Tracking Major Changes at the FDA: April 7
Let's quickly catch up on the news.
With the flurry of FDA updates, we’ll be sharing brief, semi-regular news roundups — quick, digestible explainers to keep you on top of the latest developments. Make sure you’re on our paid tier to get each issue in full.
Another major FDA reorg planned
HHS has proposed a sweeping reorganization of the FDA, consolidating its current structure into just five (or six) centralized “shared services” offices. This follows a major 2024 reorg after the infant formula crisis. The restructure, lacking key details, may bypass traditional congressional input.
User fee crisis looming
The FDA’s user fee programs are on the brink of collapse, per insiders. Due to statutory “trigger mechanisms,” mass layoffs could push the agency past thresholds that would prohibit the collection of user fees — potentially costing billions and forcing thousands more furloughs. Many staff who understood the agency’s financial guardrails were let go, accelerating the risk.
FDA staff reductions, reversals, and fallout
The FDA’s internal structure is being gutted. Top officials across CDER, policy, inspections, and communications were laid off. Notably, Peter Marks, former head of biologics, resigned. His replacement, Julie Tierney, was laid off two days later. The third acting head of CBER in four days is now Scott Steele.
Mass layoffs at the FDA, including critical staff involved in reviewing new drugs and vaccines, have raised concerns about the agency's capacity to ensure public health, as it is already beginning to erode the FDA’s drug review system.
Makary’s first speech falls flat to staff
New FDA Commissioner Marty Makary addressed staff in his first all-hands meeting the day after the layoffs. While he emphasized improving health outcomes and “challenging assumptions,” many employees found the tone out of sync with the moment, calling it “bizarre” and “tone-deaf.”