Eliminating redundancies, increasing efficiency, and cultivating a culture of collaboration were the main themes of a January 19 webinar featuring top U.S. Food and Drug Administration (FDA) officials, hosted by Alliance for a Stronger FDA to discuss the agency’s proposed reorganization.
The webinar was moderated by Alliance board members Sarah Sorsher, J.D., M.P.H., Director for Regulatory Affairs at Center for Science in the Public Interest (CSPI); and John Taylor, J.D., President and Principal of Compliance and Regulatory Affairs, at Greenleaf Health and former Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA, as well as a member of the Reagan-Udall Foundation expert panel that conducted the 2022 independent evaluation of FDA.
FDA officials present at the webinar included Principal Deputy Commissioner Janet Woodcock, M.D.; Namandjé N. Bumpus, Ph.D., current FDA Chief Scientist, who will replace Dr. Woodcock as Principal Deputy Commissioner when she retires in February; Jim Jones, the recently appointed Deputy Commissioner for Human Foods; Michael Rogers, M.S., permanent Commissioner for Regulatory Affairs (ACRA) in FDA’s Office of Regulatory Affairs (ORA); Donald Prater, D.V.M., Acting Director of FDA’s Center for Food Safety and Applied Nutrition; and Jim Sigg, Deputy Commissioner for Operations and Chief Operating Officer at FDA’s Officer of Operations.
The FDA leaders gave an overview of the ongoing agency reorganization, which was submitted for review at the U.S. Department of Health and Human Services (HHS) in December 2023. Each presenter spoke about the changes in the centers or offices under their purview, with Dr. Woodcock providing an overview of the reorganization from an enterprise-wide perspective. She emphasized that, although the Human Foods Program (HFP) and Office of Regulatory Affairs (ORA) are at the center of the reorganization plan, changes in structure at FDA are far-reaching and will affect nearly every office. The relationship between ORA, which is proposed to become the new Office of Inspections and Investigations (OII), and every other FDA department will change, not just its relationship with HFP. This is expected to improve ORA/OII’s efficiency overall.
The vision for a unified HFP and new ORA/OII model have been discussed at length by FDA previously, and organization charts for HFP and ORA/OII were published in December 2023 by the agency. In general, HFP will include three risk management offices for microbiological food safety, chemical safety and nutrition. The intent of the new HFP is to leverage data and implement a surveillance strategy to better prioritize resources based on risk. The center will employ tools to support its risk management priorities, such as partnerships, laboratories and applied science, compliance and enforcement, and communications and engagement.
The new OII will have three main focuses—inspections, investigations, and imports. Rogers explained that most inspections and investigations have been realigned more closely with HFP, especially consumer complaints intake activities. OII will continue to carry out field evaluations to check up on the “lifecycle of complaints” and ensure they are elevated when appropriate. Human foods laboratory activities will also be realigned with HFP. As the ACII, Rogers will report directly to FDA Commissioner Robert Califf, M.D., to oversee OII’s field operations in support of the agency’s product centers and programs. OII will continue to carry out cross-cutting functions, such as criminal investigations, field operations and response, import operations, and business management functions; however, OII will not manage foodborne illness outbreaks.
Regarding the Office of the Chief Scientist, Dr. Bumpus explained the realignment of color and cosmetics certifications from CFSAN to OCS, as well as the development of a new office of regulatory and emerging science to support center priorities.
Budget and Culture
Throughout the webinar, the FDA leaders stressed the agency’s focus on streamlining processes to increase operational and resource efficiency. As resources are limited at FDA, budget was top-of-mind while designing the reorganization plan, Dr. Woodcock explained. The reorganization itself is budget-neutral, and funds will be maximized as processes are streamlined. This streamlining will also drive more clarity and promptness in FDA’s execution of enforcement actions. Examples of ways in which the reorganization will increase efficiencies is by combining compliance programs to eliminate redundancies, as well as consolidating consumer complaints management and agency communications.
Dr. Woodcock also shared that FDA is making significant efforts to fix cultural issues at the organization, and to promote collaboration internally and externally. A change ambassador program has been launched at FDA to drive these cultural values at all levels of the agency, and the FDA leaders expressed that they are trying to model teamwork and engagement from the top-down. In HFP specifically, Jones provided examples of how he is going to maintain synergy through informal and formal councils and structures with key HFP leaders, some of which have already been established, and by serving as a final decision-maker when consensus cannot be reached. Dr. Woodcock added that, to promote enterprise-wide harmony, FDA is working on an inspection system for the entire agency and procedural uniformity for OII inspectorates.