FDA’s vision is guided by an independent review of the agency’s processes conducted by the Reagan-Udall Foundation. The letter expresses concern over FDA’s proposal to leave ORA’s core food inspection, laboratory, compliance, and import functions in a separate ORA organization led by an Associate Commissioner for Regulatory Affairs rather than the Deputy Commissioner of Human Foods, misaligned with the analysis and findings of the Reagan-Udall Foundation. The letter’s authors believe this would continue the existing “organizational fragmentation” of FDA’s food safety responsibilities.

The letter calls for a single, overarching leader responsible for all of FDA’s human foods functions, including those currently carried out through ORA, to facilitate a deep culture shift that the Regan-Udall Foundation deemed a requirement to improving the function of FDA. The authors of the letter request an opportunity to discuss FDA’s vision with the agency, and list their questions and uncertainties.

Several questions raised in the letter regard the Associate Commissioner for Regulatory Affairs position—if the role will continue to exist, the scope of the role’s responsibilities, to whom the associate commissioner would report, and how the associate commissioner would be held accountable to the deputy commissioner. The letter also inquires about the specifics of FDA’s plan for “transforming ORA’s operating structure into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs,” and what authorities the Deputy Commissioner of Human Foods would have over ORA. Finally, the authors request to know how the agency’s Center for Veterinary Medicine (CVM) and the Human Foods program will work together regarding food safety programs, including the deputy commissioner’s role.