Discussion Part of Ongoing Hearings Examining User Fee Agreements
WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining the Prescription Drug User Fee Act (PDUFA), which needs to be reauthorized before its expiration in September 2017. PDUFA supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies.
Discussed throughout the hearing was the 21st Century Cures Act, game-changing legislation to accelerate the discovery, development, and delivery of new cures and treatments. Dr. Janet Woodcock, Director of the Food and Drug Administration, Center for Drug Evaluation and Research, stressed the shared goals within Cures and PDUFA VI.
Dr. Woodcock stated, “Center to PDUFA VI, and its largest single investment component, are plans to elevate patient voices in developing new drugs to treat their diseases. The agreement shares the committee’s goals reflected in the 21st Century Cures Act – and the highest priority of our stakeholders – to leverage essential patient input and insights to fight disease.”
Chairman Burgess reiterated the shared goals of the 21st Century Cures, saying, “Over the course of the 113th and 114th Congresses, members of this subcommittee worked to uncover opportunities to strengthen and streamline the process by which cures are discovered and made available to patients. The resulting law touches each step of the process through which new treatments and cures come to market. I am encouraged to see in our witnesses’ testimonies that PDUFA VI will dedicate resources to complement the implementation of many of the priorities in 21st Century Cures.”
Vice Chairman Guthrie listens to Dr. Woodcock.
Vice Chairman Brett Guthrie (R-KY) asked Dr. Woodcock for an update on FDA’s Oncology Center of Excellence, a key component of 21st Century Cures and a committee-supported initiative. Dr. Woodcock elaborated on the center’s structure and the important work they’ll be doing.
Mr. Jeff Allen, President and CEO of Friends of Cancer Research, spoke to the evolution of the user fee agreements, stating, “Over time, the FDA’s more active role in product development has led to expansions to the agreements between the FDA and the drug manufacturers that supply the user fees. Recent user fee agreements have allowed funds to be applied to activities that are beyond the primary application review functions, such as programs to advance the science that serves as the basis for new product development. In addition to funding core product review and personnel, the sixth authorization of the user fee agreement will support key projects that ensure the FDA can conduct scientific programming, participate in public workshops, and develop guidance for its employees and external stakeholders regarding cutting-edge science and new strategies for drug development and regulation.”
#SubHealth recently held a hearing examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), both of which also expire in September 2017. The subcommittee will also hold a hearing next week examining FDA’s Medical Device User Fee Program. All of these user fee programs must be reauthorized by the end of Fiscal Year 2017.
For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.