The Trump administration has appointed permanent directors to lead key FDA divisions, including Dr. Michael Davis for drugs and Karim Mikhail for vaccines, following two years of intense leadership turnover and policy volatility. The appointments, which also include Bret Koplow for tobacco and Jared Seehafer for a new AI role, are seen by industry analysts as a stabilizing move that brings regulatory continuity to the agency as it awaits the confirmation of commissioner nominee Heidi Overton.
FDA permanent director appointments
- ▪Karim Mikhail, a pharmacist and former pharmaceutical executive, was named permanent director of the Food and Drug Administration's Center for Biologics Evaluation and Research
- ▪Bret Koplow was appointed permanent director of the Food and Drug Administration's Center for Tobacco Products after serving in an acting capacity
- ▪Jared Seehafer was appointed to a newly created Food and Drug Administration position as deputy commissioner overseeing artificial intelligence and technology
- ▪Dr. Michael Davis was named permanent director of the Food and Drug Administration's Center for Drug Evaluation and Research, having served as acting director since May 2026
- ▪The Trump administration and the Department of Health and Human Services appointed permanent directors for three Food and Drug Administration centers on September 8, 2026
FDA leadership turnover history
- ▪Dr. Vinay Prasad resigned twice within a single year from his role leading the Food and Drug Administration's vaccines center, with his final departure occurring in March 2026
- ▪The Food and Drug Administration's Center for Drug Evaluation and Research had five different leaders during 2025
- ▪Katherine Szarama served as acting director of the Food and Drug Administration's Center for Biologics Evaluation and Research for approximately three weeks in 2026 before Karim Mikhail took over
- ▪Dr. Tracy Beth Hoeg was fired in May 2026 from her role as acting director of the Food and Drug Administration's Center for Drug Evaluation and Research
- ▪Former Food and Drug Administration Commissioner Dr. Marty Makary resigned in May 2026 after a little more than a year in the role
Policy shifts under acting leadership
- ▪Following the departures of Dr. Marty Makary and Dr. Vinay Prasad, acting Food and Drug Administration leadership reversed some positions on previously rejected or delayed drugs
- ▪Following the departure of Dr. Marty Makary, the Food and Drug Administration cleared a series of new nicotine pouches and flavored e-cigarettes
- ▪Under former leaders Dr. Marty Makary and Dr. Vinay Prasad, the Food and Drug Administration implemented stringent requirements requiring vaccine-makers to conduct lengthy studies before updated COVID-19 shots could be approved
Industry analyst reactions
- ▪RBC Capital Markets analyst Brian Abrahams characterized Karim Mikhail as industry-friendly due to his decades of leadership at drugmakers and his advocacy for accelerated drug development
- ▪RBC Capital Markets analyst Brian Abrahams stated that appointing the interim directors permanently signals continuity and stability, which should ease industry concerns about major policy shifts
- ▪RBC Capital Markets analyst Brian Abrahams noted that Dr. Michael Davis's interest in psychedelics could benefit pharmaceutical companies like Eli Lilly that are seeking to bring psychiatric treatments to market
Pending FDA commissioner confirmation
- ▪RBC Capital Markets analyst Brian Abrahams stated that Heidi Overton is expected to delegate heavily to division directors if she is confirmed as Food and Drug Administration commissioner
- ▪President Donald Trump nominated policy aide Heidi Overton in August 2026 to serve as the permanent Food and Drug Administration commissioner
Debatable claims
- ▪The FDA should fast-track the approval of psychedelic therapies
- ▪The FDA should ban flavored e-cigarettes and nicotine pouches
- ▪The FDA should require full clinical trials for updated COVID-19 vaccines
- ▪The FDA should not appoint pharmaceutical industry executives to lead its regulatory centers
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