Drugs

Drug User Fee Agreement Public Meeting Transcript Available

FDA has released the transcript of its 9/16 public meeting that outlined the Prescription Drug User Fee Act Agreement for reauthorizing the program for fiscal years 2028 through 2032. Under the agreement, the agency is proposing new mechanisms to reduce complete response letters, improve sponsor communications and address manufacturing problems earlier in the drug review process.

At the meeting, FDA officials highlighted a new CMC Facility Lifecycle Program intended to prevent manufacturing deficiencies from derailing otherwise approvable applications. Under the proposal, sponsors could request a dedicated manufacturing facility meeting three to six months before filing an NDA or BLA to discuss supply chains, compliance risks, previous inspections and readiness for preapproval or prelicense inspections.

FDA would also establish a post-inspection meeting when deficiencies identified during a PAI or PLI could result in a complete response letter. Sponsors could discuss proposed corrective actions with FDA before the agency takes final action. FDA could extend the application's review goal date by up to three months when it believes the manufacturing problem could be resolved during that period. The agency said the objective is to reduce facility-related CRLs and avoid additional review cycles.

PDUFA VIII would also emphasize first-cycle approvals. FDA plans an assessment of its review processes and sponsor communications aimed at reducing complete responses for applications that are ultimately approvable, missed PDUFA goal dates and review-clock extensions. FDA would prioritize review of protocols for pivotal trials and permit certain multi-divisional meetings for products being developed across therapeutic areas.

Several of the current user fee program’s regulatory-science pilots would move into routine practice. The Rare Disease Endpoint Advancement Pilot would become an established program, while FDA plans up to 10 Rare Disease Innovation, Science and Exploration, or RISE, workshops. The Complex Innovative Trial Design, model-informed drug development and real-world evidence programs would also be expanded or incorporated into standard review processes. FDA also plans to sunset the Split Real-Time Application Review pilot in September 2027 because of limited industry participation.

Regarding postmarket safety, PDUFA VIII would support development of Sentinel 3.0, an enhanced active safety-surveillance system, and explore allowing sponsors to submit voluntary proposals describing how they would evaluate safety issues that could become postmarketing requirements.

The current PDUFA VII authorization expires 9/30/2027. FDA plans to transmit its final PDUFA VIII recommendations to Congress by 1/16/2027.

A video of the meeting is available here.

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