FDA Launches Five Import District Offices as Part of Broader Reorganization

The Food and Drug Administration on May 15 rolled out a reorganization of its field offices that includes the creation of five import-specific districts, an agency spokeswoman said. The five districts (here) include the Division of Northeast Imports (here), the Division of Northern Border Imports (here), the Division of West Coast Imports (here) and the Division of Southeast Imports (here), as well as the Division of Southwest Imports (here), which previously existed as the Southwest Import District and served as a model for the new import divisions (see 1704040024).

“The Import program’s district boundaries are based on workload and other factors, including proximity to Canadian and Mexican borders as well as the type of operations within the geographic area and will also provide the opportunity for increased operational coverage across time zones,” the FDA spokeswoman said. The import districts fall within FDA’s Office of Regulatory Affairs. Each division contains a main office and “resident posts” covering individual ports. Alaska is included in the Southeast district.

The reorganization of FDA’s import offices is part of a broader “Program Alignment” of the agency’s field operations. Unlike the new geographically aligned import districts, formerly regional district offices are now organized by product type, which “more closely mirrors the rest of the agency’s organization structure,” the spokeswoman said. FDA’s Office of Regulatory Affairs, which also oversees non-import-related field operations, “established program directors for each product area: bioresearch monitoring; biological products; human and animal food (including cosmetics); pharmaceutical quality; tobacco products; medical devices; and radiological health,” she said. “Each program director is tasked with managing the day-to-day operations with FDA centers.”

The reorganization “will result in an enhanced and centralized technical expertise for its staff and more uniform application of ORA’s policies and processes,” the spokeswoman said. “All specialized staff in a given program will be trained similarly so that industries across the globe experience uniform application of FDA’s regulatory standards. And, for those regulated by the FDA, the new organizational model will result in more uniformity in both process and policy across the agency, and more seamless and coordinated interactions within FDA between the field and the centers,” she said.