News|Articles|May 12, 2026

Marty Makary Out as FDA Commissioner: Report

Author(s)Mike Hollan
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Key Takeaways

  • Robert F. Kennedy reportedly initiated Makary’s ouster, and the White House signed off, underscoring HHS-driven influence over FDA leadership and the agency’s near-term policy direction.
  • Kyle Diamantas is expected to assume acting commissioner duties, creating interim uncertainty for sponsors around review standards, timelines, and cross-center alignment until a confirmed successor is installed.
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Reports also claim that Kyle Diamantas will serve as acting head of FDA.

Another major agency loses a key leadership role.

Marty Makary will no longer serve as FDA commissioner, according to a report from Politico.1 The news outlet cites an anonymous official in the administration with knowledge of the situation.

What led to Makary’s removal as head of FDA?

HHS Secretary Robert F. Kennedy reportedly made the decision to push Makary out, despite earlier reports placing the decision on President Trump’s shoulders. The White House signed off on the decision, however.

Politico also reports that Kyle Diamantas will step into the leadership role in acting capacity until a permanent replacement is named.

As of the time of this article’s publication, FDA has not released an official statement on Makary’s departure.

Pharmaceutical Executive previously reported that President Trump had been considering letting Makary go. At the time, reports suggested that a string of controversial decisions made during Makary’s time at the agency.

These decisions included:

  • A push for large, placebo-controlled trials for COVID-19 vaccines
  • Significant shifts in the agency’s approach to drug approvals
  • Attempting to restrict access to mifepristone

However, part of President Trump’s reelection campaign focused on the Make America Healthy Again (MAHA) movement, and some of these decisions fell in line with promises made on the campaign trail. It’s unclear from which direction, if any, political pressure was being applied to the removal of Makary.

Who has recently left leadership roles at government health agencies?

This also marks the latest in a series of high profile departures.

Most notably, multiple people have been appointed to and then left key leadership roles at CDER. George Tidmarsh, Richard Pazdur, and Jacqueline Corrigan-Curay have all served in the role since January, 2025.

Over at the CDC, Susan Monarez became the head of the agency in January 2025, but only lasted until the end of July that year. Jim O’Neill then served as acting head of CDC, before stepping away in February 2026. Jay Bhattacharya then served in the role until March of this year.

Most recently, President Trump nominated Dr. Erica Schwarts for the leadership role at CDC.

Notably, Vinay Prasad served as head of CBER until stepping down in March of this year. This was the second time that he stepped away from the agency. In July of 2025, Prasad briefly stepped down before returning in August of that same year.

At the time of his original departure, an FDA spokesperson said, “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family. We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

At the time of his second departure, then FDA chief Makary wrote, “A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week. Also, under his leadership, his center hit a record number of approvals in Dec. He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month. We will name a successor before his departure. I want to thank him for his service and personal sacrifice to take time away from his family.”

Sources

  1. Makary’s time atop FDA over, Diamantas named acting commissioner. Politico. May 12, 2026. https://www.politico.com/news/2026/05/12/makary-fda-resign-white-house-00916014?utm_medium=bluesky&utm_source=dlvr.it

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