PDUFA and BsUFA Quarterly Hiring Updates

Why It Matters

Staffing shortfalls constrain the FDA’s ability to review drug and biologic applications promptly, which can delay product launches and affect industry investment cycles.

Key Takeaways

• FY26 PDUFA VII hiring still 0% of 15 targeted FTEs
• FY25 CBER met only 31% of 29 hires; CDER 60% of 15
• FY24 overall hiring reached 71% of 79 FTEs across FDA
• FY23 achieved near‑full staffing: CBER 99%, CDER 90% of targets
• Unfilled positions could delay drug and biologic review timelines

Pulse Analysis

The Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) are cornerstone funding mechanisms that enable the FDA to expand its review workforce. Under the latest reauthorizations—PDUFA VII and BsUFA III—the agency is required to publish quarterly hiring metrics, offering unprecedented transparency into its capacity to meet the growing demand for drug and biologic approvals. These reports serve as a barometer for regulators, industry stakeholders, and investors who track the agency’s ability to keep pace with an accelerating pipeline of innovative therapies.

Data released for FY2023‑2027 reveal a clear trajectory: early years saw near‑full staffing, with CBER achieving 99% of its 132‑person target and CDER 90% of 77. However, momentum has stalled. FY24 concluded at 71% of 79 total FTEs, and FY25 remains well below goal, especially for CBER (31% of 29) and CDER (60% of 15). The most concerning signal is FY26, where no hires have been recorded against a 15‑person requirement. This slowdown reflects broader recruitment challenges, including competition for scientific talent and budgetary constraints, and raises questions about the FDA’s readiness to handle the influx of complex biologics and advanced therapies.

For pharmaceutical and biotech companies, these staffing gaps translate into longer review cycles, potential delays in market entry, and increased uncertainty around regulatory timelines. Companies may need to adjust launch strategies, build larger regulatory affairs teams, or engage more proactively with the FDA to mitigate risk. Policymakers, meanwhile, face pressure to ensure that fee structures and hiring incentives align with the agency’s operational needs. Monitoring future quarterly updates will be essential to gauge whether corrective actions restore the staffing trajectory needed to sustain timely drug approvals.