FDA chief departs after 13 months, sparking regulatory uncertainty

Food and Drug Administration Commissioner Marty Makary resigned from his post on Tuesday after a turbulent 13-month tenure, a departure confirmed by President Donald Trump that creates immediate uncertainty for industries representing one-fifth of US consumer spending. Kyle Diamantas, the agency's deputy commissioner for food, will serve as acting commissioner.

"There's been a lot of departures from the agency. You've seen political appointees take over what are typically career leadership positions," Dr. Scott Gottlieb, who served as FDA commissioner for two years under Mr. Trump, told "Face the Nation" on Sunday. "I think cumulatively, that's taken a toll on the agency."

Makary’s exit follows public clashes with the White House and Health and Human Services Secretary Robert F. Kennedy Jr. over several high-profile issues. President Trump reportedly pressured Makary to authorize flavored e-cigarettes, while Secretary Kennedy and conservative groups pushed for new restrictions on the abortion pill mifepristone, accusing Makary of slow-walking a requested safety review.

The leadership change injects significant instability into the regulatory process for the pharmaceutical, biotech, and tobacco industries, which rely on predictable FDA policy for multi-billion dollar investment decisions. With midterm elections approaching, the confirmation of a permanent successor is not guaranteed, leaving an acting commissioner to navigate the politically charged issues that led to Makary's ouster.

Clash Over Vapes and Pills

Dr. Makary’s brief period leading the powerful agency was defined by political battles on multiple fronts. A central conflict involved the regulation of e-cigarettes. According to reports, Makary resisted approving fruit-flavored vapes from Glas Inc., citing concerns about youth addiction, but was ultimately overruled by President Trump. The FDA approved the products on May 6, a move that sources said was a direct factor in Makary's resignation.

Simultaneously, Makary faced intense pressure from anti-abortion groups and HHS Secretary Kennedy to restrict access to mifepristone. In June of last year, Kennedy had tasked the FDA with reviewing the safety of the drug, which is used in the majority of US abortions. Critics, including Susan B. Anthony Pro-Life America, accused Makary of deliberately delaying the study and called for his removal, stating he was "severely undermining" the administration's agenda.

A Tenure Marked by Turmoil

The surgeon and author was confirmed in March 2025, pledging to accelerate FDA decisions. However, his tenure was marked by what one administration official called "constant chaos," including mass layoffs and high turnover among senior staff. His departure is the latest in a series of high-profile exits from the Department of Health and Human Services, including vaccines chief Vinay Prasad.

The turmoil raises questions about the future of the "Make America Healthy Again" movement, which Makary had supported. While some advocates for food policy reform praised his efforts to crack down on ultra-processed foods, pharmaceutical companies criticized the agency for what they saw as inconsistency in its drug review process. The constant controversy ultimately led HHS Secretary Kennedy to make the final call on his departure, according to a senior administration official.

The immediate challenge falls to acting commissioner Kyle Diamantas, who was scheduled to testify before a Senate Appropriations Committee on Wednesday in Makary's place. He inherits an agency caught between political pressures and its mandate to regulate products affecting the daily lives of millions of Americans, with the pharmaceutical and biotech sectors now watching closely for signals on future policy direction.

This article is for informational purposes only and does not constitute investment advice.