April 1, 2025
The Department of Health and Human Services terminated 3,500 FDA employees in a single day. That was 20% of the agency’s workforce. Among those fired were high-level negotiators for PDUFA and GDUFA user-fee agreements, the funding mechanism that pays for approximately 70% of the FDA’s drug review budget.
3,500 employees. 20% of the FDA. Gone on April 1, 2025. The people who fund drug reviews were among the first fired.
The FDA is not a bureaucracy that stamps paperwork. It is the agency that determines whether the medication your doctor prescribes is safe, whether the food at your grocery store is uncontaminated, and whether the medical device implanted in your body works as advertised. Every drug sold in the United States goes through FDA review.
87% to 73%
In the six quarters before the cuts, the FDA approved drugs on time 87% of the time. By Q3 2025, that rate had dropped to 73%. An RBC Capital Markets analysis found that only 78% of drug approvals in the second half of 2025 were completed on time, down from a historical range of 85-90%.
De Novo decisions, the pathway for novel medical devices, dropped 50%. The FDA missed or postponed critical meetings with drug developers. New drug applications face delays from incomplete fee processing. The agency risks breaching statutory deadlines, which could halt reviews by law.
What a Delayed Drug Approval Means
A cancer patient enrolled in a clinical trial depends on the FDA approving the drug at the end of the trial so it can be prescribed commercially. A delay of months means months without access to the treatment. For some cancers, months is the margin between survival and death.
A parent whose child has a rare disease waits years for a drug to complete trials. When the FDA cannot review the application on time because the reviewer was fired, the wait extends. The child’s condition does not pause for staffing decisions.
383 NIH clinical trials were halted by funding cuts, affecting 74,000 patients. The FDA cuts compound that damage. Research stops at NIH. Review slows at FDA. The pipeline from laboratory to pharmacy narrows at both ends simultaneously.
The University of Cincinnati Law Review Called It
The UC Law Review published an analysis in December 2025 titled “From Science to Politics: How Staffing Cuts, Deregulation, and the Rise of Political Influence Weakened the Structural Integrity of the FDA.” The title is the finding.
The 5-step pattern describes gutting the civil service as Step 2. The FDA is the civil service of drug safety. When it is weakened, the drugs do not become safer. They become less reviewed.
Read more on the Healthcare hub and the RFK measles brief.