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The Regan-Udall Evaluation – Something New or Same Old Story? 

Evaluations of FDA’s performance and programs are nothing new. Just this year, the agency has been the subject of reviews by Congress, GAO, AFDO, its own internal personnel, and, most recently, that of the independent Reagan-Udall Foundation in its Operational Evaluation of the FDA Human Foods Program

While the report poses little that is new, it does identify important deficiencies of the agency and changes that are – and have been – needed. With the report including both large-scale (creation of a separate food safety agency) and fringe (GRAS) recommendations, my penchant is to respect the investment of the report, and urge its thorough, but pragmatic, review by the commissioner as a process on which to begin to take action. The report provides the opportunity to right the ship; let’s leverage it to develop useful improvements that have been needed for quite some time.

With the evaluation and recommendations centered around culture, structure, resources, and authorities, I would encourage FDA to focus on a structure that supports the culture while investing more resources with appropriate accountability. While it may seem simplest for the agency to jump to the end of the document and apply resources to the “bolder use of existing authorities,” I would stress that is it more important for FDA to get what it needs to execute on structure, culture and accountability and stay out of the weeds for now (e.g., the GRAS recommendation). At the same time, however, it is critical that FDA understand what is likely and what is less probable. For example, while separating foods from drugs has long been heralded, it is not a Congressional priority to create a separate food safety agency, so placing a strong focus on that is not the best use of resources at this time. So fundamentally make changes that are fast, simple, and effective.

There are things that can be done now aside from a structural change, improved culture, and better accountability of current resources. One of those areas I see as critical is the report’s underscoring of “the urgency of more effective nutrition initiatives as part of the FDA’s work.” The report cites CFSAN’s annual food safety budget in FY 2021 as being $284 million (about 83% of the Center’s overall budget) with total public health benefits valued at $3.1 billion. But the nutrition budget was only $24 million (about 7% of its budget) with public health benefits valued at nearly the same figure – $2.8 billion annually.

This lopsided investment needs to be corrected. I am in complete agreement with the Foundation’s recommendation that the importance of nutrition should be elevated within the Human Foods Program. As the report states, “Food safety and nutrition activities are both critically important to the health and wellbeing of our nation—albeit in different ways—and each should be recognized and given high priority within FDA.” FDA is the federal agency responsible for the nation’s nutrition policies, yet nutrition is rarely given the attention needed. Thus, while the development of a Center for Nutrition would not only require dedicated resources and leadership, but also Congressional action, I would see this as a more feasible, and critical, area for the Commissioner to consider along with sorting out the current foods program.

Another area with which I am in agreement is the need for strong leadership. Culture is important, but it has to come from the top. The report even lays out what is needed in a good leader – no surprises there!  Everyone needs to be working together, but that doesn’t happen without strong leadership. So, yes, you need to get the culture right, and yes, you need to get the structure right, but first you need to get the leadership right. As the Foundation states, “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. … There is no clear Human Foods Program leader or decision-maker, outside of the Commissioner. Although the missions of CFSAN and OFPR have differences on paper, staff are often left wondering which program is responsible for decision-making.”

Having a designated person in the agency to lead hot issues is also not a new need (it was an issue I tried to address back in my FDA days!), but it became critically evident during the 2022 baby formula crisis when the left hand didn’t know what the right hand was doing, and the disfunction led to both an outbreak and a shortage. It is critical at such times to have a single lead, a coordinated team, and a standard process for both the investigation and information sharing.

There also are a couple areas that I see as lacking in the report – (1) that which I referenced at the beginning of this article: resources with accountability, and (2) industry interaction.

If food safety is as important as I believe it to be, it should be adequately funded by Congress. FDA should not need to increase or add new user fees to fund it (which, as the report concurs, has never worked well in the past and is unlikely to go over well in the future). That said, all resources should come with appropriate accountability. Congress has appropriated money to FDA, but I don’t see FDA adequately reporting back on what it is doing with that money. The word “accountability” is mentioned only three times in the report, and those are related to the program’s field operations and the prevention ethic of FSMA. Thus, I don’t see overall FDA accountability for the resources it uses as being brought out strongly enough in the report. Again, not a new idea, but with better accountability of funds spent and value added to public health, Congress is likely to be more willing to come up with more money.

A glaring gap I see is the lack of any recommendations for FDA to work more closely with industry. The report does recommend a “stronger, more cooperative relationship with states and other local authorities,” and it discusses the creation of a new Foods Advisory Committee, but there is no detail as to who is to be on this committee beyond its ability to provide “external input.” The report discusses the large-scale complexity of the supply chain and the myriad factors at play in food production and distribution but includes nothing about including input from those players.

Overall, I see the report as largely stating the obvious but yet being a positive investment into the continued improvement of the food safety system and its regulatory bodies. If it takes a report such as this to improve the food safety programs at FDA, then so be it.  However, it is essential that the recommendations be looked at from a practical and applicable perspective, with the Commissioner moving forward and adopting actions that can be taken quickly then working strategically toward applicable large-scale approaches.


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