The Food and Drug Administration will use an outside evaluation released Tuesday to help reform its human foods program, FDA Commissioner Robert Califf said following the release of a report by the Reagan-Udall Foundation.

Califf said “final decisions” on the human foods program would come soon. In a statement, he said he would convene a group of agency leaders to advise him and also consult with stakeholders before doing so. 

“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf said. “The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures.”

The report found a lack of clearly defined leadership has hampered FDA’s work in food and nutrition, even as concerns over those issues have received ever-increasing attention, such as an infant formula shortage caused by the shutdown of an Abbott Laboratories’ plant with safety issues, and growing obesity rates.

Although the report did not specifically endorse the creation of a deputy commissioner for foods who would report directly to the commissioner – a goal sought by a diverse coalition of groups – it did include that recommendation among its five options for structural reform. It also called on FDA to clearly state its budgetary needs, increase transparency, elevate the role of nutrition, and integrate the food-related work of the Center for Veterinary Medicine with the overall FDA Human Foods Program.

“This new vision and structure will be built on the external evaluation being released today; the internal review of the agency’s infant formula supply chain response completed in September, which has already resulted in noticeable improvements in our operations across the Foods Program; and ongoing work that allows the agency to take advantage of emerging advances in food science, with a goal of designing a system that allows us to more quickly adapt to an ever-changing and evolving environment,” Califf said.

The report examined the operations of the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response, as well as relevant functions of the Office of Regulatory Affairs. It did not look at the Center for Veterinary Medicine.

“The lack of a single, clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the report said. “Strong leadership is essential to an effective and enabling organizational culture.”

Regarding the infant formula crisis, the report said FDA’s own review “indicates that lack of communication and engagement across the agency accounted, in part, for missteps.”

“While it appears that staff at all levels sought to follow the rules and procedures within their division, there was little motivation, and apparently no requirement, to share information and interact across the agency to facilitate critical thinking and proactive decision-making,” the report said.

“In the absence of a clear vision, mission or definition, or broader identification and engagement with the Human Foods Program, FDA staff often operate in silos within the organizations or subcultures where they feel most valued and comfortable,” the report said.

The report also called for FDA to be more open with information about its regulatory progress and seek more funding from Congress or through user fees, which traditionally have been unpopular with industry.

Representatives of consumer and industry groups, as well as state regulatory officials, said they were pleased with the report and Califf’s commitment.

De Ann Davis, senior vice president for science at Western Growers, told reporters Tuesday that her group was glad to see the report emphasize the importance of prevention in implementing the Food Safety Modernization Act. Western Growers has criticized the agency for taking a more “compliance-based” approach. 

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De-Ann-Davis-Western-Growers.jpgDe Ann Davis, Western Growers

“Leadership must embrace a proactive, prevention-driven strategy that is action-oriented and fosters effective and efficient decision-making,” the report said. “Leaders must also make their support clear to staff as they make decisions. Each staff member should operate in a culture with a preference for action, where they are empowered to respond quickly to challenges as they arise.”

Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association, said the report “mirrored Consumer Brands’ call for a culture shift and a new inspection paradigm to make FDA’s food program more effective and aligned with the prevention-oriented focus of the bipartisan [FSMA].”

Steve Mandernach, CEO of the Association for Food and Drug Officials, said the idea of establishing a separate agency within HHS for the foods program "deserves longer-term evaluation and consideration. We also are strongly supportive of the option to create a new center within FDA focused on nutrition, especially with the renewed focus on nutrition in the White House’s National Strategy on Hunger, Nutrition, and Health."

A leading consumer advocate also welcomed the report. 

“For the expert panel to formally acknowledge that serious problems exist within the FDA foods program is significant because it represents an important first step toward reform,” said Brian Ronholm, director of food policy for Consumer Reports. “This will compel the agency to take action in reforming the program,” he said of the report’s findings and recommendations.

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