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HHS Names Permanent Heads for FDA Drug, Biologics and Tobacco Centers

The appointments are meant to steady the agency after heavy turnover, with a new deputy to centralize technology and AI policy.

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
FILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. (AP Photo/Manuel Balce Ceneta, File)

Overview

  • On Tuesday, Sept. 8, 2026 HHS formalized four senior FDA appointments, naming Michael Davis to lead the Center for Drug Evaluation and Research, Karim Mikhail to lead the Center for Biologics Evaluation and Research, Bret Koplow to lead the Center for Tobacco Products, and Jared Seehafer as the agency’s first deputy commissioner for technology and artificial intelligence.
  • Michael Davis will head CDER, the FDA’s largest center that oversees safety and approvals for prescription and over-the-counter drugs, and will be positioned to shape reviews of high-profile drug areas such as emerging psychedelic therapies.
  • Karim Mikhail will lead CBER, which regulates vaccines, blood products and cellular and gene therapies, returning continuity to a center that has seen repeated leadership changes this year.
  • Jared Seehafer’s new deputy role will coordinate FDA-wide strategy on software, technology and AI and create a single senior office to set policy and priorities for digital tools used in health products and reviews.
  • HHS and reporting say the moves are intended to restore stability after steep staff losses and turnover at the agency, and they take place while the Senate considers President Trump’s nominee for FDA commissioner, a pending decision that could still reshape the agency’s direction.