FDA reorganization is out for review, but impact later in 2024 could be huge

The FDA’s largest reorganization in history, involving about 8,000 employees, is far more than just “moving some boxes around.”  The proposed changes and updates to an FDA-wide reorganization plan have been out for external reviews and clearances since Dec. 13, 2023, and implementation should occur sometime during 2024.

A “Unified Human Food Program(HFP)” functional risk model is at the center of the reorganization. FDA will manage public health risks  through three areas of focus:

• nutrition, microbiological food safety, and chemical safety. Its strategic management functions leverage data to better prioritize activities and resources based on risk.

• surveillance strategy, risk-informed decision framework, and resource management for HFP and related field activities. So-called cross-cutting functions are the “tools” supporting risk management priorities.

• integrated food safety system partnerships, laboratory operations and applied science, compliance and enforcement, policy, and communications and engagement.

The Reagan Udall Foundation in 2022 evaluated FDA food programs, finding outside criticisms were justified and required fixing.

FDA Commissioner Robert Califf, who took over the agency for a second time on Feb. 17, 2022, ordered work to begin that May on the FDA-wide reorganization plan.  Califf previously served as Commissioner of Food and Drugs from February 2016 to January 2017. 

The Alliance for a Stronger FDA recently gathered FDA staff who helped draft the reorganization plan. They included:

• Deputy Commissioner Janet Woodcock, 

• Chief Scientist Namandje Bumpus, 

• Deputy Commissioner for Human Food Jim Jones, 

• Acting CFSAN Director Donald Prater.

*Deputy Commissioner for Operations Jim Sing

*Commissioner for Regulatory Affairs Michael Rogers, M.S.

The reorganization was submitted for review by the Department of Health and Human Services (HHS), which houses the FDA. Others might get involved, from the Office of Management and Budget (OMB) to the various public employee unions.

Janet Woodcock, the former acting FDA Commissioner, emphasized how far-reaching the reorganization will affect nearly every FDA unit.  The authors of the plan say it not only improves the human food program but also overall efficiency.

A new Office of Inspections and Investigations (OII) is at the center of changes.

The reorganization itself was said to be “budget neutral.”

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