Show summary Hide summary
The Department of Health and Human Services is moving to add two deputy commissioner positions at the Food and Drug Administration, including a post focused on technology and the growing role of artificial intelligence. The changes come as the agency faces heightened scrutiny over food-safety responses and recent drug-review decisions.
Two new leadership posts under consideration
HHS plans would establish a deputy commissioner for **technology** — charged with overseeing the FDA’s internal use of AI and its evaluation of AI-enabled medical products — and a deputy commissioner for **drugs**, according to people familiar with the discussions. Those sources, who spoke on condition of anonymity, said no final decisions or public announcements have been made.
Apple’s iTunes remains, but it’s now in a different form
Week 2 fantasy QBs: Who to start and who to bench
Both positions are expected to report to President Donald Trump’s nominee for FDA commissioner, Heidi Overton, who still requires Senate confirmation, the sources said. HHS did not respond to requests for comment.
Leading candidate for the technology post
Three people briefed on the matter identified Jared Seehafer as the frontrunner for the technology role. Seehafer is a co‑founder and former CEO of Enzyme, a life‑sciences compliance software company, and most recently worked at a San Francisco venture capital firm before joining the FDA as a senior advisor in August of last year.
It was not possible to learn of specific contenders for the proposed deputy commissioner for drugs. The agency already has multiple deputy commissioners, and it is unclear whether acting roles, such as the current acting commissioner who previously led food policy, would be made permanent.
Why HHS is moving now
The proposed shake‑up arrives after a turbulent period for the FDA. The agency has drawn criticism for its handling of a multistate cyclospora outbreak linked to iceberg lettuce, concerns that budget and staffing cuts have weakened its ability to contain foodborne illness, and a string of contentious drug decisions.
Recent regulatory moves cited by observers include an accelerated approval granted to Replimune’s melanoma treatment Tudriqev following earlier rejections and a public dispute with the company. In March, the FDA requested an additional clinical trial — including a controversial sham brain‑surgery placebo — for UniQure’s experimental Huntington’s disease therapy, then later allowed the company to seek accelerated approval based on mid‑stage data.
Most recently, the agency extended a review by three months for Capricor Therapeutics’ Duchenne muscular dystrophy candidate while it considered extra data after an advisory committee voted 9‑3 against recommending approval.
AI oversight and regulatory questions
The agency has already adopted artificial intelligence for internal tasks. FDA staff use a generative AI tool called Elsa for items such as document summarization and drafting.
At the same time, regulators are responsible for assessing the safety and effectiveness of medical products that incorporate AI. Last week the FDA published a discussion paper that explores possible regulatory approaches for generative AI‑enabled devices and solicits feedback from patients, clinicians, developers and other stakeholders rather than issuing formal guidance.
What the technology deputy would handle
- Supervising the FDA’s internal deployment of AI tools used by staff.
- Leading reviews of medical products that incorporate **artificial intelligence**.
- Coordinating stakeholder engagement around AI policy and the agency’s discussion paper.
Administration officials view the appointments, in part, as a way to shape the agency’s direction, according to the sources. But with nominations and job assignments still unsettled, the FDA’s leadership and its approach to AI and drug oversight remain in flux.
