When I heard Karim Mikhail and Michael Davis speak at BIO’s international convention in June, the then-acting FDA division directors said all the right things. They both prioritized the support of remaining agency staff and restoring an overall sense of normalcy.
“The very first thing I really want to focus on was morale and retention,” Davis said at an FDA Town Hall that also included Mikhail, acting Chief of Staff Lowell Zeta and BIO CEO John Crowley. “This is my number one priority.”
Both he and Mikhail described examples of listening to what their team members had to say, including about new policy proposals. Beyond that, Davis explained how he was trying to return a sense of normalcy to the agency, sharing one scene, which he characterized as “superficial,” that illustrated just how chaotic the prior months had been.
“There was a cubicle area with a big sign that said, ‘No dumping computer equipment.’ And there’s a pile of old computer equipment,” he said, drawing chuckles from the audience. “There’s just sort of a sign that things were not quite how it should be.”
Mikhail and Davis have led the FDA’s two main review units—the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)—since mid-May, having stepped into those roles on an acting basis after former division heads Vinay Prasad and Tracy Beth Høeg left the agency. Prasad and Høeg, alongside Commissioner Marty Makary, were closely tied to several controversial regulatory decisions.
Under acting Commissioner Kyle Diamantas, however, the FDA has operated under what William Blair analysts in June called “caretaker mode.” And Mikhail and Davis have been two of those caretakers, working to stop further attrition and rebuild the workforce. By most accounts, the leaders were well liked, and on Tuesday, the FDA declared them permanent directors. Bret Koplow, who had been acting as director of the Center for Tobacco Products, was also given his role on a permanent basis.
“The appointment of the current interim directors is likely to be seen as a sign of continuity and stability that should help ease concerns that the FDA will see major shifts in policy,” RBC Capital Markets told investors in a Wednesday afternoon note.
And if they continue to prioritize the people, Mikhail and Davis can hopefully help ease the next transition—turnover of the FDA’s top post. President Donald Trump has nominated Heidi Overton for FDA commissioner, though her confirmation hearing has yet to be scheduled.
RBC predicts that if Overton is confirmed, she will defer to her division directors, including Mikhail, Davis and Koplow. “We do not expect another ‘larger-than-life’ commissioner looking to remake the Agency,” the analysts said.
If they are left to continue the work they’ve started at their respective divisions, I have no reason to believe that Mikhail and Davis’ priorities have changed. And if the FDA’s leaders are valuing their staff while striving for stability and normality, there’s reason to be hopeful.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
AI front and center
The new appointments leave four roles among top FDA leaders filled in an acting capacity, while one other remains vacant. The principal deputy commissioner role is also listed as vacant on the FDA organizational chart, but that does not yet reflect this week’s changes, which in addition to the conversion of three acting directors into permanent FDA leaders, included the creation of an entirely new deputy commissioner role.
Jared Seehafer, a senior adviser within the Office of the Commissioner, will become the first ever Deputy Commissioner for Technology and Artificial Intelligence. Reports last month foreshadowed this move, and hinted that the FDA may also be adding a new deputy post focused on drugs, though this has not been formally announced.
AI has quickly become pervasive in biopharma. Many of the industry’s biggest players are partnering with major AI companies such as Anthropic and OpenAI, and dozens of techbios have sprung up to offer AI solutions built for drug development.
The FDA has prioritized rolling out its own AI initiatives under the Trump administration. The agency launched Elsa in June 2025 and announced in December last year the deployment of agentic AI to help FDA staff with tasks such as managing meetings, conducting pre-market reviews and validating reports.
But with AI come many debates about risks to humanity, from the no-longer-hypothetical scenario where our AI agents don’t follow our rules to the environmental effects and other nuanced issues surrounding its use. This summer, some of OpenAI’s autonomous models escaped a supposedly sealed sandbox environment to infiltrate a competitor’s production infrastructure to retrieve answers to the test queries they’d been given. Researchers and industry leaders sounded the alarm over the breach, calling it a shot across the bow.
This week, we got another warning from Anthropic employee Jacob Coxon, who publicly resigned in protest over how the technology is being advanced—the very same day that the FDA created a deputy commissioner role dedicated to AI. Coxon claimed that Anthropic and OpenAI, where he was also formerly employed, are “gambling with our lives.”
That’s pretty much the opposite of biopharma’s mission to discover, develop and deliver novel medicines that can improve and save lives. According to the announcement about Seehafer’s appointment from the Department of Health and Human Services, “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.”
That last item seems most critical. If AI can help us make new drugs faster, that’s great, but it shouldn’t come with added risks to our lives. Here’s hoping Seehafer sees AI for what it is—as a powerful tool that should be handled with care—and helps steer innovation safely forward. In biopharma especially, lives are on the line.