The U.S. Department of Health and Human Services announced four senior leadership appointments at the FDA on Monday,¹ stabilizing the agency's operational structure after months of turnover following the departure of Commissioner Marty Makary in May.

The appointments confirm Michael Davis, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research; Karim Mikhail, B.Pharm, MSc, as Director of the Center for Biologics Evaluation and Research; Jared Seehafer, M.S., as the agency's first-ever Deputy Commissioner for Technology and Artificial Intelligence; and Bret Koplow, Ph.D., J.D., as Director of the Center for Tobacco Products.

Both Davis and Mikhail had been serving as acting directors of their respective centers — Davis after a period of significant CDER leadership turnover that included multiple acting appointments, and Mikhail after Katherine Szarama stepped aside at CBER. Today's announcement converts those interim arrangements into permanent roles.

"We are building an FDA that moves faster, demands excellence, and delivers results for the American people," said HHS Secretary Robert F. Kennedy, Jr. "These leaders will drive the reforms needed to confront our nation's most serious health challenges and strengthen American leadership in medical innovation."

What Each Appointment Signals

• Michael Davis, CDER Director. Davis brings extensive scientific, clinical, regulatory, and management experience to the permanent role, having led multidisciplinary teams in CDER's Office of New Drugs throughout his FDA career. His stated agenda centers on three priorities: increasing patient access to safe and affordable medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain. The CDER directorship has changed hands multiple times in 2026, making a permanent appointment particularly significant for sponsors navigating the approval process.
• Karim Mikhail, CBER Director. Mikhail brings more than two decades of leadership across the pharmaceutical, biotechnology, and FDA sectors, with particular focus on initiatives to accelerate clinical development and expand domestic biopharmaceutical manufacturing. His stated priorities at CBER include modernizing regulatory frameworks to accelerate development for rare diseases without compromising scientific rigor, and strengthening vaccine safety surveillance with a commitment to transparency. CBER oversees biological products including vaccines, cellular and gene therapies, and blood products — a portfolio that has faced significant regulatory and policy scrutiny under the current administration.
• Jared Seehafer, Deputy Commissioner for Technology and AI. The newly created position is the most structurally significant of the four appointments. Placing AI governance at the deputy commissioner level — above the center directors — signals that the administration intends FDA's approach to artificial intelligence to be a cross-agency priority rather than a center-by-center initiative. Seehafer brings two decades of experience at the intersection of software, AI, and FDA-regulated medical technology. The creation of this role comes as FDA is simultaneously issuing new guidance on AI use in regulatory submissions and grappling with a 59% surge in drug warning letters, some of which the agency has attributed directly to inappropriate AI use in GMP settings.
• Bret Koplow, CTP Director. Koplow brings deep legal, policy, and regulatory expertise developed over more than a decade at FDA, including senior positions in the Office of the Chief Counsel and as Senior Counselor to the FDA Commissioner. His priorities at CTP will span promoting innovation and access to less harmful alternatives for adult smokers while protecting youth from tobacco and nicotine dangers.

What It Means for Industry

The appointments arrive at a moment when regulatory predictability has become the pharmaceutical industry's most pressing operational concern. Investor demand for greater certainty around FDA review timelines, approval standards, and center-level guidance has been cited as the single largest headwind to biotech deal flow and IPO activity in 2026.

Confirming Davis and Mikhail removes the most visible source of structural uncertainty at the two centers responsible for the vast majority of drug and biologic approvals. Whether the stability they bring translates into the consistent, predictable review environment the industry needs will depend on execution — and on the outcome of Heidi Overton's pending Senate confirmation as the agency's permanent commissioner.

Changes in leadership at HHS and FDA are a major talking point for many in the pharma and biotech industry. In May of this year, Pharmaceutical Executive spoke with David Crean, chief business officer at MedicNova, about how the industry and investors are reacting to leadership changes.

“The issue is with predictability,” he said. “You see so many changes going on at the agency. What biotech is having to think about the need to adjust regulatory strategies in response to either the staffing changes, uncertainty, or even delays at FDA.”

Source

1. HHS Announces Key Leadership Selections at FDA to Promote Innovation, Reform, and National Health Priorities. HHS. September 8, 2026. https://www.hhs.gov/press-room/hhs-announces-key-fda-leadership-selections.html