“We appreciate Commissioner Robert Califf’s recognition that significant overhaul is needed” to enhance FDA’s ability to protect and promote a safe US food supply, but the agency’s vision for a new Foods Program announced Jan. 31 “falls far short of what is required for FDA to succeed in its food safety mission,” the Consumer Brands Association, Consumer Reports, the American Frozen Food Institute, Environmental Working Group, Stop Foodborne Illness, the Association of Food and Drug Officials, Western Growers and the International Fresh Produce Association said in a letter sent to yesterday to Health and Human Services Sec. Xavier Becerra.
They argue that Califf’s proposal to create a Deputy Commissioner role to oversee the Foods Program “appears to lack the authority needed to implement and sustain the needed changes” and goes against the Reagan-Udall Foundation’s recommendations to not just unify all elements of the program under a new deputy commissioner, but also to give that person direct line management authority and accountability for the program’s success.
In a scathing report published last December by the Reagan-Udall Foundation that laid bare the far-reaching negative impacts of the agency’s current culture, structure and governance on its ability to protect public health, the independent panel of experts outlined several proposed structures to enhance communication, action and accountability.
“Every organizational option the panel provided called for unifying all elements of the program under a new deputy commissioner with direct line management authority and accountability for the program’s success. The Commissioner’s announced changes reject that advice,” the stakeholders argue in the letter.
The reorganization as outlined also fails to give the deputy commissioner direct line management authority over FDA’s food-related field inspection force, “which consumes over 60% of all FDA food resources and is crucial to the implementation of the Food Safety Modernization Act (FSMA)," as well as over elements of the Center for Veterinary Medicine “that relate directly to food safety and FSMA implementation.”
The group is requesting a meeting with Sec. Becerra after a meeting with Commissioner Califf left them unsatisfied.
“We advised the commissioner of our concerns” in a letter a meeting Feb. 14, but “our group left with the sense that the commissioner did not feel that direct line authority was needed, but encouraged us to continue expressing our concerns,” they explain.
They conclude the commissioner’s “half step” approach means “the Food Program will remain organizationally fragmented with a divided leadership structure,” which “extensive experience has shown … is not sufficient in supporting FDA’s public health mission and will not contribute to badly needed cultural changes.”