The FDA can't hire the people it needs to hire more people

The FDA wants to rehire more than 2,000 workers after last year's Department of Government Efficiency cuts. The bottleneck is not money, candidates, or political will. It is the central hiring office created to handle the DOGE-era restructuring, which is itself too short-staffed to clear the pipeline.

The numbers come from two places this week. A STAT News investigation of FDA's new-hire backlog and the Department of Health and Human Services' own FY2026 FDA contingency staffing plan agree on the constraint. The HHS plan says the agency will be able to continue core activities through Sept. 30, 2026 with the 16,089 staff currently onboard. Under a government funding lapse, the plan warns, "recruitment and hiring" would face "significant delays."

The shape of the gap is in the Office of Personnel Management workforce data cited by Food Safety Magazine. The FDA lost 3,859 employees in fiscal 2025 and another 473 in fiscal 2026 through December 2025, after roughly 3,500 DOGE-driven separations in April 2025. CDC lost 2,499 then 390. USDA lost 19,984 then 2,269. The FDA is the smallest of the three by headcount, but its decisions run through every drug approval, food recall, and medical-device clearance in the country, and its reviewer-to-workload ratio is what determines whether a generic gets to market on schedule.

When DOGE restructured the agency in April 2025, it consolidated hiring into a centralized human-resources function. That office was itself caught in the cuts, so the queue that used to take weeks now takes longer, and a target of 2,000-plus replacements becomes a multi-quarter slog rather than a rebuild. Karim Mikhail, director of FDA's Center for Biologics Evaluation and Research, told an industry conference the Monday before the news broke that the agency is "very actively hiring." The statement is technically accurate and functionally beside the point. The capacity to extend an offer is not the capacity to onboard the offer.

A patient waiting on a generic equivalent of a brand-name drug, a manufacturer waiting on a routine inspection, a city waiting on a follow-up after a food recall all depend on reviewer staffing, and all sit behind the same HR line. None of the publicly available material quantifies a specific approval-timeline slippage, and the visible STAT+ reporting does not name the HR center or its current vacancy count. The OPM data through December 2025, however, makes the trajectory unambiguous: another quarter at the current run rate removes another 400-or-so FDA staff.

This week puts the question in front of the Senate. The Health, Education, Labor and Pensions Committee is hearing Trump health nominees including deputy HHS secretary nominee Chris Klomp and surgeon general nominee Nicole Saphier, with workforce capacity on the table as a live confirmation issue. Semafor reports a separate FDA commissioner nominee is prepping for a hearing the following week. Confirmation votes are the only near-term mechanism with the political weight to staff the hiring office or change the cap that produced the bottleneck in the first place.

The next public test is the FY2026 close on Sept. 30. If the 16,089 floor is being treated as a constraint rather than a target, the agency will need either a faster pipeline or a smaller rebuild. As of the OPM data through December 2025, neither is in evidence.