FDA Unveils FY 2027 User Fee Rates: PDUFA Revenue Target Rises 6%, MDUFA Jumps 14%
核心洞察
FDA published FY 2027 user fee rates across prescription drug, generic drug, biosimilar, medical device, and OTC monograph programs, with base revenues rising across all categories.
PDUFA VII base revenue is estimated at $1.52 billion, a nearly 6% increase over FY 2026, while MDUFA V sees the steepest rise at 14% to $418.3 million.
BsUFA III base revenue is set at $58.9 million, a 5.2% increase, though the agency expects to lower BsUFA fees by more than 6% for the second consecutive year.
The US Food and Drug Administration has published its user fee rates for fiscal year 2027, outlining base revenue targets across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates, calculated by factoring the agency's resources against anticipated application volumes based on historical trends, reveal broad increases across nearly all categories.
Prescription Drug User Fee Amendments (PDUFA VII)
FDA estimates the base revenue for FY 2027 under PDUFA VII at $1,515,410,160 before inflation and other adjustments are considered. This represents an almost 6% increase compared to the FY 2026 estimate of $1,434,377,467, reflecting the agency's growing resource demands for prescription drug review activities.
Generic Drug User Fee Amendments (GDUFA III)
For the generic drug program, FDA set the FY 2027 base revenue estimate at $670,899,031 before inflation and other factors. The new estimate marks more than a 5% increase compared to the FY 2025 estimate of $638,961,803, signaling continued investment in generic drug application review capacity.
Biosimilar User Fee Amendments (BsUFA III)
Under BsUFA III, FDA estimated that base revenue from the biosimilar program for FY 2027 needs to reach $58,926,749 before adjustments for inflation, hiring, operating costs, and other factors. This is a 5.2% increase from the $56,011,943 base revenue projected for FY 2026.
The agency expects approximately 36 new biological product development (BPD) programs in FY 2027 with no reactivations — six more than the FY 2026 estimate of 30. An additional 142 BPD programs are expected to pay the annual BPD fee, up from 120 in FY 2026, bringing the total number of estimated applications to 178. Notably, FDA lowered BsUFA fees by 18% last fiscal year and expects to lower them again by more than 6% next year, even as the base revenue target rises.
Medical Device User Fee Amendments (MDUFA V)
The medical device program sees the steepest increase among all user fee categories. FDA estimates the FY 2027 base revenue for MDUFA V at $418,343,000 before inflation and other factors — a 14% increase compared to the FY 2026 estimate of $366,486,300. The agency expects to increase rates by 10% to meet its revenue targets.
Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II)
FDA also published its OMUFA II program user fee rates for FY 2027. The agency set the FY 2027 base revenue, excluding certain adjustments, at $40,648,348, up 11.5% from the FY 2026 base revenue of $36,467,438. The most dramatic change comes in OTC monograph order (OMOR) request rates and monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates, which increased by almost 150%.
The user fee programs are reauthorized every five years through negotiations between FDA and regulated industry stakeholders, with the current legislative frameworks — PDUFA VII, GDUFA III, BsUFA III, MDUFA V, and OMUFA II — governing the fee structures through FY 2027.