The FDA has converted Karim Mikhail and Michael Davis from acting leaders into permanent directors of its two main review units, while also creating a new deputy commissioner role dedicated to technology and artificial intelligence.
Mikhail and Davis have led the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research since mid-May, after former division heads Vinay Prasad and Tracy Beth Høeg left the agency. Their formal appointments, along with making Bret Koplow permanent at the Center for Tobacco Products, point to a steadier management structure after a period marked by controversial regulatory decisions and workforce strain.
At BIO’s international convention in June, both Mikhail and Davis emphasized morale, retention and restoring normalcy. Davis called support for remaining staff his “number one priority” and described listening to team concerns, including on new policy proposals. He also used a small example of discarded computer equipment in a cubicle area to illustrate how disordered the prior months had been.
The Road Here
Under acting Commissioner Kyle Diamantas, the FDA has operated in what William Blair analysts in June called “caretaker mode.” In that setting, Mikhail and Davis were presented as leaders focused on stopping further attrition and rebuilding the workforce rather than remaking policy.
RBC Capital Markets told investors that the appointments are likely to be seen as a sign of continuity and stability that should help ease concerns about major policy shifts. The firm also said that if President Donald Trump’s nominee for FDA commissioner, Heidi Overton, is confirmed, it expects she would defer to division directors including Mikhail, Davis and Koplow. Her confirmation hearing has not yet been scheduled.
Even after this week’s changes, four top FDA leadership roles remain filled on an acting basis, while one other remains vacant. The principal deputy commissioner role is also listed as vacant on the FDA organizational chart, though the source notes that chart does not yet reflect this week’s moves.
AI Moves From Tooling To Leadership
The same announcement created a new post for Jared Seehafer, previously a senior adviser within the Office of the Commissioner, who will become the first Deputy Commissioner for Technology and Artificial Intelligence. Reports last month had foreshadowed the move and suggested the FDA may also add a separate deputy post focused on drugs, though that has not been formally announced.
The agency has already been building internal AI capacity under the Trump administration. It launched Elsa in June 2025 and announced in December last year that agentic AI would be deployed to help staff manage meetings, conduct pre-market reviews and validate reports.
That progression matters because it shifts AI from a set of pilots and tools into the leadership structure itself. The Department of Health and Human Services said the new role reflects the Trump administration’s commitment to accelerating reliable AI innovation, modernizing federal technology and ensuring an effective regulatory approach.
What The Signal Is
The combined personnel decisions send two messages at once. First, the FDA is trying to stabilize core review functions by keeping widely accepted interim leaders in place. Second, it is elevating AI from operational support to a strategic priority inside the commissioner’s office.
For biopharma, that mix suggests a regulator that wants steadier review management while also increasing the use of AI to improve internal efficiency and decision support, not replace scientific judgment. Whether that balance holds may depend on how much autonomy the current center leaders retain if the commissioner role changes hands.
