In one of his last remaining acts as Commissioner of the United States Food and Drug Administration (FDA), Scott Gottlieb laid out details on the planned reorganization of several departments within the FDA. Some of the departments involved in the reorganization include the Office of the Commissioner (OC), the Center for Devises and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition, the Center for Tobacco Products, and the Center for Veterinary Medicine.
The changes in the reorganization plan are intended to modernize the FDA’s structure and help the Agency advance its mission to protect and promote the public health and ensure maximum efficiency in using resources. Commissioner Gottlieb further explained that the reorganization will realign several entities across the agency to promote strategic priorities, including changes to the Office of Policy, Planning, and Legislative Affairs and the Office of External Affairs.
Three current directorate offices (the Office of Medical Products and Tobacco (OMPT), the Office of Foods and Veterinary Medicine (OFVM), and the Office of Global Regulatory Operations and Policy (OGROP)) will be realigned to new offices within the OC and other areas across the Agency where they can be more effective. This move will help to establish a direct line between OC, Center Directors, and Office leadership. This is expected to contribute to increased alignment and efficiency throughout the FDA.
The current organization chart of the FDA can be found here.
Center Changes
The plan elevates the role of the aforementioned Centers in support of the FDA’s science-driven culture, consolidates work to be most effective, and strengthen the staffing and recruiting functions so the Agency can hire and retain top talent.
The reorganization includes several key Center changes to be implemented alongside restructuring of the OC, although each Center will be responsible for sharing details and timing separately. The proposed Center changes include:
- CDRH will establish the Office of Product Evaluation and Quality, in addition to restructuring some existing offices.
- CDER will establish the Office of Therapeutic Biologics and Biosimilars, in addition to restructuring some existing offices.
- The Center for Food Safety and Applied Nutrition will reorganize the Offices of Cosmetics and Colors, and Food Safety.
- The Center for Tobacco Products will reorganize the Office of Health Communication and Education.
- The Center for Veterinary Medicine will reorganize the Office of New Animal Drug Evaluation.
Conclusion
Commissioner Gottlieb noted in his letter that implementation would be rolled out in phases across the Agency at a “thoughtful, manageable, and realistic pace” in order to reduce interference with day-to-day operations. The reorganization, initially announced in the Summer of 2018, is set to begin on March 31, 2019, in the OC.