PDUFA VIII: Industry questions increased spending despite staff cuts, agreement on RDEA

Amid discussions to reauthorize the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA VIII) program on 19 February, industry representatives questioned increased PDUFA payroll spending in FY 2025 – despite staff cuts that year – and both sides reached agreement on continuing the Rare Disease Endpoint (RDEA) program.

The current PDUFA program is set to expire in September 2027, and negotiations for its reauthorization began in late 2025.

Industry questions PDUFA payroll increases

During the finance subgroup discussions on 19 February, the industry raised concerns about the increase in PDUFA spending, especially in light of recent significant layoffs. Specifically, they requested more context regarding the rise in PDUFA payroll from FY 2024-2025. These questions were driven by FDA’s FY 2025 PDUFA financial report to Congress.

FDA attributed the increase to “lump sum leave payouts, severance payments to eligible staff who performed PDUFA-covered work and were separated due to the Reduction in-Force, hiring in 2024 and early 2025, and a larger than average pay raise in 2024.” FDA said the pay raise in 2024 was 5.2% and represented the largest increase since 1980.

“FDA indicated that while lump sum leave payouts were completed in FY 2025, FY 2026 payroll may still show higher than expected values due to some separated staff receiving biweekly severance payments until July 2026, depending on length of service.”

FDA officials also noted that the agency experienced an increase in hiring during FY 2024 and the first quarter of FY 2025, contributing to higher year-over-year FTE levels.

Higher PDUFA spending generally results in higher fees for the pharmaceutical industry.

Agreement on RDEA

During a meeting between the FDA and the industry premarket subgroup, both parties agreed to the counterproposal regarding the RDEA pilot that the agency presented at an earlier meeting on 12 February.

The counterproposal said that “RDEA will move towards Type C, RDEA-focused meetings starting in fiscal year 2030. FDA agreed to draft commitment letter language for the RDEA proposal and will present it at a future meeting.”

The RDEA program is currently in its pilot phase, having been launched in October 2022. It was created to fulfill a mandate outlined in PDUFA VII, which aims to encourage the development of therapies for rare diseases. During the PDUFA VIII negotiations, industry representatives have been advocating for the FDA to eliminate the separate pilot structure for RDEA meetings and integrate the program into the existing review process. This change would make the program more accessible to sponsors.

Finance Subgroup minutes; Premarket subgroup minutes

PDUFA VIII: Industry questions increased spending despite staff cuts, agreement on RDEA

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