kyle Diamantas, JD, previously the agency’s deputy commissioner for food, will serve as acting commissioner until a replacement is found. Any replacement would have to be confirmed by the United States Senate, and given the strong political forces at work and the upcoming midterm elections, Diamantas could find himself serving in the acting role for quite a while.^1,7

Diamantas brings a legal and policy background to the role. As Deputy Commissioner for Food, he led the FDA's Human Foods Program, overseeing nutrition and food safety activities, resource allocation, and risk-prioritization strategy. He has also served as a liaison between the FDA, HHS, and the White House and has represented the agency in dealings with foreign governments and international organizations.^1,7,8

The task ahead for Diamantas is formidable. The conventional charge of an acting commissioner—keep the agency stable, avoid controversy, maintain stakeholder relationships—will be difficult given the sheer volume of open issues Makary left behind. Diamantas is expected to lean heavily on HHS leadership, including senior counsel, as he navigates both the legal and political dimensions of the role.

Mifepristone: The Issue That Isn't Going Away

Whoever leads the FDA, on an acting or permanent basis, will inherit an immediate, high-stakes decision on mifepristone. In early May 2026, a 3-judge panel of the Fifth Circuit Court of Appeals sided with Louisiana and stayed significant expansions of mifepristone's availability—specifically, provisions allowing the drug to be dispensed via telehealth and through pharmacies—that were formally adopted in 2023.⁹

The Supreme Court has since issued a temporary order leaving women's access to the pill intact while the justices consider whether to allow the restrictions to take effect. A formal FDA safety review of mifepristone, expected in the fall, could offer the agency an opportunity to assert its regulatory authority. However, experts are skeptical the review will be favorable to the drug's current access framework.^9,10

For pharmacists who currently dispense mifepristone or who work in states where access remains contested, the outcome of that review and the direction a new commissioner takes on it will be closely watched.

What This Means for Pharmacy Practice

The uncertainty at the FDA's top carries real downstream consequences for pharmacists. Drug approval timelines, OTC rulemaking, dispensing requirements for high-profile medications, and the future of telehealth-enabled prescribing all touch daily pharmacy operations in direct ways.

In the near term, pharmacists should expect the pace of OTC-related regulatory activity to slow as new leadership finds its footing. The question of whether a behind-the-counter model gains traction—one that would expand medication access while keeping pharmacists central to the dispensing process—may depend significantly on who ultimately takes the commissioner's chair and how receptive they are to pharmacy stakeholder input.

On mifepristone, the situation calls for close attention: a Supreme Court decision, a pending FDA safety review, and a new acting commissioner who will be navigating all of it simultaneously make for a volatile combination. Pharmacists who dispense the medication, or whose patients rely on telehealth access to obtain it, should monitor developments closely in the weeks ahead.

What is clear is that the leadership transition at the FDA, far from resolving the agency's instability, has opened a new chapter of it. The policies that will emerge from it and who will be empowered to shape them remain an open question.

REFERENCES

1. Halpern L. Amid mounting pressure, FDA Commissioner Marty Makary resigns. Pharmacy Times. Published May 12, 2026. Accessed May 13, 2026. https://www.pharmacytimes.com/view/breaking-news-amid-mounting-pressure-fda-commissioner-marty-makary-to-resign

2. Frank RG, Glied S. The Trump administration’s NIH and FDA cuts will negatively impact patients. Brookings. Published May 14, 2025. Accessed May 13, 2026.

3. 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

4. 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

5. Lovelace Jr B, Marquez A, Alba M. Dr. Marty Makary is out as FDA commissioner. NBC News. Updated May 12, 2026. Accessed May 13, 2026. https://www.nbcnews.com/health/health-news/dr-marty-makary-fda-commissioner-rcna344765

6. Whyte LE, Dawsey J. Inside Marty Makary’s downfall at the FDA. Published May 12, 2026. Accessed May 13, 2026. https://www.wsj.com/politics/policy/inside-marty-makarys-downfall-at-the-fda-6ca97054?st=6wL2Xn&reflink=desktopwebshare_permalink

7. Kyle Diamantas J.D.—Biography. FDA. Updated April 9, 2026. Accessed May 13, 2026. https://www.fda.gov/about-fda/fda-organization/kyle-diamantas

8. Brooks A. FDA commissioner Marty Makary resigns, Kyle Diamantas steps in as acting head. HCPLive. Published May 12, 2026. Accessed May 13, 2026. https://www.hcplive.com/view/fda-commissioner-marty-makary-resigns-kyle-diamantas-steps-in-as-acting-head

9. McGovern G. SCOTUS temporarily restores access to mifepristone via telehealth, mail, and pharmacies. Pharmacy Times. Published May 4, 2026. Accessed May 13, 2026. https://www.pharmacytimes.com/view/scotus-temporarily-restores-access-to-mifepristone-via-telehealth-mail-and-pharmacies

10. Gaffney T. Former FDA leaders, pharma speak out on mifepristone. STAT News. Updated May 8, 2026. Accessed May 13, 2026. https://www.statnews.com/2026/05/08/supreme-court-mifepristone-amicus-briefs-pharma-former-fda-leaders/