HHS Announces Key Leadership Selections at FDA to Promote Innovation, Reform, and National Health Priorities

WASHINGTON, D.C. — September 8, 2026 — The U.S. Department of Health and Human Services today announced the selection of four senior leaders at the U.S. Food and Drug Administration (FDA), strengthening the agency’s leadership team as FDA advances its public health pillars to deliver profound benefits for patients, consumers, and public health. These appointments reflect a deliberate strategy to drive innovation and meaningful reform across FDA, positioning the Agency to lead on its core priorities: advancing innovation and global leadership, strengthening national health security, increasing access to affordable medicines and medical products, and promoting health wellness for the American people.

• Jared Seehafer, M.S. has been selected to serve as FDA’s first Deputy Commissioner for Technology and Artificial Intelligence;
• Michael Davis, M.D., Ph.D., has been selected as Director of the Center for Drug Evaluation and Research (CDER);
• Karim Mikhail, B.Pharm, MSc, has been selected as Director of the Center for Biologics Evaluation and Research (CBER); and
• Bret Koplow, Ph.D., J.D., has been selected as Director of the Center for Tobacco Products (CTP).

“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.”

“These selections are not just about filling leadership roles — they signal the direction we are heading,” said FDA Acting Commissioner Kyle Diamantas, J.D. “These leaders will help us attract and retain best-in-class talent while building the workforce and infrastructure needed to accelerate innovative across all FDA centers.”

Jared Seehafer — Deputy Commissioner for Technology and Artificial Intelligence

As FDA’s first Deputy Commissioner for Technology and Artificial Intelligence, Seehafer will serve as the agency’s senior leader for technology, software, and AI and will provide leadership in establishing FDA-wide strategy and priorities in these areas.

Seehafer brings two decades of technical and leadership experience at the intersection of software, AI, and FDA-regulated medical technology.

The newly created position underscores the Trump Administration’s commitment to accelerating reliable AI innovation, modernizing federal technology, and ensuring an effective regulatory framework for emerging technologies.

Michael Davis, M.D., Ph.D. a — Director, Center for Drug Evaluation and Research

Dr. Michael Davis has been selected to serve as Director of CDER after serving as the center’s Acting Director and previously as its Deputy Center Director.

Davis brings extensive scientific, clinical, regulatory, and management experience to the role. During his FDA career, he has held leadership positions in CDER’s Office of New Drugs and has led multidisciplinary teams responsible for the review of drugs and the development of regulatory science and policy.

As CDER Director, Davis will lead the FDA center responsible for helping ensure that safe, effective, and high-quality drugs are available to the American public.  He will direct CDER's reform and innovation agenda with a focus on three critical areas: increasing patient access to safe and affordable critical medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain.

Karim Mikhail, B.Pharm, MSc — Director, Center for Biologics Evaluation and Research

Karim Mikhail has been selected to serve as Director of CBER after serving as the center’s Acting Director.

Mikhail brings more than two decades of leadership experience spanning the pharmaceutical and biotechnology sectors as well as FDA. Since joining FDA, he has worked on initiatives to strengthen U.S. competitiveness, accelerate clinical development, and expand domestic biopharmaceutical manufacturing.

As CBER Director, Mikhail will lead the center responsible for regulating biological products, including vaccines, blood and blood products, and cellular and gene therapies.  He will focus on modernizing regulatory frameworks to accelerate drug development, including for rare diseases, without compromising rigor, and work to strengthen vaccine safety surveillance with a commitment to transparency and scientific precision.

Mikhail brings three decades of extensive leadership experience spanning the pharmaceutical and biotechnology sectors as well as FDA. Since joining FDA, he has worked on initiatives to accelerate clinical development, strengthen U.S. competitiveness, and expand domestic biopharmaceutical manufacturing.

As CBER Director, Mikhail will lead the center responsible for regulating biological products — including cellular and gene therapies, vaccines, and blood and blood products — ensuring American patients have access to the most innovative and safe treatments available.

Bret Koplow, Ph.D., J.D. — Director, Center for Tobacco Products

Dr. Bret Koplow has been selected to serve as Director of CTP after serving as the center’s Acting Director, after serving as the center’s Acting Director.  Koplow brings deep legal, policy, and regulatory expertise developed over more than a decade at FDA.

Koplow has served at FDA since 2011 in a series of senior legal, policy, and leadership positions. Before becoming Acting Director of CTP, he served as Senior Counselor to the FDA Commissioner, where he focused principally on regulatory, policy, and operational matters involving tobacco products. His FDA service has also included positions in the Office of the Chief Counsel and Office of Legislation.

As CTP Director, Koplow will lead CTP’s dual priorities of promoting innovation and access to less harmful alternatives for adult smokers, and taking decisive action to protect American youth and minors from tobacco and nicotine dangers.

With these leadership selections, FDA is moving forward with a clear focus on advancing its public health priorities and delivering results for the American people.