— EXCLUSIVE —
I was given some time to talk with Dr. Califf about the recent call by the Regan-Udall task force he empowered to give recommendations as to how the food side of the FDA should be restructured. Here are his thoughts on how he is responding to those recommendations.
Bill Marler
I was one of the people that testified in front of the Reagan Udall group. I think I may have been the only person who was a speaker who stayed all two days and watched the whole thing. So, I had a kind of ringside seat to see a lot of good people testifying in a great committee you set up. I know what your proposal is for the new, revised position, and I guess at a 35,000-foot level — it seems — like we’re going back to the way it was with Doctor Hamburg and Mike Taylor in the Obama administration. I’d like your thoughts as to whether this new proposal is similar in kind or different from what was under the previous administration — in the Obama administration?
Dr. Robert M. Califf
Yeah, I think if all you did was look at the boxes, I completely agree with you. It’s a similar construct, but what’s very different is the focus on the operational infrastructure and how it functions, and the clarity of decision rights in a matrix organization. So, I think it is fundamentally different, but not at the box level, more at the functional level. And the systems that we’re putting into place, I would call it a modernized construct of how a complex organization should be run. I think if you look at most major corporations or universities, you’ll see a similar set of constructs because it is complex and so thinking of it all as a linear hierarchy is, in my view, not the best way to get all the things done that need to get done in a complex organization.
Bill Marler
I know you know everything in DC has a lot to do with timing. What’s your thoughts on the timing of the rollout of this? Is it something that we’re going to see in 2023? 2024? Is it going to get wrapped up into the presidential race? And then the other question is, have you thought about what the role, and the kind of person you’re going to be looking for in this deputy Commissioner?
Dr. Robert M. Califf
I think of the rollout in three phases, one of which is already well underway. A lot of things have been done with the Solomon report and the testimony of Reagan Udall, and, as I keep saying, the background of the FSMA documents and the New Era (of Smarter Food Safety) document. We got all the writing that we need to know a lot of things that need to be done. And so many of those at that sort of fundamental enterprise level are being done, like a better complaint system. All sorts of things related to the personnel. Then there’s an intermediate phase which is, we got to find a person and hire them to be the leader. We’ve got this operational group of young leaders from all the elements of the program meeting. And I think it’s always amazing when you take people that are highly dedicated to a mission who’ve not had the chance to say, “OK, if you had a hypothetical country and you were starting afresh, how would you do it?” All kind of interesting things come out. And then there’s the long term, sort of cultural things that people talk about — you don’t change those overnight. And there will be elements that will require significant investments — like information technology that will take time. Some of these are things that in private industry or in university you would do very quickly, but they can’t be done quickly in government, because we, as I’ve said, have a lot of bosses. And we also have an obligation to the employees and the unions that represent them to make sure that we reach agreement on the best way forward before we implement anything.
Bill Marler
The proposal that you have does, or does not, require congressional approval or buy off? Or is it something that can be done within FDA?
Dr. Robert M. Califf
We can do everything within this proposal with congressional notification, but this is not my first time around this block and notifying Congress with all the opinions that exist is tantamount to getting approval. Because there will be opinions expressed heavily and we want Congress’s support. This is a big change in the way the FDA functions and we want everyone to get on board and have input where it’s going to be helpful. You mentioned the leader. I’m from South Carolina, so I have these aphorisms, but “barking cat” is not a bad phrase to use because I’ve noticed in the food world that there’s not agreement across the whole food world about what should get priority. And the nutrition world and the food safety world live are connected — but they live in different universes. And we’ve got this looming issue of chemicals and the environment, which affect food, which gets into a whole different area of science. We need a leader who can bring these elements together.
Bill Marler
Obviously in in my world, I’m a hammer and E. coli and listeria are nails. So that’s kind of how I view the world. But it was fascinating sitting there listening to the folks who are very interested in nutrition testify to the Udall group. They were gentle to say, ‘gosh, you guys spend way too much time paying attention to pathogens. They sicken people right away, and you’re not paying attention to the big issues of obesity, heart disease, diabetes as much as you should.’ Do you see that as part of what you see the role of this new person? To be better at integrating nutrition and food safety and chemicals into one thing?
Dr. Robert M. Califf
Yes, and it needs to go beyond. The fine art of being an FDA politician — you learn how to say that whatever is brought up is your top priority. You need to get beyond the lip service here. I just want to hammer home this nutrition thing because it’s not either or. There are amazing things we can do with food safety as you well know but we’ve got a decline in life expectancy in this country, to the point that we’re living five years shorter than the average of other high-income countries. Driven by COVID with misinformation about vaccination, but equally as much now by the resurgence of common chronic disease, which has a nutritional origin, and if you look at the future — look at our teenagers and young adults, 600,000 teenagers with Type 2 diabetes within this decade, all driven by nutritional issues. No question about it. We’ve got to fix this. And it’s not just FDA’s issue, of course, but we have a role to play, and we need to make sure it’s elevated and done well.
Bill Marler
I think that’s the balancing act that hopefully this new person will adeptly do. I got a copy of a recent letter sent to Secretary Becerra from a large group of consumers and industry groups. I don’t know if you’ve seen that, but it did take to task your suggested change. Specifically, commenting on how this new change wouldn’t bring in ORA and veterinarian medicine aspects of the FDA under the Food Commissioner. I don’t know if you’ve seen the letter, but I think you probably heard from them in one form or another. I just wondered if you had any thoughts or comments about the concerns raised by those groups?
Dr. Robert M. Califf
I’ve talked with these groups multiple times, as you well know, and I’ve seen the letter. What I’ve said to them is, keep the drumbeat going about what you see as a problem. I’m happy to have you make suggestions, but I’m much more attuned to solving the problems, than I am to being told who should report to who. It’s OK to suggest it, but if you’d really like to get involved in that, we got jobs. So, feel free to apply and you can be involved in those details. So those are going to be worked out by the operations group that we have in play. I’m very attuned to the issues that they’re raising. I think they’re raising the right issues, but my solutions may take a different form. And if they’re not solving the problem, then we’ll have to change what we do. For example, the Center for Veterinary Medicine — I think you’re familiar with the arguments on both sides — I would say that’s emblematic of modern complex organizations where people need to be able to wear two hats at the same time. If you’re in CVM, the majority of your work is going to be animal drugs and devices. And a significant part of the work is going to be directly related to the human foods program. And so, to only wear one hat isn’t going to work. The CVM is like FDA in its entirety for animals, including all the components. So, I think it would be a mistake to have that. If you look at what happened in the old configuration, it never really worked with CVM to be only contained within a food organization. The good news is CVM is highly respected by the constituents it has, and they’ve been pretty vocal — don’t mess with our CVM. ORA is 100 years of history. Remember that I’ve been an inspectee. I’ve been on the other side of the fence. And I think the thing that’s really important is that we maintain the independence and integrity of the inspectorate, but also that the priorities are unified for whatever the program is — and that is again a matrix organization issue that we’re going to need to solve by looking at the details of exactly what are the functions and where should those functions reside within FDA and in the different organizations. Where there’s overlap or redundancy, we want to reduce it as much as we can. And where there’s interaction across areas, we need decision rights about who makes the call, which is one of the things people have pointed out over and over. When you have a situation where it’s not clear who can make the final call, and the lack of clarity leads to indecision, which is, given the pace at which things are changing out there in the world, that’s not the way to do it.
Bill Marler
When I was speaking in front of the group, I looked at how the organization of FSIS is in compared to the Under Secretary of Agriculture. Obviously, I’ve been dealing with those folks for 30 years. But I always kind of know who it is, who I need to deal with — the Under Secretary of Agriculture in charge of food. I think one of the frustrating things that I get in hearing from the variety of groups or people who’ve been at FDA in the past, or consumer groups or industry groups, is — and maybe I’m hearing something from you that maybe you and I agree — is that I think it’s sometimes not knowing who are the decision makers for those things as it relates to understanding how inspections are done, and how that fits with the whole idea of preventive controls under FSMA. I guess that’s the part of the thing that a lot of these groups, and frankly myself wonder, if not having some sort of clearer structure is going to continue this same wondering who’s in charge. Do you have any thoughts about that?
Dr. Robert M. Califf
If we succeed in our plan, there won’t be any question who’s in charge. But I would also say, you know my background was in medicine, and there was a time when the surgeon was in charge of the operating room and no one else could say anything. That was not good. And there’s plenty of research to show that team based clinical care, where the nurse can speak up, the cardiologist can come in the room and say, ‘wait a minute that’s not the right part of the heart you’re operating on,’ – I’m a cardiologist – and the surgeon is accountable and in charge but operates under rules where people have a voice. You wouldn’t expect a surgeon to be an expert in where all the instruments were being kept in the operating room. I think by the same token, you wouldn’t expect a person who’s an expert in food safety overall and in the concepts of preventive controls to understand what’s involved in the logistics of walking into a plant or a farm and knowing all the things you have to do as an inspector. So there needs to be a voice for the inspectors, but the priorities should be the human foods program and it should be a team. The team needs to have someone who is accountable for different kinds of decisions depending on what the decisions are. If it’s what’s the most efficient way to route the flights for a multitude of inspectors — I used to run a clinical trial monitoring operation as a component to what we did in academic clinical trials — God forbid that I would have to figure out which airline to use for our monitors. That’s something that an inspections group should be able to do really first rate and save money for the organization and have a good set of flight patterns. So, it’s all about teamwork, but teams don’t work if no one knows who’s in charge. I’m also a basketball person and I grew up with Coach K. Can you imagine if you had the huddles during the timeouts and no one was ultimately going to call the shots about what the next play was going to be? And everyone had a discussion and argued about it and left with different impressions of what the next play was going to be? That wouldn’t work very well. I think this idea of the linear hierarchies are better than well-functioning teams — It’s been proven wrong in almost every aspect of society.
Bill Marler
I was a bit surprised by the Reagan Udall Foundation. Their one recommendation regarding structure, right out-of-the-box, was splitting the FDA into having two Commissioners. One Commissioner of Food that had all the aspects of food, including nutrition and the food aspects of ORA and CFSAN. And one under that Commissioner, then reporting to the HHS Secretary. And then a person with drugs and medical devices. Your portfolio in and of itself is overwhelming. But what about a structure that breaks food out of the FDA and had drugs on one side, food on the other. Do you think that’s a workable solution? Over the last 30 years, you’ve heard, Rep. Rosa Delora and Sen. Dick Durbin, and various consumer groups and industry groups tout that. How are you going to respond to that and how is what you’re doing now going to maybe assuage some of their feelings?
Dr. Robert M. Califf
The first point to make is that that’s not my call. My job is to take what I’ve got and make the best of it. Second thing I’ll say is my job is not to assuage their feelings, but it’s nicer if you do. Life is better if they feel better about it. I think it’s important to keep in mind a couple of things. One is the competition for resources and the functioning of an infrastructure, in the US government it helps to be a certain size. I think a lot of people have made the point that deconstructing this would have a significant cost. And in a time where so much change is going on in with what we’re regulating, it’s sort of like changing the tires while the thing is going down the street. So many people have raised it. I’m not saying it’s an irrational idea. One example that I think is really important to consider about the reason the FDA is a good home for a lot of this. In addition to having an inspectorate, which if as we modernize, and I think there are real economies of scale and efficiencies. Let’s look at genetic modification of organisms. The tools to do that are changing at an exponential rate. Such that you don’t have to be that sophisticated to deploy them, but you got to be really sophisticated to have some idea of what they’re doing to an organism. Whether it’s a child with a genetic disease or a plant or an animal, the basic tools are actually the same and there’s a real advantage to the expertise that we got here at FDA as we try to figure out how to regulate these technologies. I think these are going to be essential in a time of climate change on the food side, to enable us to feed the US and the world. We look at infant formula, with the specialty formulas there’s a case where having pediatricians and nutritionists who are tied in with the medical community turns out to be really, really important. I could go on and on. But it’s not my decision to make. I’m going to do the best with what I can do.
Bill Marler
The broader change of splitting and reorganizing would obviously be a congressional or presidential sort of push as opposed to the reorganization that you can accomplish with the structure of the FDA as presently designed.
Dr. Robert M. Califf
Yeah, that’s how I see it.
Bill Marler
Anything that I failed to ask you that you wanted me to ask you and that I can help you with?
Dr. Robert M. Califf
You could have asked about the vision for 10 years from now.
Bill Marler
Oh, yeah. You’re going to stick around that long?
Dr. Robert M. Califf
No, but this not about me, right? Remember, I had no reason to come back to the FDA. I was having a really, really good life and so was my family when I got the call. There was a need. If they had found somebody else to do it, I would have been perfectly happy with that.
Bill Marler
Okay, I’ll ask you the question. So where do you see this all in 10 years?
Dr. Robert M. Califf
Yeah, let’s think about climate change, supply chains, digitization, information infrastructure and architecture, including all of our new favorite thing: Chat GPT and its competitors. So, you can imagine a world where there’s a digital supply chain system, and you have the investigators doing their inspections but armed with very sophisticated algorithms about where the risks are. An education system which is just in time and immediately accessible to the whole spectrum of the 600,000 entities that we regulate in the foods system — God knows how many there will be over 10 years from now. Where regardless of your level of sophistication or knowledge or education, you can tune in and get what you need to know to prevent the problem from occurring. But if you’re not behaving, there’ll be a much better way to tell that you’re likely not behaving, based on the system that is in place. And for food outbreaks, genetic sequencing is going to be in a whole different arena. We should be able to very quickly tell and probably also include some social media component. You’re aware of that with social media, you can tell what restaurant caused the outbreak — that’s been published. And for nutrition and chemicals, we’re in this whole new era for things that were only theoretical before, like: What is the right level of something in a food, whether it’s a nutrient or a toxicant? You’d say, well, zero for toxicants. But you know, we live on a place called Earth, so 0 is not possible for a lot of things. But to figure that out, you need both exquisite measurement of the thing you’re measuring and its effect on biology and also its effect on human populations, which requires big data. We now have no limitation of big data or computer storage. So, it’s possible to envision that we could be feeding the US, a big part of feeding the world, much more nutritious food at a much lower cost to the environment, maybe even a positive environmental effect. That may be far out, but maybe. And where you could be much more assured about the safety of what you’re eating. And employees would be very happy because they wouldn’t be spending their time hand entering data, they’d be taking a picture of whatever they were doing, and AI would take care of storing all of its metadata. That’s what we’re aiming for.
Bill Marler
For a guy who’s been cut off by a judge now and again. I’m pretty good at my timing, so I’ll let you go do your do the rest of your work.
Dr. Robert M. Califf
All right, take care.
Bill Marler
All right. Thank you very much.
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