The Editorial Board had a conversation with FDA Commissioner Robert M. Califf, who was commissioner in 2016 and returned in early 2022, and Principal Deputy Commissioner Janet Woodcock, who has been at the agency more than 35 years. Below are the highlights of the Jan. 6 conversation, edited for length and clarity.
Post Editorial Board: Should the FDA be broken up so there is a separate human food agency?
Mr. Califf: That decision is not one for us to make. We’re running an agency. It’s totally fair for people to have discussions about it and think about it. In addition to the benefits of totally breaking things apart, you’ve got to look at the risks and the costs. There are operational costs. 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’s configured — got off the ground.
Remember that the remit of the FDA with food is not just safety. It’s not just outbreaks. The chemical part of safety is very different than the outbreak part of safety. Nutrition is [also] an enormous responsibility and very closely linked science-wise to other things the FDA does. So as we look at it, there’s a lot for us to work on, but there’s a lot of reason to say this is a good place for this [human food] function to be.
The commonality of the underlying science — on deep sequencing of bacteria and the human genome — is [something in] common, and the expertise that resides in the FDA is substantial. The systems for inspections and the underlying information systems and all of the infrastructure that goes with that — duplicating that, seems to me, would be a waste of resources. It wouldn’t be a good thing to do. There are many aspects of what we do that are not just specific to food.
I think the critique and what’s in the [Reagan-Udall Foundation] report is fair. It does need more attention. More resources are needed and better organization is needed. That’s what we’re working on.
Ms. Woodcock: Since I joined the agency in the 1980s, people have been talking about this. Generally, they are talking about standing up a single food agency, which many other countries have. Despite all the conversation, that hasn’t happened. Pulling food out of the FDA and leaving it in HHS (Department of Health and Human Services) to stand alone wouldn’t be as strong. Because don’t forget HHS has agencies such as the CDC (Centers for Disease Control and Prevention), the NIH (National Institutes of Health), the FDA and the CMS (Centers for Medicare and Medicaid Services) — giant agencies and giant remits. I would be concerned about the idea. I understand the appeal of the single food agency, but none of these are really our call.
Post Editorial Board: If we don’t break up the FDA, then how can we ensure there is true reform in the human food division after years of problems? It wasn’t just the baby formula crisis last year, but going back to the 2016 Inspector General report warning of dangerously slow responses. The same problems come up over and over.
Mr. Califf: I think what you’re hearing is a consistent message. I was there in 2016 when all of that discussion went on in terms of what we’ve got to do. We are a couple of weeks away from announcing the architecture. Where does each box fit? We’ll talk about the leadership [of the FDA].
In 2016, there was a deputy commissioner who was empowered. First, I was very comfortable with it. Secondly, it didn’t fix all the problems. There are still issues within that that need to be dealt with. We are coalescing on a plan.
Underneath the [organizational chart] boxes, the really important things are what is the mission and what is the purpose, and how does the organizational structure and alignment with the finances and decision-making relate to the purpose of what we’re trying to get done? Ms. Woodcock has a group of leaders — some young [people] that have a lot of ideas. They’re working more on not just how do the [organizational] boxes get depicted, but how do we get the work done in a different way that’s more effective?
Almost 100 percent of what’s in the [Reagan-Udall Foundation] report is, not surprisingly, quite good. But a report stops at a certain level. Actually operationalizing it is a different kind of work that takes into account a lot of “sausage making.”
Our food is basically safe despite all of this, but it could be better. We also know more about nutrition than we’ve ever known. … A lot has been done already. We don’t look bad compared with other countries, but it could be so much better because the science has evolved. I think the thing that’s really hard in this environment is: How do you create systems that survive the political back and forth? How do you expect an agency to do well when it has had seven commissioners in seven years?
Our real effort is how do we create something that will survive? I had a deputy commissioner [when I was FDA Commissioner in 2016]. Scott Gottlieb [the next FDA Commissioner] changed that. If a commissioner comes in with grandiose ideas and gets halfway through a change, that’s not good for people. I think we are going to put in structures that are going to survive.
Ms. Woodcock: I’m all about results. The 2011 Food Safety Modernization Act was an inflection point. There was pivoting and new regulations. We call it “program alignment,” which caused the field organization, which is 60 percent of the foods program by budget, to have to develop a food inspectorate. Before it was all mingled together and all in the districts. They had to align their programs. That was a big change. They really had to think about what they were doing.
In this case, we have to take that a lot further and really insist on what was intended in the Food Safety Modernization Act: A quality systems approach and preventive management approach where we are partly educators. We work very closely with the states to have an integrated food system that is seamless, and we have better data systems to support us, which we do not have right now.
I believe what is different is we’re trying to change the organization, not just the top. We’re trying to actually change how things operate and make them more functional and modernize them. I always object to the idea that some leader will come in and fix everything because that is not my experience. Whatever leaders come in, of course they have to believe in that. We need to have some continuity at the civil service level. Then we can produce a lot more and be a lot more functional.
Mr. Califf: Our brains work entirely different, but [Ms. Woodcock and I] come to the same conclusions almost 100 percent of the time. The second thing is to remember my career was in big clinical trials and then big tech. Look at a fact in the report: There are 600,000 entities that we’re supposed to regulate. Today we’re in Denver visiting the field office. You need to employ modern information and data methods. It’s all about risk-based surveillance. That’s going to be a big change. Once that’s done, I think the people will love it and it will be a different place. I think the goal is to get it far enough along to have it stand on its own.
The third thing I wanted to say is the report’s reference to “constant turmoil.” The FDA as a whole is always in constant turmoil because we’re making thousands of decisions a month that affect a lot of people. A high proportion of those decisions make somebody unhappy, and it’s stressful. I also agree with a concept at the top there’s been turmoil because of the uncertainty about who’s in charge and things that we can fix.
I’ve been working a lot in the food sector the past eight months. Those focused on nutrition have a very different view than those focused on outbreaks. We have to adjudicate all of that. Fixing the decision ranks and organization at the top will make the lives of the average worker much better.
Ms. Woodcock: It’s a historic opportunity. I regard this as an opportunity to really change the course and really modernize.
We have the federal employee viewpoint survey data — the “morale of the troops” — and we do better than almost everybody. If we were a bigger agency, we would score at the top of the federal government.
It isn’t as if people are downtrodden and unhappy. It’s that every single decision: Is this an outbreak? Does this company need to better its manufacturing? Each one of those are controversial and have different sides and are very public.
Post Editorial Board: What else needs to be done to modernize food safety?
Ms. Woodcock: Right now infant formula manufacturers are voluntarily providing their production data to the FDA. We have to buy retail data to understand what is on the shelves. To get integrated food safety, we have to have better information to share with the states. We’re constrained by confidentiality laws by the federal government.
Mr. Califf: The food is basically safe now. It’s as good as any other country. What’s frustrating is you can see how much better it could be.
The supply chains are increasingly becoming digitized. It is not a technological issue anymore. It’s not technically difficult to federate the data. The thing the companies are worried about is some nosy federal person is going to go in and disrupt their competitive systems.
When there’s a shortage, we have to go begging for data. Legally, we can’t actually get the data unless they agree to give it to us. Similarly, with the states [state food safety inspections and programs], if we give them data and they make it publicly available, we’re liable.
Post Editorial Board: So you need additional data access to really modernize? Most Americans probably think you already have access to all the data you need.
Ms. Woodcock: [Part of the issue is] sunshine laws in the states. Many legislative fixes have been proposed by various factions. We need to be able to look at records and be able to access records or get food manufacturers records, for example.
Mr. Califf: We need a change in industrial policy. Supply chains are fragile. “Just in time” methods are great when things are good, but when something goes wrong, there’s no resiliency in the system. Equal access to information is a key part of this.
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