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Life Science Daily – House health subcommittee makes user fee agreement reform high priority

Life Science Daily – House health subcommittee makes user fee agreement reform high priority

The House Energy and Commerce Committee’s health subcommittee pushed the Prescription Drug User Fee Act (PDUFA) higher up the priority list during a hearing earlier this week.


PDUFA, which supports the review and regulation of innovative drug products and helps ensure patients receive timely access to safe and effective new therapies, must be reauthorized before it expires in September. Subcommittee members and witnesses, however, said the sixth version of the prescription drug agreement should get passed by July and then added as an enhancement to the 21st Century Cures Act, which Congress passed last year.


The 21st Century Cures Act—considered game-changing legislation that accelerates the discovery, development, and delivery of new cures and treatments—shares many of the same goals found in PDUFA VI, Janet Woodcock, director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, testified.


“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,” Woodcock said.


Subcommittee Chairman Rep. Michael C. Burgess (R-TX), reiterated the shared goals and said that “PDUFA VI will dedicate resources to complement the implementation of many of the priorities in 21st Century Cures.”

According to Jeff Allen, president and CEO of Friends of Cancer Research, there are numerous benefits coming once PDUFA is reauthorized.


“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,” Allen said.


The health subcommittee recently held a hearing to examine the Generic Drug User Fee Amendments and the Biosimilar User Fee Act, which both also expire in September. The subcommittee will hold a hearing March 28 to examine the FDA’s Medical Device User Fee Program, also facing a reauthorization deadline by the end of fiscal year 2017.…