The Department of Health and Human Services (HHS) is set to create two new deputy commissioner roles at the Food and Drug Administration (FDA), one dedicated to technology and artificial intelligence, and the other to drug oversight.
This move is seen as an attempt by the Trump administration to exert more control over the FDA, which has faced scrutiny for its handling of food safety and drug approvals. Jared Seehafer, a senior advisor with a background in medical devices and venture capital, is the frontrunner for the technology role.
The FDA has been under pressure due to its management of a cyclospora outbreak linked to iceberg lettuce and controversial decisions regarding drug approvals, including the recent accelerated approval of Replimune's melanoma drug and the contentious demands placed on UniQure for its Huntington's disease treatment.
The agency is also exploring the use of artificial intelligence in its operations, having recently released a discussion paper on regulating AI-enabled medical devices. The new deputy commissioner for technology will be responsible for overseeing both the internal use of AI at the FDA and the evaluation of AI-integrated medical products