FDA Sets September Meeting on PDUFA VIII Fee Deal

FDA has put its opening bid for the next five years of brand-drug review economics on paper. On 14 August 2026 the agency published its draft recommendations for PDUFA VIII — the Prescription Drug User Fee Act agreement covering fiscal years 2028 through 2032 — and set a hybrid public meeting for 16 September. Comments are due a month later, on 16 October.

Four fee programs, one deadline

PDUFA is one of four human medical product user-fee programs — alongside the Medical Device User Fee Amendments (MDUFA), the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) — that Congress reauthorizes together roughly every five years, most recently in 2022. All four expire on 30 September 2027, and FDA is running their public-meeting processes in parallel this quarter: it published MDUFA VI's draft commitment letter on 8 July, GDUFA IV's on 11 August, and now PDUFA VIII's on 14 August. Miss any one of the four and the corresponding review program loses its fee-funded staff on 1 October 2027, regardless of what happens to the other three.

The 50 percent fee cut for US-run trials

The single biggest departure from PDUFA VII is a proposal to cut the NDA or BLA application fee in half for sponsors whose submission includes data from at least one Phase 1 trial conducted in the United States, provided that trial was initiated after 1 October 2027. FDA and industry frame it as an incentive to anchor early-stage clinical development onshore rather than in lower-cost trial markets abroad — a priority the current administration has pushed across several 2026 user-fee negotiations, including a parallel non-orphan indication supplement fee proposal industry has separately flagged concerns about. The discount applies only to trials that start after the fiscal year turns over in October 2027, so it rewards decisions sponsors have not yet made rather than trials already under way.

Meeting access gets more formal

• Face-to-face by default: sponsors can request in-person pre-IND, Type C, Type D and INTERACT meetings; if FDA offers a written response instead of the requested format, the agency must give a specific rationale rather than a form denial.
• Multi-divisional meetings: sponsors developing a product across more than one therapeutic area can request a single meeting spanning the relevant review divisions, instead of separate parallel meetings with each.
• Everything else carries over: the core review-goal letter for most submission types — NDAs, BLAs, manufacturing supplements — is proposed unchanged from PDUFA VII, which FDA and industry present as a program that is largely hitting its existing marks.

What is not settled

Everything here is still a draft. FDA can revise the recommendations after the September meeting and the comment period that follows, and Congress still has to legislate the fee schedule itself — nothing in the notice sets actual dollar fee amounts for FY 2028 onward. What is fixed is the calendar behind it: HHS must formally submit the negotiated agreements to Congress no later than 15 January 2027, and lawmakers are expected to debate and pass reauthorizing legislation before PDUFA VII's authority lapses on 30 September 2027. FDA has used the intervening years to reauthorize all four fee programs at once since 2012; missing the deadline on any one has never happened, and the agency's public messaging gives no indication it expects that to change now.