Uncertainty at the FDA

By Joel Morse, CEO & Co-Founder

This is the top story from the FDA today. I think everyone in the clinical trial industry should be planning for delays and disruptions.

Craig Lipset – what do you think?

EXECUTIVE ORDER TARGETS STAFF REDUCTIONS: A new executive order published last night by President DONALD TRUMP calls for federal agencies to coordinate and consult with the Department of Government Efficiency (DOGE) to “shrink the size of the federal workforce and limit hiring to essential positions.” Critically, agencies will only be able to hire “one employee for every four employees that depart from federal service,” subject to some public safety exceptions. That could put pressure on FDA staff who might be thinking about leaving to stay in their seats for fear of their position going unfilled in the future – a concern we’ve already been hearing from agency staff. The order also calls for agencies to develop and submit within 30 days a report that discusses “whether the agency or any of its subcomponents should be eliminated or consolidated.” With ROBERT F. KENNEDY JR. likely about to take over the Department of Health and Human Services (HHS), this could put pressure on FDA to identify offices to eliminate.
EXECUTIVE ORDER IMPACTS ON FDA: Yesterday, AgencyIQ published a comprehensive resource looking at the impacts that Trump’s dozens of executive orders will have on the FDA. If you feel like you don’t have a handle on executive orders or how they could impact the life sciences sector, definitely give this a read.