PDUFA VIII Commitment Letter Outlines Changes to Drug Review, Manufacturing Oversight
FDA has released proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act (PDUFA VIII), outlining changes to drug review, manufacturing oversight, regulatory science programs and the structure of industry fees for fiscal years 2028 through 2032. The proposed PDUFA VIII commitment letter follows negotiations with the pharmaceutical industry and monthly stakeholder consultations conducted from 11/2025 through 5/2026. FDA says the proposals address priorities raised by industry, patients, healthcare professionals and other stakeholders.
Among the major changes, FDA would establish a process to prioritize review of pivotal clinical trial protocols. Sponsors would identify qualifying protocols intended to provide the primary basis for an efficacy claim, allowing FDA to prioritize their review before studies begin.
FDA also proposes changes to formal meetings with sponsors, including greater use of multi-divisional meetings for products being developed under multiple INDs and a process allowing sponsors to request that certain pre-IND, Type C, Type D and INTERACT meetings be conducted face-to-face. If FDA declines a face-to-face format, the agency would provide a specific rationale for why a written response is sufficient.
The proposal would also expand the use of regulatory science programs, including incorporating the Rare Disease Endpoint Advancement, Complex Innovative Trial Design and Advancing Real-World Evidence programs into existing formal meeting processes. FDA also proposes up to 10 Rare Disease Innovation, Science, and Exploration workshops and public meetings focused on patient experience data and the use of regulatory science tools.
A new risk-based CMC facility lifecycle program would provide additional opportunities for FDA and sponsors to address manufacturing facility deficiencies before, during and after application review. The proposal includes a CMC facility pre-submission meeting and, when necessary, a post-inspection meeting to discuss findings affecting approval and potential corrective actions.
FDA also proposes changes to PDUFA's financial structure. The agency would eliminate several existing adjustments, reduce the maximum operating reserve and establish a personnel compensation and benefits set-aside intended to support staffing of the drug-review program. The proposal also calls for independent assessments of PDUFA operations and potential administrative efficiencies.
The proposed fee structure would give sponsors a 50% reduction in the application fee when an application includes clinical data from at least one U.S.-anchored Phase 1 trial initiated after 10/1/2027. Other changes would affect fees for certain supplements involving non-orphan indications, orphan-product fee exemptions and small-business eligibility.
The proposed commitment letter would also discontinue some PDUFA VII initiatives, including the Split Real-Time Application Review and CMC Development and Readiness Pilot programs, which FDA said were underutilized or had been overtaken by newer enhancements.
Reacting to the commitment letter’s release, Biotechnology Innovation Organization (BIO) had this to say: “For more than 30 years, PDUFA has helped deliver hundreds of new medicines to American patients. As a lead industry negotiator for the PDUFA VIII agreement, BIO supports the PDUFA VIII commitment letter and its strengthening of regulatory review, advancing innovation, and helping deliver safe and effective treatments to patients. Specifically, the PDUFA VIII agreement includes important commitments that bolster the FDA’s core review activities, ensure accountability for predictable performance, improve financial sustainability and improve communication, transparency and efficiency.”
The industry group said it is committed to working with Congress to ensure the program’s reauthorization by 9/30/2027.
Meanwhile, FDA has announced plans to hold a 9/16 public meeting on the reauthorization and proposed enhancements.