Regulatory Focus™ > News Articles > 2021 > 1 > Industry, FDA begin to hammer out PDUFA VII details

Industry, FDA begin to hammer out PDUFA VII details

Posted 13 January 2021 | By Kari Oakes 

Industry, FDA begin to hammer out PDUFA VII details

Discussions continue between industry and the US Food and Drug Administration (FDA) regarding the upcoming reauthorization of user fees for prescription drugs, biologics and generic drugs. After public hearing and a first round of meetings that gave a peek into priorities for industry and regulator representatives, this next round began to sort out some detail. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiations, Regulatory Focus 29 October 2020)
 
On 20 November and 11 December 2020, public stakeholder meetings were held on the Prescription Drug User Fee Amendments reauthorization (PDFUA VII) that will span the fiscal years 2023-2027. Broadly, the 20 November meeting presented information on FDA’s drug safety system, which has been modernized during PDUFA VI. Participants in the meeting discussed “how FDA post-market processes address health disparities and representativeness and how new information and additional research affects FDA review of black box warnings,” according to FDA’s record of the meeting.
 
The Sentinel Initiative was another focus of the 20 November meeting, with FDA laying out how it has met the PDUFA VI goals related to the program. In particular, Sentinel is being better integrated into the drug review process, with a comprehensive training program planned for all regulatory staff who touch the system. Other post-marketing surveillance systems were also reviewed by the agency.
 
The use of real-world evidence and real-world data (RWE/RWD) is addressed both by PDUFA VI and the 21st Century Cures Act. “These commitments included initiating appropriate activities to address key issues in the use of RWE for regulatory decision-making purposes and publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions,” according to the meeting minutes. A point made by FDA during this portion of the meeting is that real-world data sources can augment, but not supplant, clinical trials during the regulatory decision-making process.
 
During the 11 December meeting, representatives from the Center for Biologics Evaluation and Research’s Office of Tissues and Advanced Therapies (CBER’s OTAT) were present and gave an overview of the state of cell and gene therapy programs at CBER. This expanding field of therapeutics will demand increased resource needs across several areas, including regenerative medicine and advanced therapies. The agency is also projecting increased work in post-market surveillance and a need for information technology modernization.
 
After a PDUFA financial status update, the stakeholder meeting addressed the broader issue of CDER modernization as it applies to the information infrastructure for new drug review. Talent management – recruitment and retention of experienced and competent reviewers – is a key part of this initiative in light of the agency’s “perennial talent shortage.”
 
Several PDUFA VII subgroup committees continued negotiations work during the latter part of 2020, with the finance, post-market, manufacturing and inspections, digital health and informatics, and finance subgroups all holding meetings to hammer out their areas of focus. On 10 November 2020, the PDUFA VII steering committee met to hear high level updates from each subgroup. On that date, the steering committee agreed to look at tabulation of the overall resources requested across the subgroups “after some discussion.”
 
A meeting scheduled for the following week was to examine the tentative resource request table and set the agenda for future meetings; at press time, minutes from that and any subsequent meetings were not available.
 
The reauthorization meeting for the Generic Drug User Fee Amendments (GDUFA III) held on 3 December 2020, as with earlier meetings, touched on advancing earlier approvals. The meeting also featured discussions about the pre-submission facility correspondence program.
 
According to the minutes, the history of capacity planning adjustment was laid out by FDA, who also discussed the proposed inflation and operating reserve adjustments, as well as a proposal to do away with limits on allowable fee expenditures.
 
Representatives from the generics industry “will consider these further details and provide the Agency with further questions” for future discussion, according to the minutes.
 
PDUFA VII meeting information
 
GDUFA III minutes
 
 

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