• FDA, Industry Stakeholders Advance MDUFA IV Reauthorization Negotiations, Agree to Three Priorities
  • December 9, 2015
  • Law Firm: Loeb Loeb LLP - Los Angeles Office
  • The FDA and members of the medical device industry agreed to limit their focus in MDUFA reauthorization discussions to three priority areas - incorporating patient perspectives into FDA review, better utilization post- and pre-market evidence, and FDA cross-center collaboration. The final recommendations will head to Congress in January 2017.

    As they look ahead to the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, the FDA and industry stakeholders came to terms on three priority areas.

    Although both sides say the program has improved and is heading in a positive direction, they identified three priorities for the 2017 iteration, which is required by law - patient engagement and the science of patient input, use of evidence for post-market and pre-market purposes, and cross-center coordination.

    The first priority area focuses on incorporating patient perspectives into FDA reviews, with both regulatory authorities and industry members agreeing to discuss limitations in the use of scientific data on patient preference (PP) and patient reported outcomes (PRO). Specifically, the pair said they will address resource constraints that stymie the use of scientific data on PP and PRO, as well as limitations of getting devices to market using such data. In order to overcome the issue, they called for an expansion in the use of patient registries. The FDA also emphasized the importance of demographic subgroup data and discussed section 907 of the Food and Drug Safety and Innovation Act, which calls on the agency to examine specific demographic data for inclusion in clinical trials.

    The second priority focuses on how post- and pre-market device evidence can be better utilized. The industry and FDA acknowledged the need to find the right balance between pre-market and post-market evidence collection and the need for more efficient collection and use of data from various sources, such as device and patient registries, particularly because data collection is beginning to shift, in certain cases, from pre-market to post-market. They encouraged the FDA to adopt a total product life cycle approach in which pre- and post-market are not separate from one another.

    The final priority area focuses on how FDA centers can better coordinate in areas such as combination products and companion diagnostics, emphasizing the need to identify areas for efficiencies and consideration of how to ensure adequate user fee funding.

    At the next negotiation meeting, the FDA and industry will present final proposals. They hope to reach an agreement that can go into clearance by mid-2016, after which the FDA will conduct the public process for review of draft recommendations by fall 2016. Final recommendations will be delivered to Congress on Jan. 15, 2017.