FDA in reorganization mode

This just fell into my inbox:

I’m reaching out to provide an update on FDA’s proposal to unify the Human Foods Program (HFP).  The proposed reorganization package is now under review at HHS, which begins the formal external review process. The FDA’s proposed reorganization package includes new updates that not only shift how the agency’s food and field work is conducted, but also impacts a number of additional FDA offices outside of these programs.  

The proposed changes highlight the agency-wide nature of the proposed reorganization package, including the following: 

·         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 the 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.  

·         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 in the Office of the Commissioner to drive high-priority cross-cutting business process improvement efforts.   

In addition to HHS’ review, there are several critical steps remaining before the agency can implement the proposed program, including review by the Office of Management and Budget and issuing a Federal Register Notice. We are hopeful that implementation can begin in calendar year 2024. 

Today, the FDA is also releasing a progress update on the important actions the agency has taken to address areas for improvement found in FDA’s Internal Evaluation of the FDA’s Infant Formula Response. 

More information about today’s updates on the HFP and additional modernization efforts can be found in FDA’s Press Release at https://www.fda.gov/news-events/press-announcements/fda-advances-reorganization-proposal-unified-human-foods-program-field-operations-and-additional. 

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.