The lack of strong, defined leadership of the Food and Drug Administration’s human foods program has hindered the agency’s mission, says a report that is expected to shape FDA reform efforts.

The Reagan-Udall Foundation report delivered to FDA Tuesday echoed comments from industry and non-governmental organizations that have criticized the agency’s slow pace and lack of transparency in making regulatory decisions.

FDA Commissioner Robert Califf requested the report in July as the agency tried to answer questions about why the nation was suddenly dealing with an infant formula shortage, and the general perception that the “food” in FDA was not receiving enough attention or resources in the agency.

Califf asked the foundation to examine the Center for Food Safety and Applied Nutrition, headed by Susan Mayne, and the Office of Food Policy and Response, led by Frank Yiannas, as well as relevant parts of the Office of Regulatory Affairs. It did not specifically look at the Center for Veterinary Medicine.

“The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration,” the report said. “FDA has dedicated staff who are committed to protecting public health, but the current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal.”

Several factors contribute to this culture, “including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program,” the report said.

“The lack of clarity in authority lines across and within the components of the Human Foods Program leads to frustration and substantial confusion among both staff and leadership,” the report said. “For example, the similar food safety responsibilities of OFPR and CFSAN create an environment where work may be duplicated. The structure also reinforces confusion or conflict, as a ‘decision’ made in CFSAN may or may not be sustained or may be second-guessed in OFPR.”

“The ambiguity about leadership and the subsequent lack of clarity also results in a lack of communication, particularly around the context for decisions and the ‘big picture’ of Human Foods Program priorities, such as the transition to a prevention mindset envisioned in [the Food Safety and Modernization Act].”

The panel chaired by former FDA Commissioner Jane Henney offered five different structural changes as options, including creating a separate FDA within the Department of Health and Human Services or creating a deputy commissioner for foods, an option that has been embraced by a wide variety of groups.

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Its recommendations address the culture of FDA, resource constraints, the agency’s organizational structure, and the authorities it operates under. Here’s a list, copied from the report:

  • Identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.
  • Establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.
  • Develop and nurture a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework.
  • Commit to transparency, timeliness, and predictability in decision-making, with a preference towards action.
  • Commit to an on-going process of culture change from the highest levels of FDA leadership.
  • Develop and implement a change management strategy that not only manages change, but also effectively improves and monitors the environment for cultural change.
  • Build expectations and incentives into the system to embrace a positive, collaborative culture that expects, values, and rewards teamwork.
  • Create a culture of feedback and authenticity where continuous, honest, and constructive feedback is given and received.
  • Nurture current staff and recruit, hire, and promote top quality staff, including strong managers.
  • FDA should increase the visibility and prominence of the Human Foods Program.
  • The Human Foods Program should have clear lines of authority.
  • Within the Human Foods Program, the importance of nutrition should be elevated.
  • The foods portfolio of ORA should be integrated directly with the other elements of FDA’s Human Foods Program.
  • The food-relevant work of CVM should be integrated with the overall FDA Human Foods Program.
  • A new Foods Advisory Committee, at the Commissioner-level, should be established to strengthen external input to Human Foods Program activities.
  • Structure changes should be implemented with cultural transformation efforts
  • (Urgent) FDA should secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act to improve its ability to recruit, hire, and retain personnel with the needed skills to effectively meet its public health mandate around food. FDA should also work with OPM to develop solutions to facilitate hiring professionals matching the Human Foods Program’s needs
  • To further expand its utilization of state capabilities, FDA should move to a stronger, more cooperative relationship with states and other local authorities
  • To help agency staff keep pace with scientific advancements and industry innovation, FDA should expand staff engagement in outside conferences
  • To develop a workforce pipeline of future FDA Human Foods Program staff and improve scientific engagement, FDA should develop and implement a strategic plan for a robust competitive external research structure.
  • FDA should develop and adequately resource an internal Human Foods Program research strategy.
  • FDA should give the highest priority to the formulation of an appropriations strategy that begins with a well-defined agenda and a clear case for why increased Program funding is necessary.
  • Separately, FDA should more fully implement the industry fee authorities provided by FSMA. In addition, while the Panel recognizes that prior efforts have been unsuccessful, FDA should actively engage stakeholders to explore additional mechanisms for industry support of the Human Foods Program
  • Internally, FDA should do more to support the Human Foods Program budget
  • FDA should invest and adequately resource its Enterprise Modernization initiative, particularly the Human Foods Program components
  • (Urgent) FDA should seek to amend the Federal Food, Drug, and Cosmetic Act, specifically, section 708 (21 U.S.C. 379), to allow for disclosure of non-public information to state, local, and U.S. territorial government agencies with counterpart functions related to FDA-regulated products by preempting related state, local, or territorial disclosure laws
  • Request records from food manufacturers in advance of or in lieu of an inspection, with a reasonable timeframe, within reasonable limits, and in a reasonable manner, and either in electronic or physical form.
  • Be notified when designated food categories, such as medical foods/infant formula, are likely to experience shortages or when supply chain disruptions are anticipated.
  • (Urgent) FDA should seek a substantial amount of ‘no-year’ funding for Human Foods Program, particularly for funding infusions intended to address longer term challenges (such as IT) and engagement with SLTT partners for inspectional activity.
  • FDA should actively engage stakeholders to explore industry financial support, such as user or registration fees, to increase financial resources for the Human Foods Program.,
  • FDA should seek authority to align the consequences for violations of the Preventive Controls rule requirements with the violations of FDA’s food safety Hazard Analysis Critical Control Point (HACCP) requirements
  • FDA should strengthen its implementation and use of existing FSMA authority to collect user fees.
  • FDA should work with stakeholders to better structure the approach to the [Generally Recognized as Safe] designation, including exploring a routine assessment of what qualifies for GRAS designation.
  • FDA should explore efforts to routinely review, either through an internal or a National Academies process, current and recent FDA practices related to GRAS implementation in light of current U.S. Dietary Guidelines and the evolution of modern manufacturing practices.
  • In addition to seeking new authority regarding data sharing and records access, FDA should explore applying existing authority that infant formula manufacturers must retain microbiological testing records−and that those records “shall be made available . . . for review and duplication upon request” by FDA− to require real time disclosure of final product testing results from infant formula manufacturers.
  • FDA should use its mandatory recall authority more frequently, recognizing that a process should be in place to assure that accommodations are made for life-sustaining products that are the only source of nutrition for certain populations (e.g., infant formula).
  • FDA should identify opportunities to monitor both industry and consumer behavior, to better understand industry implementation and consumer response to FDA’s nutrition initiatives.
  • FDA should maintain the forward progress on “healthy” associated with the September 2022 White House Conference on Hunger, Nutrition and Health to lead to a timely approval and to establish a program for rigorous assessment and monitoring of the impacts of “healthy” on consumer and industry behavior. 

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