July 9, 2012, the President signed S. 3187 also known as the Food and Drug Administration Safety and Innovation Act. The act is designed to help spped safe and effective medical products to patients and maintain our status as the leader in biomedical innovation.

Original Source is US Department of Health and Human Services website

S.3187 is a collaboration of work of Administration, Congress, patients, pharmaceutical and medical device industries, the clinical community, and other stakeholders. It provides the Food and Drug Administration with the tools needed to continue:

1. to make drugs and devices accessible to the public safely and quickly
2. promote innovation in the biomedical industry
3. help secure the jobs supported by drug and device development
4. drive timely review of new innovator drugs and medical devices
   

   Learn more about the passage of the Safety and Innovation Act

5. implement the program proposed in the 2013 President’s Budget to accelerate approval of lower-cost generic drugs
6. fund the new approval pathway for biosimilar biologics created by the Affordable Care Act
7. 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
8. enhance the safety of the drug supply chain in an increasingly globalized market
9. increase incentives for the development of new antibiotics
10. renew mechanisms to ensure that children’s medicines are appropriately tested and labeled and
11. expedite the development and review of certain drugs for the treatment of serious or life-threatening diseases and conditions

While enactment of S. 3187 marks an important moment for innovators across industry, research and clinical care settings, its most important beneficiaries are the patients and families that will be helped by the next generation of affordable medical products this bill will help to foster.

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