FDA Outlines New Changes to Drug User Fee Program
FDA has posted its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place beginning 10/1/2022. The commitment letter’s goals and commitments will be discussed next month at a public meeting (see earlier story).
Under the revised user fee program, FDA proposes to establish new timelines, performance goals, and a new process for pre-approval review of postmarketing requirements (PMRs). Sponsors would also have the opportunity to request a review of existing PMRs for release.
The agency is proposing a “Split Real Time Application Review Pilot Program” for efficacy supplements that meet specific criteria. Applications that move into the pilot program will be submitted in a “split” fashion, specifically in two parts with each component submitted about two months apart. “The goal is to shorten the time from the date of complete submission of the application to the action date,” FDA says.
To improve its meeting management, FDA is proposing creating two new meeting types — Type D and Interact. “The Type D meeting allows for quicker discussion on a narrow set of issues (no more than two focused topics) between FDA and a sponsor, such as a followup question that raises a new issue after a formal meeting,” the agency says. “The Interact meeting facilitates Investigational New Drug Application (IND) enabling efforts where a sponsor is facing a novel, challenging issue that might otherwise delay progress of the product towards entry into the clinic in the absence of this early FDA input. There would also be a new followup opportunity to pose clarifying questions after meetings or a written-response-only communication.”
Additionally, FDA is proposing a new pilot program around real-world evidence (RWE) to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements.
And, FDA is proposing enhancements and modernization to its drug safety system. Specifically, user fees will provide support for modernization and improvement of Risk Evaluation and Mitigation Strategies assessments and optimization of the Sentinel Initiative through: (1) maintenance of Sentinel Initiative capabilities and continued integration into FDA drug safety activities and (2) enhancement of the analytic capabilities of the Sentinel Initiative to address questions of product safety and advance the understanding of how RWE can be used for studying effectiveness.