User Fees
Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.
FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.
The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.
The agency offered to commission a third-party study of efficiency, workload and other factors to determine whether the base PDUFA revenue should be lowered mid-program cycle.
Industry continues to oppose domestic manufacturing incentives that the FDA wants to include in the PDUFA reauthorization.
Including OTC studies in special protocol assessments will be addressed in FDA guidance required in 15 months on improving predictability of process and standards for approval of OTC drug applications, while stepwise labeling information will be post online to improve visibility and searchability fo
The idea proposed by industry could be an attempt to increase first-cycle approvals and reduce overall review times, but the FDA has questions.
User fee program changes traditionally are technical and FDA-specific, but the Trump Administration appears to also want policies advocating its “America First” agenda included.
As the US biosimilars market sees long-desired changes in areas such as regulatory streamlining and interchangeability, Julie Reed – executive director of the Biosimilars Forum – says there are still aspects that need to evolve.
In latest meeting of PDUFA reauthorization nonprescription subgroup, FDAS officials acknowledged stepwise labeling submissions “already available under current regulations but may not be widely known or consistently applied.”
The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.
In PDUFA reauthorization subgroup meetings, CHPA suggests expanding FDA’s special protocol assessment program to include OTC drug studies before FDA notes Congress has required it to provide switch-specific guidance before current PDUFA expires.