U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the results of an external evaluation of the program conducted by an expert panel of the Reagan-Udall Foundation.

FDA commissioned the review, which identified several issues with the agency's culture. In a statement, Califf said the agency has carefully reviewed the findings of the panel, as well as the findings of a separate review of the agency’s infant formula supply chain response.

"The findings and recommendations from these reviews identified issues surrounding culture, structure, resources, and authorities,” he said. “They also noted several areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory program."

The restructuring plan calls for functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of ORA to be unified into a new organization, the Human Foods Program. Califf said FDA will hire a deputy commissioner to oversee the program.

Califf said ORA’s operating structure will be transformed into an “enterprise-wide organization supporting the Human Foods Program and all other FDA regulatory programs by focusing on its critical activities.”

“This realignment will allow ORA to be singularly focused on excellence in its core mission—inspections, laboratory testing, import, and investigative operations,” he said. “This will optimize ORA’s operations in line with the FDA’s public health and prevention-oriented goals.”

Califf said FDA has formed a group to develop a detailed plan. He anticipates additional public updates on the reorganization by the end of February 2023.