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Retired Deputy FDA Commissioners Criticize Proposed FDA Structure

04/03/2023

In submission to the U.S. House of Representatives Subcommittee on Healthcare and Financial Services, three previous FDA Deputy Commissioners have urged for either a unified food component for the Agency or alternatively removing food jurisdiction from the FDA. This would involve creation of a separate agency headed by a Commissioner for Food Safety and Nutrition.

 

Dr. Stephen Ostroff former Deputy Commissioner for Foods and Veterinary Medicine and Acting Commissioner from 2016 to 2018; Michael R. Taylor former Deputy Commissioner for Foods and Veterinary Medicine 2010 to 2016 and Dr. David Acheson, former Associate Commissioner for Foods and Veterinary Medicine 2007 to 2009, all commented on the low priority afforded food in the hierarchy of the FDA.

 

Current commissioner Dr. Robert Califf was criticized for his intransigence over failing to implement the recommendations made by the expert committee appointed by the Udall-Reagan Foundation.  This body recommended the appointment of a Deputy Commissioner responsible for food with consolidation into a single organizational entity.  Disregarding recommendations by the Committee and also comments by informed individuals, Dr. Califf appears intent on implementing a matrix structure that will perpetuate deficiencies in intra-agency communication. This situation is exemplified by the infant formula crisis, an evident failure to predict and take either preemptive action or to respond to a credible whistleblower.

 

The three former FDA Deputy Commissioners advise quick action to restructure the FDA food-related activities stating “With decisive action now, America can get the unified efficient and forwarding-leading food program they deserve and expect.  With half steps, disunity and disfunction that was so evident during the infant formula crisis will persist and history will surely repeat itself.” 

 

Certainly, with the respect to food, FDA is a broken agency with a culture that will resist change and defeat the most able Deputy Commissioner even if a qualified candidate can be recruited irrespective of the degree of autonomy and authority offered.  It is the considered opinion of CHICK-NEWS and many observers that a separate food safety and nutrition agency is required headed with equal status to a stripped down Federal Drug agency.  CHICK-NEW goes further in unifying aspects of food safety by advocating for incorporation of the Food Safety and Inspection Services currently under the USDA into the proposed agency.