FDA HFP/ORA Reorganization Plan Under External Review, Implementation Possible in 2024

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The U.S. Food and Drug Administration’s (FDA’s) proposed reorganization package for a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model is now under review at the U.S. Department of Health and Human Services (HHS), which begins the formal external review process. Following several remaining critical steps, the agency is hopeful that implementation of the new structure will occur sometime in calendar year 2024.

In addition to previous announcements, FDA’s proposed reorganization package includes the following new updates that not only shift how the agency’s foods and field work is conducted, but also impact a number of additional FDA offices outside of these programs. The proposed changes highlight the agency-wide nature of the proposed reorganization package, including:

Making FDA’s HFP and product centers solely responsible for receipt, triage, and closing consumer and whistleblower complaints, rather than this role being split between centers and field offices. This will refine the processing of complaints, ultimately improving FDA’s ability to detect problems faster.
Renaming ORA as the Office of Inspections and Investigations (OII) and solidifying its role as the frontline of FDA’s field-based inspection, investigation, and import operations.
Establishing an Office of the Chief Medical Officer (OCMO) in the Office of the Commissioner to strengthen central coordination of cross-agency medical issues, including special populations such as people with rare diseases and children. This includes a new Office of Public Health Preparedness and Response to support medical countermeasure policy, emergency preparedness work, and medical product shortage coordination across the agency.
Merging the Office of Counterterrorism and Emerging Threats (OCET) and the Office of Regulatory Science and Innovation (ORSI) to form a new office; both offices are currently housed within the FDA’s Office of the Chief Scientist (OCS). This new, merged office in OCS, proposed as the Office of Regulatory and Emerging Science, will strengthen support of regulatory science and preparedness research efforts.
Creating an Office of Enterprise Transformation. This proposed new office in the Office of the Commissioner will work across the FDA to drive high-priority, cross-cutting, business process improvement efforts. The proposed shift will result in more strategic and efficient use of agency resources.

In addition to HHS’ review, there are several critical steps remaining before the agency can implement the proposed reorganization. These steps include review by the Office of Management and Budget, providing Congress with a 30-day notification period, issuing a Federal Register notice, and engaging in all necessary negotiations with unions representing impacted staff.