4 November, the talks focused on enhancing efficacy supplement reviews to expedite access to “treatments that may demonstrate a substantial improvement over currently available therapies.” (See table below for current supplement review goal times.) A change to the assessment timeline would be the first since standard and priority original application reviews were lengthened by two months in PDUFA V, which began in 2012. The agency and industry agreed to hold the start of the review clock, essentially making the targets 12 and eight months for standard and priority applications, and in return created mid- and late-cycle meetings with sponsors to discuss application concerns. The main goals of the extra two months were to increase communication and first-cycle approvals. () A timeline change also may require additional agency staff. During the 28 October meeting, industry and the FDA discussed the impact of the expansion on resource requirements. User fees for supplement filings were eliminated in PDUFA VI as part of a restructured fee schedule. () The industry proposal seems aimed at bringing many of the techniques used by the agency’s oncology reviewers into different disease areas. () The push for faster reviews may have also been prompted by the FDA’s response to the coronavirus pandemic, in which assessments for COVID-19 treatments and vaccines were dramatically sped up while traditional user fee goals for other products were maintained. The Pharmaceutical Research and Manufacturers of America (PhRMA), one of the trade associations negotiating on behalf of industry, said that it wants PDUFA VII to codify many of the efficiencies realized during the pandemic. () The story continues after the table… Move PMR, PMC Talks Up In Assessment Cycle, Industry Says Industry representatives also want postmarketing commitment (PMC) and postmarketing requirement (PMR) discussions conducted earlier in the assessment process. Typically, the tail end of an application assessment includes discussions of PMRs and PMCs, which usually are intended to answer lingering questions about a product. Sponsors want to “decrease the incidence of late-stage negotiations on PMRs/PMCs,” according to 12 November subgroup minutes. Industry, as well as the FDA, have complained that assessments can be rushed as they near completion and in some cases PMRs or PMCs are hurriedly agreed to even though they are not well conceived. However, while earlier discussions may be possible, the potential for fruitful conversations may be in question given that talks could be forced to start before there is a complete understanding of potential postmarket issues. FDA guidance for staff indicates that potential postmarketing commitments should be identified by FDA staff before Day 45 of the assessment. Agency staff also should indicate if more PMC discussions will be needed during the internal mid-cycle meeting. Postmarketing commitment negotiations should begin three weeks before the review division sign-off of an application. Sponsors want more “consistency and predictability of communication practices” related to PMRs, PMCs and labeling during application assessments, according to the 28 October subgroup minutes. Industry and FDA representatives also discussed “specific challenges noted by industry with currently available mechanisms for discussing the feasibility and potential release or reissue of PMRs,” according to the 12 November minutes. The FDA was hoping technology upgrades would improve PMR and PMC oversight after the Health and Human Services Office of Inspector General found the agency had trouble tracking sponsors’ progress. () CDER Version Of INTERACT Proposed New formal meeting types “to establish additional opportunities for obtaining the agency’s feedback on focused issues,” also are on the table, according to the 21 October subgroup minutes. And industry representatives want to bring the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) program to CDER. The CBER INTERACT program allows sponsors to receive advice from the FDA on innovative investigational products before the pre-IND meeting phase. Industry representatives proposed a “novel formal meeting” for “innovative product development programs,” as well as a “CDER-specific equivalent of CBER’s INTERACT program,” according to the 28 October subgroup minutes. Industry also wants to “expand the scope of and expedite timelines within INTERACT,” according to the 12 November minutes. CBER implemented INTERACT in 2018 to help clarify its expectations to sponsors and facilitate more efficient product development programs, as well as allow FDA staff to become more familiar with new products. () The FDA’s thoughts on a potential expansion were not detailed in the minutes, but the agency on 12 November “noted the estimated resources required to enable such enhancements for both CBER and CDER,” suggesting more staff or funding could be needed for the endeavor. Decisions on the CDER INTERACT program and many other PDUFA VII proposals could hinge on resource availability, and whether industry thinks that potentially higher fees might be justified by the increased FDA programs they could create. () By Derrick Gingery
