HHS Cuts Likely to Delay FDA Progress on AI/ML
Summary
On March 27, 2025, the U.S. Department of Health & Human Services (HHS) announced a significant reorganization in accordance with President Trump's Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” HHS estimates that this restructuring effort will result in a total reduction of roughly 20,000 employees, including 3,500 employees of the Food & Drug Administration (FDA). Those dismissed include some high-ranking officials specialized in AI. FDA has been at the forefront of policymaking regarding medical devices and pharmaceuticals that rely on AI/ML, and cuts throughout the agency may stall their progress. FDA released a number of guidance documents related to AI/ML at the tail end of the Biden Administration. Without sufficient staffing, sponsors may experience significant delays in product review and further development of critical guidance will stall.
