Susan Thaul, Coordinator
Specialist in Drug Safety and Effectiveness
Erin Bagalman
Analyst in Health Policy
Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology
Judith M. Glassgold
Specialist in Health Policy
Judith A. Johnson
Specialist in Biomedical Policy
Sarah A. Lister
Specialist in Public Health and Epidemiology
Amanda K. Sarata
Specialist in Health Policy/Acting Section Research Manager
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.
Date of Report: February 4, 2013
Number of Pages: 49
Order Number: R42680
Price: $29.95
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