In its July 9, 2026 quarterly update, the Food and Drug Administration reported no hires under the Prescription Drug User Fee Act VII (PDUFA VII) or the Biosimilar User Fee Act III (BsUFA III) for fiscal year 2026 through June 30. The filing lists every FY26 hiring category at 0% completion across the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and other FDA divisions. Outstanding positions from FY25 remain open, CBER at 38% (11 of 29 hires completed) and CDER at 60% (9 of 15). For FY24 goals, CBER had reached 77% (37 of 48) and CDER 90% (28 of 31). BsUFA III recruiting, however, stayed at 0% for each of the past three fiscal years.
The update highlights persistent hiring lags in FDA’s user-fee-funded programs. These programs were created to speed regulatory review and strengthen scientific staffing, but the numbers show otherwise. Sustained vacancy rates at CDER and CBER could constrain the agency’s ability to meet review timelines or broaden biologics oversight as intended under PDUFA VII. User-fee funds can only support faster approvals if the people are actually in place to make that possible. And a zero-hire start for FY26 points to deeper structural difficulties in FDA recruitment, not just routine delays. For industry and payers, that may mean continuing swings in review throughput for new drug and biosimilar applications. The next test comes with Q4 hiring, whether the agency can regain footing before the fiscal year ends in September 2026.
