The Department of Health and Human Services on September 8, 2026, named four permanent senior leaders at the Food and Drug Administration, filling the top posts at the drug, biologics, and tobacco centers and creating a new deputy commissioner role focused on technology and artificial intelligence.
Michael Davis, M.D., Ph.D., moves from acting director to permanent director of the Center for Drug Evaluation and Research. Karim Mikhail, B.Pharm, MSc, moves from acting director to permanent director of the Center for Biologics Evaluation and Research. Bret Koplow, Ph.D., J.D., moves from acting director to permanent director of the Center for Tobacco Products. Jared Seehafer, M.S., is named the agency’s first Deputy Commissioner for Technology and Artificial Intelligence, a newly created position.
The four appointees will report to the acting commissioner, Kyle Diamantas, J.D. According to the HHS release, the technology and AI role is intended to set FDA-wide strategy for software, AI, and emerging medical-technology review. The three center directors are expected to lead reviews of new drugs, vaccines and other biologics, and tobacco products, respectively.
The four selections were announced together and follow a period during which each of the three center posts had been filled on an acting basis. Davis was previously CDER’s acting director and, before that, its deputy center director. Mikhail was previously CBER’s acting director. Koplow was previously CTP’s acting director and had earlier served as senior counselor to the FDA commissioner, focused on tobacco regulatory matters.
According to the HHS announcement, Davis is expected to focus CDER on three areas: patient access to affordable critical medicines, the science of drug development and evaluation, and the domestic and global drug supply chain. Mikhail is expected to focus CBER on regulatory frameworks for rare-disease therapies and on vaccine safety surveillance. Koplow is expected to continue his focus on tobacco regulation. Seehafer’s new deputy commissioner post is described as covering technology, software, and AI strategy across the agency.
The FDA’s Center for Drug Evaluation and Research reviews and monitors the safety of prescription and over-the-counter drugs sold in the United States. The Center for Biologics Evaluation and Research regulates vaccines, blood and blood products, and cellular and gene therapies. The Center for Tobacco Products regulates the manufacture, distribution, and marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act.
