WASHINGTON, United States – The U.S. Food and Drug Administration has filled four senior leadership positions, including permanent directors for its drug, biologics and tobacco centers and its first deputy commissioner for technology and artificial intelligence.
The U.S. Department of Health and Human Services announced the appointments Sept. 8, describing them as part of an effort to strengthen FDA leadership and advance the Trump administration’s priorities for regulatory reform, innovation and public health.
The appointments place Michael Davis at the Center for Drug Evaluation and Research, Karim Mikhail at the Center for Biologics Evaluation and Research, Bret Koplow at the Center for Tobacco Products and Jared Seehafer in the newly created technology and artificial intelligence position.
Four positions receive permanent leadership
Davis, a physician and scientist, has been serving as acting director of CDER and previously held the center’s deputy director position. HHS said he will oversee the FDA division responsible for regulating prescription and over-the-counter drugs.
The department said Davis will focus on expanding access to critical medicines, advancing drug-development science and strengthening domestic and global drug supply chains.
Mikhail will permanently lead CBER after serving as its acting director. The center regulates biological products including vaccines, blood and blood products, and cellular and gene therapies.
According to HHS, Mikhail’s priorities will include modernizing regulatory frameworks, accelerating clinical development and strengthening vaccine safety surveillance.
Koplow, who has also been serving in an acting capacity, will become director of the Center for Tobacco Products. HHS said he has held senior legal, policy and leadership positions at the FDA since joining the agency in 2011.
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His responsibilities will include regulating tobacco and nicotine products while addressing both access to less harmful alternatives for adult smokers and risks to young people.
FDA creates new technology and AI post
Seehafer will become the FDA’s first deputy commissioner for technology and artificial intelligence.
HHS said the new position will give Seehafer responsibility for the agency’s technology, software and AI strategy. The role is intended to support modernization of federal technology and the development of a regulatory framework for emerging technologies.
The appointment gives AI a dedicated senior leadership position within an agency that regulates products increasingly connected to digital technologies and software.
Appointments come after leadership upheaval
The permanent selections come after a period of significant turnover at the FDA.
The agency’s current leadership profile lists Kyle Diamantas as acting commissioner, while the principal deputy commissioner position is vacant.
The FDA also lost its previous commissioner, Martin Makary, who served from April 2025 until May 2026, according to the agency’s official leadership record.
The new appointments therefore give permanent leadership to three of the FDA’s major regulatory centers while leaving the agency’s top commissioner position under acting leadership.
Leadership changes could shape regulatory policy
The four appointments cover areas with major consequences for pharmaceutical companies, biotechnology firms, tobacco manufacturers and technology developers.
CDER handles the FDA’s drug-regulation responsibilities, while CBER oversees vaccines and other biological products. The tobacco center regulates tobacco products, and the newly created technology role is intended to coordinate agency-wide work on software and artificial intelligence.
HHS Secretary Robert F. Kennedy Jr. said the selections were intended to support faster decision-making, innovation and reform. FDA Acting Commissioner Diamantas said the agency needed to attract and retain talent while strengthening its workforce and infrastructure.
The appointments do not by themselves change individual drug, vaccine or tobacco-product decisions. Their significance lies in establishing permanent leadership in several areas where the administration has identified regulatory reform and modernization as priorities.
Reporting Credit: U.S. Department of Health and Human Services — Sept. 8, 2026 announcement identifying Jared Seehafer, Michael Davis, Karim Mikhail and Bret Koplow and outlining their responsibilities and policy priorities; U.S. Food and Drug Administration — official leadership records confirming the agency’s current senior leadership structure and acting commissioner.
