Regan-Udall issued a critical report on the operational evaluation of the FDA human food program

In July 2022, FDA Commissioner Robert Califf requested that the Reagan-Udall Foundation1 convene an Independent Expert Panel to evaluate the FDA Human Foods Program comprehensively.

Recognizing the situation's urgency, the Commissioner requested the evaluation be completed within 60 business days. The report is critical of the FDA and mentions that its culture lacks a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and an ultimate decision-maker responsible for the Human Foods Program. The FDA staff often operates in silos within the organizations. The lack of clarity in authority lines across and within the components of the Human Foods Program leads to frustration and substantial confusion among staff and leadership. The report emphasizes that the FDA's culture that is risk avert should foster both incremental and far-reaching innovation and encourages responsible and well informed risk-taking. The Panel recommends that FDA leadership consider various changes: ● Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement. ● Establish an organizational structure with a clear leader ● Create a culture where regulatory decision-making is rooted in scientific evidence ● Create a system to embrace a positive, collaborative ● Promote top quality staff, including strong managers. The committee recommends creating a new operating division within the HHS separate from a Federal Drug Administration, each with a Commissioner reporting directly to the HHS Secretary.  @

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