User Fees
Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.
Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.
In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.
The agency offered to drop annual IND fees for sponsors not conducting Phase I trials in the US, but industry still raised several concerns about fee incentives for onshoring clinical development.
The consolidation of HR and other services into one unit may require PDUFA funding system changes, and industry rejects the FDA’s proposal to limit the orphan drug fee waiver.
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.
March's FDA user fee calendar is defined more by repeated review cycles and regulatory recalibration than breakthrough innovation, signaling a cautious start to 2026’s novel approval momentum.
The interim facility inspection designation is being used as the basis for complete response letters and is part of a pattern of agency regulatory and administrative measures to avoid missing user fee deadlines, experts told the Pink Sheet.
Industry continues to oppose domestic manufacturing incentives that the FDA wants to include in the PDUFA reauthorization.
About one-third of the departures between the end of FY 2024 and the start of the second quarter of FY 2026 were from the drug and biologics centers.
Pink Sheet editors consider the impact of Trump Administration-aligned proposals on the FDA user fee program, as well as discuss the latest updates on the Moderna flu vaccine application.
The idea proposed by industry could be an attempt to increase first-cycle approvals and reduce overall review times, but the FDA has questions.
The proposals are aimed at ensuring a more consistent, predictable review process for new drug applications, onshoring more Phase I trials, codifying agency measures to encourage rare disease drug development, and encouraging biosimilar and generic competition.
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.
The public qualification pathway created in the 21st Century Cures Act has “not lived up to its billing,” but draft commitment letter language could help to address funding, expertise and incentive shortfalls.
As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.
The FDA proposed allowing sponsors that use domestic API suppliers and finished dosage form manufacturing and conduct BE testing in the US to receive a shorter ANDA review.
CDER and CBER added more people in the first quarter of FY 2026 than the previous two quarters combined, but departures still outnumbered the additions.
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.