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PDUFA VII: Negotiations continue with focus on regulatory decision tools, digital health and CMC

Posted 07 December 2020 | By Michael Mezher 

PDUFA VII: Negotiations continue with focus on regulatory decision tools, digital health and CMC

The US Food and Drug Administration (FDA) on Monday released its latest batch of meeting summaries in the ongoing negotiations with the pharmaceutical industry that will shape the next Prescription Drug User Fee Act (PDUFA VII) program.
The meetings, all of which took place in October, shed light on the programs and priorities FDA and industry are pursuing as they hammer out an agreement over the next five years of the agency’s multibillion-dollar drug review program. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiations, Regulatory Focus 29 October 2020; PDUFA VII: FDA, Industry take up manufacturing, postmarket issues, Regulatory Focus 11 November 2020).
Regulatory Decision Tools
In its latest meeting, the regulatory decision tools subgroup picked up where it left off discussing FDA’s complex innovative trial design (CID) program.
“FDA identified a need to build upon the current pilot in order to provide time, expertise, and resources to progress toward full implementation of the appropriate use of CIDs,” FDA said, noting its interest in enhancements that could move the program out of its pilot phase.
Industry representatives presented their own proposals related to CID and suggested building upon the current program and sought further clarification on the program from FDA and to promote greater acceptance of CIDs.
The two sides agreed to have follow-up discussions at the committee’s next meeting on CIDs, MIDD, patient-focused drug development (PFDD) and to introduce and discuss a new topic, advancing translations models and tools.
Digital health and informatics
The Digital Health and Informatics subgroup met twice to discuss FDA’s IT governance structure and information management programs and roadmap for the future.
At the first meeting, the two sides agreed that investing in a program focused on “continually improving the ability to utilize [digital health technologies] DHTs in drug development and oversight would be mutually beneficial.” FDA and industry set their sights on additional guidance on the use of DHTs and increasing consistency with regard to digital health at the agency. At the following meeting, FDA and industry found “points of alignment regarding primary objectives” for a DHT proposal, including convening public forums on the use of DHTs in clinical trials. FDA also stressed the need for IT support and a cloud-based infrastructure to facilitate the review of DHT-generated data.
The third meeting focused on FDA and Industry’s plans for data and technology modernization at the agency and included a presentation on FDA’s new Digital Health Center of Excellence. (RELATED: FDA launches digital health center of excellence, Regulatory Focus 23 September 2020).
Manufacturing and inspections
In its most recent meeting, the manufacturing and inspections workgroup discussed an industry proposal on accelerated reviews for chemistry, manufacturing and controls (CMC) data. Industry also expressed interest in guidance from FDA on the CMC content expected in regulatory submissions for expedited pathway products. FDA pushed back on the notion that a general guidance could cover the nuances of CMC across various products. The two sides discussed the potential for a CMC rolling review for certain expedited pathways, though FDA raised concerns that doing so could create inefficiencies in the review process.
FDA and industry also discussed an industry proposal to better “delineate what content should be included in a submission and what content should be included for inspection,” and agreed to discuss the proposal further.
Steering committee
The negotiations steering committee met four times in October, each time including a high-level update on the discussions at the various subgroups and discussing staffing and resource management under PDUFA VI and what the two sides hope to obtain for PDUFA VII.
At the first meeting, FDA said that a limitation under PDUFA VI is the “focus on headcounts when talking about FDA’s resources” and suggested that “effort and capacity may be more meaningful and gives the program more flexibility.” The second meeting saw FDA present findings from an interim report on PDUFA VI hiring.
At the third meeting, industry pitched its proposal for PDUFA VII enhancements that could ensure the agency is able to attract and retain qualified staff. Both sides agreed to develop “guiding principles” for addressing human resources and hiring, which were presented at the fourth meeting. FDA’s principles “focused on reporting, including data that would be efficient to collect and post; that captures meaningful metrics to describe the health of the workforce, gaps in staffing and barriers to realizing needed staffing; that articulates steps to overcome barriers; and ensures accountability and transparency in resource utilization,” whereas industry set its sights on hiring and retention of “essential staffing, recruiting critical expertise, retaining high-performing personnel, improving HR functions, and reporting detailed and useful metrics.”


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Tags: drugs, PDUFA VII, US

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