The Department of Health and Human Services is developing plans to create two additional deputy commissioner positions within the Food and Drug Administration. One role would concentrate on technology and the intersection of artificial intelligence with healthcare, while the second position would serve as deputy commissioner for drugs. Officials within the Trump administration view these appointments as a mechanism to increase oversight of the agency, according to sources who requested anonymity due to lack of authorization to discuss the matter publicly.
Jared Seehafer, a senior FDA advisor and veteran in the medical devices sector, is the leading candidate for the technology-focused position. Seehafer previously founded and led Enzyme, a life sciences compliance software company, and most recently held a position at a San Francisco-based venture capital firm before joining the FDA as an advisor in August of last year. No specific candidates have been identified for the drugs deputy commissioner role, and no formal announcements or final decisions regarding these positions have been made.
The new leadership structure would operate under Heidi Overton, President Donald Trump’s nominee for FDA commissioner, who remains pending Senate confirmation. 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 deputy commissioner for technology would be tasked with overseeing both the agency’s internal artificial intelligence applications and its regulatory review of AI-enabled medical products.
These structural changes arrive during a challenging period for the FDA, which has faced criticism regarding its handling of a multistate cyclospora outbreak associated with iceberg lettuce and concerns about budget and staffing limitations affecting foodborne illness investigations. The agency has also drawn attention for various drug approval decisions, including accelerated approval for Replimune’s melanoma treatment following years of rejection, and regulatory reversals regarding treatments for Huntington’s disease and Duchenne muscular dystrophy. Additionally, the FDA has expanded its use of artificial intelligence for internal operations, including a generative AI tool called Elsa for document processing, while simultaneously bearing responsibility for evaluating the safety of AI-enabled medical devices.
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