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FDA Reorganization

06/03/2024

Following the 2022 infant formula debacle that exposed severe deficiencies within the Food and Drug Administration, an external review by the Reagan Udall Foundation was mandated.  Among numerous recommendations, the Review Committee recommended organizational changes to improve internal communications and define the relative responsibilities of managers and their subordinate operations.  Dr. Robert Califf, Commissioner of the FDA, was instructed by a Congressional Committee in May 2022 to introduce changes to avert any future food related incidence.  The reorganization included a new office responsible for a human foods program in accordance with the Food Safety Modernization Act.  The reorganization makes provision for:-

 

  • A sub-Agency responsible for receiving and responding to consumer complaints.

 

  • Establishing the Office of Inspections and Investigation to supplant the previous Office of Regulatory Affairs.

 

  • Establishing an Office of the Chief Medical Officer in the Office of the Commissioner to strengthen coordination of cross-agency medical issues including the Office of Public Health, Preparedness and Response.  Merging the Office of Counterterrorism and Emerging Threats and the Office of Regulatory Science and Innovation under the Office of the Chief Scientist.

 

  • Establishing an Office of Enterprise Transformation responsible for introduction and dissemination of improvements across all subagencies within the FDA.

 

The final version of the reorganizational plan has been approved and will be implemented on October 1st.  The key to the consolidation of food and nutritional related activities is the appointment of Jim Jones, a thirty-year veteran of the Environmental Protection Agency to the post of FDA Deputy Commissioner for Human Foods.

In commenting on the new organization Dr. Califf stated, “This is a distinctive moment for the FDA.  I am very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the FDA we are a step closer to seeing the largest reorganization of the Agency in recent history.

 

The reorganization plan received praise from the Association of Food and Drug Officials.  Steven Mandernach executive director of the Association stated, “Deputy Commissioner Jones has been engaging and making excellent steps to move program forward.  The approval of the reorganization allows for a much fuller implementation of the vision of the broad human food stakeholder community.”  Consumer Reports and the National Association for Food and Drug Officials also approved of the reorganization plan noting that the changes “will help ensure the nation’s food supply is safe.”

 

It is hoped that the impending organizational changes are more than moving deck chairs around on the Titanic.  Temporarily the reorganization and reassignment of responsibilities will place in abeyance more radical solutions to the problems of food safety including a new independent Food and Nutrition Agency as considered by Reagan-Udall.  This possibility will however be revisited should there be a series of adverse food related events in the future. This unfortunate outcome would confirm that despite changes in structure, the culture and mores of the FDA were not appreciably altered.