FDA reorganization greenlit, slated to begin in October

The US Secretary of Health and Human Services gave the greenlight to the US Food and Drug Administration’s (FDA) proposed reorganization that includes unifying the human foods program and revamping field operations to focus on inspections.

The reorganization plan, which has been in the works for more than a year, is slated to take effect on 1 October 2024. FDA detailed the final reorganization plans in an announcement in the Federal Register last year. (RELATED: FDA’s human foods, regulatory affairs office reorg edges forward, Regulatory Focus 13 December 2023)

“This is a distinctive moment for the FDA,” FDA Commissioner Robert Califf said in a statement. “I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall.”

The reorganization plans grew out of recommendations from a Reagan-Udall Foundation evaluation, an internal review of the agency’s response to the 2022 infant formula crisis, feedback from external and internal stakeholders, and listening sessions with FDA employees.

Restructured ORA

FDA will change the name of the Office of Regulatory Affairs (ORA) to the Office of Inspections and Investigations (OII) with a core mission focused on inspections, investigations and imports. The agency said the new name will “better convey the organization’s role as the frontline of the FDA,” providing real-time insights and evidence to help safeguard the quality of regulated products.

ORA compliance functions will be taken up by FDA’s individual centers while its laboratory safety functions will be handled by the Office of the Chief Scientist.

During a webinar hosted by the Alliance for a Stronger FDA in January 2024, Michael Rogers, FDA’s Associate Commissioner for Regulatory Affairs, explained that the ORA changes would mean that the ORA staff would decrease, with about 1,500 staff members being reassigned to the FDA’s individual product centers. (RELATED: FDA leaders detail reorg plans, say 1,500 ORA staff will be reassigned, Regulatory Focus 19 January 2024)

Unified foods program and modernization

A key component of the reorganization plan is the creation of a unified Human Foods Program (HFP) that encompasses the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and certain functions of the former ORA under a single program. FDA said the new structure will better position it to respond to food-related emergencies like the infant formula shortages.

The reorganization also includes moves aimed at modernizing the agency that complies with the Food and Drug Omnibus Reform Act of 2022 and the Modernization of Cosmetics Regulation Act of 2022.

FDA announcement

FDA reorganization greenlit, slated to begin in October

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