Jul 4, 2023
FDA proposes restructuring of Office of Regulatory Affairs

The FDA continues to reorganize its Human Food Program (HFP) by now restructuring the Office of Regulatory Affairs (ORA), which could include a new name.

Compliance functions currently managed within ORA will be merged into the HFP to streamline operations, while the eight Human and Animal Food laboratories currently managed by ORA will also be realigned into the HFP. Those labs will combine with the four labs currently in the FDA’s Center for Food Safety and Applied Nutrition to form a unified food lab enterprise, according to the FDA.

Additionally, a deputy commissioner for Human Foods is being sought and will be announced at a later date. This position will oversee all budget and resource allocations for the entire HFP, including ORA resources, according to the agency.

The FDA also may rename the office to align its title more appropriately to the structure and functional duties of the agency’s field operations.

“With a human food landscape that is rapidly evolving as consumer preferences, products and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs,” Robert M. Califf, commissioner at FDA, said in the agency’s statement. “Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges.”

In February, in response to an external evaluation following the resignation of Frank Yiannas, the former deputy commissioner at FDA, the agency announced changes to counter criticism of its organizational structure in a report from the Reagan-Udall Foundation, a group tied to but separate from the FDA, which called for an overhaul of the agency’s leadership and culture.

“Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened,” Califf said. “We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and centers.”

Proposed changes

  • Establish ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or centers.
  • Transition certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant centers and offices to monitor and manage coordinated responses to emergency situations, such as product recalls, hurricanes, fires and floods.
  • Unify state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. This office will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods.
  • Review support functions across ORA and proposing realignment of certain resources and personnel to support these changes. This includes staff and resources in ORA’s Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management.
  • Prioritize recruitment, retention and training opportunities for field-based employees with the availability of Title 21 hiring authority to support the agency’s ongoing efforts to increase its inspectional activities domestically and internationally.

These proposed changes align with many recommendations Reagan-Udall Foundation’s evaluation recommended as well as a separate internal review of the agency’s infant formula response completed last year, according to the statement. The proposed changes are reflected in a chart provided by the FDA.

Recruitment stage

The agency is in the final stages of the recruitment process for the Deputy Commissioner for Human Foods, according to the statement, and also recently began recruiting for the position of Associate Commissioner for Regulatory Affairs to lead ORA through the proposed changes.

Final organizational structure

“I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies, like recalls, and enhance the agency’s ability to align inspection resources with our center and program priorities while also supporting our employees and the public we serve,” Califf said. “We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.”


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