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

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.

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"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:

  • Expansion of the Rare Disease Program at the Center for Drugs and extension of this program to the Center for Biologics
  • A new initiative t
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SOURCE National Organization for Rare Disorders (NORD)
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