The Department of Health and Human Services is preparing to create two additional deputy commissioner roles within the Food and Drug Administration, according to multiple sources with knowledge of the initiative. One position would concentrate on technology and the convergence of health care and artificial intelligence, while the second would focus on drugs. The sources indicated that no final determinations have been reached and no formal announcements have been made at this time.
Jared Seehafer, a senior FDA advisor with extensive experience in the medical devices sector, has emerged as the leading candidate for the technology-focused position. Seehafer previously co-founded and led Enzyme, a life sciences compliance software company, and worked at a venture capital firm in San Francisco prior to joining the FDA in an advisory capacity last August. Kyle Diamantas, who previously served as deputy commissioner for food before assuming the acting FDA commissioner role in May, may or may not continue in that department-specific function. The candidates for the drugs deputy commissioner position remain unclear.
The newly created positions would report to Heidi Overton, President Donald Trump’s selection for FDA commissioner, who is awaiting Senate confirmation. HHS declined to provide comment on the initiative. Administration officials view the reorganization as an opportunity to expand influence over the agency’s operations.
The restructuring follows a period of significant challenges for the FDA. The agency has faced criticism regarding its response to a multistate cyclospora outbreak associated with iceberg lettuce, raising concerns about whether budget constraints and staffing limitations are compromising foodborne illness management capabilities. The agency has also attracted attention for multiple drug approval decisions in recent months, including accelerated approval for a melanoma treatment, a contentious exchange with a biotech company over clinical trial requirements for a Huntington’s disease therapy, and a review extension for a muscular dystrophy drug following an adverse advisory committee vote.
The FDA has increasingly incorporated artificial intelligence to support internal functions through tools like its Elsa generative AI system, which aids with document summarization and drafting. The new deputy commissioner for technology would oversee both the agency’s internal AI applications and its evaluation of AI-enabled medical products. Last week, the FDA distributed a discussion paper examining potential regulatory frameworks for generative AI-enabled medical devices, inviting feedback from various stakeholders rather than issuing formal guidance.
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