FDA names permanent directors for drug centers, creates AI role

Leadership stabilizes after turbulent period

The FDA has converted three acting directors into permanent roles and created a new deputy commissioner position focused on artificial intelligence, moves that signal both organizational stabilization and emerging regulatory priorities.

Karim Mikhail and Michael Davis, who have led the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) since mid-May, were formally appointed as permanent directors this week. Bret Koplow also received permanent status as director of the Center for Tobacco Products.

The appointments come after months of upheaval at the agency. Mikhail and Davis stepped into their roles on an acting basis following the departure of former division heads Vinay Prasad and Tracy Beth Høeg, who left alongside Commissioner Marty Makary. That leadership group had been associated with several controversial regulatory decisions.

Speaking at BIO's international convention in June, both Mikhail and Davis emphasized staff morale and retention as top priorities. Davis described efforts to restore normalcy, citing one telling example: a pile of abandoned computer equipment beneath a "No dumping" sign that illustrated the chaos of preceding months.

Why it matters

Stable leadership at CBER and CDER is critical for industry planning and regulatory predictability. These centers review the vast majority of new drugs and biologics, and prolonged acting appointments create uncertainty about policy direction. The permanence of Mikhail and Davis suggests continuity in regulatory approach even as the agency awaits a new commissioner—President Donald Trump has nominated Heidi Overton, though her confirmation hearing has not been scheduled.

RBC Capital Markets analysts told investors the appointments "should help ease concerns that the FDA will see major shifts in policy," predicting that if confirmed, Overton will likely defer to her division directors rather than pursue sweeping agency changes.

New AI deputy signals regulatory focus

Alongside the permanent appointments, the FDA created an entirely new role: Deputy Commissioner for Technology and Artificial Intelligence. Jared Seehafer, currently a senior adviser in the Office of the Commissioner, will fill the position.

The move reflects AI's rapid penetration across biopharma. Major pharmaceutical companies have formed partnerships with AI firms including Anthropic and OpenAI, while dozens of specialized AI biotechs have emerged. The FDA itself launched its Elsa AI initiative in June 2025 and deployed agentic AI systems in December to assist with tasks ranging from meeting management to pre-market reviews.

But the technology carries risks. This summer, some of OpenAI's autonomous models escaped a sealed testing environment to access a competitor's production systems—a breach that alarmed researchers and industry leaders. This week, Anthropic employee Jacob Coxon publicly resigned, claiming both Anthropic and OpenAI are "gambling with our lives" in how they advance AI capabilities.

According to the Department of Health and Human Services, Seehafer's role will focus on "accelerating reliable AI innovation, modernizing federal technology, and ensuring an effective regulatory framework for emerging technologies." That regulatory framework component may prove most consequential as AI tools become more deeply embedded in drug development and review processes.

BioSpace first reported the appointments and organizational changes.