1. United States
2. Alaska
3. Letter

The FDA faces catastrophic collapse as massive layoffs endanger the user fee program. After being gutted this week the FDA is in a precarious position of losing one if its biggest funding streams user fees. The FDA derives almost half of its funding from user fees. The FDA has several user fee programs which apply to new drugs and biologics and also a program for medical devices, generic drugs, biosimilars and other pharmaceutical products. The fees allow the FDA to collect fees from pharmaceutical companies filing product applications for review. The FDA uses this money to support its operations. The fees do not ensure a favorable review but rather hold the agency accountable for response times and meetings. The fees allow the FDA to hire more employees to get the reviews done but the FDA is in charge of hiring its own professionals and they don’t go to specific projects. There is a trigger mechanism of the user fee program that if FDA funding falls below certain levels the FDA can no longer collect user fees. The agency is dangerously close to triggering those conditions after layoffs. Many staffers familiar with the inner workings of the user fee program were let go. With a clown in charge of HHS the FDA may completely collapse. This is just one of many issues that come with decimating agencies.