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Public Policy Newsletter Article

BIO & PhRMA Preview PDUFA VII Reauthorization Wish List

  • 2020-07-30T15:00:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

The Food and Drug Administration held its first meeting leading to the reauthorization of the Prescription Drug User Fee Act (PDUFA). The meeting was the starting point for negotiations with the industry on defining the goals for the new drug review program for FY2023 – FY2027.

FDA Commissioner Stephen Hahn opened the meeting by touting the successes of the current PDUFA program.
• “Since FY2016, CDER and CBER have approved over 150 new molecular entities, new drug applications and biologics license applications,” Hahn said, nearly half of which have been for orphan indications.
• FDA reached a new high for priority applications, filed – 72 – and total applications filed – 166 – and again are on track to meet or exceed most of our review performance goals.
• FDA has published more than 30 draft or revised guidances, held more than 20 public meetings and workshops and published nine public reports as part of its PDUFA VI commitments.

Representatives from both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) presented their industries’ goals for the next user fee program.
• PhRMA supports more predictable and timely engagement and better communication during drug development.
• PhRMA would support the establishment of a flexible and scalable global framework for digital technology development.
• PhRMA would like to see greater support for real world evidence (RWE) in FDA’s decision-making.
• BIO’s top three objectives are to “continue to optimize the current program and processes; to ensure science-based and effective post approval requirements and activities; and third, to develop new initiatives that will best prepare us for the future.”
• BIO support the agency’s ability to hire and retain “world-class personnel.”
• BIO would like to see more funding going to the Center for Biologics Evaluation and Research (CBER) to accommodate the increased workload around cell and gene therapies.
• BIO would also like further clarification on the evidentiary standards for FDA’s expedited pathways such as the agency’s new regenerative medicine advanced therapy (RMAT) designation.
• BIO called for the establishment of processes and best practices to improve the efficiency and effectiveness of meetings between sponsors and FDA.
• Additionally, BIO would like to see FDA establish new mechanisms and timelines for communication with industry, such as providing an opportunity for sponsors to ask clarifying questions after milestone meetings and setting structured timelines for communication for labeling, postmarket requirement (PMR) and postmarket commitment (PMC) processes and pediatric study plans.