FDA HFP and ORA Reorganization Proposal

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FDA Proposes Reorganization for HFP and ORA

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Friday, December 15, 2023

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On December 13, 2023, the U.S. Food and Drug Administration (FDA) provided a reorganization proposal for the unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. The proposed reorganization package is currently under review at the U.S. Department of Health and Human Services (HHS). FDA hopes implementation of the plans will occur sometime in 2024.
In addition to previous announcements, FDA’s proposed reorganization package includes the following new updates:
- Making the 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.
- 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).
- Creating an Office of Enterprise Transformation, which will work across FDA to drive high-priority cross-cutting business process improvement efforts.
Before the proposal is implemented, it must be reviewed by the Office of Management and Budget. FDA must also provide Congress with a 30-day notification period, issue a Federal Register notice, and engage in all necessary negotiations with Union representing impacted staff