Exploring Strage New Worlds – FDA’s 2016 Program Alignment and Strategic Priorities

This article provides an overview of the FDA’s initiative to realign programs from location-centered structures and specializations to commodities specializations, and its impact on the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA).

The Food and Drug Administration (FDA) is overhauling its program alignment to shift from a regional structure to commodities-based specializations and vertically-integrated programs. It is an effort aimed at responding to innovations in technology, globalization in FDA-regulated industries, and the demands of new legislation, according to Douglas Stearn, Director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs (ORA). As a result, 2016 will be a year of transition for the Agency, which expects to have a program structure in place later this year, Stearn explained to attendees at the 2015 Enforcement, Litigation, and Compliance Conference. These changes will have a profound impact on FDA oversight efforts, especially as they pertain to the Food and Drug Administration Safety and Innovation Act (FDASIA).