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The Department of Health and Human Services is planning to create two new deputy commissioner roles at the Food and Drug Administration, one of which would focus on technology and the intersection of health and artificial intelligence, CNBC has learned, establishing a significant new FDA deputy commissioner technology role within the agency’s leadership structure.
What This FDA Deputy Commissioner Technology Role Would Actually Cover
One role would focus on technology, including healthcare and AI, while the other would oversee drugs, according to two people familiar with the plans. No final decisions have been made and the agency has not formally announced the appointments.
The Agency’s Existing Deputy Commissioner Structure
The agency already has several deputy commissioners, including an acting deputy commissioner for food, though it is unclear who will step into that role permanently, suggesting this restructuring may extend beyond just the two newly reported positions.
Who Is the Leading Candidate for This FDA Deputy Commissioner Technology Role
Jared Seehafer, a senior advisor to the FDA and medical devices industry veteran, is the leading candidate for the technology role, according to three people familiar with the matter. Seehafer is a co-founder and former CEO of Enzyme, a life sciences compliance software company, and most recently worked at a venture capital firm in San Francisco before stepping into his FDA advisory role in August of last year.
Why Seehafer’s Background Fits This Role
Seehafer’s combination of medical device industry experience, life sciences compliance software entrepreneurship, and venture capital exposure gives him a profile spanning both the regulatory and technology commercialization sides of healthcare innovation, a combination that may prove particularly relevant to a role explicitly tasked with overseeing the FDA’s approach to AI.
Who Would Oversee This FDA Deputy Commissioner Technology Role
The two new positions would report to President Donald Trump’s pick for FDA commissioner, Heidi Overton, who still needs to be confirmed by the Senate, according to two people familiar with the plan. CNBC could not learn of any specific candidates for the deputy commissioner for drugs role.
Why HHS’s Motivation Matters
HHS officials would appoint the new leaders in what some in the Trump administration view as a bid to exert greater influence over the agency, according to the sources, who asked to remain anonymous because they were not authorized to speak publicly. HHS did not respond to multiple requests for comment.
The Turbulent FDA Backdrop Behind This New Technology Role
The new leadership structure would come after a tumultuous stretch for the FDA. The agency has faced intense scrutiny over its handling of a multistate cyclospora outbreak linked to iceberg lettuce, which exacerbated broader concerns about federal budget and staff cuts hindering the agency’s ability to rein in foodborne outbreaks.
Recent Drug Approval Controversies
The FDA has also been under the spotlight for a series of decisions around certain new drug products. For example, the FDA earlier this month granted accelerated approval to Replimune for its melanoma drug, Tudriqev, following a high-profile regulatory battle with the company and two prior rejections of the treatment. In March, the FDA also drew sharp backlash from the biotech industry after demanding an extra clinical trial for a separate product.
How This Fits the Current FDA Leadership Vacuum
Kyle Diamantas was most recently the deputy commissioner for food before stepping in as the acting FDA commissioner in May after Marty Makary’s resignation over the agency’s authorization of fruit-flavored vapes. It’s unclear if Diamantas would return to the food role once permanent leadership is established.
Why This Timing Matters
Creating a dedicated technology and AI-focused deputy commissioner role at this specific moment, alongside a separate drugs-focused position, suggests HHS is attempting to formalize more structured oversight over two of the agency’s most consequential and fast-evolving areas simultaneously, even as the FDA works through the fallout from recent food safety and drug approval controversies.
What This FDA Deputy Commissioner Technology Role Means Going Forward
With no final decisions confirmed and HHS declining to comment, this reporting represents an early-stage personnel plan rather than a finalized organizational change, meaning both the structure and the specific candidates, including Seehafer, could still shift before any formal announcement. Given that both new positions would report to Heidi Overton, whose Senate confirmation as FDA commissioner remains pending, the practical implementation of this leadership restructuring may depend on the broader confirmation timeline playing out first.
What to Watch Going Forward
As this personnel plan develops, industry observers, including medical device and pharmaceutical companies navigating FDA regulatory processes, will likely watch whether Seehafer is formally confirmed for the technology role and who emerges as the candidate for the parallel drugs-focused position. Given the FDA’s recent turbulence spanning food safety oversight and contested drug approval decisions, this FDA deputy commissioner technology role and its companion position may signal a broader effort to reshape how the agency approaches AI, healthcare technology, and pharmaceutical review under new Trump administration leadership.
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