On July 9, 2012, President Obama signed into law The Food and Drug Administration Safety and Innovation Act (FDASIA), S. 3187. In their news release, the EveryLife Foundation for Rare Diseases highlights a key aspect of this legislation as pertinent to SMA drug development – it will “empower [the] FDA to use all the science available for allowing surrogate endpoints in clinical trials for rare diseases to determine whether a drug is working, significantly decreasing the development time and cost.”

Please see below the news releases from the U.S. Department of Health and Human Services (HHS) and the EveryLife Foundation for Rare Diseases.

News Release

For Immediate Release
July 9, 2012
Contact: HHS Press Office
(202) 690-6343

Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and Drug Administration Safety and Innovation Act

Today, the President signed into law S. 3187, the “Food and Drug Administration Safety and Innovation Act.” This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our Nation’s role as a leader in biomedical innovation.

S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development.

This legislation will drive timely review of new innovator drugs and medical devices, implement the program proposed in the 2013 President’s Budget to accelerate approval of lower-cost generic drugs, and fund the new approval pathway for biosimilar biologics created by the Affordable Care Act. These new programs are important to increasing patient access to affordable medicines.

S. 3187 also enhances the tools available to the FDA to combat drug shortages by requiring manufacturers of certain drugs to notify the FDA when they experience circumstances that could lead to a potential drug shortage. This is consistent with the administration’s request to Congress to complement the actions directed by the 2011 Executive Order to address this significant public health issue.


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