FDA Policy/General

Califf Expands on ORA Restructuring

David McFarland

— 2 min read
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FDA commissioner Robert Califf says his vision in revamping the agency’s human foods program and the Office of Regulatory Affairs (ORA) “is focused on a new agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with clear decision rights so that everyone knows who has authority.” Califf first announced the restructuring on 1/31.

In an update, he says he is creating a new model that better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs. A national search is underway for a new deputy commissioner for human foods, he says, and that person and other program heads will be charged with setting strategic direction for food inspections and have authority over program resource allocation. He says FDA has started the process of:

  • assessing specific functions of ORA, the Center for Food Safety and Applied Nutrition (CFSAN), and the Office of Food Policy and Response to be unified into a new Office of Integrated Food Safety Systems Partnerships that will engage with state, local, tribal, and territorial food safety regulatory partners;
  • analyzing inspection and compliance functions that sit within both ORA and program offices across the agency to determine opportunities to streamline operations and clarify decision-making authority at each step of the inspection process as well as integrate new automation and information technology support;
  • determining how best to empower the deputy commissioner for human foods and leaders of other programs, with the associate commissioner for regulatory affairs, to oversee program and field resource allocation, including publicly mapping the budget to functional activities to provide clarity on resource allocation;
  • ensuring seamless coordination across FDA and state-operated food laboratory operations by evaluating the food laboratory programs;
  • improving FDA’s ability to conduct risk prioritization to deliver the highest public health benefit by performing an extensive evaluation of how the human foods program accomplishes risk management and particularly risk prioritization;
  • planning for greater enterprise transformation of certain ORA information technology functions, coordinated with the FDA Office of Digital Transformation; and
  • evaluating training programs, including for FDA investigators, to see how they can best serve the needs of FDA, regulatory partners, and regulated industry.

As part of the restructuring, Califf says, cosmetics regulation and color certification functions will be taken out of CFSAN and placed in the Office of the Chief Scientist, to better align the expertise of the agency’s cosmetics subject matter experts with the chief scientist, who is focused on research, science, and innovation that underpins the agency’s regulatory mission, and to recognize the evolution and innovation in this product space.

The commissioner says he wants to finalize the proposal this fall.

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