The Prescription Drug User Fee Act of 1992

The first fee Congress let FDA charge for reviewing a new drug application was $100,000. Public Law 102-571¹, signed October 29, 1992, set that amount for fiscal 1993 and scheduled it to climb to $233,000 by fiscal 1997. For fiscal 2027, which began October 1, the full fee for an application that relies on clinical data is $4,600,753, according to the fee notice FDA published on July 30, 2026².

Congress has renewed the Prescription Drug User Fee Act six times since 1992, always on a five-year clock. The current authority expires in September 2027. FDA has posted a proposed commitment letter for PDUFA VIII³, covering fiscal 2028 through 2032, and held a public meeting on it on September 16, 2026. The generic drug program that borrowed PDUFA's design in 2012 faces the same deadline.

This history traces what the 1992 law did, how each renewal changed it, how large the program has grown and how the model reached generic drugs.

Why Congress agreed to fees in 1992

In the late 1980s the median time for FDA to approve a new drug application was 29 months, according to a Congressional Research Service report⁵ on the program's history. FDA said it lacked the scientists to clear incoming applications and a growing backlog. The drug industry had long opposed user fees, CRS wrote, because it feared the money would flow to the Treasury rather than to drug review.

A compromise cleared the way by meeting two industry demands. FDA would commit to performance goals with target review times, and the fees would add to congressional appropriations rather than replace them. Both found their way into the statute. Its findings tied the fees to review goals set out in letters dated September 14 and September 21, 1992, from the FDA commissioner to the chairs of the House and Senate health committees. CRS notes that every version of the law since has carried “triggers” that let FDA collect and spend fees only if Congress keeps funding the agency at or above set levels.

What the first law charged

PDUFA I levied three kinds of fees, each set to raise one-third of the total, a split that lasted through PDUFA V. The schedule in the 1992 statute¹ looked like this.

Those fees applied to new drug applications under section 505(b) of the Food, Drug, and Cosmetic Act, to antibiotic applications then filed under section 507 and to biologics licenses. Abbreviated applications for generic drugs were left out of the definition entirely. Businesses with fewer than 500 employees and no product yet on the market paid half the application fee and could defer it for a year. FDA's PDUFA page⁴ still defines the covered applications as 505(b) new drug applications and 351(a) biologics license applications.

Six renewals, each riding a larger bill

Each reauthorization came packaged with broader FDA legislation, and each rewrote the goals FDA promised to meet.

Dates come from FDA's pages on PDUFA II⁶, PDUFA III⁷ and PDUFA IV⁸, FDA's FDASIA page⁹, and the enacted texts of the 2017¹⁰ and 2022¹¹ laws. The 2007 renewal, FDA says, “significantly broadened and upgraded the agency's drug safety program” and added resources for reviewing television drug advertising.

Standard and priority review, the two tiers FDA still uses, date to PDUFA I, CRS wrote. Under the PDUFA VII commitment letter¹², FDA aims to act on 90 percent of standard applications for new molecular entities within 10 months of the 60-day filing date, and on 90 percent of priority applications within six months of it.

Revenue grew with the program. In PDUFA's first year, fees made up 9.7 percent of FDA's human drugs program budget, and by fiscal 2017 user fees of all kinds made up 63 percent, CRS reported. The 2017 renewal dropped the establishment and product fees and created an annual program fee that supplies 80 percent of revenue, CRS wrote. For fiscal 2027 FDA set PDUFA's target revenue at $1,498,081,000. Application fees are set to raise 20 percent of that, about $299.6 million, and the rest comes from an annual program fee of $416,857 charged on an estimated 2,875 fee-paying products.

The generic version arrives in 2012

Generic applications sat outside the system for two decades, and the review queue showed it. In March 2012 the median review time for an abbreviated new drug application, or ANDA, was about 31 months and FDA had a backlog of more than 2,500 of them, according to a 2021 CRS report on generic user fees¹³. Fewer than 1 percent of ANDAs were approved in a single review cycle.

Congress closed the gap in the FDA Safety and Innovation Act, signed July 9, 2012, which added the Generic Drug User Fee Amendments, known as GDUFA, along with a separate fee program for biosimilars. GDUFA I set first-year revenue at $299 million for fiscal 2013. For fiscal 2027 the target is $665,986,000 and the fee to file one ANDA is $375,684, according to the fiscal 2027 GDUFA notice¹⁴. GxRadar covers that program in detail in its own explainer, and the review goals in a piece on ANDA goal dates.

Approval counts rose after the fees began, although the number of applications filed drives the totals as well. GxRadar's count of original ANDA approvals in FDA's Drugs@FDA data¹⁵, through October 28, 2026, shows the pattern.

No year in the series, which begins in 1984, tops 2017. The full year-by-year count is on GxRadar's approvals page, and the longer arc is in forty years of generic drug approvals.

The September 2027 deadline

All three human drug fee programs expire together. FDA's PDUFA VIII page³ lists negotiation sessions with industry running through a steering committee meeting on May 15, 2026, before the September public meeting. The GDUFA IV page¹⁶ shows a parallel process, with its own public meeting on September 17, 2026. For biosimilars, FDA held a meeting on October 26, 2026, and is taking written comments through November 25, 2026, according to its Federal Register notice¹⁷.

FDA then revises the recommendations in light of the comments. Congress has to pass the next reauthorization by September 30, 2027. Without it, FDA would lose authority to collect fees that are set to bring in about $1.5 billion for brand drug review and $666 million for generic review in fiscal 2027 alone. The 2022 renewal was signed on September 30, the last day of PDUFA VI's final fiscal year.