Prescription Drug User Fee Act (PDUFA)

PDUFA was enacted in 1992 in response to a specific, well-documented problem: FDA’s New Drug Application review times had grown to an average of around 29 months during the 1980s, leaving approved drugs — and the patients waiting for them — behind a bottleneck largely attributed to FDA’s own resource constraints, not scientific difficulty. PDUFA gave FDA a new, dedicated revenue stream — fees paid directly by the sponsors submitting applications — to supplement (not replace) its congressional appropriation, specifically to hire additional review staff and expand review capacity. In exchange, FDA committed to measurable performance goals, most notably review-time targets. Within roughly six years of PDUFA’s first authorization, median review times had fallen from around 29 months to about 12.

What PDUFA actually funds and requires

PDUFA is not itself a review pathway — it does not grant designations, set eligibility criteria for expedited programs, or determine whether a specific drug qualifies for faster review. It is the statutory and financial architecture underneath FDA’s human drug review program. Two things happen under PDUFA: sponsors pay fees tied to the applications and products they bring to FDA, and FDA, in a negotiated agreement with industry (developed with public input and submitted to Congress ahead of each reauthorization), commits to specific performance goals it will meet using that additional funding — goals covering review timeliness, but also, in more recent reauthorizations, commitments around meeting management, drug safety, and program modernization.

The best-known PDUFA performance goals are the review-time targets applied to a first review cycle for a marketing application: a Standard Review goal of 10 months from the filing date, and a Priority Review goal of 6 months from the filing date (see FDA Priority Review for how an application qualifies for the shorter goal). These are internal FDA performance targets FDA has committed to meet under the PDUFA agreement — they are not statutory deadlines guaranteeing a decision by that date, and they say nothing about whether an application will ultimately be approved. An application that does not meet FDA’s standards can still receive a Complete Response Letter well within the PDUFA goal date.

Fee types

PDUFA fees fall into a small number of categories that have been consolidated somewhat across successive reauthorizations, but generally include: an application fee, paid by a sponsor submitting a covered human drug or biologic application requiring clinical data (e.g., a New Drug Application or Biologics License Application); and an annual program fee (in earlier reauthorizations, separate establishment and product fees), paid for each approved prescription drug product a company markets. Exact fee amounts are set annually by FDA under the statutory fee-setting formula and published each fiscal year — they are not fixed figures in the law itself, so a specific dollar amount should always be checked against FDA’s current fee schedule rather than assumed to still apply from a prior year. Certain applications and sponsors — including some orphan drug applications and, under specific statutory criteria, small businesses — can qualify for fee waivers or reductions.

Reauthorization: a recurring five-year cycle

PDUFA is not a permanent, self-renewing authorization — FDA’s authority to collect these fees lapses unless Congress reauthorizes the program, which it has done roughly every five years since 1992: PDUFA II (1997), PDUFA III (2002), PDUFA IV (2007), PDUFA V (2012), PDUFA VI (2017), and PDUFA VII, signed into law on September 30, 2022 as part of the FDA User Fee Reauthorization Act of 2022, covering fiscal years 2023 through 2027. Each reauthorization is preceded by a negotiation process between FDA and regulated industry, with opportunities for public and patient-advocacy input, resulting in a detailed commitment letter that goes beyond fee amounts and review-time goals to cover priorities for that five-year cycle. PDUFA VII’s commitment letter, for example, addresses areas such as advancing regulatory science for cell and gene therapies, drug development tools, manufacturing modernization, and digital health technology capacity, alongside adjustments to FDA’s formal meeting-management commitments with sponsors (see FDA meeting types).

Because PDUFA reauthorization is a recurring congressional action rather than a settled, permanent statute, research administration and regulatory affairs offices tracking a long-horizon drug development program should treat reauthorization years as a genuine planning variable — a lapse in reauthorization affects FDA’s fee collection authority and, historically, has been a factor in agency contingency planning during periods when reauthorization legislation was delayed.

PDUFA vs. the pathways it funds

PDUFA is frequently conflated with the expedited programs that operate inside the review process it funds, but the two are conceptually distinct: PDUFA is the fee-and-performance-goal framework; Priority Review, Breakthrough Therapy designation, Fast Track, and Accelerated Approval are pathways and designations that determine how a specific product moves through that review process. A useful way to keep them distinct: PDUFA answers “how is FDA’s drug review program resourced, and what turnaround does FDA commit to,” while the expedited pathways answer “does this specific product qualify for faster development support or a shorter review clock.” A Priority Review Voucher is yet a third, separate mechanism — a transferable incentive under rare pediatric and tropical disease programs — that is also sometimes confused with PDUFA’s own Priority Review goal despite sharing the “priority review” name.

Related user-fee programs

PDUFA was the first FDA user-fee statute and the model for several that followed, each covering a different regulated product category: the Generic Drug User Fee Amendments (GDUFA, first enacted 2012) for generic drug applications, the Medical Device User Fee Amendments (MDUFA, first enacted 2002) for medical devices, and the Biosimilar User Fee Act (BsUFA, first enacted 2012) for biosimilar applications. Each is reauthorized on its own parallel cycle, generally aligned with PDUFA’s five-year schedule, but each has its own fee structure and performance goals — a PDUFA goal does not apply to a generic, device, or biosimilar application.

Why this matters for research administration

For research administrators, technology transfer offices, and regulatory affairs staff supporting an institution’s IND-holding investigators or spin-out companies, PDUFA is directly relevant to two practical questions: budgeting (application and program fees are a real, sometimes substantial, cost in a marketing-application regulatory strategy, separate from clinical trial conduct costs) and timeline planning (the Standard and Priority Review goal dates PDUFA underwrites are the reference points regulatory affairs teams use to plan downstream activity — site activation for confirmatory studies, commercialization timelines, or licensing milestones — around an anticipated approval decision).