Updated
Updated · CNBC · Aug 25
HHS Plans 2 New FDA Deputy Posts as Trump Team Seeks More Sway
Updated
Updated · CNBC · Aug 25

HHS Plans 2 New FDA Deputy Posts as Trump Team Seeks More Sway

3 articles · Updated · CNBC · Aug 25

Summary

  • Two new FDA deputy commissioner roles—one for technology and AI, one for drugs—are being planned by HHS, with both posts set to report to commissioner nominee Heidi Overton if confirmed.
  • The restructuring would let HHS appoint new leaders directly, a move people familiar with the plan said some in the Trump administration see as a way to exert greater influence over the agency.
  • Jared Seehafer, an FDA senior adviser and former Enzyme CEO, is the leading candidate for the technology post; no clear candidate has emerged for the drugs role, and no final decision has been announced.
  • The plan follows a turbulent period for the FDA, including scrutiny over a multistate cyclospora outbreak and contentious drug calls such as Replimune's accelerated approval, UniQure's reversed trial demand and Capricor's 3-month review extension.
  • The technology role would span the FDA's internal AI push—including its Elsa tool—and oversight of AI-enabled medical products, after the agency last week issued a discussion paper on regulating generative AI devices.

Insights

Will adding a new AI deputy commissioner accelerate or hinder the approval of next-generation medical devices?
How can the FDA balance its high-tech AI ambitions with the immediate crisis of massive foodborne illness outbreaks?
Will a new leadership layer for drug reviews streamline pharmaceutical approvals or just create more bureaucratic delays?