July 25, 2012 >> back to issue

FDA Safety and Innovation Act Becomes Law

President Obama signed the FDA Safety and Innovation Act into law this month. The bill provides significant incentives for the development of drugs and devices for the rare disease community, including:
  • Accelerated patient access to new medical treatments
  • The development of Humanitarian Use Devices (medical devices for small patient populations)
  • Accelerated development of "breakthrough therapies" — those that show early promise
  • Enhanced FDA consultation with rare disease medical experts
  • A rare pediatric disease priority review program

The National Organization for Rare Disorders (NORD), of which PHA is a member, led efforts to pass the bill and describes it as “the most groundbreaking measures for rare disease patients and their families since the Orphan Drug Act of 1983.”

Learn more.

Thank Congress for passing the FDA Safety and Innovation Act.

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The National Organization for Rare Disorders (NORD) awarded PHA the Abbey S. Meyers Leadership Award in 2012 for outstanding service to PHA members in advocacy, education and other key areas.