• Food and Drug Administration Safety and Innovation Act of 2012
  • August 13, 2012
  • Law Firm: Covington Burling LLP - Washington Office
  • On July 9, 2012, President Barack Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). This law, containing 11 titles, reauthorizes and amends both the prescription drug user fee program and the medical device user fee program. It also authorizes new user fees for generic drugs and biosimilars. In addition to the provisions relating to user fees, the FDASIA amends the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) in ways intended to, among other things, encourage the development of pediatric drugs, combat potential drug product shortages, and enhance patients’ access to medical treatments and participation in medical product regulation. This memorandum summarizes the FDASIA, presenting the law’s provisions in the order of the FDASIA’s titles.