Up on my wall. Some of them might be a little crooked, but you better not touch them, because I did them like stepping into them. Let me
try this on my
own. Once you do certain things, you don't know what you're capable of, Commissioner we're delighted to have you again. I think we sat just right here this time last year again. Obviously,
the world has changed just a little bit since then. The most important thing about how the world has changed is that Duke lost. Oh,
bad night, last night. It was great up until the last minute, and then it turned bad. Yeah,
yeah. Well, obviously there are more serious things than that, although we are very big Duke fans, I just wanted to actually start off with, actually a word of thanks and gratitude for the service that you have provided for the country, two tours of duty, you can say now at FDA, incredible leadership that you have demonstrated and provided at really critical times. I don't think you expected the infant formula crisis when you started. Did you
something about my first day and the job at FDA? I won't go into the first time, but this time, the day I was confirmed, was the day of the recall and Abbott that created the whole crisis in performance. So I was thrown right into it, no question about it. Yeah,
absolutely. So as you reflect on these two stints that you've had, what do you think about in terms of your legacy? What are you the most proud of? What are the areas that you just feel you've had the greatest impact?
Well, you know, there's something about my Baptist upbringing that I don't like to call it legacy, because that's not, it shouldn't be what's important. It's really what's happening for people now. And when I look at the current situation, I think across the whole expanse of FDA, there have been major changes. You know, a lot of it got started the first time. And, you know, I've said this many times before, but in that transition, Scott Gottlieb, coming into the job was a real gift, because a lot of the things that had been started, he continued, and then, of course, did his own things in addition this. But this time, I had a chance to have a pretty good idea of what I wanted to do. And the biggest thing, of course, is the whole reform of the food side of the FDA
had the big reorganization of the food program 8000 people. And
people don't realize the vast majority of the food budget doesn't go to nutrition. I wish more of it did, but as allocated by Congress, most of it is for inspections, because we have over a million establishments that we're supposed to be watching over in this very complex global supply chain that involves everything from farms to distribution systems and freight shipping and imports, and then, of course, our own internal us, economy of agriculture, which is complicated, and I've learned a lot about it, so that was important. But when we look at the medical product side, which I know is where this audience tends to focus. I was just talking to John Crowley the rare disease changes that have been made. I'm very proud of the effort at FDA. It takes a lot to say, we don't just stay in our cylinders. We're going to work together across different parts of FDA on behalf of patients and families in this situation where the science is completely explosive, and I think the teams have risen to the occasion, and that's well underway, but otherwise, as we've discussed many recently, everywhere in the world I go, No one is arguing that the US is deficient in innovation and creative products. We are creating the products, and I'm proud that the FDA has a role to play, not only in helping create the guardrails for product development and approval, and it's good. But also remember that 90% of drugs and most efforts at devices fail because they don't work despite our best idea. So that's a very important part of the system, is keeping the bad stuff off the market. So the
reality is, the FDA is that gold standard internationally. Obviously, you know, there is quite a bit of attention now focused on the FDA, but if you look across regulators around the world, they really hold FDA in high esteem with the scientific knowledge and basis for making those decisions. I pride
myself in being willing to accept criticism and correction when I'm wrong, but everywhere I go, that's what people say. That is not, I don't maintain that's not our problem in the US. We can always do better with innovation. We can get much better at the science of developing products that really work. And you know, I include food very much in that, because if you look at the climate change that was just referred. To we're seeing these changes in climate that make growing crops entirely different, and invasion of all sorts of pests that didn't used to be in places are now showing up, including pests that transmit human diseases. So we have to be very worried about the h5 in one crisis. Now our problem is in the delivery of the things that do work. We're in last place in high income countries and losing ground. It's very concerning. Well, it's not the FDA problem, but we need to do our part.
So from your perspective, FDA works really well. It's doing the job that it needs to do very well. Obviously, the rooms for improvement. But as we talked about in the slides previously, even in the data that was shown by Harris Poll, the vast majority of Americans don't feel like they can have access to the health care that they need. And that's not an innovation problem. Maybe it's an innovation and delivery problem, but it's not upstream in where products are developed.
You know, my latest theory on this, which was helped yesterday, I got to attend your milk and board meeting, which was a very lively discussion, but it was reinforced a bit there. I learned from several of my mentors in the history of the FDA that the best regulation is regulation that helps the industry evolve in ways that where the science meets the need. And I think what we've got is it's walking and chewing gum, as we discussed yesterday, if chewing gum is innovative, creativity for serious diseases that need intricate detail, things like the cardiac valves and defibrillators that I used to work on, we're doing a lot of that that can get better, we need to point innovation towards the integration of human care, access to care, and basic, fundamental things. I mean, what? That was a great set of slides from Harris, I got to say, and I hear about it. If you look at our trends, most Americans are eating a terrible diet. They don't have access to human reminders. And I personally believe the idea that you're going to replace humans with digital stuff, it's already been tried a bunch of times. It's not going to work. What we need is digital support for human interactions as close to the where people live as possible, and we're failing at that in the US in a major way.
So if we go back to a bit of the FDA role, and we'll talk a little bit more about some of the key priorities that you laid out at the beginning of your time here, one is around, of course, evidence generation, but as we talk about digital so many people are focused on innovations that deal with AI. You've had these questions multiple times, which is, does FDA have the regulatory authority that it needs in this whole new paradigm where AI is being used from accelerating the identification of molecules all the way through design of clinical trials. Is FDA situated to be responsive to this really evolving ecosystem, or does it need new authorities to do
that? I'd say the FDA is pretty well situated for the parts of it that you mentioned. In other words, things like protein folding, target identification, the biology of underlying disease, the industry is taking off, and the FDA doesn't really have a lot to say about that. We need to understand it, but that's the industry's business. Ultimately, a product needs to be developed, it then gets tested in clinical trials, and that's where the FDA has a major role. And I think even the clinical trials part, I think, is going to move along, I still gets back to the human part, as we've discussed, no matter how good. I mean, how many companies have been identifying patients by going through electronic health records, and then what happens? I was just at a place they identified, I think it was 30,000 patients eligible for a trial. 30 have signed up because there's this people, if they're sick, they have a disease, they want a human being that they interact with at that interface. And that's what we don't have, right? But I think the place where we're least well equipped and no one knows exactly what to do is decision support built into healthcare delivery, where we know as AI gets more generative. And I do like to say I used to work with three people that just won the Nobel Prize. Of course, I didn't actually work with them. They just happened to be working in this vast expanse of alphabet where I was working. There's a real risk, if you put an AI model in situ, in any environment, it's going to change, and that's a good thing, as long as the AI is monitored, because it could get worse, or it could get a lot better. The more information it gobbles up, the better it gives. And we don't have systems to do that monitoring. I feel good that the FDA has made it clear that needs to happen. But it can't just it can't be the FDA that does it. It's going to have to be an ecosystem. And here, I just would say, this is no different than farms. If you look at food safety, we only inspect a farm or a place of business every five years in between, we have a set of rules that people self govern because they want to grow crops that are useful to people. And we need that kind of ecosystem in AI. I don't believe we have that right now, and it needs work well,
the challenge and the opportunity is that there are going to be low hanging fruits with AI. It's going to be helpful on administrative sides, right with helping doctors notes, et cetera. The question is really going to be about, is it only going to be used in ways that streamlines cost, helps with claims data, et cetera, rather than actual patient care? And that's what I was alluding to in my opening comments there, and it sounds like there's much more for us to see there. I do want to go back to this question around evidence generation, because this, of course, is an area that you have spent your entire career. There was a requirement coming out of omnibus two years ago with diversity in clinical trials. You and I have talked about this, but one thing that you have mentioned is twofold. One is that we're not we're seeing a trend to smaller trials, especially here in the US. So this idea of capturing more patients in clinical trials is going to hit an inevitable challenge with the trials that are getting smaller. Yet at the same time, we see this gap in life expectancy, where rural parts of the country, poor parts of the country, are not really able to get standard of care. So how do we close this gap in terms of where patients are, where patients need help, and how they have access into these new technologies that could be really transformational for them?
Well, first of all, it's going to be really interesting to see the required diversity action plans, and we're hoping that people will not just literally go by the law and say, we're submitting a plan for our phase three trial. We're asking that people look at their whole development program so that the expanse of development can include diversity that represents the people who are likely to be treated. So those plans will come in, they'll be analyzed, and I think we'll learn a lot in great iterative loops, I hope of making this better. Secondly, you've heard me say this many times. I don't think clinical trials can correct for a system which is structurally biased, and you saw the factors in the Harris Poll, and we still have all the same old disparities we've had, but the big things that are growing, and I think getting a lot worse, the rural, urban split and the net wealth split, which showed up in the poll, and I think we'd better pay attention to that. But I don't think clinical trials can fix that, having said that we should do our part in the clinical trials enterprise, and that inevitably, because there's a lack of providers. Let's just say you're in rural West Virginia, and you need to get into a diabetes trial. There may not be an endocrinologist for a long ways. So we're going to have to test out this digital human interface thing in the clinical trials arena, too. But also, know, you're working globally, and I don't have a solution to this problem. But as trials get smaller, how are you going to represent the 250 ethnicities of the world, two thirds of the world's I saw you've been in Asia. I have to a lot in my last 20 years, two thirds of the world's population lives in Asia. So I think the answer of this is, in the post market, we need a it should not be Helter Skelter. And
you talked about that in your JAMA article, which is that we have more opportunities in the post market with pragmatic trials than even pre market. The question is, who are the kinds of stakeholders that need to be involved in doing those kinds of trials and then obviously funding them? You
You would think that health systems and insurers would have a vested interest in knowing what the right treatment is. And I mean, I've worked up my rhetoric on this. I'll just give it to you.
Well, you know, there's nothing to lose at
this point, completely uncensored here. But you know what is getting FDA approval is that the benefit outweighs the risk for one indication in one population for some period of time, it says nothing about how it compares to other treatments, how you combine treatments, how long you should give it, whether the dose is even the best dose. It has to be a dose at work, but there may be better doses. And of course, the value of the product one of the real human benefits that occur with more accelerated approvals. We know very little about that. At the time. So we need a system that answers those questions. We don't have it right now.
What can FDA do in that system? Well, one
thing that's been happening, and I hope this article will get out, is working with CMS within the IRA to develop the standards. In other words, if CMS going to consider evidence in the post market phase, FDA has some methodology, and a lot of people that know about it, and I would say, also participating, there's a lot of fear of FDA out there, out there in clinical research sites, as you know that we need to turn around that thinking, and you'll see some publications now of a lot of work done at FDA to distinguish those early phase trials need to be extremely complicated and time oriented and rigorous and collecting all kinds of data later phase, you already know the basics of safety of a drug, you can do a very pragmatic trial at a much lower cost with a larger population,
which will have much more of an impact on the clinical applications. As we like to see, two questions remaining for you. One is, public health is in the bull's eye right now, and there is questions around the role of FDA as a public health entity. Your stout supporter of public health. Do you have any comments or reactions to the perceived attack on public health, or in particular certain areas within public health? Well,
I think it's going to be really important that the external community sort through this and decide what it's going to support about public health, I worry that a lot of our society right now is wrapped up in immediate reaction to how things feel when, as you know, the major triumph of public health is when nothing happens. And I think very much in terms of the FDA, a very similar set of issues are in play. That is, if we do a good job, things just go along. No one talks about it. And so yet, the problems that are being discussed as being problems like the bad diet of Americans, our lowest life expectancy of any high income countries. This is not a time to say everything's fine with public health. Let's be complacent. But I think the diagnosis is correct in many ways, the treatments that are being advocated, that's where we need to have the arguments. Like, I don't think dietary supplements are an answer to the need for better diet.
Yeah, yeah. And our minute remaining, what would be your advice to the next FDA commissioner? They will inevitably have their own crises. Some had the COVID 19 pandemic. You had infant formula. So it's hard to predict the future, but as you think about the work that you've done twice over, what would be your advice to the next Commissioner?
First of all, there's a crisis every day at FDA, when you're regulating 20% of the economy, you'd be amazed at the things that happen that just require an intervention. So I was asked about this yesterday, and I think I got this right. The number one quality is be an executive, which means you got to be able to listen to people and have experience with the issue. In other words, saying someone who comes into the FDA preaching about what it should or shouldn't do is going to sober up very quickly when there are a few supply chain shortages and food outbreaks and farms and far away places. Number two is have a strong belief in evidence that we've got to generate that that evidence and pay attention to it. And number three is respect the Civil Services making key decisions without too much political influence. I also commented yesterday, and the idea that you totally separate the science from politics. That's kind of but for individual products, those decisions should be made based on the evidence that's presented. The higher the quality, the easier the decision is. For policies that affect groups of products, that's where the politics come in. Absolutely.
Well, I'm going to end where I begin, which is, thank you for your service, and let's give him a hand of applause for your committee, for the American public applause.
