FDA floats chaotic reorganization as staff purges continue

The 10,000 mass firings at the Department of Health and Human Services, including 3,500 positions at the Food and Drug Administration, have plunged all federal health agencies into a spiral of chaos and disarray. The cuts are arbitrary, sweeping, and devastating to the FDA’s food and medical product programs, leaving the agency teams who communicate about and prevent foodborne outbreaks, review food chemicals, and ensure the safety and effectiveness of medical products scrambling to operate. 

Unfortunately, the chaos at the agency is poised to get much worse. A plan to reorganize the FDA, leaked to Inside Health Policy, would recklessly rip apart the specialized centers within the agency and create new offices based on function, presumably reporting to the commissioner. According to the report, one of these will contain all the agency’s review functions, undermining the current system designed to protect reviewers from the kinds of political interference that can damage public health.

The proposal will also unravel years of effort to organize FDA staff more effectively towards solving emerging problems within product categories, including a groundbreaking reorganization of the FDA Human Foods Program announced last fall. That food reorganization implemented lessons from the 2022 infant formula outbreak, when the expertise and knowledge needed to respond was scattered across the agency, leading to delays and chaos.  

To work effectively for Americans, FDA teams need to focus on the problems they solve, not the regulatory powers they wield. And that means teams should be focused on particular regulated products, as regulating foods is very different from regulating tobacco.

The new reorganization proposal will reverse and destroy current alignment around products, breaking apart existing teams and eliminating the ability to plan and cooperate in a way that prioritizes food and medical product safety. And, unlike FDA’s thoughtful, deliberative, transparent reorganization of its foods program, the new proposed reorganization could be rushed through without adequate stakeholder input.  

When Dr. Marty Makary was confirmed as FDA commissioner, we said his top priority should be to stop the bleeding of scientific expertise needed to keep our food and drugs safe, and to resist additional cuts to the agency. But in six days at the agency, Makary has loosened the tourniquet and accelerated the bleeding.