The Department of Health and Human Services is planning to establish two additional deputy commissioner positions within the Food and Drug Administration, one dedicated to technology and the intersection of health and artificial intelligence, and another for drugs. HHS officials would make the appointments as part of what some Trump administration officials view as an effort to expand influence over the agency, according to multiple sources requesting anonymity because they were not authorized to discuss the matter publicly. No formal announcements or final decisions regarding these roles have been made at this time.
Jared Seehafer, a senior FDA advisor and veteran in the medical devices industry, is the leading candidate for the technology-focused position. Seehafer co-founded and formerly served as CEO of Enzyme, a life sciences compliance software company, and most recently held a position at a venture capital firm in San Francisco before joining the FDA in an advisory capacity. Kyle Diamantas, who previously served as deputy commissioner for food before assuming the role of acting FDA commissioner in May following Marty Makary’s departure, may or may not return to his former position. The identity of potential candidates for the deputy commissioner for drugs role remains unclear.
The two new positions would be subordinate to Heidi Overton, President Trump’s nominee for FDA commissioner, who awaits Senate confirmation. The restructuring follows a difficult period for the agency, marked by scrutiny over its handling of a multistate cyclospora outbreak connected to iceberg lettuce and concerns that budget and staff reductions have compromised its capacity to manage foodborne illness outbreaks. The FDA has also faced intense examination regarding recent drug approval decisions, including an accelerated approval granted to Replimune for its melanoma treatment Tudriqev after prior rejections, and a subsequent reversal of its initial rejection of UniQure’s Huntington’s disease candidate.
The proposed technology-focused deputy commissioner would oversee both the agency’s internal artificial intelligence applications and its evaluation of AI-enabled medical products. The FDA has increasingly incorporated AI into its operations through tools such as Elsa, a generative AI application used for document summarization and drafting. The agency recently released a discussion paper on potential regulatory strategies for generative AI-enabled medical devices and is soliciting feedback from various stakeholders rather than issuing formal regulatory guidance at this stage.
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