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Matrix Organization Plan for FDA under Intense Criticism

03/05/2023

Following the Regan-Udall review of the structure and operation of food-related aspects of the U.S. Food and Drug Administration, Dr. Robert Califf (pictured right), Commissioner of the Agency has proposed a matrix management structure. This is common in the private sector that operates with demanding performance standards. Dr. Califf considers this to be inappropriate to government service. Is this a tacit admission that he considers his personnel to be unmotivated, indolent or lacking in commitment? Criticism of the proposed FDA reorganization is centered on the foods program with indistinct lines of authority that in the past have facilitated the emergence of a silo mentality contributing to problems manifest in deviations from optimal food safety and security. 

 

Critics of the proposed organization include Roberta Wagner, Vice president of Regulatory and Technical Affairs for the Consumers Brands Association, Brian Ronholm, Director of Food Policy for Consumer Reports and other industry association including the American Frozen Food Institute. Qualified observers together with the Regan-Udall reviewers all advocate for centralization under a competent Deputy Commissioner with line authority over subordinate sections tasked with research, regulation and policy relating to food. It is now up to Congress to take note of criticism and to exert pressure on the FDA to adopt a more consolidated approach to the food component of their mission

 

EGG-NEWS has frequently commented that the “F” in the Agency title is subordinate to the “D” dealing with drugs and medical devices. This is evidenced in negligence in addressing food related public health problems including obesity, salt, sugar and fat levels in foods. The Agency has neglected to regulate production facilities leading to the infant formula crisis, outbreaks of foodborne infections attributed to leafy greens, heavy metal contamination of fruit juices and outbreaks of salmonellosis, listeriosis and campylobacteriosis.

 

Congress and the FDA will continue to play ping-pong until a new Food Safety Agency is created, analogous to the EPA. In addition this new entity must of necessity incorporate the current regulatory aspects of red meat and poultry traditionally under the purview of the USDA-FSIS. This would be a radical but ultimately effective solution to an ongoing problem of divided jurisdiction.