A Separate Food Agency?
This week, the Washington Post editorial staff called for separating food programs from the rest of the FDA. At the same time, the Post published an interview with Drs. Califf and Woodcock about food safety reform. It reveals some of their thinking about the Reagan-Udall Foundation (RUF) report, but they are clearly not done deciding on the elements of their action plan for food safety.
The Alliance - through testimony, blog columns, and press releases - has advanced a vison of changes needed to stabilize a dysfunctional food situation and improve the food and nutrition components of FDA.
We have said:
Resources. When a complex regulatory system is under resourced—as is the case with human food safety at FDA--you get what you get: mostly good, but very vulnerable. Importantly, you lose the ability to develop and maintain a system that is intentionally excellent. Significant resource investments (budget, personnel, and systems) are needed.
Reform. Everyone sees the vulnerability, particularly in the lack of systematic approaches to address known problems and map out improvements. There is a strong consensus—in government as well as among members of the Alliance—that FDA needs to fundamentally change how it runs its food safety and nutrition programs.
Resources and Reform. Reform and increased resources are necessary complements: money without reform will fail, but reform without money will also fail.
Accountability and Transparency. The first step is appointment of a single leader with day-to-day authority over food programs and who can make and enforce decisions. Without that accountability, you cannot have transparency, accountability, or responsiveness to the Commissioner, Congress, and the public. In particular, funding (our focus) cannot be spent effectively or with appropriate intentionality without accountability. Note that a single leader does not negate the need for greater reforms.
The Post is correct that substantial additional resources are needed. However, it is hard to see how breaking FDA apart advances any of this. It seems particularly antithetical to improving a vulnerable system.
As Commissioner Califf says in the Post interview: “Creating a new federal agency is a non-trivial exercise. During the interim, there would need to be duplication of functions for some period of time until the new entity — however it is configured — got off the ground.”
It seems simpler, more direct, and less expensive to go where, based on the interview, Drs. Califf and Woodcock seem to be headed. In my words (not theirs), they intend to: Reimagine food safety and nutrition structure and programs (i.e., reform) such that substantial additional resources can produce food safety and nutrition programs that give Americans confidence in the safety and healthiness of the food supply and ensure the agency can keep pace (internally and externally) with innovation.
The Alliance sees that as an appropriate goal, with no judgment (on our part) as to how much reorganization might be needed.
The Post position seems predicated on their belief that our food supply has grown less safe since the Food Safety Modernization Act (FSMA) was enacted in 2010. I am skeptical of their conclusion, which they support by reference to retrospective tracking and enforcement data. That is but one set of possible metrics in evaluating our complex food regulatory system.
What made FSMA so consequential was a more proactive preventive control approach to mitigating food safety risks. The goal was to make foods safer through the entire farm-to-table cycle rather than rely solely on identifying unsafe products when they reach market, eatery, or home kitchen.
The Commissioner, the Alliance, the entire stakeholder community agree with the Post that the level of dysfunction is high, and any fix needs to include substantial new resources. The Post’s urgency is valuable to the cause, even if their solution might involve far more disruption than is needed.
The key point for the Alliance is that no set of solutions for food and nutrition programs can be successfully implemented without leadership, a comprehensive transparent strategy, and more resources.