ARTICLE SUMMARY:
Senate Health chair loses primary and FDA AI chief departs. Excerpted from Pathways’ Picks May 21: Congress, FDA Exits, Notified Body Layoffs, CPT Codes, and More.
Device industry ally Sen. Bill Cassidy (R-La.) was ousted from the Senate in a May 16 Republican primary. Cassidy, a physician who served in the Senate since 2015 and in the US House prior to that, has been active on FDA issues for years, generally pressing for policies intended to streamline product reviews. The work culminated in becoming ranking member of the Senate Health, Education, Labor, and Pensions Committee (HELP) in 2023 and ascending to chairman in 2025, a post where he would have lead FDA user fee reauthorization and reform efforts next year. Two candidates with better ties to President Trump will compete in a Republican runoff next month. Cassidy’s vote to convict Trump after the 2021 impeachment of the president is widely cited as key reason for the senator’s decline in popularity in Louisiana. More recently, Cassidy has appeared to try to mend fences with the administration, including with his vote to confirm Robert F. Kennedy Jr. as HHS secretary despite significant disagreements over vaccine policies. Cassidy will retain the HELP chair post for the remainder of the year, where he will oversee the FDA commissioner confirmation process following last week’s resignation of Marty Makary, MD, once the president makes a nomination.
Jeremy Walsh, FDA’s chief AI officer, has reportedly left the agency. His is one of series of departures coming in the wake of Makary’s resignation as commissioner last week. Walsh, who was hired by Makary last year, was the point person on the agency’s recent vigorous push to incorporate AI tools, including the internally developed Elsa large language model, into FDA’s workflows and other IT upgrades. “In the past year, the FDA staff have worked tirelessly to transform a slow, siloed, document-based organization into a real-time, AI-native regulatory operating system,” Walsh touted in a LinkedIn post last week. Tracy Beth Høeg, who most recently served as acting director of FDA’s drug center, also left FDA in the wake of Makary’s ousting.