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An outside group that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. The FDA has long been accused of giving its food program short shrift, and it came under fire from members of Congress and others for not heading off a formula shortage that left many parents scrambling to feed their infants. (Reiley, 12/6)

The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-related group. Experts with the group, the Reagan-Udall Foundation, which was asked to examine the food division after widespread criticism stemming from the infant formula crisis, concluded in the report that the division’s management structure and mission should be overhauled. (Jewett, 12/6)

According to the report from the Reagan-Udall Foundation released Tuesday, “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 food program is led by officials with overlapping jurisdictions, and the independent report recommended either establishing a food safety agency that would be separate from the Federal Drug Administration or establishing better, clearer lines of command within the existing agency. (Weixel, 12/6)

In response to the report, the FDA said in a statement that it plans to release a public update on the “new vision” in January 2023 and any changes to leadership as well as internal process and procedures by February 2023. The “new vision and structure” will be based on the RUF report, the internal review of the FDA’s response to the infant formula crisis as well as new advances in food science. (Brown, 12/6)