	Background

The Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144 , continues the five-year reauthorization cycle of the prescription drug and medical device user fee programs that allow the Food and Drug Administration (FDA) to collect fees and use the revenue to support the review of brand-name drug, biological product, and device marketing applications. In addition to titles that would reauthorize the drug and device user fee programs, FDASIA includes additional titles that create new user fee authority for generic drugs and biosimilar biological products; permanently authorize programs to encourage or require studies of drugs for pediatric use; and amend the law regarding medical device regulation, drug regulation, and several areas, such as advisory committee conflict of interest, that cut across FDA product areas. Title V permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Titles VII through X address the regulation of drugs, including the supply chain, antimicrobial development, expedited drug approval, and shortages. The remainder of this report presents a general overview of FDASIA by title and section, providing a narrative overview of each title, as well as a brief description of each section in the statute. Appendix A lists the time-specific requirements of federal entities dictated by FDASIA. 112-144 law. Title I—Fees Relating to Drugs

FDASIA reauthorizes the prescription drug user program for another five years, from FY2013 through FY2017. 107-109 ) and the Pediatric Research Equity Act (PREA, P.L. Subtitle B—Medical Gas Product Regulation
Subtitle B addresses the regulation of medical gases, such as oxygen. Requires the Secretary, within one year of enactment, to establish a strategy and implementation plan, consistent with user fee program performance goals, for advancing regulatory science for medical products, and to identify in such plan a vision and priorities related to medical product decision-making, and ways to address regulatory and scientific gaps, among other stated requirements; and requires the Secretary to include a report on progress on those goals as part of the FY2014 and FY2016 performance reports required for the prescription drug, medical device, generic drug, and biosimilar biological product user fee programs (§1124).
The Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144, amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorization act, FDASIA does include four titles relating to user fees. Titles I and II reauthorize the prescription drug and medical device user fee programs (PDUFA and MDUFA). Titles III and IV authorize new user fee programs for generic drugs (GDUFA) and biosimilar biological products (BSUFA).
Title V of FDASIA reauthorizes and amends provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); it also includes other pediatric research sections. Title VI addresses the regulation of medical devices across such diverse topics as clarifying the definition of a custom device; extending for another five years the ability of the manufacturer of a humanitarian use device (one with a limited number of potential users) to make a profit on sales for pediatric use and the expansion of that ability to sales for nonpediatric use; and authorizing the Secretary of Health and Human Services to enter into arrangements with nations regarding harmonization of device regulation.
Titles VII through X address the regulation of human drugs, highlighting the areas of supply chain security, anti-infective product development incentives, expedited development and review of drugs, and drug shortages. Title XI contains a miscellany of provisions including, for example, medical gas product regulation, advisory committee conflicts of interest, and required reports and guidance from the Secretary.
For each title of FDASIA, this report provides a brief policy background narrative and an overview of provisions in P.L. 112-144. An appendix lists the time-specific requirements of federal entities in FDASIA.