Trump Administration Plans New FDA Deputy Commissioners for Technology and Drugs

The U.S. Department of Health and Human Services is preparing to create two new deputy-commissioner positions at the Food and Drug Administration. One role will focus on technology, including the agency’s use of artificial intelligence, while the other will oversee drug review and approval. Sources familiar with the plan say that Jared Seehafer, a senior FDA advisor and former co-founder and CEO of the life-sciences compliance firm Enzyme, is the leading candidate for the technology post. No candidate has been identified publicly for the drugs position. The appointments have not been finalized and the FDA has not issued a formal announcement.

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President Donald Trump recently named White House policy aide Heidi Overton to serve as FDA commissioner, a nomination that still requires Senate confirmation. Overton replaces Marty Makary, who resigned in May after clashes with the White House over flavored vaping products, a stalled abortion-pill safety study, and disputes with drugmakers such as Replimune, Sarepta and Moderna. Acting commissioner Kyle Diamantas, formerly the deputy commissioner for food, has led the agency through a series of contentious decisions, including a reversal of approvals for rare-disease therapies from Regenxbio, uniQure and Replimune. The FDA has also faced criticism for its handling of a multistate cyclospora outbreak linked to iceberg lettuce and for broader concerns about budget cuts and staffing shortages.

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Seehafer joined the FDA as a senior advisor in August of the previous year after a career in medical-device consulting and venture capital. He co-founded Enzyme, a compliance-software company, and most recently worked at a San Francisco venture-capital firm. His background blends regulatory experience with technology entrepreneurship, positioning him as a potential leader for the agency’s AI initiatives.

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The new technology deputy would supervise both the FDA’s internal AI tools—such as the generative-AI system Elsa used for document summarization—and the agency’s evaluation of AI-enabled medical devices. In March, the FDA released a discussion paper outlining regulatory approaches for generative-AI medical products. On the drug side, the agency recently granted accelerated approval to Replimune’s melanoma therapy Tudriqev after a high-profile dispute, reversed a demand for a sham brain-surgery placebo in UniQure’s Huntington’s disease trial, and extended the review of Capricor Therapeutics’ Duchenne muscular dystrophy drug following a 9-3 advisory-committee vote against approval.

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HHS officials have indicated that the new deputy-commissioner roles are intended to give the administration greater influence over the FDA’s strategic direction. Overton’s pending confirmation and the planned leadership changes come as the agency seeks to stabilize morale after a period of staff losses and high-profile policy battles. A news conference was scheduled for April 22, 2025, to discuss the agency’s broader agenda, underscoring the administration’s focus on reshaping FDA oversight.

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