让新FDA提速：Marty Makary谈科学、权力与患者

Marty Makary, commissioner of the FDA. Welcome to San Francisco.

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

Thanks. It's the J.P. Morgan Healthcare Conference this week in San Francisco, considered probably the biggest and most important biotech conference globally. It's a very important week, so you're visiting this week for the conference?

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

Thanks for sitting down with me. You and I have gotten to know each other a little bit over the last year or so, and 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? Maybe we can go all the way back to your very outspoken views during the COVID pandemic, and how that brought attention to you and the philosophies that drove this role.

My interest in academia started when I went to graduate school for public health and served on the faculty of the Johns Hopkins Bloomberg School of Public Health, while also having a clinical practice in GI and cancer surgery at Johns Hopkins. My interest was always in the root causes of our healthcare system problems, from quality to transparency to price.

In my work on price, I led a national effort to try to get more price transparency for 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 and invited me in. In that first Trump administration, we had a lot of great conversations, and then they implemented the idea. I was so impressed. It made sense. We want common-sense ideas.

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 there. 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. It's been awesome.

COVID—you mentioned COVID—it was a crazy time. The sociology of medical dogma is a fascinating historical thing, and we still suffer from it: paternalism, the suppression of ideas that are not the legacy ideas, and the sacrificing of the basic principles of science—to question everything and have no sacred cows.

You saw the worst of that bad behavior during COVID: cloth masks on toddlers for 3 years, vaccine mandates for young college students, and recommending COVID boosters with such absolutism in young, healthy children. Ignoring natural immunity was one of the most scientifically dishonest things a scientist could possibly say about the virus and immunity, along with shutting kids out of school for nearly 2 years, which I fought tooth and nail, along with Jay Bhattacharya and others, starting in the fall of 2020.

Initially, we were okay with just doing stuff while we didn't understand it, but once the data emerged, we made a strong case to reopen the schools. To some degree, I feel like we lost that battle, but people now see that the data has caught up with public health officials. I'm proud to be in office now to be a part of an effort to rebuild public trust in our health institutions.

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

I meet with folks at the FDA, and if you meet with them with their bosses and everybody else in the room to get a briefing on a topic, then they give you one glowing story. But if you meet with one individual scientific reviewer and give them the safety of anonymity and say, “Look, I want to hear how it's going on the ground, or what big ideas do you have that you've always wanted to do but haven't been able to do,” 4 out of 5 people, or sometimes more, will not really give you anything interesting.

But then somebody will say, “You know, it makes no sense that we do it this way. We could do it better, and we could do it this way”—something they wouldn't feel comfortable offering if their supervisor were in the room. We've been running with these ideas.

We have announced 42 major reforms in my 10 months in office at the FDA, and it has challenged the status quo. 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 it's just become the status quo. We've got to challenge these deeply held assumptions.

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

And that was not the case before.

They talked about it for 30 years, and we got it done. They talked about banning food dyes for 35 years. Within weeks of coming into office, we took action to remove all 9 artificial petroleum-based dyes. We're getting stuff done. We're not afraid to move fast.

In that role, some people have left the FDA, and then they've been outspoken critics of yourself. Maybe you can respond to some of the criticisms that it's chaotic, that there's a lot of turmoil. I've worked at many startups, and I know that when you move fast, things 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 who have quit or left the FDA and provided 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. 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.

Anytime you do something in government, you take headline risk, but we felt it was the right thing to do. I came in right after that massive change. 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-one priority of the commissioner who preceded me, he said, was to fight misinformation. 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. I think every employee at the FDA knows that mission.

We have incredible teamwork. Our turnover rate is at the baseline of 5% to 7% that has been there for the last 10 years at the agency. So there's no exodus and no mass departures. We are actually hiring 1,500 new scientists because we have very ambitious goals for our new accelerated-type pathways. We're building up the 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 U.S. versus China. I want to read this report that came from the National Security Commission on Emerging Biotechnology. 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 U.S., according to this commission, has a 3-year window to act to keep up with Chinese innovation and the speed of biotech. In 2022, Chinese companies were just 5% of licensing deals. In 2025, it was 42%. Recently, one of the biggest licensing deals ever was 3SBio's deal with Pfizer: $1.25 billion up front, with $6 billion total.

China had, 10 years ago, only 50% of the published scientific papers of the U.S. Today, they have 50% more than the U.S. So I just want to walk through your view on U.S. biopharma innovation as it relates to China. Is there a race, and if so, what are the priorities for the administration in helping the 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 clocked by China, Australia, and other countries that were doing things more efficiently, with less red tape.

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 1s and INDs overseas.

That means we need to rethink our entire Phase 1 process. We have to convene hospitals. Part of the problem is outside the walls of the FDA. When hospitals have IRBs—institutional review boards that approve research—that meet monthly, you can run into serious delays. At Johns Hopkins, I had a study that took a year and a half to go through the IRB.

It was a survey. What were we worried about? It was a survey. It was a nutrition survey, and at the end of a year and a half, it was not approved. That kind of stuff is intolerable when we're competing with China, where they're doing Phase 1s in 4 weeks, and with Australia, which is doing Phase 1s in 6 weeks.

We need to have more centralized IRBs, and we need to streamline hospital contracting. Right now, if you want to do a trial, each hospital wants to negotiate the margin they want. Sure, they have to customize the contract because every study is different, with 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.” We have got to have more centralized contracting and a centralized IRB in order to compete. Those are big priorities.

We also have to reduce the red tape and regulation on our own INDs and phase 1 trials. 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. That kind of stuff is intolerable in the modern world. It 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 1 day. We’re going to use AI. 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 efficiency and turnaround time, how much can you do on your own versus how much do you need Congress to act—to pass legislation to support those changes? Are there priorities that you’re working with Congress on to try and accelerate drug-approval timelines that are necessary?

Right now, we have user fees, which means that if you submit an application, there’s a fee associated with it because there’s an unknown number of applications each year. It’s a system that’s been around for a while. I’d like to see those user fees much higher if your phase 1 is done overseas, and lower if it’s done in the United States. 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 1 goal was to make sure that morale was good, the culture was good, and the trains were running on time, coming in right after the restructuring.

I’m proud to report that in 2025, this past year, we hit 100% of our user-fee target dates. The trains were all running on time. 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 Evaluation and Research—another 9 drugs. We want to keep going hard and strong and innovate. The first goal in the first 9 months was to make sure the trains were running on time and that we were strong. I’m happy to report the FDA is strong and is going to continue to be strong.

Going back to this point about cutting down on timelines for phase 1, phase 2, and phase 3, maybe you can, for the audience that may not work in this industry, very briefly explain phase 1, phase 2, and phase 3, and then where we think there’s the biggest 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, or investigational new drug, application process. That’s step 1. Most of those are actually filed by academics, and 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 1 trial—typically a small number, a handful. Then you give the drug to subjects with the condition, and that’s a phase 2 trial. It’s a limited study. 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 2 pivotal trials for a drug to 1 pivotal trial for a drug. It’s just math. You can achieve the same statistical power if you design 1 good clinical trial properly with a good control group. That, by the way, saves like $100 million to $300 million for some companies and shortens the time.

We’re reducing animal testing. That’s the pre-IND, or pre-phase-1, work: 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 2 months ago.

Typically, 144 chimpanzees are used for a monoclonal antibody.

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. 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 requirement of 2 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. Ninety percent 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. We also have something called organ-on-a-chip technology, where you grow, say, 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.

They’re doing it in China.

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 had one pharma executive tell me, “Hey, I love that you’re going from 2 to 1 pivotal trial. 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 bias. 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 with incurable conditions, or being at the bedside in the ICU. When you do that, it has a profound impact on your brain and your soul, and you think about what we can possibly do to give this individual some hope. When I see a 10- to 12-year time period for 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.

We’ve got a new pilot program now to get decisions out in weeks.

It’s unheard of. It’s unprecedented.

We just announced the first medication 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. The criteria we chose are drugs in line with our national priorities: an unmet public-health need, such as a new, amazing cure for cancer where the tumor shrinks in front of your eyes and you don’t need surgery or chemotherapy. 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. That’s a massive priority for this president: lowering drug prices. So we have this pilot underway, and it’s going extremely well.

So the drug company gets a voucher if they qualify under 1 of those 3 criteria, and that gives them a fast track?

That’s right.

Yeah. And when will we get a readout on how that program’s going and whether it becomes standard?

Internally, it’s going great. I’ve got employees at the FDA telling me, “Gosh, I love this. It makes sense.” 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. The target date is about a year.

So if you’re an expeditious scientist, or you have the ability to do your work expeditiously and get your result in 2 weeks, it doesn’t matter, because the pharm-tox person—or whoever else is in another part of that—has until the day before. Guess when they’re going to submit it? The day before.

We are changing the incentives internally, the bonus structure. We’re changing the alignment. We’re changing the culture. Our goal is to streamline that process.

Going back to the computational point, we are collecting more data and digitizing that data on patients than ever before. That data should generally be accessible.

Is there a world where we can transition from phase 1, phase 2, and phase 3 trials into a phase 1, phase 2/3 model by taking into account all of this additional data? Some people have talked about using AI plus other health data that’s collected and allowing phase 3 to roll into phase 2, creating a much more expedited, computationally assisted approval process. Is that something that’s on the roadmap or being discussed?

Absolutely. There has been tinkering with combining phase 1 and phase 2—phase 1/2 hybrid trials—and phase 2 and phase 3 hybrid trials, approving something with a sort of preliminary approval after phase 2 if the results are really promising. 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, print it out, and have everybody look 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 and issues that start to emerge in certain populations?

It's almost as if the approval happens and then you find out years later that maybe there was an issue we should have caught sooner. If you move to a more data-driven, continuous observational system, can you have both faster approvals and faster recognition of safety concerns for specific populations?

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 at 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 submit another 50-page application to start your junior year. But that's what we're doing at the FDA.

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-efficacy tradeoff.” But why did we learn 5 years after Vioxx was approved that it may have killed 38,000 people? In the modern world, with 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 who are affected. There may be a drug-drug interaction.

You think about the opioid epidemic: 15 years of prescribing it, having no idea. I was guilty. I was doing this. I was prescribing it. My patients were getting addicted and coming back for refills. I thought it was a one-off thing. A lot of people come back and ask for refills. No, it was a national pattern we should have identified in big data.

We're going to do postmarket surveillance in a way like we've never seen before, using big data. If we get it right—and this is 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 about the example of putting the Waymos, or 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 occur. 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 who died in that same period of time. Fortunately, he was able to get the therapeutic, but think about all the people who 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, along with 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. Safety is our number one priority. We are here to safeguard the public. But having 144 chimpanzees undergo studies for 8 months has risks to the general public. Not identifying efficacy in a trial with Bayesian statistics early enough has risks, because that extra lag period is time when patients like those I treated at Johns Hopkins are told, “Sorry, we don't know of anything out there.”

Unnecessary time delays have risks, and I think that is something we don't think about enough at the FDA. At the FDA, we think, “Oh, we have this concern. Let's sleep on it.” You get a night to sleep on it, not 9 months.

I want to give a flip to this. The Right to Try law gives patients access to drugs when they're in a certain condition, allowing them to access the drug before it's gone through full approval. What's the current state of Right to Try? Where do you view that going? 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?

I believe in both the letter and the spirit of Right to Try. It's an amazing achievement of U.S. President Trump in his first term, and I have signed 100% of 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 and costs $3 million, with their churches 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 they 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're getting rid of some of the regulatory requirements for cell and gene therapy. Those are used for a lot of rare diseases, but we had requirements—what we call PPQ runs for batches. It's part of the manufacturing requirements for cell and gene therapies.

We were holding them to the same standards we were, say, for mass manufacturing of a pill. A cell or gene therapy can be developed in a lab at UCSF or Stanford. Are we going to require that they use the same broad manufacturing 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?

We had Baby KJ go home from the hospital early in our time there. This infant got gene-editing therapy. You can't do a randomized trial on that. There aren't enough kids who have it. For these bespoke therapies, we created essentially a novel pathway. Dr. Vinay Prasad 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.

Right. And what about CAR-T therapy? There's this blossoming class of therapeutics in CAR-T that's historically been used exclusively in oncology, for cancer. There's increasing discussion about using it for autoimmune conditions. Does this help with the CAR-T therapy pathway, enabling faster routes to market, 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, but the stuff that we have seen is mind-boggling.

So yes, and just for folks to understand, they take T cells, edit them, and put them back in the body. Those T cells go after targets in the body and destroy those targets. Many blood cancers are now seeing extraordinary results with these CAR-T therapies, and now they're going after autoimmune conditions.

But it definitely seems that there needs to be a faster path to market and lower cost, because the pricing is still half a million to a million dollars.

Yeah, it'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. We did find that, in the Biden administration, there was 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 infuse in Americans.

When I found out about that, we shut that thing down so fast. We have to do things carefully.

What else have you discovered since you've been in the FDA that shocked you? Just going on a side note for a second, I'm curious to know what the biggest shocks are. You've now been there for some time, and 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 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 lawyers said they couldn't email the information to the other center because each center was like its own secret government before we got there.

Each center of the FDA.

Same agency.

Yeah, same agency. Seven centers. It was like they had their own boundaries and territories, their own lawyers, and their own communications staff putting out their own releases and press releases. They did their own legislative affairs and scheduled their own hearings.

The commissioner was out of the loop sometimes. We restructured the entire agency, and now we've centralized those services. But in the days of this siloed world of the agency, by the way, it was a nightmare for developers that had a drug-device combination.

Right.

I mean, it was like gerrymandered lines determining what was included in one center versus another center, based on infighting. People had served long terms there. They'd served terms like President Robert Mugabe of Zimbabwe, who'd been there forever. These people just were there forever, right? It was just their way.

Anytime 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. We're onboarding 450 of them right now, and 50 of them have already started.

I met a guy whose job was to change the ink cartridge on one fax machine. Healthcare has single-handedly kept the fax industry alive. The guy's job was to be the ink guy for the fax machine, to swap out the cartridge.

Wow.

There's a lot of that.

Well, let's shift over to food. Maybe I'll 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 they weren't made before.

We've had decades 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 often curated by the food industry or by 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 eradicate natural, healthy fats from the U.S. food supply, ignoring that we replaced fats with refined carbohydrates, which are not healthy.

We have this carbohydrate-heavy diet now for American children. 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 and added sugar. Sixty to 70% of the calories of a child in America today are refined carbohydrates. No one has talked about it. It's been a blind spot, as the medical establishment has had this myopic focus on the boogeyman of saturated fat.

We had a food pyramid that was entirely backwards, so we flipped it upside down using good science and talking about a previously ignored area of nutrition: the importance of protein. We've been getting about half the protein that we need. The protein levels in the previous dietary guidance were really just enough to prevent withering away. We want our American kids to thrive, right?

Look at the status of kids today: low in protein, with muscle wasting and weakness, underperforming in school, and high in refined carbohydrates and added sugar, giving them that kind of 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 still at a desk for 7 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 reexamine the root causes. Flipping this food pyramid upside down and focusing on protein is the first step, and I'm very proud of what we were able to do.

What have you uncovered now that you've been inside the organization and can see the paperwork related to the legacy of how the old food pyramid was constructed and maintained for so long? What were the motivations, and 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 chance to do a deep dive and some investigative journalism, if you will, to learn how we got the dogma of what to eat so wrong. I think it was a lot of groupthink, just like we saw with “opioids are not addictive.” The medical establishment got that wrong for 15 years.

“Young kids should avoid peanut butter until they turn 3.” We got that wrong for 16 years—tragically wrong. It ignited the modern-day peanut-allergy epidemic because peanut-butter exposure in infancy reduces the risk of peanut allergies through something called immune tolerance, right?

We're the only country in the world with high rates of peanut allergies, along with the U.K. and a few other European countries that fell for our dogma-based recommendation to avoid peanut butter until the kid turns 3. 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 recognized natural immunity, you might not need to be fired from your job because you had 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.

We're trying to get back to gold-standard, objective science. It is crazy that the fundamental premise of science is that you ask a question and then test whether there's one answer or another. 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 hold ground, then great—let's maintain them. If they don't, we should be able to change them.

And then the word “science,” historically, has been used to justify not testing something.

That's right.

It's crazy to me. What roles have food companies played? What roles have people who might have an economic incentive in keeping the food pyramid as it was played historically? Is that permanently changed at this point, or is it changed while this administration is here and 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.

I think the industry did what the medical field told them to do, which was to address the risk of mass starvation, deal with food insecurity, and accept 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, so they moved to refined carbohydrates. They stripped the grains of fiber to mass-produce them. They would even chop them up, which made them increase your glycemic index—in other words, they basically function like sugar. You have cereals, breads, and pastas functioning like sugar.

We ushered in a generation of kids, and you and I were the first generation—the first generation in human history—with massive insulin spikes day to day in our normal, everyday lives. We've never seen insulin spikes to that degree. Of course, that drives something called insulin resistance.

The organs in your body that perform important functions are trying to block out all this extra glucose. They change the configuration of the insulin receptor to try to resist all this sugar coming in. It is at the root of almost every chronic disease: insulin resistance and systemic inflammation. 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 that you can have this if you sit on the treadmill for this amount of time. We've got to talk about the soil that food comes from, the farming techniques used for animal products, and the cleanliness and chemical-free waters that seafood comes from. We've got to talk about the importance of protein, the value of whole grains, and what we call real food.

The website is realfood.gov. My only criticism is the lack of vegetarian protein at the top of the pyramid. As a vegetarian, I eat eggs and dairy. It could use a few more nuts and beans up top, but I'll talk to Joe Gebbia about it.

It could. No, it could. I think The New York Times had a conniption about the blueberries.

The blueberries.

I think it was disproportionately—disturbingly—large blueberries.

That was the criticism. 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, are clinically obese in this country, and these incretin mimetics—GLP-1 drugs and others—have really taken the market and our population by storm.

I realize that much of this is in response to an obesity epidemic that we're facing in this country. But it turns out that these incretin mimetics may actually have other systemic benefits, and I think there are now 60 indications they're being tested against, including kidney, neurological, and cardiac conditions. There seems to be a lot of potential benefit 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—that 60% of Americans are going to be on? And if that 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 kind of blaming of children for not having the discipline. It's not a willpower problem. This is highly addictive, chemicalized food that's ultraprocessed, put in front of kids, and they want more. You put these vibrant colors in them from petroleum-based dyes. This is something adults have done to kids. So, I think that we have failed. We've given people the wrong information: calories in equals calories out, this demonization of fat, and all that stuff we talked about.

GLP-1s mimic a natural hormone in the body. When you get supplementation of that, it's doing the job of increasing satiety, slowing down GI motility, and it has a profound impact on a number of conditions because you are also reducing insulin resistance and systemic 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 to this positive thinking.

We've seen it in a breast and 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 positive thinking, and maybe that's one of the reasons we're seeing reductions in addiction. Maybe we're seeing cardiac benefits. 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.

Just to go back to the China point, because we did talk about competitiveness with respect to speed, the other piece I wanted to address was funding of research. That biotechnology council I mentioned recommended a $15 billion robust investment in research. When I meet with scientists, there's a view that the Trump administration is antiscience and 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 with the next set of molecules or therapeutic modalities that are going to change lives and improve lives. Maybe you can comment a little bit on whether we're funding enough scientific research through the government. What's the right steady state for us? And how do we address the points about the Trump administration being antiscience?

Yeah. Well, look, we live in partisan times now, where people get spun up and they're in toxic polarization. The truth is, if we want to know the facts, in the Trump administration, we have not cut $1 of NIH funding. We have not cut $1 from the general Medicaid budget—that is, the overall Medicaid fund. And 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 studying food as medicine, school lunch programs, the microbiome, and gut health. We've got to start talking about school lunch programs, not just putting every 6-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 antihypertensive medications. We've got to talk about environmental exposures that cause cancer, not just the chemo to treat it.

We want to see funding go to the root causes of diseases. That is something that has unfortunately been 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. I'm going to oversimplify it: the gene is responsible for our health problems, and the gene can solve all of our health problems.

I believe in gene therapy, and we're doing amazing stuff with that. But where's the research on why 1 in 6 girls today will develop an autoimmune disease? What's triggering that antibody response? Which 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 they are 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.

Right? 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. So is that not the fundamental truth, because the money is being reallocated to other scientists and other research institutions?

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

Fourteen percent of NIH grants went to DEI research, and NIH grants are about $40 billion a year. Does that sound right?

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.

Yeah, and increases access. But these grants were not doing it. They were just describing health disparities. 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 but haven't studied. At the FDA, we have put a big emphasis on the value of 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, food, the microbiome, and cutting-edge areas of science. They just had this myopic focus on one area. It's an important area, but it's one area.

They were funding the Wuhan lab to get bat coronaviruses and insert a furin cleavage site so it could infect humans. What are you doing? It's a bunch of mad scientists. Fourteen percent of grants were going to DEI. The NIH, when we came in, was a mess. Under President Trump, it is massively being reformed, and Jay Bhattacharya is doing a great job.

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

Great. He's great. Thanks for asking.

Yeah. And we talked about the hepatitis B vaccine, which we declined on the day he was born.

Because I started going very deep on the origin of the hepatitis B vaccine being given the day that a child is born. Why is this being given to them? We have no hepatitis 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 what you mentioned earlier, you take for dogma and recognize, “Wait a second, there may be some unfounded principles at play here. I should not be doing this.” And we make a difficult decision against the tide and the recommendations, and suddenly you're in social conflict with people around you, right? 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 the big changes were, and 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'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 hepatitis B-negative?” Within a matter of weeks of having broader conversations, you feel like you're a fugitive of the law, like you've done something terribly wrong for choosing not to vaccinate.

We went through the same thing, and having a kid is so special. We were talking about that. So, yeah, we just went through this. Our son was born about 6 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. With hepatitis B, you’re preventing an infection that is sexually transmitted or that you can get from bloodborne-pathogen exposure. 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 sort of anti-vax label, or—

Or you have to qualify it.

That’s right. I’m not an anti-vaxxer, but I’m asking this: What’s going on here? This sort of McCarthyism around this schedule—which, by the way, the United States vaccine schedule was an international outlier, with 72 doses recommended between the ages of 0 and 18.

So, President Trump asked us to review the international landscape of vaccine recommendations, and we looked at 20 other developed countries. We 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 around a group of core essential vaccines. We wanted to put that in front of the American people to say, “Look, all vaccines are still recommended by the CDC, but here is a list of core essential vaccines.”

So we gave them a list that constitutes about 38 doses from age 0 to 18. The idea is to increase vaccination rates among children, which 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.”

Thirty-eight is better than 0. 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 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, or the inconvenience.

Forty percent 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. What we should be doing is telling 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. You’re practicing substandard care, and women may tell other women that they can also get an ultrasound. We don’t want women getting an ultrasound instead. The paternalism that results in this disconnect is hurting people in the United States today.

With identifying the list of core essential vaccines, we are trying to meet people where they are at to see more vaccinations, because childhood vaccines have declined over the last 4 years of COVID. People have lost trust in the dogma of cloth masks for toddlers and vaccine boosters in perpetuity, and you have to fire a teacher if she already had COVID. Ignore natural immunity. 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 that 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 or to HHS anymore because they don’t know what they’re doing because they’re the Trump administration. They’re not doctors. They’re not scientists. Clearly, this is all political.”

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, take a very clear-cut scientific approach, and get people aligned around this? Do you do engagement on this stuff?

I don’t. 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.

And it’s a lot of character attacks.

I mean, it was put together by doctors with impeccable credentials. Tracy Beth Høeg, MD, PhD, a phenomenal epidemiologist who is deep on the science on this stuff. You know, all of us—Jay Bhattacharya, MD, PhD; Mehmet Oz, vice chair of surgery at Columbia University—I mean, these are impeccable credentials. Four hundred scientific publications.

I’ve published 350 scientific, peer-reviewed publications in my career. I’ve been at the Harvard School of Public Health, at Georgetown, and at Johns Hopkins. I’ve been on the faculty, I’ve had tenure, and I’m in the National Academy of Medicine. It didn’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 sort of 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. The anthrax vaccine was a disaster. H1N1 killed people. It was a disaster, and it was taken off the market. The rotavirus vaccine was taken off the market in 1999 because kids were dying from intussusception.

Rotavirus 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 rotavirus, the number of deaths per year went from 3,000 to 1,600.

Or round it up—let’s say 2,000. It went from 3,000 to 2,000 with mass vaccination.

And the vaccine that was used up until 1999 was taken off the market for safety concerns. So when you have a parent ask a question about the necessity, we cannot respond with absolutism. American medicine needs to show some humility.

When I had a patient ask me a question and I didn’t know the right answer, I’d say, “I don’t know. Maybe I’ll look into that. Maybe one of my colleagues knows.” In COVID, the right answer many times was, “We don’t know.”

Do you find that there’s a path forward?

I hope so. We’re hoping to restore gold-standard science and just talk objectively about it. We’ve had universities cancel, crush, censor, and railroad doctors who 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. So it’s not good for science.

Most great scientists start out as heretics, just to be clear, by the way.

That’s right.

Yeah. So, Marty, one of the other big challenges that we talk a lot about in this country is the cost of drugs. Healthcare today costs roughly 15% of our GDP. That’s an insane statistic, and it is rising year after year in the United States. It’s such a complex issue.

By some measurements, though, the price of drugs in the United States is almost 3 times what it is outside the United States. So I’d love to hear a little bit about the specific role of pricing drugs. What sort of 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 rip-off. You could buy a GLP-1 drug for $1,300 in the United States and go to London, where it sells for $88. Or 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 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-favored-nation pricing. Thanks to Dr. Oz, Chris Klomp, 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-favored-nation pricing. That’s going to radically lower the price of drugs. With the GLP-1 example, it’s going to come down to $149 for the first 3 months. Other countries are going to pay more. We have been financing 60% of the R&D cost for pharmaceutical companies.

Other countries need to pay their fair share. When it comes to this president, whether it be 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. Let me back up for a second. The fastest area of healthcare spending growth is drug-price spending growth, and the fastest area of drug-price spending growth is a class of medications called biologics, which means you need a cell line to manufacture them.

These are typically the $60,000, $100,000, or $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 that 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. We are reducing the cost of R&D for biosimilars by $100 million or more, and we are shortening the timeframe from 5 to 8 years to 2 and a half years or more.

So we’re going to see a whole new class of biosimilars come out in this administration that are going to finally compete—

With the biologics.

Humira is one of the most famous biologics. It took years after the patent and market exclusivity for a biosimilar to come out, and when one did come out, you didn't see the price of Humira 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.

And then, a 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 paternalism in medicine coming out again—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—home COVID testing. We fought this battle. We wanted home COVID testing, and the establishment was like, “No, 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. And let me tell you why that lowers drug prices. When a drug is on the shelf in a store, there's a price underneath 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.

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. Your employer is getting ripped off, 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. 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 nonprescription drugs. We have new leadership that I brought in at the Office of Nonprescription Drugs at the FDA. We want to see companies request to be nonprescription, 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, as doctors, we often need to do to check your liver function tests—it 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 nonprescription.

Think about the number of useless ER visits out there. The whole medical-industrial complex cha-chinging 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 up 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. We're having these conversations internally as well, because they had this old construct: Here's our reimbursement scheme for prescription drugs, and here's our reimbursement scheme for nonprescription drugs. They've 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.

We've got to be honest. We've got to all come to the table. The President's bringing them all to the table and having very frank conversations. And he's 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 nonprescription. 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 and 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 should not be prescribed. So we have to talk about educating people, trusting people, and getting away from the paternalistic model of medicine.

And, well, look, if you guys get it done, I think it'll be a profound change for America and for the price of health care, which I think is really challenging a lot of people 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 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: Half of U.S. physicians never see a representative to learn about new drugs that are coming to market, and 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 are 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's view on pharmaceutical advertising on TV? Where are things headed?

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 are always singing and dancing, right? 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. They charge so much for 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.

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 2 regulations that were not enforced in the Biden administration: Ads cannot create a misleading impression, and 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 loophole. We're changing the regulation to close that loophole.

The Biden folks, in the year before I came to the FDA, sent out 0 enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out 0 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 ads that are advertising drugs without the same side effects that pharmaceutical companies list when they do the ads.

We're cracking down on it. We want free speech, but we also want fair speech. This is part of our jurisdiction, so we are taking this very seriously. I'd personally love to see pharmaceutical companies take some of the 20% to 25% of the money they spend on marketing and use it to lower drug prices for everyday Americans.

Okay, great. 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 and 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 or a replacement? And then how do we allow them to proliferate if they're good? Do they need to be regulated? Or are we going to end up regulating these AI doctors, these AI medical systems?

First of all, AI is producing information at a rate that no one can keep up with. 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.

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 autonomous AI.

And so, last week at the Consumer Electronics Show, I outlined new guidance on AI decision support and wearables. It creates a clear consumer lane. But if you're making medical claims of a medical nature, that's something we're going to want to take a look at, and that's something you're going to want the FDA's 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, glucose monitors, those sorts of things—get deregulated, more accessible, lower-priced, and so on.

That's right. They're going to be deregulated. So you can give those results for any physiologic parameter. But if you say that it's a quote-unquote medical-grade blood pressure, then we're going to want to see the data to make sure that it's validated against the gold-standard blood pressure readings. We don't want people redosing their blood pressure medications based 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 my career is alternative proteins, and this is something that your agency regulates. This means making animal proteins—eggs, cheese, milk, and so on—using bacterial or yeast cells rather than making them from the animal. You get the same protein, and you just use a different mechanism to make that protein, or cellular meat, where they're actually growing the chicken breast or growing the beef.

Historically, there's been a system called GRAS, or generally recognized as safe, that a lot of companies have relied on as they've developed these techniques and protocols. You've made a few changes. Maybe you can highlight the balance between innovation and the benefits of these systems: lower cost, less energy, taking the animal out, and less cruelty. There's an ethical driver for some of us.

There's an incredible amount of lobbying pressure from ranchers and animal agriculture against these systems, and I'm assuming that's starting to make its way into D.C. We've seen it make its way into states where they've outright banned cellular meat. So I'd love to hear your view on this alternative-protein market, the changes you've made in GRAS, 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 at a bunch of meetings.

I'll get you some eggs afterward.

Great. And not egg-white only. I do not believe in egg-white-only. I mean, what are we doing? Egg-white-only eggs—that is sort of the ultimate epitome of the old dogma.

By the way, my uncle came to the United States. He had eaten eggs every morning, and he loved eggs. It was his livelihood, his morning eggs. He came to the United States in his 30s, and his doctor said, “No eggs.” He found out he was eating eggs, wagged his finger, and told him to stop. So, for 30-some years, he had this miserable life without eggs until we finally got to him and said, “It's okay. 2 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.

A happy man.

A happy man eating his eggs every morning.

I'm a 2-to-3-egg guy as well.

Oh, you are? Okay. It's a great source of protein.

GRAS, for those who may not know, is a way in which companies have created chemicals or brought in chemicals from the environment, added them to food, and could self-declare them as safe. It's kind of 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 GRAS was created for those sorts of things, like salt, but then over time it got abused. All of these engineered chemicals would just get a free pass.

We've said, “Look at where we are today.” You turn over the packaging of some of these ultraprocessed foods, and there are 40 ingredients. Nobody knows what they are. In Europe, they have basic principles for introducing chemicals. Basically, it's, if you will, guilty until proven innocent: You have to demonstrate safety before something can be introduced. In the United States, we have this innocent-until-proven-guilty approach.

So we've basically said that we have 1,000-plus chemicals in the U.S. food supply that are not allowed in other food supplies. Froot Loops was making cereal for Canada, where petroleum-based dyes were banned, and a different Froot Loops for the United States, for American kids. We've said we have to close the loophole on GRAS. We started the regulatory process to do that.

Then we have to think creatively about those situations you mentioned, where there may be ways to get more amino acids into some of these foods. We know that kids are low in amino acids and protein because of this myopic focus on fat as the bogeyman. 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 urinary nitrogen levels, which 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, as you said, you're vegetarian—you have to think a little differently about your protein requirements.

But the cellular-meat industry—you don't think it's doomed? There's potential for the industry?

It's going to continue to evolve. We've seen, under my time at the FDA, new cellular-food products come—not just beef, but seafood.

Yeah.

It happens at the state level, and 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. So, what is causing autism in the United States? There was a conference a few weeks ago. You and Secretary Kennedy talked about leucovorin 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? What are the core drivers? What have you learned? And is this an ongoing process?

Well, there is more diagnosis, for sure. But 1 in 12 boys in California are now being diagnosed with autism. You didn't see that 2 generations ago. You didn't see the repetitive tics and self-harm, and 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's going on for sure.

What's causing it? I don't know, but there are some interesting hypotheses. One is that, for some kids, it may be an autoimmune phenomenon triggered by something, where the antibodies bind to the folate receptors, preventing folate from crossing the blood-brain barrier. Folate is necessary for neural development. Some doctors report—and these are experts in the field who have been studying this their whole lives and see a lot of patients—that if you give leucovorin, as an example, which bypasses the blocked receptor and allows methylated folate to get into the brain, they have seen clinical improvement.

There's 1 study that's looked at the microbiome, which we now know produces a lot of molecules involved in brain health. Ninety percent 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.

And in the modern world, we just torture the microbiome. Some things are necessary, like C-sections, but they're not good for the microbiome. Infant formula instead of breast milk is not good for the microbiome. Antibiotics are used like candy. The average 2-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 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 is supposedly the most painful thing. I've never had one; patients say it is. It's not the stone scraping along the lumen. It is the blockage causing distension proximally, stretching the ureter—that's what hurts. Gallbladder pain is stretching the gallbladder—that's what hurts like crazy. And the GI tract, with low levels of inflammation, is irritating that lumen and also causing this sort of discomfort at a low level. For a kid, it may manifest as feeling sad or depressed.

And so we give kids all these chemicals and ultraprocessed foods. We alter their microbiome, and we change the production of what normally comes out of the microbiome cells: certain vitamins, hormone regulation, and serotonin. What are we doing? We're ignoring this physiologic cause and drugging our nation's kids at scale.

So we've got to talk about the value of the microbiome. I would not be surprised if we had the research on that, instead of just the DEI stuff we talked about, and studied 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 found that giving a certain protease can help. It was a randomized trial. I couldn’t believe it when I saw it because sometimes studies are not reproducible. In JAMA, our most widely circulated medical journal, there was a randomized trial giving a probiotic to kids with autism and noticing an improvement. 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 whether there’s a genetic cure for autism.

And the underlying environmental contributors—there’s just so much going on that’s different in our environment and in our food system that is also being addressed and, over time, hopefully will result in maybe less of the general health effects caused by, call it, an adverse environment.

Yeah. 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, and 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, is the most common cause of death in the United States. We thought it was just saturated fat, but 3 large studies failed to show that association. The Minnesota Coronary Experiment 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 were 9,000 Minnesotans randomized—the low-fat group had more heart attacks, not less.

They suppressed the results for 16 years. When Gary Taubes asked the senior author, before he died, “Why didn’t you publish this for 16 years?” he said, “The results just didn’t turn out the way we expected.”

Well, other large studies failed to find this clear association between normal saturated fat intake—not massive overdosing—and heart disease. So anyway, 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?

You know, we at the FDA try to be referees. We see different technologies competing. For example, in sickle cell disease, there are monoclonal antibody treatments and gene therapy treatments. We tend to get excited about one over the other, 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. I’d like to see a powerful treatment for ALS, and treatments for certain kinds of cancer where we’ve seen PD-1 blockers and KRAS inhibitors melt the tumors away, so you don’t need surgery or chemotherapy. You talk about health reform—that’s more powerful than a lot of the health reform ideas we have out there. You don’t need surgery, chemotherapy, or radiation. 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 also 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 are suffering. We are still losing 7,000-plus veterans a year to suicide. 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. That’s one of my personal goals.

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

Very optimistic. We’re 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.

Yeah.

Without their bosses, just one-on-one, 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?”

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 creative. It’s different. And if it works, it’ll be amazing.” We’ll often issue that company a priority voucher.

A treatment came out for a certain type of congenital deafness. It’s a gene therapy-device combination, and 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—and we called the company and confirmed that about a dozen kids got it. A couple had normal hearing. I mean, that’s amazing. So we immediately issued them a voucher.

A new treatment for multiple myeloma was a game changer—3 times better than anything out there. It was 80% progression-free survival, I believe, at a couple of years out. There’s nothing like that on the market. We called that company and had internal discussions within 24 hours of that abstract being printed in the preconference materials for the American Society of Hematology. We had been in touch with that company and issued them a voucher.

What are we waiting for? What are we worried about? We’ve 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, I don’t know how anyone could disagree with the sentiment or 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.