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Will “Reimagined” FDA Unification Move the Agency Forward?

It may not be quite the single national food agency that is so often advocated, but if the vision for the FDA’s “reimagined” Human Foods Program pans out the way it is proposed, this agency will, at least, be a step closer to unification.

Developed in response to the Reagan-Udall Evaluation and FDA’s internal review of its infant formula response, the plan’s overarching goal is to address the recommendations of both reports with an agency that is more unified, focused, and adaptable making it able to respond more quickly and oversee human food in a more effective and efficient way. As such, it unifies the functions of Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) under a single leader, the Deputy Commissioner for Human Foods, who reports directly to the Commissioner. But just how much of the ORA function falls under this umbrella is a little hard to determine based on what has been said to date.

Key elements of the program include:

  • The Deputy Commissioner for Human Foods, for which FDA will be conducting a “competitive national search,” will be empowered with executive leadership and strategic direction over the entire program.
  • A larger executive team, reporting to the Deputy Commissioner and responsible for the program’s major areas, will be created, including a Principal Associate Commissioner who provides operational management of the program’s day-to-day operations.
  • The Human Foods Program will also include newly formed:
    • Center for Excellence in Nutrition to elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity. Within the center, an Office of Critical Foods will manage the regulation of infant formula and medical foods.
    • Office of Integrated Food Safety System Partnerships to prioritize and unify FDA’s work with state and local regulators and strengthen the nation’s Integrated Food Safety System as envisioned in FSMA.
  • A new Human Foods Advisory Committee of external experts will advise the FDA on challenging or emerging issues in food safety, nutrition, and innovative food technologies.
  • In realigning certain ORA functions with the Human Foods Program, ORA’s goals will be set by the regulatory programs and take a more prevention-based approach to food safety inspections; ORA will focus on strengthening and modernizing its core operations and increase its specialization in concert with the regulatory programs; and state and local food safety partnership functions will be unified into the Human Foods Program.
  • A strengthened system of information technology and analytical capabilities will support the program to enable more efficient operations and risk algorithms to guide the program and fieldwork.
  • The Center for Veterinary Medicine (CVM) will continue to operate separately reporting to the commissioner, but will have dotted line coordination with the Deputy Commissioner for Human Foods as relevant to human food safety. 

As indicated in the statement from FDA Commissioner Robert Califf, the plan is, at this point, a “vision.” Thus, the next step is to develop a concrete reorganizational proposal to begin to bring the unification program to a reality. While it is encouraging to see there is at least a vision from the Commissioner, in reality these changes are, to some degree, a rehash of past structures at FDA and only partially address the needs of food safety in the US. But it sounds good, and such change is needed so we can only hope that changes happen quickly and the FDA is able to do its job efficiently with the appropriate focus on important public health risks.

Exactly what this will involve and how long it will take was not related. So, while the initiative could be seen as another slow-moving government notion that will be outdated before it is implemented (i.e., its depiction as a “reimagining”), the fact that it is FDA’s response to the major infant-formula incident – for which it, and the industry, have been under intense scrutiny from Congress and consumer groups – will likely keep some momentum under its wings.


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