The Department of Health and Human Services is preparing to establish two new deputy commissioner positions at the Food and Drug Administration focused on technology and drugs, sources tell CNBC. These roles are designed to oversee critical aspects such as the agency's increasing use of artificial intelligence and the regulation of pharmaceuticals. These appointments, which have yet to be finalized or publicly announced, will report directly to Heidi Overton, President Donald Trump’s nominee for FDA commissioner, who still awaits Senate confirmation.

One of the proposed roles, deputy commissioner for technology, will handle the agency’s internal application of AI tools and its regulatory oversight of AI-enabled medical products. Jared Seehafer, a senior FDA advisor and co-founder of the life sciences compliance software firm Enzyme, is reported to be the leading candidate for this technology-focused position. The deputy commissioner for drugs role remains unfilled by any known candidates so far.

The new leadership strategy comes amid a challenging period for the FDA, including public scrutiny over its response to a cyclospora outbreak linked to lettuce and several contentious drug approval decisions. Recent controversies involve accelerated approvals, additional clinical trial demands, and extensions of review timelines on treatments for melanoma, Huntington’s disease, and Duchenne muscular dystrophy, highlighting the complexities faced by the agency in managing emergent medical products.

Additionally, the FDA is increasingly integrating AI to improve internal operations and regulatory processes, exemplified by tools like Elsa, which assist in tasks such as document summarization and drafting. A recently released FDA discussion paper also seeks public input on regulating generative AI-enabled medical devices, signaling the agency’s proactive stance in shaping regulatory approaches in this evolving technological landscape.