Transcript of Supercharging a New FDA: Marty Makary on Science, Power & Patients

Marty McCarry, Commissioner of the FDA. Welcome to San Francisco.

Great to be here, Dave. Good to be with you.

Yeah, thanks. It's J. P. Morgan Health Care Conference this week in San Francisco, considered, I think, probably the most important biotech conference globally. Very important week. You're visiting this week for the conference? Yeah.

120,000 people. Great conversations. You hear from everybody. Just not enough time to meet with everybody you want to meet with, but it's a great time.

Well, thanks for sitting down with me. You and I have gotten to know each other a little bit over the last a year or so. I'm really excited to hear a little bit about how things are going. It's been almost a year since you've been in the role. I think maybe for our audience, you could share a little bit about how you got this role. How did you get involved with this administration How did you get connected with them? And maybe we can go all the way back to your very outspoken views during the COVID pandemic and maybe how that brought attention to you and your philosophies that drove this role.

Yeah. So my interest in academia, I Went to graduate school for public health and served on the faculty of the Johns Hopkins School of Public Health, as I also had a clinical practice in GI and Cancer Surgery at Johns Hopkins. And my interest was always in the root causes of our healthcare system problems, from quality, transparency, and price. And in the work on price, I led a national effort to try to get more price transparency of hospital prices. I wrote a book on it that did very well. It took me to the White House where they had read the book, invited me in. And in that first Trump administration, we had a lot of great conversations, and then they implemented the idea. And I was so impressed. This makes sense. We want common sense ideas. And so we got the hospital price transparency executive order signed by the President. That's where I developed some of the relationships and got to know the folks. And then when President Trump got reelected, he gave me a call days after the election, and I was very honored to be offered this role. So it's been awesome. Covid, you mentioned COVID.

It was a crazy time. I mean, the sociology of medical dogma is a fascinating historical thing, and we still suffer from it. Paternalism, the suppressing ideas that are not the legacy ideas, the sacrificing the basic principles of science to question everything, to have no sacred cows. And you saw the worst of that bad behavior during COVID. Cloth masks on toddlers for three years, vaccine mandates for young college students, recommending COVID boosters with such absolutism in young healthy children, ignoring natural immunity, one of the most scientific dramatically dishonest things that scientists could possibly say about the virus and the immunity, and shutting kids out of school for nearly two years, which I fought tooth and nail, along with Jay Badachari and others, starting in the fall 2020. Initially, we were okay just doing stuff while we didn't understand it. But once the data emerged, we made a strong case to reopen the schools. And to some degree, I feel like we lost that battle. But people now see that the data has caught up with public health officials. And so I'm proud to be in office now to be a part of an effort to rebuild public trust in our health institutions.

And you must be having a lot of conflict then because you really are fundamentally trying to rewrite the way these institutions operate, have operated. And in some sense, you are degrading the success and the career and the authority that some have vested themselves over time in those roles. How has that been? And what's the pushback been like as you've gone through this exercise?

So I meet with folks at the FDA. And if you meet with them, with their bosses and everybody in the room to get a briefing on a topic, then they give you one glowing story. But if you meet Meet with one individual scientific reviewer and give them the safety of anonymity and say, Look, I want to hear, how is it going on the ground? Or, What big ideas do you have that you've always wanted to do but not been able to do. Four out of five people, or sometimes more, will not really give you anything interesting. But then somebody will say, It makes no sense that we do it this way, and we could do it better, and we could do it this way. Something they wouldn't feel offering if their supervisor were in the room. And so we've been running with these ideas. We have announced 42 major reforms in my 10 months in office at the FDA. It has challenged the status quo of doing things, but we have to. Why does it take 10 to 12 years for a new drug to come to market? We've become so lukewarm and passive accepting that horrible timeline that has just become the status quo.

We've got to challenge these deeply held assumptions, and we're doing it. We are doing it with new programs, new priority reviews, new pilots, new forms of transparency. We made our our rejection letters public so that if the FDA does not approve a drug, the public deserves to know why. It creates accountability.

That was not the case before.

They talked about it for 30 years, and we got it done. They talked about banning one food dye for 35 years. Within weeks of coming into office, we took action to remove all nine artificial petroleum-based dyes. We're getting stuff We're not afraid to move fast.

In that role, some people have left the FDA, and then they've been outspoken critiques of yourself. Maybe you can respond to some of the criticisms, that it's chaotic, that there's a lot of turmoil, oil. I've worked at many startups. I know that when you move fast, things feel, or they may feel too busy, or they may feel like there's too much going on. It's overwhelming at times, but at the end of the day, progress is what matters. Maybe you could just comment on some of the reports made by employees that have quit the FDA, left, and provided some comments on how things are going.

There were 2,000 HR people at the FDA just before I got there. There were 1,500 IT people.

For a staff of how many total?

20,000 employees just before I got there. And so there was a goal to say, Hey, we're going to go back to 2019 staffing levels, and the cuts are not going to be to scientists or reviewers. No scientific reviewer was laid off. But there were significant consolidations in HR, procurement, IT, and the duplicative services that were out there. Now, anytime you do something in government, you take headline risk. But we felt it was the right thing to do. And so I came in right after that massive change. And since then, we've had a great culture. We've had more teamwork. We have new leaders, and they believe in this new vision. The number The number one priority of the Commissioner that preceded me, he said, was to fight misinformation. Well, my number one priority is not to censor Americans. It's to deliver more cures and meaningful treatments, faster to the American public, and healthier food for children. And I think every employee at the FDA knows that mission. We have incredible teamwork. Our turnover rate is at the baseline 5 to 7 % that has been there for the last 10 years at the agency. So there's no exodus.

There's no mass departures, we are actually hiring 1,050 new scientists because we have very ambitious goals on our new pathways, accelerated-type pathways. And so we're building up capacity to have a whole new line of pathways so that we can deliver faster for the American people. Great.

Well, look, let's start with a framing. The framing is the US versus China. I want to read this report that came from the National Security Commission on Emerging Biotechnology. Technology. We're here at a biotech conference, so I figured we could start here because everyone's talking about China and the race against China. The US, according to this commission, has a three-year window to act to keep up with Chinese innovation and the speed in biotech. In 2022, Chinese companies were just 5% of licensing deals, 2025, 42%. And recently, one of the biggest licensing deals ever was 3S Bio, 1. 25 billion upfront with a $6 billion total with Pfizer. China had, 10 years ago, only 50% of published scientific papers to the US. Today, they're 50% more than the US. I just want to walk through your view on US biopharma innovation as it relates to China. Is there a race? And if so, what are the priorities for the administration in helping American biotech industry remain competitive?

There is a race. And when we came to office, we were losing that race. We were behind. We were getting clot by China, by Australia, and other countries that were doing things more efficiently with less red tape. And we made it a massive priority to say, We need to retain our number one position in life sciences and biomedical research, and we've got to think innovatively. We can come up with some protectionist strategies, but ultimately, what we need to do is be more competitive with what's going on with Phase Is and INDs overseas. That means we need to rethink our entire phase 1 process. We have to convene hospitals who are... Part of the problem is outside of the walls of the FDA. When hospitals have IRBs, that is the institutional review boards that approve research, that meet monthly. At Johns Hopkins, I had a study, took a year and a half to go through the IRB. It was a survey. What are we worried about? It was a nutrition survey. At the end of a year and a half, it was not approved. That stuff is intolerable when we're competing with China, where they're doing phase ones in four weeks with Australia that's doing phase ones in six weeks.

We need to have more centralized IRBs, and we need to streamline the hospital contracting. Because right now, if you want to do a trial, each hospital wants to negotiate their margin of what they want and ensure they have to customize the contract because every study is different, has different requirements and resources that are needed. But you go to Australia and they say, Sure, sign here on the dotted line, you have access to these 14 hospitals or so. And so we have got to have more centralized contracting and a centralized IRB in order to compete. Those are big priorities. And we also have to reduce the red tape and regulation on our own I&Ds phase ones. And the entire process, when we came in, It took 60 days for the FDA just to tell you whether or not they were going to consider a supplemental application. I mean, that stuff is intolerable in the modern world. It took, and often still takes, 60 days just for the FDA to tell you that your application is complete. We're going to get that down to one day. We're going to use AI. So we've got to modernize the agency and be more competitive, not just talk about protectionist strategies.

As you think about those work streams in improving the efficiency, turnaround time, how much can you do this on your own versus how much do you need Congress to act to pass legislation to support those changes? And are there priorities that you're working with Congress on to try and accelerate drug approval timelines that are necessary?

So right now we have user fees, which means if you submit an application, there's a fee associated with it because there's an unknown number of applications each year. So it It's a system that's been around for a while. I'd like to see those user fees much higher if your phase one is done overseas. If it's done in the United States, it's going to be a lower user fee. That's what I'd like to see. It's an America-first policy. I'd love Congress to do a bunch of stuff, but we're not going to wait for them. Congress is slow. We're moving incredibly fast. Our number one goal was to make sure that the morale was good, the culture is good, and the trains are running on time, coming in right after the restructuring. I'm proud to report this year, in 2025, this past year, we hit 100% of our user fee target dates. That is, the trains were all running on time, that every accept or reject decision by the FDA was consistent with the accept or reject decision by the primary review team. That is, we're not doing secret deals, we're not messing with things. We are standing by our scientists.

Last month, we had a record number of drugs approved by our Center for Biologics, Selling Gene Therapies and other nine drugs. We want to keep going hard and strong and innovate. But the first goal in the first nine months was to make sure the trends are running on time and that we are strong, and I'm happy to report, the FDA is strong and it's going to continue to be strong.

Going Back to this point about cutting down on timelines for phase one, two, three. Maybe you can just, for the audience that may not work in this industry, very briefly explain phase one, two, three, and then where we think there's the biggest, call it excess regulatory burden that's causing these extended timelines on drug approvals, just to frame it up a little bit.

Sure. There's something called the IND, Investigational New Drug Registration Process. That's step one. Most of those are actually filed by academics. I think people forget that we still have a lot of great innovation in our academic spaces. It's not just the pharma labs. Then you try a drug in healthy subjects. That's called a phase one trial. Typically a small number, a handful. And then you give the drug to subjects with the condition, and that's a Phase 2. It's a limited study. And then Phase 3 is a large, randomized, controlled trial. We call it the Pivotal Trial. We announced just last month that we are going to go from a baseline default requirement of two Pivotal trials for a drug to one Pivotal trial for a drug. It's just math. You can achieve the same statistical power if you design one good clinical trial properly with a good control group. And so, by the way, that saves $100 million to $300 million for some companies, shortens the time. We're reducing animal testing. That's the pre-I&D or pre-Phase 1 work. That is, how does it work in animals? We are eliminating a lot of animal testing requirements.

We have a roadmap. You no longer officially have to submit chimpanzee studies for monoclonal antibodies. That was announced two months ago. We said, so typically, 144 chimpanzees are used for a monoclonal antibody. By the way, it's a joke.

You're making me sick because this has always been, from my point of view, one of the most troubling bioethical concerns I've had about the industry because you don't get a lot of statistical power or benefit from doing this, and it's just awful that we do it.

You actually get misleading information sometimes. Some say aspirin would not have been approved today if we had the old animal testing requirements, two species, because drugs that have safety concerns in animals may not have safety concerns in humans, so we may miss out on cures. And vice versa, 90% of drugs that pass animal studies do not pass safety and efficacy in humans. So what are we doing? We have computational modeling now. A computer can look at a drug and actually make better predictions. And we have something called organ on a chip technology where you grow, say, the liver cells or heart cells in a lab, administer the drug, and then look for any enzyme leaks or disturbances. These are modern techniques. We've got to modernize the agency. It's a massive goal.

And they're doing it in China.

They're doing it in China.

And if we don't, then we're also putting our industry at risk.

We've got to be more competitive, 100 %. And so what does this do? It compresses the time for approval. It allows R&D to be done at a lower price point, translating into lower drug prices for everyday Americans. More drugs can be evaluated. I mean, I had one pharma executive tell me, Hey, I love you're going from two to one pivotal trials. That means we can run twice as many drugs through large pivotal trials. That's what we want. We want to see more. Look, I'm coming in with a... We all have our biases. I have a bias, and it's just a matter of recognizing your biases when we talk about reforms. My bias is being at the bedside, breaking bad news to people within curable conditions or being at the bedside in the ICU. When you do that, it has a profound impact on your brain and your soul. You think about, what can we possibly do to give this individual some hope. And so when I see a 10 to 12 year time period of bringing a drug to market, I think in the modern world, it makes no sense. Just think about the advances in science and technology.

So I'm committed to that mission, and we've got a new pilot program now to get decisions out in weeks. It's unheard of. It's unprecedented. We have the first medication we just announced after 55 days. We have a lot to change in the workflow to get that time frame down, but we have, I think, 18 products that have vouchers for this new pilot program. If you're going to do something new, you have to pick criteria. You can either do it randomly or you can pick criteria. So the criteria we chose are drugs in line with our national priorities, unmet public health need. Say a new amazing cure for cancer where the tumor shrinks in front of your eyes and you don't need surgery or chemo. That's a real thing. I'm actually giving you a real example. We gave those companies a voucher. If you're bringing manufacturing back to the United States, that's a national security issue. If you are going to make the drug affordable, that's an access issue, and that's a massive priority for this President, is lowering drug prices. We have this pilot underway, and it's going extremely well.

The drug company gets a voucher if they qualify under one of those three criteria, and that gives them a fast track?

That's right.

When will we get a readout on how that program is going and whether it becomes standard?

Internally, it's going great. I mean, I've got employees at the FDA tell me, Gosh, I love this. It makes sense. And the reason we haven't done it before is that we farm out the application to a dozen offices, and everybody has until the target date to get their final reports in. Well, the target date is about a year. So if you are a expeditious scientist or you have the ability to go do your work expeditiously and In two weeks, you have your result. Well, it doesn't matter because the farm talk person or whoever else has another product has until the day before. Guess when they're going to submit it? The day before. So we are changing the incentives internally, the bonus structure. We're changing the alignment, we're changing the culture, and our goal is to streamline that process.

Going back to the computational point, we are collecting more data, digitizing that data on patients than ever before. That data should generally be accessible. Is Is there a world where we can transition from phase one, phase two, phase three trials into a phase one, phase two, slash three by taking into account all of this additional data? Some people have talked about the idea of using AI plus other health data that's collected and allowing the phase three to roll into phase two and create a much more expedited, computationally-assisted approval process. Is that something that's on the roadmap or is discussed?

Absolutely. There has been tinkering of combining phase 1 and two, phase one, two hybrid trials, phase two and three hybrid trials, approving something with a preliminary approval after phase two if the results are really promising. And those are all steps in the right direction. But I think of something much bigger. Can we move to continuous trials? Can we use Bayesian statistical evaluation, which we announced this week? We are now going to allow Bayesian statistics to be used. So Now, if something works, instead of having a committee meet twice a year to do a cut of the data and print it out and everybody looks at it, I was literally on those committees. Why can't we, in real-time with AI tools, Figure out when there's a safety signal or efficacy established, and then call it at that point, allowing more people to get the drug as soon as we know it works.

Is there more continuous tracking that's also possible to look for risks risks and issues that start to emerge in certain populations? Because this is something that it's almost like the approval happens, and then you find out years later that, well, maybe there was an issue that we should have caught sooner. If you move to a more data-driven, continuous observational system, can you both have faster approvals, but also faster recognition of safety concerns for a specific population?

Yeah, I love the way you're thinking. I want to see continuous trials with endpoints in the cloud so that the reviewers are looking on to the endpoint. You don't do your freshman year of college and then submit a giant 50,000-page application to start your sophomore year. Then do your sophomore year and start another 50-page to start your junior. But that's what we're doing at the FDA. Now look, it had good intentions, but we live in a modern world We're using computers now, not stone tablets. We can run more continuous trials. That's the goal. We can use Bayesian statistics, which we announced this week, a big new milestone with that. I want to see us continue to have eyes on a drug after approval. Approval is a point where we say, Hey, the world can use it with a fair degree of confidence on the safety and efficacy trade-off. But why did we learn five years after Viox was approved that it may have killed 38,000 people? Well, in the modern world big data, we can have eyes on a drug as it's being used in real-time to call out that safety signal immediately and let people know.

It may be a subgroup of people that are affected. It may be a drug-drug interaction. You think about the opioid epidemic, 15 years of prescribing it, having no idea. I'm guilty. I was doing this. I was prescribing it. My patients were getting addicted, coming back for refills. I thought it was a one-off thing. A lot of people come ask for refills. No, it was a national pattern we should have identified in big data. And so we're going to do post-market surveillance in a way like we've never seen before using big data. And if we get it right, if we get it right, and it's a big priority, it can actually change the threshold of approval because you know you're going to have eyes on a drug immediately.

For people in the general audience to understand, this begs the question, and I think people will bring this up as a critique, of absolute safety. I always talk We'll talk about the example of you put the Waymos or the autonomous cars on the road. They cut down on fatalities by 95%. But as soon as one person gets killed by a Waymo, the media goes crazy and says, These autonomous cars are killing people. This begs the question about the understanding of safety and risk versus the benefit that can accrue. I was sharing with you about a family member who had to wait a long time to get a certain therapeutic, and I was thinking about the thousands of people that died in that same period of time. Fortunately, he was able to get the therapeutic, but all the people that died because they couldn't get access to this drug. How do we convey to the general population the idea that speed matters in saving lives, and this question about absolute safety and absolute risk around drug approval? This is really important when you talk about risk to a general audience, how do you convey that second-order effect?

That's right. So safety is our number one priority. We are to safeguard the public. But having eight months of 144 chimpanzees undergoing studies has risks to the general public. You may be holding back a curative medication for eight months. Not identifying the efficacy in a trial with Bayesian statistics early enough has risks because that extra lag period is time when patients like the patients that I treated at Johns Hopkins are told, Sorry, we don't know of anything out there. So time delays that are unnecessary have risks. And I think that is something we don't think about enough at the FDA. We think, Oh, we have this concern. Let's sleep on it. Okay, well, you get a night to sleep on it, not nine months.

So I want to give a flip side to this. The right to try law gives patients access to drugs that when they're in a condition, they can access the drug before it's gone through full approvals. What's the current state of right to try? Where do you view that going? And does the threshold for right to try change over time, giving patients and their doctors more rights and more access sooner? Or does the FDA still have to hold firm? How do you think about that over time?

So I believe in both the letter and the spirit of Right to Try. It's an amazing achievement of President Trump in his first term. And I have signed 100% of I have right to Try requests that come across my desk. Of course, the companies have to agree to make the medication available, but it's a great program. We don't want people getting spun up on snake oil that doesn't work, that's cost $3 million where their churches are doing GoFundMe campaigns when we know a drug does not work. We do have a responsibility, and we have to be good stewards of the Medicare program. They're using taxpayer dollars to fund things. But if there's a signal that something works and somebody wants to try a drug, who are we to say you can't? We look at safety, but beyond safety, we have to be as flexible as possible with our regulation. We announced just this week that we are getting rid of some of the regulatory requirements for cell and gene therapy. Now, those are used for a lot of rare diseases, but we had requirements, what we call PPQ runs for batches of... It's part of the manufacturing requirements for cell and gene therapies.

We were holding them to the same standards we were for, say, mass manufacturing of a pill. Well, a cellular gene therapy can be developed in a lab at UCASF or Stanford. And are we going to require that they use the same manufacturing broad standards to do multiple batches when you've got a scientific platform that works, a vector platform that works, and you're basically doing surgery on the human genome just in different locations? So we made that announcement earlier this week.

So let me just understand that one. I've spent a little time in this space. Does this mean that I will not need to go through a GMP or good manufacturing practice facility to bring those therapeutics to a broader set of patients? And does it also mean that once I've got a system that works, I can use it for different indications and maybe help understand a little bit about where this goes? Because there's many patients that today are looking at papers on cell and gene therapies, early data, and they're saying, When can I get access? I'm at risk. This matters a lot to patients sense, and maybe you can help contextualize how this translates into speed and access.

The announcement that we made on Sunday was that we're going to customize the manufacturing requirements to the drug and the population being treated. There's a number of flexibilities, including the ones you mentioned, but it's no longer going to be this hard and fast, you have to do it this way. For example, the three batch runs that have been required. Those ingredients are expensive. I mean, those ingredients could cost $100,000 for just one ingredient. And so we have to use common sense. When you see something perform, something magical to a kid with no help right in front of your eyes, you've got to say, What are we doing getting in the way? We just had early in our time there, baby KJ go home from the hospital. So this infant got gene editing therapy. You can't do a randomized trial on that. There's not enough kids who have it. So these bespoke therapies, we created essentially a novel pathway for them. Dr. Vinuy-persaade described it in the New England Journal of Medicine. It's called the Plausible Mechanism Pathway, and it's basically combining gold standard science with common sense.

And what about for CAR T therapy? So there's this blossoming class of therapeutics in CAR T that's historically been used exclusively for oncology, for cancer. Increasing discussion about using it for autoimmune conditions. Does this help with the CAR T therapy pathway and enabling faster routes to market and more access and lower cost?

It can. And by the way, CAR T is amazing. Car T is amazing. I'm not here to promote any one class of drugs. It is amazing. But the stuff that we have seen is mind boggling.

So yes. And just for folks to understand, when they take T cells, edit them, and put them back in the body, and those T cells go after targets in the body and destroy those targets. And many blood All cancers are now seeing extraordinary results with these CAR T therapies, and now they're going after autoimmune conditions. But it definitely seems to be that there needs to be a faster path to market, lower cost, because the pricing is half a million to a million dollars still.

It That's amazing. We're essentially activating your own immune cells to have a very clear path and target something in your body that needs to be targeted. Now, we did find that there was in the Biden administration, approval to have the cells of Americans for CAR T therapy shipped to China, where the Chinese did the gene editing and then shipped back to the United States to infusion Americans. When I found out about that, we shut that thing down so fast. Yeah, so we have to do things carefully.

What else have you discovered since you've been in the FDA that shocked you? Oh, man.

A lot. Let's just go on an aside for a second.

I'm curious to know what are the biggest shocks that you've uncovered? I mean, you've now been there for some time. You mentioned before we sat down that you're actively digitizing millions of files that historically have not been digitized. I'm assuming you can now use AI and other tools to go read through them very quickly. What's been shocking to you?

Where do I start? Somebody was carrying a box from one building to another building with a drug file in it. It turns out that the lawyer said they couldn't email the information to the other center because each center was like their own secret government before we got there.

Each center of the FDA.

Each center of the FDA.

Same agency.

Yeah, same agency, seven centers. It was like they had their own boundaries and territories. Lawyers They had their own communications staff, put out their own releases, their own press releases, did their own legislative affairs, had to schedule their own hearings. The commissioner was out of the loop sometimes. We restructured the entire agency now. We centralized those services. But in the days of this siloed world of the agency, and by the way, it was a nightmare for developers that had a drug device combination. It was like gerrymandered lines of what was included in one center versus another center based on infighting. People had served long terms there. They'd served terms like President Mugabe of Zimbabwe, who'd been there forever. These people just were there forever. It was just their way. Any time there was an opening in leadership, 19 times out of 20, it went to an internal candidate. So you didn't have a lot of fresh new ideas. We have a lot of fresh scientists coming in there. I mentioned the 1,000 new scientists where we're onboarding right now. 450 of them, 50 of them already just started. But I've met a guy who his job was to change the ink cartridge on a fax machine, on one fax machine.

Like Health care has single-handedly kept the fax industry alive.

The guy's job was the ink guy on the fax machine?

Yeah, just to swap out the ink cartridges.

The fax machine ink guy.

There's a lot of that. There's a lot of that.

Well, let's shift over to food. Maybe I'll just give you a moment to share what you changed in the food pyramid in the announcement last week, why you made those changes, and why weren't they made before.

We have had decades needs of medical dogma and corruption putting together food pyramids that make no sense. People can tell. The open secret was that they make no sense. They're scientifically inaccurate, and they were oftentimes curated by the food industry or the food industry's influence on academia. Nutrition science may be one of the most corrupted fields in all of science. It gave us the dogma that we had to focus on saturated fat and just eradicating natural healthy fats from the US food supply, ignoring that you replace fats with refined carbohydrates which are not healthy. We have this carbohydrate-heavy diet now for American children. And guess what? 38% of kids have prediabetes or diabetes. Is that a surprise? The rise has paralleled the shift from saturated fat or regular food to pumping refined carbohydrates added sugar. 60, 70% of the calories of a child in America today are refined carbohydrates. No one has talked about it. It's been in a blind spot as the medical establishment has had this myopic focus on the boogie man of saturated fat. We had a food pyramid that was entirely backwards. We flipped it upside down using good science, talking about a previously ignored area of nutrition, and that is the importance of protein.

We've been getting about half the protein that we need. The protein levels in the previous dietary guidance was really just to prevent withering away. We want our American kids to thrive. Look at the status of kids today. Low in protein, muscle wasting weakness, underperforming in school, high in refined carbohydrates, and sugar, giving them that sugar coma, food coma, after a refined carbohydrate breakfast. Again, we hit them hard in the afternoon. They get very little or no natural light exposure. They're told to sit at a desk still for seven hours a day. They can't do it. And what do we do? Tragically, we have drugged our nation's kids at scale. It's wrong. It needs to stop. We have to re examine the root causes. And so flipping this food pyramid upside down, focusing on protein is the first step. I'm very proud of what we were able to do.

What have you uncovered now that you've been inside the organization and you can see paperwork related to the legacy of how the old food pyramid was constructed and maintained for so long about the motivations, who was involved in setting that food pyramid? When you mentioned the corruption of nutrition science, help us understand the root of that.

I wrote a book just before coming into office where I had a to do a deep dive and do some investigative journalism, if you will, to learn how this dogma of what to eat, we got so wrong. I think it was a lot of group think, just like we saw with, Opioids are not addictive. Medical establishment got that wrong for 15 years. Young kids should avoid peanut butter until they turn three. We got that wrong for 16 years. Trust me, Tragically wrong. Igniting the modern day peanut allergy epidemic because peanut butter exposure in infancy reduces. There's something called immune tolerance, and it reduces the risk of peanut allergies. We're the only country in the world that has high rates of peanut allergies, along with UK and a few other European countries that fell for our dogma-based recommendation to avoid peanut butter until the kid turns three. We got that 180 degrees wrong. There are dogmas in the medical field that take on a life of their own, and you're not allowed to question them. We saw a little bit of it during COVID. If you recognize natural immunity and may not need to be fired from your job because you have circulating antibodies to COVID, but they were just antibodies that the government did not recognize, this dogma can take on a life of its own.

And so we're trying to get back to gold standard objective science.

It is crazy that the fundamental premise of science is you ask a question, and then you test whether there's one answer or another. And the idea that you can't ask questions indicates that it's not science from my point of view. All standards should be challengeable. You should be able to ask the questions. And fundamentally, if they hold truth or they hold ground, then great, let's maintain them. And if they don't, we should be able to change. And then they use the word science, or historically, the word science has been then used to justify I'm not testing something.

That's right.

It's crazy to me. What are the roles that food companies have played? What are the roles that folks that might have an economic incentive in keeping the food pyramid as it was played historically in this? And is that permanently changed at this point, or is it changed while this administration is here and it's going to change again next cycle? Help us understand a little bit about the role that industry has in influencing some of this regulatory process.

Well, I think the industry did what the medical field told them to do, and that is to address the risk of mass starvation and deal with food insecurity, and that calories in equals calories out regardless of where those calories come from. That was the dogma and the mandate to the food industry. They did what they were told to do. They moved to refined carbohydrates. They stripped the grains of fiber to They would even chop them up, which made them increase your glycemic index. That is, it basically functioned like sugar. You have cereals, breads, pastas functioning like sugar. We ushered in a generation of kids, and you and I were the first part of this, the first generation in human history, with massive insulin spikes day to day in our normal everyday life. We've never seen insulin spikes to that degree. Of course, Of course, that drives something called insulin resistance. That is the organs in your body that do important functions are trying to block out all this extra glucose. They change the configuration of the insulin receptor to just try to resist all the sugar coming in. It is at the root of almost every chronic disease, insulin resistance, general body inflammation, and we never talk about these things.

Never. We talked about them front and center in our new guidance, the types of grains matter. It's not calories in equals calories out. It's not you can have this if you sit on the treadmill for this amount of minutes. We've got to talk about the soil that food comes from and the farming techniques that animal products come from and the cleanliness and chemical-free waters that seafood comes from and the importance of protein and the value of whole grains and what we call real food. And so the website is realfood. Gov.

My only criticism is the lack of vegetarian protein in the top of the pyramid, where as a vegetarian, I eat eggs and dairy. It could use a few more nuts and beans up top. I'll talk to Joe Gebbia about it.

It could. No, it could. I think the New York Times had a connipption about the strawberries. The strawberries? I think it was disproportionately, disturbingly large.

Disturbingly large strawberries? That was the criticism? Yeah. Okay. That wasn't one that bothered me. Let's talk about the adult population. I think 40% to 60%, depending on how you measure it or are clinically obese in this country. These Incertain mimetics, GLP-1 drugs and others, have really taken the market by storm, taken our population by storm. I realized that much of this is in response to an obesity epidemic that we're facing in this country. But it turns out that these Incertain mimetics may actually have other systemic benefits, and I think there's 60 indications that they're being tested against, including kidney, neurological, cardiac. There seems to be a lot of benefit potentially in using them for other disease indications. Can you speak a little bit about your view on where this market, where this class of therapeutics is headed? Is this something that some people have estimated or 60% of Americans are going to be on. If it is the case, does that mean we failed with our food system?

Well, first of all, we have failed with our food system. Look at the fact that 40% of American kids have a chronic disease. Between the lines in the medical textbooks in medical school was a blaming of children for not having the discipline. It's not a willpower problem. This is highly addictive, chemicalized foods that are ultra that are put in front of kids, and they want more. You put these vibrant colors in them from the petroleum-based dyes. This is something adults have done to kids. I think that we have failed. We've given people the wrong information, the calories in equals calories out, this demonization of fat, and all that stuff we talked about. Glp-1s are mimicking a natural hormone in the body. When you get a supplementation of that, it's doing the job of increasing satiety, slowing down GI motility. It has a profound impact on a number of conditions because you are also reducing insulin resistance and general body inflammation. That's why we're seeing so many other benefits. Plus, you feel better. When you feel better, you're going to have benefits we haven't even appreciated yet because there's an incredible value, this positive thinking. We've seen it in a lung cancer study from Mass General.

They randomized people to palliative support versus chemotherapy, and the palliative support did better, even though the chemo drug is more effective than standard of care. You see this incredible value to of positive thinking, and maybe that's one of the reasons we're seeing reductions in addiction. Maybe we're seeing cardiac benefits. So we'll see. As a regulator, we're a referee, and we want to see products come to market quickly and safely. But I think we're at a pretty interesting time.

Yeah. Just to go back on the China point, because we did talk about competitiveness with respect to speed. But the other piece I wanted to address was funding of research. So That biotechnology council I mentioned recommended a $15 billion rushed investment in research. When I meet with scientists, there's a view that the Trump administration is anti-science, is defunding a lot of research institutions in the United States that are going to save people's lives and develop amazing cures. Why are they doing this? There's this council that recommends that even in the face of China, they're putting out tremendous funding to support research scientists coming up those next set of molecules or therapeutic modalities that are going to change lives and improve lives. Maybe you can comment a little bit on, are we funding through the government enough scientific research? What's the right steady-state for us? How do we address the points about the Trump administration being anti-science?

Yeah, well, look, we live in partisan times now where people get spun up in there in a toxic polarization. The truth is, if we want to know the facts, is that in the In the Trump administration, we have not cut $1 of NIH funding. We have not cut $1 to the general Medicaid budget, that is the overall Medicaid fund. The proposal for the future is to increase Medicaid by $200 billion. You hear all the time, Oh, Trump cut Medicaid, Trump cut the NIH. No. What we want to see is reallocating money at the NIH from just chemotherapy and proton beam therapy work to study the Food as medicine and school lunch programs and the microbiome and gut health. We've got to start talking about school lunch programs, not just putting every six-year-old on Ozempic. We've got to talk about the quality of sleep as it is a cause of high blood pressure when you sleep poorly, instead of just throwing people on anti-hypertensive medications. We've got to talk about environmental exposures that cause cancer, not just the chemo to treat it. We want to see go to root causes of diseases. That is something that has been, unfortunately, in a blind spot because the culture of the NIH is the culture of Francis Collins and Tony Fauci and the group for the last 50 years that, and I'm going to oversimplify it.

The gene is responsible for our health problems, and the gene can solve all of our health problems. Well, look, I believe in gene therapy, and we're doing amazing stuff with that. But where's the research on why one in six girls today will develop an autoimmune disease. What's triggering that antibody response? What of the many exposures in the life of a child is causing their bodies to be triggered? These studies can be done. It's not that difficult to model the antibody that's involved in type 1 diabetes or MS and exposures in the environment to see if it is triggering that same configuration that the antibody binds to. But no one's been interested in it because everything has been about coming up with a treatment when we have to look at causes.

The scientists on the ground see their funding go away. They complain, they get media attention. There's a lot of amplification of those stories. Is that not the fundamental truth because the money is being reallocated to other scientists and other research institutions?

Correct. Fourteen 14% of NIH funding went to DEI research.

14%?

14% of NIH grants went to DEI research.

Nih grants are about $40 billion a year. Does that sound.?

It's a little over $20 billion in terms of grants that go out the door, but about $47 billion for the entire NIH budget because they run their own hospital and clinical center and others. By the way, I'm all for anything that reduces health disparities and increases access. But these grants were not doing it. It was just describing health disparities. Well, we already know there are health disparities. Simply describing them with another 50 studies in JAMA does not help people who are suffering from these health disparities. We've seen money shifted to root causes and areas of research that we need to study that we've not studied. At the FDA, we have put a big emphasis on the value hormone replacement therapy for postmenopausal women, something the NIH demonized for the last 22 years, saying that women shouldn't take it because it causes cancer. When we came in, the NIH was a mess. Almost all the money was going to genetic research, which then becomes the priority of every academic institution. They're not studying causes and food and the microbiome and cutting-edge areas of science. They just had this myopic focus on one It's an important area, but it's one area.

They were funding the Wuhan lab to get back coronaviruses and insert a furon cleavage site so it could infect humans. What are you doing? It's a bunch of mad scientists. And 14% of grants were going to DEI. So the NIH, when we came in, was a mess. And under President Trump, it is massively being reformed. And Jay Batachari is doing a great job.

Okay, let's shift over to vaccines. Our wives had kids around the same time. Hope yours is doing Great.

He's great. Thanks for asking. Yeah.

And we talked about the Hep B vaccine, which we declined on the day he was born. Because I started going very deep on what's the origin of the Hep B vaccine the day that the child is born? Why is this being given to them? We have no Hep B exposure in our household. We don't need it. It doesn't protect anyone else. What are we doing this for? You end up going down these rabbit holes. And a lot of, again, what you mentioned earlier, you take for dogma and you recognize Wait a second. There may be some unfounded principles at play here. I should not be doing this. We make a difficult decision against the tide and the recommendations, and suddenly you're in the social conflict with people around you. It was very hard. You guys recently made some big changes to the vaccine schedule. I'd love to hear a little bit about how those changes were made. What were the big changes? Then what got us to this point, where when you look at the data, you're like, Wait a second. That may not make as much sense.

I I'm just laughing as you talk, Dave, because you do. You just ask some good questions like, does my newborn in the first hour of life need to be injected with a hepatitis B vaccine when the mom is hep B negative? Within a matter of weeks of having broader conversations, you feel like you're a fugitive of the law. You've done something terribly wrong for choosing not to vaccinate. We went through the same thing. Being a part of having a kid is so special. We were talking about that. So, yeah, we just went through this. Our son was born about six months ago, and we were offered the hepatitis B shot. Now, maybe they figured out who I was and didn't push it as hard as some of my friends have had it pushed on them, and we declined. You're preventing with hepatitis B an infection that is a sexually transmitted infection or can get it from a bloodborne pathogen exposure. So that's not going to happen until they're a teenager, at least, or further down the road. But when you ask the question, immediately you get this anti-vax label, or you have to qualify That's right.

I'm not an anti-vaxxer, but I'm asking this, What's going on here? This McCarthyism around this schedule, which, by the way, the United States vaccine schedule was an international outlier with 72 doses recommended between ages of zero and 18. So President Trump asked us to review the international landscape of vaccine recommendations, and we looked at 20 other developed countries and found that not only are we the international outlier in how high the number of doses we recommend is, but that there's a consensus of a group of core essential vaccines, and we wanted to put that in front of the American people to say, look, all vaccines are still recommended by the CDC. But here are a list of core essential vaccines. We gave them a list that constitutes about 38 doses from age zero to 18. The idea is to increase vaccination rates among children that have been dropping because of a loss in public trust by saying, Here's a hierarchy of what we believe to be a list of core essential vaccines. I don't want to see someone because a doctor is pushing the sixth COVID booster in a young, healthy 12-year-old girl. I don't want to see the mom say, Well, I'm not going to get the measles shot for my next child because something's not right about this.

38 is better than zero. You can still get them all. They're all paid for. But we have a hard time in the medical culture, and this is part of the the sociology of medicine, meeting people where they're at. For example, as a cancer surgeon, I would see women tell me they don't want to get a mammogram. I disagree. I think they're safe. But a woman may be concerned about the radiation, the discomfort, the inconvenience. 40% of women who are candidates for a mammogram are not getting a mammogram in the United States today, showing you the massive disconnect between the medical field and where people are at. Now, you know what we should be doing? Is we should tell those 40% of women, How about an ultrasound? It picks up 90% to 95% of the lesions that a mammogram would pick up. But doctors don't recommend an ultrasound because you're violating the gold standard and there's liability, and you're practicing substandard care. And women may tell other women that they could also get an ultrasound. We don't want women getting an ultrasound instead of... The paternalism that results in this disconnect is hurting people in the United States today.

And so with identifying the list of core essential vaccines, we are trying to meet people where they are at see more vaccinations because childhood vaccines have declined over the last four years of COVID because people have lost trust in the dogma of the cloth masks for toddlers and vaccine boosters in perpetuity, and you have to fire a teacher. If she already had COVID, ignore natural media, they have to be fired from their job. That absolutism has caused tremendous damage, and we're trying to rebuild public trust.

What's frustrating to me to observe is there are now states like California and the California DPH that are saying, We're going to set our own vaccine schedule. We're not going to listen to the FDA, to the HHS anymore, because they don't know what they're doing because they're Trump admin. They're not doctors. They're not scientists. Clearly, this is all political. And is there a process of engagement that you and your organization go through to try and bring some of these other folks along with you? Because I think the point you just made can't be a point that they can fundamentally disagree with. What is the process by which we can break the political rancor around things like vaccines and just take a very clear-cut scientific approach and get people aligned around this? Do you do engagement on this stuff?

Look, I think it's sad. We have this toxic polarization that's crept in. It's in society, but it's now crept into medicine. It's a lot of character attacks. I mean, it was put together They're by doctors with impeccable credentials. Tracey Beth Hogue, MD, PhD, phenomenal epidemiologist who is deep on the science on this stuff. All of us, Jay Badachari, MD, PhD, Mehmet Oz, Vice Chair of Surgery at Columbia University. I mean, these impeccable credentials, 400 scientific publications. I've published 350 scientific peer-reviewed publications in my career at the Harvard School of Public Health at Georgetown at Johns Hopkins on the faculty, tenured National Academy of Medicine. It doesn't matter all the impeccable credentials you can put in front of people. There's this sense of we just have to say the contrarian thing to whatever they are saying because of this mantra of all vaccines are good regardless, and you cannot have an honest conversation. I talk to doctors, and they've never heard of a vaccine they didn't love. Anthrax vaccine was a disaster. H3n3 killed people. It was a disaster taken off the market. Rotovirus vaccine in 1999, taken off the market because kids were dying from intersusception.

Rotovirus is not in our core essential vaccine schedule in the United States. Overseas, it's a little different. But in what we put out, it's not in there. After mass vaccination with rotovirus, the number of deaths per year went from 3 to 1. 6, or rounded up, let's say, 2. It went from 3 to 2 with mass vaccination. The vaccine that was used up until 1999, was taken off the market for safety concerns. When you have a parent ask a question about the necessity or we cannot respond with absolutism, American medicine needs to show some humility. When I had a patient ask me a question I didn't know, the right answer, I don't know. Maybe I'll look into that. Maybe one of my colleagues knows. During COVID, the right answer many times was, We don't know.

Do you find that there's a path forward?

I hope so. I mean, we're hoping to restore gold standard science and just talk objectively about it. We've had universities cancel, crush, censor, railroad doctors that pose different ideas about things. I'm not talking about the political hot button issues. I'm talking about the fact that ulcers were not caused by stress. They were caused by a bacteria called H. Pylori. Well, that guy was railroaded. His research was rejected from the national meetings, and then he gets the Nobel Prize because he ends up being correct. It's not good for scientists.

Most great scientists start out as heretics, just to be clear, by the way. That's right. Marty, one of the other big challenges that we talk a lot about in this country is the cost of drugs. Health care today costs roughly 15% of our GDP. That's an insane statistic, and it is rising year after year in the United States, and it's such a complex issue. By some measurements, though, the price of drugs in the United States is almost three times what it is outside the United States. I'd love to hear a little bit about the specific role of pricing drugs What actions have you guys taken and can you take to help bring down the price of drugs for patients, for care providers, for insurance companies, and ultimately for the economy?

It's been the great American ripoff. You could buy a a P1 drug for $1,300 in the United States and go to London. It sells for $88, where you go to Germany or France and buy any of the drugs that cost a lot of money in the United States, and they're half a third or a quarter of the price. President Trump has given us a clear charge, and he says, Look, we're the largest purchasers of drugs. We want the best price in the developed world. It's called Most Fevered Nation Status Pricing. And thanks to Dr. Oz and Chris Klopp and others at CMS, we did our part at the FDA to be a part of this. We've gotten drug companies to the table, and we've got them to agree to Most Fevered Nation Status Pricing. That's going to radically lower the price of drugs. With the GLP-1 example, for example, it's going to come down to $149 for the first three months. Other countries are going to pay more. We have been financing 60% of the R&D cost to pharma companies. Other countries need to pay their fair share. When it comes to this President, whether it be at NATO, membership fees or whatever, he wants to see other countries paying their fair share, and so we're getting that delivered.

Another big way in which we are going to lower drug prices is by cutting the red tape at the FDA for biologic drugs. So most, 51% of the... Let me back up for a second. The fastest area of health care spending growth is drug price spending growth. And the fastest area of drug price spending growth are a class of medications called biologics, which means you need a cell line to manufacture them. And so these are typically the 60,000, 100,000, $150,000 medications. They have generic versions called biosimilars. But the FDA red tape to get a biosimilar approved has been so long and arduous, it takes 5 to 8 years and $300 million or so. We have changed the requirements so that we use the same principles we use for small molecules. If you are structurally the same as a small molecule-branded drug, we're going to approve you with some other stipulations. And so we are reducing the cost of R&D of biosimilars by $100 million plus, and we are shortening the time frame from 5 to eight years to two and a half years or more. And so we're going to see a whole new class of biosimilars come out in this administration.

They're going to finally compete with the biologics. Now, Humera is one of the most famous biologics. It took years after that patent market exclusivity for a biosimilar to come out. And when one did come out, you didn't see the price of Humera come down that much, almost an implied price collusion. We need a lot of biosimilars to come out, and we're going to see the floodgates open up on biosimilars. Then, final point, why are a lot of drugs requiring a prescription? In the United States? What are we worried about? Somebody overdosing on anti-nausea medication or somebody picking up a prostate medication without a prescription? This is the paternalism in medicine, again, coming out, the same paternalism that blocked women from having home pregnancy tests because women can't handle that information. They have to come in and we have to share it with them. It's this paternalism you see, and by the way, it happened again with COVID testing. We saw it. Well, home COVID testing, we fought this battle. We wanted home COVID testing, and the establishment was like, No, we have to tell them. They can't have this information. Why are drugs not over the counter?

We're going to get more drugs over the counter. Let me tell you why that lowers drug prices. Because when a drug is on the shelf in a store, there's a price underneath of it. There is something magical with competition and people who shop, even if a small segment of the consumer market is shopping on price, it keeps prices in check for everybody. And so you will enable price transparency, and you will bypass the crazy money games of PBMs, pharmacy benefit managers. When you pick up something behind the counter, they ring you up, you have no idea the shell game that's going on behind the scenes with your employer is getting ripped off and your PBM is making money on this, and the broker who sold the PBM to the employer group could be making $6. 50 on every prescription set. For what? For the PBM just to tell you what your copay is going to be and set the copays? All of those money games disappear with the disinfectant of sunlight and a price on the shelf, we want to see a mass transition to more non-prescription drugs. We have new leadership that I brought in at the Office of Non-Perscription Drugs at the FDA.

We want to see companies request to be non-prescription, and it's going to have very simple criteria. If your drug does not have abuse potential, if your drug is safe, if your drug does not require laboratory testing, which doctors, we often need to check your liver function tests, or does not need to be closely tracked, it should be able to be over the counter. If you're not going to use the drug in some meth lab to make some dangerous street drug? If you meet those basic criteria, the drug should be non-prescription. Think about the number of useless ER visits out there. The whole medical industrial complex, to change everything every time you need a refill.

I got pink eye from my kids, and it was such a headache to get the drops, to get my pink eye to go away. I spent so much money just getting a few drops of antibiotics to put in my eye. But if I were able to buy that medicine, the antibiotic drops over the counter, and I could just pick it off the shelf, how do I get my insurance to pay for it? How does that process work? Just explain to the everyday consumer what that's going to look like.

We need insurance companies to modernize how they reimburse for medications. And we're having these conversations internally as well because they had this old construct of, Here's our reimbursement scheme for prescription drugs, and here's our reimbursement scheme for non-prescription drugs. Well, they got to modernize. We've got to come up to the 21st century. And remember, the insurance companies own the PBMs a lot of times, so we've got to be honest. We've got to all come to the table. President's bringing them all to the table and have a very frank conversations, and they've been successful.

I've got to imagine at 15% of GDP, this is a giant ship you're trying to reset and redirect. Can you get this done in this administration? Can you make the changes of moving many of these medications over the counter and get them to fit under insurance reimbursement plans?

It's a massive priority this year for me. One of my big 2026 goals is that we want to see more drugs move to non-prescription. If writing a prescription by a physician like myself is supposed to regulate and serve as a way to administer drugs judiciously, then history would show we failed. Opioids, OxyContin, 60% of antibiotics prescribed in the United States are unnecessary. That study has been done over and over again, 10 different ways. Most antibiotics people take, they should not be prescribed. We have to talk about educating people, trusting people, and get away from the paternalistic model of medicine.

Yeah. Well, I mean, look, if you guys get it done. I think it'll be a profound change for America for the price of health care, which I think is really challenging a lot of people on a day to day. One of the other things that's been a little bit of a hot button is pharmaceutical advertising on TV. Some people have claimed claimed that the pharmaceutical companies have significant influence over media because of the money they spend. They're one of the biggest spenders. I spoke to a pharmaceutical CEO about advertising. He said, The ROI is incredible. We've never been able to influence media, so it doesn't make a difference to us in that sense. But fundamentally, the reason we do it is because it gets awareness out there for therapies that patients might not know are available to them. He said this interesting statistic to me, which is that half of US physicians never see a representative to learn about new drugs that are coming market. Two-thirds of physicians report never reading a journal article or going to a conference in the past year. So they're not aware of some of the new medicines that have come to market or coming to market.

You've been a physician, you are a physician, you understand how this might go. You're busy, you're treating patients, you have a lot going on. Maybe you're not up to speed on the newest medicines coming to market. What's the administration? What's your view on advertising, pharmaceutical advertising on TV? Where are things headed?

Well, raising awareness, as your friend mentioned, is a good thing. But creating a misleading impression and creating a massive storm of demand where patients come knocking on our door, insisting and begging that they get certain medications that are not indicated for them is a problem. The drugs that they are advertising nonstop on TV, and they're always singing and dancing. Always singing and dancing or marching from some fake town to another. I don't know where they're going, but it's always this idea that life is great once you take this medication. It's the biologics that they're advertising. Because they charge so much on the biologics, and look, they do cost a lot more to make, but because some of these biologics have been so expensive, that's where they're seeing this big ROI. So we are lowering drug prices, and I think that's going to affect whether or not it's worth it for them to advertise. We have a duty at the FDA to enforce two regulations that were not enforced in the Biden administration, and that is that ads cannot create a misleading impression and that there has to be a fair balance of information. There's also a loophole called the Adequate provision loophole, which says you don't have to list all the risks or side effects.

You can put it somewhere else, like on a website. We're closing that loop. We're changing the regulation to close that loop. The Biden folks, the year before I came the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters, sent out zero enforcement letters. I sent out 1,500 enforcement letters, including over 100 cease and desist letters for ads that were creating a misleading impression, including online pharmacies that are advertising drugs without the same side effects that pharma companies list when they do the ads. And so we are cracking down on it. We want free speech, but we also want fair speech, and this is part of our jurisdiction. So we are taking this very seriously. I'd personally love to see pharmaceutical companies spend that 20 to 25% of their money that they spend on marketing, take some of that and use it to lower drug prices for everyday Americans.

Okay, great. Well, it sounds like there's some balance and change that's required. One of the other things that we talk a lot about in Silicon Valley is this shift in AI, in using AI to diagnose your condition. So many stories have come out where people upload their lab data or an MRI image, and they're getting readouts that they weren't getting from the doctor or more accurate readouts, or they're able to find care that they weren't finding through the traditional physician process. What's this administration's view on these AI tools? Are they a supplement, a replacement? And then how do we allow them to proliferate if they're good? And do they need to be regulated? Or are we going to end up regulating these AI doctors, these AI medical systems?

Well, first of all, AI is producing information at a rate that no one can keep up with. And so if we use the traditional regulatory mindset to say we have to make sure the information is accurate, then you wouldn't be able to do a Google search because you're going to get a hit that's going to give you something that's not accurate. And so what are we doing? What road are we going down? We can't outrun this lion. We have to use common sense and demarcate information that you're getting from AI that automatically triggers some health intervention, that is automated AI. And so last week at the Consumer Electronics Show, I outlined new guidances on AI decision support and wearables, and it creates a clear consumer lane. But if you're making medical claims of a medical grade blank, then that's something we're going to want to take a look at, and that's something you're going to want the FDA seal about. So it creates predictability, because developers tell me all the time, they just want predictability from the FDA. Markets want predictability, developers want predictability, and investors want predictability.

So wearables meaning heart rate, blood pressure. That's right. Glucose monitors, those sorts of things get deregulated, more accessible, lower price, and so on?

That's right. They're going to be deregulated. So you can give those results of any physiologic parameter. Pressure. But if you say that it's a medical-grade blood pressure, then we are going to want to see the data to make sure that it's validated with the gold standard blood pressure readings. We don't want people redosing their blood pressure medications on something that claims to be medical grade when it is not medical grade. Got it.

Okay. One other area I've spent some time in in my career is in alternative proteins. This is something that your agency regulates. So Making animal proteins, eggs and cheese and milk and so on, using bacterial or yeast cells rather than making them from the animal. You get the same protein, you just use a different mechanism of making that protein, or cellular meat, where they're actually growing the chicken breast or growing the beef. There has historically been a system called GRAS, or generally recognized as SAFE, that a lot of the companies have relied on as they've developed these techniques and these protocols. You've made a few changes. Maybe you can highlight the balance between innovation because the benefit of these systems, lower cost, less energy, and you take the animal out, less cruelty. That's an ethical driver for some of us.

Yes.

But I'd love to hear the view on balancing those benefits against the risks to consumer health. There's an incredible amount of lobbying pressure from ranchers and animal agriculture against these systems that I'm assuming is starting to make its way into DC. We've seen it make its way into states where they've outright banned cellular meat in some states. I'd love to hear your view on this alternative protein market and the changes you've made in grass and looking out for consumers against the benefits.

You're making me hungry because I love eggs, and I didn't get my egg breakfast this morning because we're out here in a bunch of meetings.

I'll get you some eggs afterwards.

Great. And not egg white only. I do not believe in egg white only. What are we doing? Egg white only eggs? That's the ultimate epitome of the old dogma. And by the way, my uncle, he came to the United States. He had eaten eggs every morning, and he loved eggs. It was his livelihood, it's the morning eggs. And he came to the United States in his 30s, and his doctor said, No eggs. Found out he was eating eggs and just wagged the finger and then it'll stop. And so for 30-some years, he had this miserable life without eggs until we finally got to him and said, It's okay. Two eggs in the morning is okay. It's a good source of protein. Don't worry about the saturated fat. He's now 95 years old, I believe, in Florida. And a happy man. Happy man eating his eggs in the morning.

I'm a 2-3 egg a morning guy as well. Oh, you are?

Yeah. Okay. It's a great source of protein. Yeah. On grass. Grass, for those who may not know, is a way in which companies have created chemicals or brought in chemicals from the environment, added it to food, and they could self-declare them as safe. And so it's a unique thing in the United States, and it was started with good intentions so that the FDA wouldn't regulate salt and butter. What are we doing regulating salt? I'm sure some people may want to, but we're not going to regulate salt. So grass was created for those things like salt. But then over time, it got abused. So all of these engineered chemicals would just get a free pass. And we've said, look at where we are today. You turn over the packaging of some of these ultra-processed foods, and there's 40 ingredients. Nobody knows what they are. And in Europe, they have basic principles of introducing chemicals. Basically, it's, if you will, guilty until proven innocent. That is, you have to demonstrate safety to be introduced. In the United States, we have this innocent till proven guilty. We have basically said, We have a thousand chemicals plus in the US food supply that are not allowed in other food system's supplies.

Fruit Loops was making cereal for Canada, where the petroleum-based dies were banned, and a different Fruit Loops for the United States for American kids. We've said we have to close the loophole on grass. We started the regulatory process to do that. Then we have to think about, creatively, those situations you mentioned where there may be ways to get more amino acids in some of these foods. We know that kids are low in amino acids and protein because of this myopic focus on fat as the boogie man. We have not gotten the protein that we need. Part of that was also flawed studies approximating how much protein your body needed that used urea-nitrogen levels. That massively underestimated the amount of protein metabolism in your body. Every food has different levels of protein bioavailability and amino acid bioavailability. That's why you said you're vegetarian. You have to think a little differently about the protein requirements. So all fun talk.

But the cellular meat industry, you don't think it's doomed? There's a potential for the industry, and it's going to continue to evolve?

We've seen under my time at FDA, we've seen new cellular food products come, not just meat, but seafood. It happens at the state level. The FDA actually does not have jurisdiction over what somebody creates, but we do ask for a registration, in a sense, to be in the loop.

Okay. What is causing autism in the United States? Yeah. There was a conference a few weeks ago, you and Secretary Kennedy talked about lucovoren as a new line of treatment for autism patients. But some people have since debated the merits of the data. Are we seeing rising autism rates in the United States, and what are the core drivers? What have you learned? Is this an ongoing process?

Well, there is more diagnosis for sure. But one in twelve boys in California now being diagnosed with autism. You didn't see that two generations ago. You didn't see the repetitive ticks and the self-harm. You didn't see that. You still don't see people in their 60s and 70s with those symptoms at the rates that you do in young kids today. So something It's going on for sure. Now, what's causing it? I don't know, but there's some interesting hypotheses. One is that for some kids, it may be an autoimmune phenomenon triggered by something where the antibodies are binding to the folate receptors, preventing taking folate from entering the blood-brain barrier, folate's necessary for neurodevelopment. And so some doctors report, and these are experts in the field, I've been studying this their whole lives and see a lot of patients, they have observed that if you give lucovourin as an example, which bypasses the blocked receptor, allowing methylated folate to get into the blood-brain barrier, they have seen clinical improvement. There's one study that's looked at the microbiome, which we now know produces This is a lot of molecules involved in brain health. 90% of your body's serotonin, which is involved in mood, is made by your gut.

We're just recognizing this giant frontier of the microbiome. In the modern world, we just torture the microbiome. I mean, so many things. Some things are necessary, like C-sections, not good for the microbiome. Infant formula instead of breast milk, not good for the microbiome. Antibiotics used like candy. The average two-year-old has already received over 2. 5 courses of antibiotics. It's carpet bombing your microbiome in certain places. What results is bacterial overgrowth, less biodiversity, and you have more inflammation later in life. When you have inflammation of the gut, the most painful thing in medicine is when a tubular structure stretches. A kidney stone, supposedly, is the most painful thing. I've never had one patient say it is. It's not the stone scraping along the lumen. It is the blockage causing distension, proximally stretching the ureth. That's what hurts. Gullbladder pain, stretching the gallbladder. That's what hurts like crazy. The GI tract with low levels of inflammation, is irritating that lumen and also causing this discomfort at a low level. For a kid, it may manifest as feeling sad or depressed. We give kids all these chemicals and ultra-processed foods. We alter their microbiome, and we change the production of what comes out of the microbiome cells normally.

That is, certain vitamins, hormone regulation, serotonin. And what are we doing? We're ignoring this physiologic cause, and we're drugging our nation's kids at scale. So we've got I wanted to talk about the value of the microbiome, and I would not be surprised if we had the research on that instead of just the DEI stuff we talked about. And study the microbiome the same way we were funding the Wuhan lab to study coronavirus manipulation. I think we could finally understand this great frontier of medicine that may be involved in autism. One study has found that if you give a certain protease, it's a A randomized trial. I couldn't believe it when I saw it because sometimes the studies are not reproducible. In JAMA, our most widely circulated medical journal, a randomized trial giving a protease to kids with autism and noticing an improvement. Now, again, it needs to be replicated. I don't know if it's real, but maybe there's something to the microbiome. I don't know what causes autism, but we have some clues, and this is something worth studying, not just, is there a genetic cure for autism? Yeah.

The underlying environmental contributors, there's just so much going on that's different in our environment and our food system that are also being addressed that over time, hopefully, will result in Maybe less of the general health effect caused by, call it an adverse environment.

Yeah, I mean, the number of proteins that we ingest that are denatured in some way, the number of chemicals or molecules that do not appear in nature that go down the GI tract. What's happening is you're getting an inflammatory response, but it's not a sudden acute inflammatory response. It's a low-grade response. It may be causing general body inflammation. The one thing I wish I would have learned in medical school is that most chronic diseases are from general body inflammation and insulin resistance. Heart disease, for example, most common cause of death in the United States. We thought it was just saturated fat. Three large studies failed to show that association. The The Minnesota Heart Study was supposed to be the end-all randomized trial in the 1960s. It showed the opposite of what they thought, the low-fat diet group. These are 9,000 Minnesotans randomized. Low-fat group had more heart attacks, not less. They suppressed the results for 16 years. When Gary Tobbs asked the senior author before he died, Why did you publish this for 16 years? He said, The results just didn't turn out the the way we expected. Well, other large studies failed to find this clear association between saturated fat.

We're talking about normal saturated fat intake, not massive overdosing. Normal saturated fat and heart disease. Anyway, so there are these things that we have to reevaluate.

Okay, last question. What's most exciting to you in the frontiers of science in human health?

We at the FDA try to be referees, so we see different technologies is competing. For example, sickle cell disease. There are monoclonal antibody treatments, and there are gene therapy treatments. Now, we tend to get excited about one or another, but the reality is we don't know which horse is going to win that race, and so we want to be the referees. I would like to see in the Trump administration during our term a cure for type 1 diabetes or some meaningful treatment for type 1 diabetes, a powerful treatment for ALS, treatments for certain kinds of cancer where we've seen now PD-1 blockers and K-RAS inhibitors melt the tumors away so you don't need surgery or chemo. You talk about a health reform. That's more powerful than a lot of the health reform ideas we have out there. You don't need surgery or chemo or radiation. I mean, think about the reduction in expenditures. We'd like to see a universal flu shot, so we're not guessing every year. Something that gives you lifelong protection against future strains because it targets a different part of the influenza virus. I'd like to see something powerful for PTSD. A lot of Americans are still suffering from PTSD, some from having served in a war.

These are young people oftentimes who stood up to serve their country, and they're suffering. We are still losing 7,000 plus veterans a year to suicide. So the wars are over, but our men and women keep dying, and many of these wars were unnecessary. I think we owe it to them to deliver a powerful treatment for PTSD if the data supports that there's something out there. So that's one of my personal goals.

You're optimistic about the pipeline you're seeing there?

Very optimistic. We're just seeing really interesting stuff. It's been published in part, so I'm not sharing anything here that's not public, but we've seen phase 2 trial results that are promising. And I go, Dave, to the scientific reviewers at the FDA without their bosses, just one on one. And I ask them, Are you seeing anything early on that looks amazing? Are you seeing anything in the pipeline, anything in animal studies that's actually working in animals that could extrapolate to humans in a way that could be a game changer? And I'd say 90% of the time they say, Nothing really that much of a leap. We do a lot of non-inferiority studies, for example. But every now and then somebody will tell me, Yeah, there's this mechanism. It's It's creative, it's different, and if it works, it'll be amazing. And we'll often issue that company a priority voucher. A treatment came out for a certain type of congenital deafness. That's a gene therapy device combination. It came out in the New England Journal of Medicine. We read the article, because we love to read these articles. That's our nature. We called the company and we confirmed.

About a dozen kids got it. A couple had normal hearing I mean, that's amazing. And so we immediately issued them a voucher, a new treatment for multiple myeloma. That was a game changer, three times better than anything out there now. Eighty % remission free survival, I believe it was at a couple of years out. There's nothing like that on the market. We called that company. We had internal discussions. Within 24 hours of that abstract being printed in the pre-conference materials for the American Society of Hematology, we had been in touch with that company issued them a voucher. What are we waiting for? What are we worried about? We have got to move at the speed that my patients demanded, not at government speed. So we are streamlining and modernizing the FDA, and we are not wasting time. We're getting stuff done.

Well, for that, I don't know how anyone could disagree with the sentiment, the intent. Thanks for the service. Thanks for the work, Marty. It's been great chatting today, and thanks for being with me.

Great to be with you, Dave. Thanks so much. I'm going all in. 'M going all in.