WASHINGTON, May 24, 2012 /PRNewswire-USNewswire/ -- The National Organization for Rare Disorders (NORD) applauds legislation passed today by the U.S. Senate -- S 3187, the Food and Drug Administration Safety & Innovation Act of 2012 (FDASIA) – and says it contains the most comprehensive improvements to public policy for rare disease therapies since the landmark Orphan Drug Act of 1983.
"NORD has been working very hard over the past two years to ensure that the interests of the rare disease patient community are well represented in this important legislation," said NORD President and CEO Peter L. Saltonstall. "We are thrilled that our nation's leaders in Congress are working together and making substantive policy improvements to bring new therapies to patients who desperately need them."
"When this process began over two years ago," he added, "our focus was on obtaining a commitment by the FDA to further incorporate the exceptional nature of rare diseases in the review of promising new therapies and medical devices. What we've been able to achieve since then, with our members and advocacy partners in the rare disease community, is nothing short of astonishing. Our sincerest thanks go to all who have helped to make this day possible."
The bill contains numerous provisions that will enhance the regulatory process at FDA, incentivize further investment by innovators into rare disease therapies, and expand the scientific armamentarium needed to bring the most cutting-edge therapies to patients as quickly as possible.
Specific commitments by the FDA include:
Legislative provisions in the bill include:
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.
|SOURCE National Organization for Rare Disorders (NORD)|
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