FDA Names 4 Center Directors as Psychedelics Reviews Take Shape

For biopharma sponsors, the most consequential appointment is Michael Davis as permanent CDER director. Davis's prior work in the FDA's psychiatric drug division and at a psychedelic-focused nonprofit, combined with explicit support from President Trump and HHS Secretary Robert F. Kennedy Jr., could translate into faster review pathways for psilocybin, MDMA, and LSD—and a meaningful shift in psychiatric drug development.

On Tuesday, September 8, 2026, the Department of Health and Human Services announced that four senior positions at the Food and Drug Administration had been filled on a permanent basis, including the directors of the agency's drug, vaccine/biologics, and tobacco product centers. The move is a direct response to months of leadership turmoil and high-profile departures that have raised questions among industry, providers, and lawmakers about the FDA's ability to maintain predictable oversight. According to the announcements reported by MedPage Today and the Associated Press, Michael Davis, MD, PhD, was named permanent director of the Center for Drug Evaluation and Research (CDER), the agency's largest center. Karim Mikhail, BPharm, MSc, was named permanent director of the vaccines center. HHS also filled the top tobacco product center role, converting several acting leaders into permanent appointees.

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For biopharma sponsors, the most consequential appointment is Michael Davis as permanent CDER director.

Davis, a physician-researcher who previously led the FDA's psychiatric drug division, returns to a role that carries outsize importance for the psychiatry and psychedelic drug pipeline. He had been serving as acting CDER director since May, when Tracy Beth Høeg, MD, PhD, said she was fired from the position. Høeg's brief tenure focused heavily on scrutinizing antidepressants, COVID-19 shots, and pediatric drug use, creating friction with some industry and advocacy groups. Davis left government for a nonprofit focused on developing psychedelic drugs before returning as a deputy director last year. Now as CDER's permanent director, he will oversee reviews of psilocybin, MDMA, and LSD studies for psychiatric conditions. Both President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. have stated that they want to speed up psychedelic drug reviews, and Davis's background suggests he is positioned to execute that agenda.

Mikhail, a pharmacist and longtime pharmaceutical executive who joined FDA in the spring of 2026, becomes permanent head of the Center for Biologics Evaluation and Research, which oversees vaccines. His leadership arrives after a period of intense public scrutiny of vaccine policy under the administration. The naming of a permanent tobacco center director, while not detailed in the initial reports, also stabilizes a center that has faced major policy shifts in nicotine regulation. Together, the appointments fill three of the FDA's six centers and reduce some of the ambiguity that has troubled sponsors of new drugs, vaccines, and tobacco-related products.

For drug developers, especially those in the psychiatric and psychedelic space, the appointment is a stronger signal than prior acting assignments that the FDA may prioritize new treatments for depression, PTSD, and other conditions. But it also raises safety and regulatory questions because psychedelic compounds remain Schedule I and have complex abuse and efficacy profiles. The permanent leadership could accelerate advisory committee meetings, novel trial designs, and postmarket safety planning. At the same time, senators and consumer groups who warned about politicized drug decisions may intensify oversight if they believe the center's direction has shifted toward faster approvals at the expense of safety.