Food and Drug Administration Reform Act of 2012 (H.R. 5651)

Issues: Health Care
  • This bipartisan bill ensures that Americans have access to crucial medicines and medical devices, improves access to new and innovative medicines and devices, helps prevent and mitigate drug shortages and reduces drug costs for consumers by speeding the approval of lower-cost generic drugs.
  • The bill reauthorizes through FY 2017 FDA’s prescription drug and medical device user fee programs, which give FDA the ability to collect user fees from drug and medical device companies to help fund its reviews of their products.  These user fee programs provide the FDA the resources to enable the efficient review of applications and give patients access to therapies at the earliest possible time.
  • The bill authorizes a new user fee program for generic drugs, which is expected to slash review times to a third of current levels.  It also authorizes a new user fee program for biosimilars, biological products shown to be biosimilar to an FDA-licensed biological product.    
  • The bill reauthorizes and makes permanent two complementary pediatric drug programs, which foster the development and safe use of prescription drugs for children.
  • The bill modernizes FDA’s global drug supply chain authority, to improve patient safety.  The FDA has been trying to keep pace with our increasingly globalized drug supply chain using an outdated statute.  This legislation will give FDA critical new tools to police this dramatically different marketplace.
  • The bill provides new incentives for the development of antibiotics to address the public health threat of antibiotic resistance. 
  • Finally, the bill includes important provisions to help prevent and mitigate drug shortages, which have unfortunately now become an all-too-frequent occurrence.