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NORD Calls Senate Bill Most Important Since Orphan Drug Act
Date:5/24/2012

o further qualify and categorize biomarkers for use in clinical trial design, including under Accelerated Approval and similar mechanisms
  • A new initiative to evaluate patient tolerance to risk of proposed therapies and to incorporate more patient input in the review process

    • Legislative provisions in the bill include:

    • Codification and modernization of the Accelerated Approval process
    • Improvements to policies governing conflicts of interest that will allow expert participation on FDA Advisory Committees
    • Creation of a new category of "breakthrough" therapies that will encourage early public and private collaboration to aid in clinical trial design and review
    • Expanded access to experts for rare diseases beyond the review process
    • Expansion of devices intended for use in very small patient populations, including the possibility of profit for such devices when used in adult populations

    The US House of Representatives is working on companion legislation (HR 5651 – the Food & Drug Administration Reform Act of 2012) that has already been unanimously approved by the Committee on Energy & Commerce in a similar bipartisan fashion.  Adoption of that measure is expected when the House resumes its session at the beginning of June.

    Both the House and Senate bills are the culmination of a process conducted every five years to reauthorize the Prescription Drug User Fee Act (PDUFA) and related legislation that provides critical funding to allow FDA to review potential new therapies in a timely manner.  As the voice of rare disease patients and their families in the U.S. since 1983, NORD has served as the primary representative of the rare disease patient community over the past two years as needs were prioritized and the legislation now being voted upon by the House and Senate was drafted.


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    SOURCE National Organization for Rare Disorders (NORD)
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