Dr. Marty Makary Reveals How He’s Transforming the FDA

One of my first actions at FDA was to remove all pharma and industry members of FDA advisory committees wherever statutoily possible. That's because the scientific evaluation process has to be impeccably independent. In this exclusive interview, I spoke with FDA Commissioner Dr. Marty McCary about his first 100 days in office and how he's reforming the agency. There's a routine animal testing requirement with drugs. It turns out that 90% of drugs that pass on animal testing do not pass in human studies on safety and efficacy. We discuss everything from illegal Chinese vaping products to food guidelines to supply chain vulnerabilities and we address criticism of some of the FDA's recent decisions surrounding vaccines. For people who think that we approved a COVID vaccine for say healthy children, that's incorrect. That's not true. We're no longer going to push these co vaccines in healthy subjects. This is American Thought Leaders and I'm Ya Kellik. Marty McCary, such a pleasure to have you back on American Thought Leaders. Great to be with you, Yan. 100 days on into your job, going to ask you a bunch of questions. Yeah. And the big one that I have is, you know, what's it like to take on a massive agency like this at the outset? Was it obvious to you what you were going to do? Was it clear how it was all working? Did you step into something that was, you know, obvious somehow or was it just uh, you know, figure it out as you go? You know, it was a range of emotions. I was in the operating room the day before my Senate confirmation hearing to become the FDA commissioner. And when I walked into the FDA, there was a lot that surprised me. I'm I'm in both directions. Uh I'm continue to be in awe of the regulatory authority of the agency. It regulates 20% of the US economy. There's a tremendous amount of good that can be done at the FDA because the F stands for food. It doesn't stand for federal as some people might think. And so drugs is just a part. The FDA is working on addressing illegal Chinese vaping products that are affecting children. It authorizes and regulates microwave ovens and cat scan machines. It is involved in the safety of the food supply and it's involved in drugs and devices as well. So, uh there's a huge range of opportunities at the FDA. I began by doing an assessment of where the biggest reforms are needed. I continue to be impressed by the scientists at the FDA, many of whom are dedicated scientists who who just want to do what's right and do what's good. Uh we learned about some things that were happening at the FDA that should have never been happening. So there's a lot of opportunities to reinvigorate the culture, get back to the core mission of the agency. The last commissioner stated that his number one priority at the FDA was to fight misinformation. Well, my number one priority is to get back to accelerating and delivering more cures for the American people, to deliver meaningful treatments, powerful diagnostics that educate people about their own health, and a healthier food supply specifically for children. And if we do all that well, we can rebuild the public trust because public trust has been in dire straits in American public health over the last four years. If you look at the reasons why people don't trust doctors and hospitals, it's not because some of us were pointing out that there's a thing called natural immunity or we were pointing out that there's a risk of myocarditis with the co vaccines. It's because public health officials did one of the most dangerous things you can do as a physician, and that is insist that people do things with an absolutism when the data was really not that definitive. And over time, you do that again and again with insisting that kids, including toddlers, wear a mask for over 3 years, insisting that schools stay shut down for a year and a half, insisting that every teenage boy should be getting a COVID booster, ignoring the risks of myocarditis, insisting that young, healthy people were at high risk of COVID uh mortality when the data didn't support it. Um, you do that over and over and over again and you get yourselves into trouble. And that's what happened with public health officials. I mean, look, they'll say, "We're trying our best." No, they were insisting that soldiers and teachers and firefighters be fired from their jobs. They had circulating antibodies from natural immunity, but they were antibodies the government did not recognize, and they wanted them fired because they would not be obedient to the vaccine mandate. So, we're we walked into a um situation where public trust was at record lows. Wasn't just at the FDA. The NIH had 14% of its grants going to descriptive studies on health equity and and diversity. Um now, if those studies were reducing gaps in health and equity, that would be great, but they weren't. They were descriptive studies and they were funding a lab in China that may have killed 20 million people and cost $25 trillion. What were we doing? What where are the studies on food as medicine and the school lunch programs and the chemicals in our food supply and the environmental exposures that that cause cancer, not just the chemo to treat it. So that we have had this myopic perspective in the medical establishment from our government over years. And so we're working to try to get back to science and away from medical dogma. One of the tasks that we're doing is to rewrite the broken food dietary guidance, the broken food pyramid. It basically written by industry, not because of they had a sense of what was medically best for you to eat, but they had a sense of what they wanted you to buy. And so was written by lobbyists and stakeholders. We're getting back to gold standard science and common sense. And that is a charge from Secretary Kennedy. From this White House, we're focused on everything from reducing the price of drugs, uh, lowering the cost of medications for everyday Americans to increasing our national security by domesticating manufacturing. We've got a broad agenda. We've done work to reduce animal testing. Uh, so we've done a lot in these first 100 days. Happy to chat about you with any one of those uh things, but we've been busy and we're just getting started. I I I want to talk about a great many of those things that you just mentioned, but let me you mentioned at the FDA there's some things that should never have happened. Can you give me a few examples at the FDA of what those are? Well, the FDA sat on data on myocarditis risk with the mRNA COVID vaccines in young men. They they literally slowwalked any action on that data. We we got all the details. We found out that the FDA in the prior administration had approved gene therapy in Americans whereby the cells were gene edited in Chinese labs. Literally the cells were taken from Americans, sent to Chinese labs where they were genetically altered and then shipped back to the US where those cells were infused back into American patients. When we found out, we said, "Let's put a halt on this there." So there was a lot going on, but I think also um the agency needed to refocus its mission on delivering a stamp of safety and efficacy on drugs and devices and ensuring a safe food supply. uh we have inspectors, law enforcement officials, thousands of scientists and I think um this is a good time for for us to rehone and refocus on that core mission of the FDA. Well, so since you mentioned the mRNA uh product, this is one of the big contentious issues, right, that that a lot of people have opinions on around me. Absolutely. and frankly in very in in very different directions. Yes. You know, and one thing that was surprising to many uh of the people I know who were um I think in involved in the what would be called the Maha movement was the authorization of Spike from 6-month-old to 11year-old children, you know, high-risk children. But if you could clarify what that situation is and also um you know explain why this might be done. Yeah, I'm glad you asked Young because we are officially pivoting away from the rubber blindly rubber stamping co vaccines each year and we've made that clear in guidance in the New England Journal of Medicine. So we have a situation whereby we would love these companies to run a proper randomized control trial. And so if you um do nothing, if you reject the co vaccines as they come to you for approval, then you have no leverage uh to be able to ask the company to do that. And those studies may never be done. We we don't commission studies at the at the FDA. These are gigantic and expensive studies that I think in my opinion desperately need to be done because a parent is curious, does their 12-year-old girl really need a booster every year for the rest of her life? And I would like the data to come out to tell us what the truth is. Now, I have a pre-est hypothesis of what that truth will be, but we'd like a clinical trial done. So we basically said we're not going to approve COVID vaccines in low-risk and healthy Americans without a randomized control clinical study first. We want to see that first. Now in the situations where you've got a kid with imunosuppression from HIV and a cancer therapy with chemotherapy where they are have an incredible immune susceptibility and their doctor feels like they would benefit from a co shot. We're sticking to the promise of Secretary Kennedy that we're not going to take anyone's vaccines away from them and if you want a vaccine you can get a vaccine. But uh in saying that we are going to be okay with the co vaccines in high-risk Americans which is a much more limited indication. We now can ask the companies that uh this approval comes on the condition that you were going to run a proper randomized control trial so we can get the final answer this year because it's been four years since the last randomized control trial. Back then the vaccine was a better match with the circulating strain. We didn't have a good grasp on the safety of mRNA vaccines like we now do with myocarditis in young people. So uh for people who think that we approved a covid vaccine for say healthy children that's incorrect that's not true. It is for those high-risk exceptions where a doctor feels strongly and as a matter of fact as uh already echoed uh the views of others in in saying that we're no longer going to push these co vaccines in healthy subjects. There's been a number of studies that have been done and I think just observational at this point um that there there appears to be something going on with these mRNA products and the immune system right and it's I I I haven't seen any kind of you know definitive answers there however there seems to be all sorts of very concerning signals which people are pointing to whether it's you know incre increase in rare cancers maybe some sort of deregulation who knows have you been following ing this uh and and and how does that fit into what you're telling me here? Yeah, I do follow it and the FDA does follow it. So, let let me be clear. These adverse event reporting databases that we've had are too clunky to make any inferences about rates. So, when we have concerns about something in the field, we need a proper study. And that's what we're begging for. We want to see a proper study. Be it done by the NIH or the companies or both. We want to see good data. Now, so this is a common situation. The FDA and CDC has a very clunky database where you were supposed to go in there and say that you've been harmed from a vaccine. Well, we have seen preliminary data from our look under the hood when we came in that most people who start reporting on those adverse event reporting systems give up. The the website's just too gnarly. It's too complicated. It takes too long. It's not userfriendly. the interface is poor and so how on earth can we derive conclusions about rates in both directions? How can we say, "Oh, well, we have very few vaccine injuries in this in this database." Um, even though it's a self-reported database, well, people are giving up that you're not capturing. And we did our own analysis of myocarditis and under my leadership, we just issued a strong warning label on myocarditis. Um, but there are other things we have to look at, and we have to do it systematically. Um, also like if if people have reported uh injuries that were not injuries on that database, it's very difficult to to understand what's actually going on without the circumstances. So, I'm just saying in both directions, these clunky adverse event reporting databases are not good. They can occasionally give us a signal in the data that is a screening tool, basically a flag that hey, maybe there's something here. And that's what that's what needs to trigger a more definitive analysis in big data. So, we're committed to that. We're committed to that. And I don't want people to think that, you know, we're blowing off the safety signal that many people have described. I personally know of people who have been injured by the vaccine. I personally know of friends who have lost a loved one from the mRNA COVID vaccine. So I think it is reasonable at this time to say we want good solid definitive data and the conditional limited approval of the co vaccines is in that framework that we want to see a proper data set come to us so we can take a good look at that data. Do you have a sense of how long that might take? like let's say we began soon because the I mean these are these are the types of questions that that that people I'm hearing from are asking and yeah and look I I think it's good people are asking this um I think within the next six months these trials can be done now the question is is that sufficient to look at safety signals with a host of potential outcomes and I would say we can do both we can look at the clinical trial that is a randomized control trial and continue to have eyes on not just the co vaccines but any new FDA product in real time for an extended period of time. We shouldn't be learning 19 years after Oxycontton was approved that it may have killed nearly a million people. We shouldn't be learning about 5 years after Vio was approved that it may have killed up to 38,000 Americans. we should have eyes on a product immediately. That means in real time and that means now for these co vaccines. So um look, we've taken action on warnings on safety. Uh we've limited the indication. We're continuing to look hard at it and we want to do this with the proper scientific methodology. And so that's been our approach. We want to approach this methodologically, get the right data in and be able to make conclusions rather than, you know, opinions dominate this vacuum, this void of inadequate data. We want data to fill that void. Let me and let me touch a little more on on something you mentioned. You mentioned you're aware of some people who have been injured and even lost a loved one through these mRNA products. Um there's a kind of a a whole movement of people. Um, for example, you know, React 19 is, I think, the most prominent nonprofit that that is acting to help people who have been injured or or believe they have they have been injured. And is is there any action being taken to try to help them? I know that, you know, as we're recording here, there's about to be another hearing related to um, you know, the experiences of those people and and the the prospects of them getting help because that in in many cases they were not given it. Yeah. Well, first of all, vaccine injury is real. I I do believe that. I also think there were some cases of longco mis ascribed to long co when they may have it may have been simply vaccine injury. Now, I'm not saying that's all of them. I don't want people to read too much into that, but I would like people to be patient with us as we try to approach this methodologically collecting the proper data. It is easy to react. I was I was very angry when I learned that a friend's father had died from the COVID vaccine. And look, we we're convinced it was causal until proven otherwise. You can always nitpick and say, well, there this could have been a random event, but no, the um there are many reasons why we are confident that it was causal. Now, when I say we, not the FDA, but me and my circle of friends and loved ones who know this individual who lost their father. So um it is people have a right to be angry. They have been deceived on different aspects of the COVID pandemic. Uh they have been ordered to march into a vaccine line even if they were healthy and low risk and already had circulating antibodies. People have a right to be upset but I would ask people to be patient with us as we do this the proper scientific way. Well, so why don't we jump to another uh question? What would you think is the most impactful thing you have been able to accomplish thus far uh at the FDA 100 days in? Well, gosh, we've we've done a lot towards our goal of using gold standard science and common sense to deliver more cures for Americans and healthier food for children. So, for example, one of those things is we took action to reduce animal testing. There's a routine animal testing requirement with drugs and it turns out animal testing is not very good in predicting toxicity in humans. It turns out that 90% of drugs that pass on animal testing do not pass in human studies on safety and efficacy. So computational modeling now is getting more mature where where a a computer can analyze a molecule that is the drug and predict whether or not it's going to cause injury to organs and toxicity to a human and so that computational modeling is premature especially in certain areas of medicine like monoconal antibodies. So we have a pathway. It's a roadmap now on FDA's website to reduce animal testing towards an ultimate elimination of animal testing if we can get there. Now um this has a lot of implications. One, it does the right thing by sparing animals as the subject of drug testing when we have computational modeling and something called organ on a chip technology. That is you can test a drug in a cell culture medium of liver cells or heart cells and watch the cells react. Are they being injured? Uh there are things called organoids or mini organs and you can actually see whether or not the drug is causing some uh damage to the organ. And using both that technology and the computational modeling you can actually get a toxic toxicity predictive uh value that it may be better than the animal testing. We also found that animals were being uh used for drug testing when the drug was already approved in Europe and used in humans. That we got to use common sense. Okay. Um, if we do this well, it can lower research and development costs, lower the barrier to entry into the FDA approval process, lower capital costs for that research and development, which could translate into lower drug prices, and it could speed up approvals because those animal tests can take a year uh, six months to a year. So, we think there's a lot of benefits. That's just one of the things we did. We also gave our scientific reviewers a powerful AI tool. We are piling piloting a new pathway to get a decision out to companies a couple weeks or several weeks after the final application is submitted to us instead of nearly a year. Um, and we're asking ourselves, what red tape in the system can we cut without cutting any corners on safety? Why does it take over 10 years for a drug to come to market? Why are we wasting idle time in that drug approval process when a clinical trial is taking place? We now are saying we'd like to see in this pilot program the lion share of the application that talks about the manufacturing and the label and uh the marketing materials all the stuff in an FDA application we can start reviewing while the clinical trial is taking place. We can use that idle time to speed up approvals without cutting corners on safety. And then once the trial is complete, we get those endpoints immediately, convene and render a decision. So there's a lot we can do more efficiently. We can run more continuous trials. The idea now is you you do a step and submit an application, do another step, resubmit a uh another application, you do phase one, phase two, phase three. You wouldn't apply for college after every year of college. And we're saying, can we use more common sense in the approval process that, let's be honest, was developed in the 1960s, we can do better. When you have a rare or debilitating or uh severe neurodeenerative condition that's otherwise hopeless, maybe they believe in the spirit of right to try. And I believe in the president's letter and spirit of right to try that he's been talking about. And so we can operationalize that while still safeguarding the public against false claims and dangerous drugs. So drug pricing is also something that's been very important to the president. Maybe you can tell me what you know where things have come with respect to this issue. Yeah, look, the president does, our this president, President Trump, does not like to see Americans getting ripped off. And the fact that the same drug in the United States is half or a fifth or a tenth the price in England or Germany or France is the great American ripoff. And that should enrage anybody that believes in this country. So, uh, we have a charge from the president to address this great American ripoff. And that means that Medicare and Medicaid under me Oz is going to be working closely with the drug manufacturers to ensure we get the best price. We deserve the most favored nation pricing because we're the largest purchasers of these drugs and we finance their research and development. I mean the majority we we finance more research and development on drugs than any other country in the world. Are we subsidizing lower prices for other countries? And I don't even blame these drug companies. I blame these other countries that um are trying to get a uh price that's below um what we are getting and then they're shaking down these drug companies. And so just like with NATO, just like with the WHO fees, just like with membership fees and any other international organization, other countries have not been paying their fair share and this president would like them to pay their fair share. Um research and development costs are about 20 to 25% roughly of the uh money that drug companies have of their expenditure. Well, direct to consumer ads might be more. They might be 25% of the budget of these large companies. So, there is room there to offer better pricing for Americans and to end this great American ripoff. We have a role at the FDA. The FDA does not directly set drug prices, but it's something I've been passionate about for a long time. And there is something we can do. We can approve more generics and bioimilars. Bioimilars are basically generics for these biologic infusion drugs that you see on commercials are running all the time. They're always dancing and singing. And so those drugs have generic versions. We call them biologics. And so um we can reduce the red tape to get more generics and biologics and more competition which will lower drug prices. We also have this national priority review program that is this sort of expedited review. And um one of the criteria uh as to who will get a national priority voucher which is designed by the way for companies acting in our national priorities is to reward companies that equalize their price with other OECD countries. Um, other criteria include companies or drugs that are meeting a large unmet public health need. Another criteria is the domestic manufacturing of drugs. We'd like to see more manufacturing in the United States. We'd like to see more APIs in the United States. It's a national security issue. Well, so let me jump in on that because the last I checked it's still something like 95% of these various components are still manufactured primarily in China in some cases even transshipped as we've been as we've been discovering which is obviously you know a major national security issue. And by the way, uh, you know, I'm I'm so glad to hear that you removed that gene editing. You stopped that gene editing arrangement, uh, which, you know, we should I have a whole episode about, uh, uh, uh, some other time. Um, before I jump to the pricing, I wanted to touch on one thing that you mentioned, um, which is the direct to consumer advertising. You know, I this is something that the HHS Secretary Kennedy, I I understand, doesn't think should should exist, and I there's only two countries that do it. What's the status of that? We're taking a look at it. Look, are they creating a misleading impression? There's a regulation that these ads should not create a misleading impression. And it's not just the ads where everybody's singing and dancing and overweight people are marching. You know, I'm sitting at home watching some of these ads. And by the way, it's nonstop on some of these shows non-stop and it's a big source of revenue from pharma to the media outlets. And so, um, look, we live in a free country and we have the first amendment, but are these ads creating a misleading impression? It's not just these ads. Social media influencers are being paid to promote drug and device products without any disclosures with um skirting around the requirement to list side effects. There are drug ads now that don't even mention side effects. It's just you just see people coming on and singing and and dancing or just dancing. There's no word spoken in the ads and it just says the name of the drug. Um, so we have to look at the regulations. We have to look at what authorities we have. And we're doing that right now. We're taking a look at this because I don't think most Americans um want to watch non-stop um advertisements on drugs where uh we're they're not getting the full story. I want to jump back to the supply chain issues. I know this is something that's important to you. We've we've discussed it in the past. Um, you know, the Chinese Communist Party actually did threaten to withhold products during the pandemic. You know, it kind of gave us a sense of gave us a taste, I think, of what it could do. Um, the president has suggested um, you know, dramatically increase tariffs as a way to help, it seems to me, to repatriate some of these supply chains, but that would work in the other direction. That might increase increase the prices. I don't know. color that picture for me like where are we at with this because it's something we've known about for at least a decade I think now at this point. Yeah. Something something almost a decade very clearly. Yeah. People have been talking about this for decades and we got sort of a a bite uh uh at us during COVID. We got a little taste of this sort of power imbalance. This is an administration that has been willing to go extremely bold on America First policies. And so we are serious about the domestication of pharmaceutical manufacturing in the United States as a national security issue. And so there's a lot of things that are happening and one of the things that we are doing at the FDA is to make it friendly and not put companies in the United States through the ringer. We have said we will partner with you so that you don't build it and then apply to the FDA and then cross your fingers that it's going to be the way that they like it. We are actually going to walk with you in the design and building of a manufacturing facility so that when it's built, it's ready to go. And that's a tremendous benefit. Look, we want to reward good behavior in the marketplace. We want to reward the domestication or onshoring of manufacturing. We want American pharmaceutical businesses to thrive and we want businesses that do their work in the United States to thrive. This is an America first administration and we are serious about all of these things. It's it's hard to imagine more in some ways existential issues than for example you know the the rare earths is another one where the Chinese regime has flexed its muscles but it's a kind of this it it shows us what it can do what kind of leverage it can exert um so you have you know remanufacturing as you said plus dealing with the national security issue of having you know a country which says it's waging a 's war against America controlling precursors and and along those lines, Yan, the in China, these childhood vaping products where we don't even know what's in them, they're banned in China and they ship them over to the United States and you go to these vape shops that's now on every corner in America and what do you see? You see illegal Chinese vaping devices. And some of these devices are designed to look like a highlighter so a kid can use it in school and it be sort of disguised. Uh obviously it's designed for children. It's intended and marketed for children. There are Chinese vaping devices that have a handheld video game with an inhalation port. It's a single device that's both a video game and a vaping inhaler. And it's obviously designed to get them hooked and addicted to the game as they continuously vape. I mentioned we're learning a lot about what's what happened in the last administration. We learned what was happening is that the FDA would inspect these boxes, see these illegal Chinese vaping products, and they would then give them back to the manufacturer by putting them back on a ship to go back to China. What are we doing? Oh, those they're not they're laughing at us. They would then take those boxes and bring them to another US port. It's called port shopping. And so essentially, our border has been entirely porous to these illegal vaping products. And and so um I don't want to see these companies laughing at the United States anymore. We're taking serious action on them and we're cracking down and we're taking a broad administ approach throughout the administration to address this top issue. Foreign manufacturing sites where pharmaceutical products have been made. In the US, we have surprise inspections. But overseas, we're letting them off easy by scheduling the inspection. Well, they're laughing at us. They know exactly the day and the time we're arriving. They were sending limousines to pick up the FDA inspectors to go inspect their facility. They were laughing at us. And so when we found out about that, we put a halt. No more limousine pickups and we're moving to surprise inspections. And we're also changing the way we do inspections to be smarter. So we have got to stand up for ourselves. This is the United States of America. We have been the biomedical and life sciences leader in the world. We have been the uh king of manufacturing in the world and so we have got to restore policies that bring back dignity and value to the United States and protect our children. So to qualify one thing the 95% number uh I mentioned earlier about uh you know the drug components being made in China that's for generics and one of the things in India I think India and China both collectively consume the majority of generic manufacturing correct correct and then there's of course this question of trans shshipment which is which is we've been learning is in increasingly increasingly a big issue so from what I understood I I looked at some preliminary data from the department of defense looking at uh basically drugs that are being used there and um there a lot of quality control issues that that are coming up through their testing. Um I think I I don't think the final report has been issued yet, but one of the things was that the it became clear that the generic manufacturers rely on the sort of stamp of approval of the FDA who may or may not have actually looked at the products themselves and then they can kind of say, well, the FDA said it's okay for us to bring it in. Um are you aware of this situation and if and if so, is there anything being done about that? Well, even worse, we learned um actually a a group of investigative journalists just several weeks into the time that I was at the FDA had a story that there were massive safety violations in foreign pharmaceutical manufacturing facilities that were overridden by FDA individuals because they didn't want there to be a drug shortage. So, they allowed these drugs to come from facilities with horrific conditions. We're going to be honest with the American people, and this is a big priority uh for my uh team at the FDA. Um we have got to ask ourselves, how can we deliver safe and effective medications where we know what's in the medications and we have eyes on the manufacturing. And you know what? Maybe we have to start using some modern technology. Maybe we have to look into using it to be able to provide more real time assessments and monitoring of these facilities overseas. I want to touch on the dietary guidelines for a moment. You mentioned that at the beginning is something that you're tackling headon. There's actually a South Park episode about this, right? That the food I don't know if you've seen it, but the food pyramid is inverted. the kids call the FDA and it's an emergency and the lunches are about to be served and they flip the pyramid and the world is saved. I think that that's how it goes. I'm not a big South Park guy. This was very very thoughtful. I mean it the point is that the food pyramid has been grossly wrong. What's the program around that? So this is a balance because I believe the government is not your doctor and we should not be in the business of being your doctor. But at the same time, we have to inform the meal programs that the government pays for with taxpayer dollars, including school lunches. USDA spends about $400 million a day on school lunch programs and other programs. Um we have uh hundreds of thousands of people eat every day. in our military um facilities. We have hundreds of thousands of government workers eat at their government workplace. So, there is an opportunity to help make America healthy again by addressing the food that is purchased with taxpayer dollars. And so we'd like to see an evidencebased dietary set of guidelines that's not using dogma like fat is bad for you and that it directly causes heart disease. That was a 70-year-old dogma started by Dr. Anel Keys in the 1960s. And there was a healthy debate where doctors were like, "Wait a minute, this is very flimsy data to support it." But then in the 1980s or so the I would say an early form of censorship or group think moved in and it was just sort of accepted dogma and we are still seeing the remnants of that dogma. You still see skim milk and lowfat and you know in the dietary guidelines you see um calls for reducing saturated natural fat fat content in some of in the current dietary guidelines. So, we're rewriting those dietary guidelines along with USDA and we're using the best available evidence. We're also pointing out that you need fiber that all of this ultrarocessed food which is essentially stripped of any fiber um has consequences for your health. We want to be very honest about what is known, what is not known, and where we need more research. Um, so we're going to put all of that together and put together a very honest food pyramid, if you will, a set of dietary guidelines that'll uh be very transparent and allow people to start thinking about dimensions that have never been thought of before. In the old food pyramid, it didn't matter how you got your calories in those groups. It could be natural whole foods or it could be super ultrarocessed versions of those foods. Well, it does matter if those are whole foods or those are super ultrarocessed versions of those foods. 70% of the diet of children now is ultrarocessed. No one has talked about it. In my career as a physician, going through all the academic regalia, visiting all the top institutions, giving grand rounds as a visiting professor, never once did anyone talk about ultrarocessed foods, the chemicals in our foods or environmental exposures and factors that may impact health. So, we've got to talk about school lunch programs, not just putting every six-year-old on Ozmpi. We got to talk about environmental factors that may cause cancer, not just the chemo to treat it. We've got to talk about how we can partner with people to address chronic diseases because I can tell you as a doctor, the hard part about treating chronic disease is not just telling people what to do, it's helping them do it. And so we're seeing now creative programs come out of CMS, that is the Center for Medicare and Medicaid Services, led by Dr. Oz. We're seeing new research studies out of the NI NIH on the the root causes of our chronic disease epidemic. Not just funding a lab in China that may have been implicated in a pandemic. You're seeing now a renaissance in health care. You're seeing now for the first time funding to ask the big questions. Why are sperm counts down 50% in the last half century? Why do one in six to one in seven girls born today develop an autoimmune disease in their lifetime? Something that was rare two generations ago. Why do a third of kids have insulin resistance to the point of having pre-diabetes? Something that a pediatrician would rarely see just two generations ago. Why do one in 31 kids have autism? Sure, there's more diagnosis, but you you didn't see that a generation ago. the repetitive motions, the sort of self-inflicted harm, the ticks, the complete nonverbal uh individuals. You didn't see that a generation ago. What's going on? You know, one thing that I thinking about just going back to the food for one moment is something the contention around something I didn't expect to be contentious, which was uh removing the sugary drinks from the SNAP program. Yeah. What is the status of that? Yeah. So look, this is the first time in history. People have been talking about it for decades. But under President Trump, you are seeing the USDA under Secretary Rollins in partnership with this Make America Healthy Again agenda make a dramatic shift in the way that the government funds SNAP, granting waiverss so that at the state level, those state governments can say we're not going to pay for sugary drinks, which is the number one thing um on paid for but with SNAP dollars. We're not going to pay for ultrarocessed junk food. And so you're starting to see movement around asking big questions, touching and disrupting um you know some of these deeply held assumptions in the way the government runs its SNAP program. And so look, it's exciting and there's no single bullet that's going to make America healthy again. But all of these things in aggregation together can help with these incremental steps just like we saw with removing the nine petroleum based food diets from the US food supply. You're seeing movement. When we made that announcement just several weeks ago, the naysayers were saying, "Well, the companies are not going to do this and and we want to see the hard regulation that you're going to ban these." Well, you know what? We started the discussions with the food industry. We now have 40% of food manufacturers totally on board within weeks of that announcement. Why is that? It's because they see the vision. It's because there are not Republican children and Democrat children and independent children. These are American children. And you're seeing an appeal to something higher. and that is can we agree that the health of our nation's children is the most nonpartisan thing out there? It's a unifying issue and that's why you saw Republican, Democrat, and independent moms show up in high numbers to vote for President Trump on this very issue that Secretary Kennedy is championing. And so, uh, the food dies is one step. It is one of the ingredients. Uh the maker of Skittles announced they're going to remove titanium dioxide. That's another level. We were very pleased to see that voluntary action. And I think you can win more bees with honey than fire. And if we can sit down with these companies and say, "Look, you did what we asked you to do 60 years ago when we wanted you you to address food insecurity. You focused on mass production and increasing shelf life. But given the chronic disease epidemic explosion in our lifetime with now a 40% rate of chronic diseases in American children, we have got to pause and look around us and ask what is going on? What has changed? We have shifted in that same generation where we've gone from healthy kids to sick kids. We have converted a diet to a 70% ultrarocessed diet. We have introduced refined carbohydrates and added sugar and artificial sugars at incredibly high rates into the food supply. You know, we were the first generation to have our pancreas organs stimulated to the extents that they have been stimulated. And nobody really can talk about the long-term implications because it's never been studied. It was the largest uh social experiment in human history. We fed a generation a highly processed high glycemic index diet and we are witnessing the results. Now there may also be the impact of chemicals and environmental exposures but no one has been talking about this until this administration. U I'm going to switch gears for a moment here again. I uh you just reminded me actually that one I recently had a couple of uh the members of the new ASIP panel um on the show just to talk about some of the in workings of what actually happened in the committee meetings which were which were very long. It was fascinating discussion and of course there's there's so there's this CDC side of the equation and then there's uh the FDA side of the equation and um I know that you've actually committed to removing conflicts of interest. I think that was the plan with the replacement of these different uh the different members on ASIP. How is that going on the FDA side? So, one of my first actions at FDA was to remove all pharma and industry members of FDA advisory committees wherever statutoily possible. That's because the scientific evaluation process has to be impeccably independent. Um, so we did that and uh we are at the same time asking ourselves how can we restore gold standard science to some of these processes. Now, uh, there has been a good system in place for most of the trains running in and out of the FDA and the trains are running on time. For most of the reviews, there has been a very high bar and a good standard that has set. When it comes to rare conditions, obviously, we have to tailor the regulatory process to that rare condition. If only 300 kids in the world has a rare disease, you can't expect to run a randomized control trial. and the framework that was developed for the co vaccines we have uh reset with a new framework that we published in the New England Journal of Medicine. The FDA has a long history of putting science first. It has had moments in its history when it may have been in pockets of the agency been captured by the industry it's supposed to regulate. Just look at the approval of Oxycontton where it got a label for chronic pain. the indication was for chronic pain based on a study that was a 14-day study. So that um should have never happened and then the regulator immediately goes to work for Purdue Pharma. So um I I do believe in the agency. I do believe in the people at the agency and I think we can continue to uphold gold standard science. Absolutely. And so what I'm alluding to to some extent is what is the plan for VERPAC? I don't have any plans for Verac. that is up to the director of the uh center called SBER that oversees that section of the FDA. I have full confidence and Dr. Vana Prasad who is the leader of that center. Um I do think that it is good to have fresh ideas and a diversity of ideas. Um I don't think you should have uh people running an organization like NIAD for 38 years. I think it's good to have fresh ideas. It's good to have age diversity. You want to have young folks with their fresh ideas and you want to have folks that have been there for a while. So, um that's my personal view. But in terms of the composition of Verac, that's up to the director of that center, Dr. Prasad. And I I I might mention that Dr. Prasad uh well in in in addition to yourself was someone who helped me during the COVID pandemic actually understand some of the very you know kind of concerning things that I was seeing um at the outset. So I'm very I'm very curious to see what what he'll do. He's a scientific genius. He has published over 500 scientific peerreview studies. something that I would say less than one in 50,000 physicians will ever achieve in their lifetime. And he's done it by the age of 42. He is impeccably objective. He's not afraid to uh anger people on any side of a scientific debate because he is so true to the scientific process. And I think it's pretty impressive. and people that know him or have listened to him and they can listen to him on a number of the FDA uh channels now where we've given them a platform. I think they're they'll be very impressed with Dr. Prasad. And while we're on the general topic, I wanted to talk a little bit about uh the reauthorization of the PREP act, which happened just before uh this new the Trump administration came in and and you and you got your job. And so that extending emergency use authorization across a range of products, including these mRNA products. Um, this I realize this might not be your specific wheelhouse at the FDA, but this is another one of the things that a lot of people have been asking about like what does it make sense to have this emergency use authorization all the way to 2029 uh given the current realities. Yeah, that so just before we came into office that was extended to 2029 I believe you're correct on the date there and it provides immunity for the pharmaceutical makers uh of these vaccines. Now it is outside of the jurisdiction of the FDA. It's really something that um uh is determined outside of the the walls of the FDA. But I think it's good to have a a healthy and vigorous debate around that. I wanted just to talk about some of the um elimination of waste, fraud and abuse because that this has been kind of a call sign of the administration. I know that that's something that that that that you have done. So where has that happened and 100 days in? Well, so um I would say what we saw at the FDA uh just before I I came in and once I came in were some duplication of services. There were uh there was a sort of feathdom culture whereby the centers of the FDA had their own lawyers and IT staff and travel offices and HR staff and lobbyists for Capitol Hill within the center and they reported within the center and then so you had duplication of all these services. There were 12 travel offices. There were over a thousand HR personnel and budget and procurement staff. And so we made an effort um to examine that landscape. And before I came into office, there was an attempt to consolidate a lot of those services. And so when you do that, you just have to make sure it's done right. It's never going to be done perfectly. So I've been busy doing an assessment and trying to make sure that everything is running smooth with the new consolidation. where has the new consolidation not worked very well and we need to go back to bringing services from HHS back to the FDA and we've done that in partnership look this is the first time in my lifetime that I know of where the secretary of HHS the head of the NIH Jay Badachari the head of CMS Meett Oz and myself at FDA have been working in lock step we talk all the time we have ideas for studies ideas for Medicare payment at the FDA. We're on the phone and so uh sometimes the secretary will pose a question and then we'll have a robust discussion and that's the civil discourse that we should be having. In the past they would be at each other's throats and there be so much territorialism sometimes nothing is getting done. Uh so we I'm um one of the surprises uh that I've had at this job at the FDA has been how the incredible friendship and teamwork that we have among the leaders of the agency has translated into all of us being more effective for the American people. Your work has been kind of criticized sort of from both ends. On the one hand, you have people who are concerned that existing structures are being gotten rid of or, you know, there's too much change too quickly, people losing their jobs and so forth. On the other hand, you have people who believe that you're not moving nearly quickly enough, for example, around some of the vaccine products and things like this. I'm curious if you have a something general to say to each group as we actually finish up. Well, look, I I've always uh felt like you as a scientist, I've got to follow my northstar. And so, I have always found that to be the scientific method. And I believe that what what makes somebody a distinguished and noble scientist is somebody who is willing to evolve their position as new data comes in. And so if I were sort of just trying to appease different groups and there's a lot of opinions, people have a lot of strong opinions on some of these topics, then I wouldn't be true to myself. So I have been uh doing what I think is right and best for the American people and sometimes it's not popular. Um at the same time I think there are tremendous opportunities right now for all of us to learn together and if we can disarm and approach questions with scientific objectivity I think we can learn a tremendous amount of information for example what are the big areas where we can see improvements in the health of the of Americans you've got giant areas where there have No cures. Can we see a cure for type 1 diabetes, for PTSD? All these veterans with PTSD, we, you know, we lose as many veterans to suicide each year as we lost in the entire Iraq war. We lose more each year from suicide. So, the war is over and the soldiers and veterans are still dying. Are there meaningful treatments or cures for PTSD that we can help deliver? Can we see a meaningful cure uh treatment or cure for Alzheimer's or ALS or other neurodeenerative diseases? There are some interesting and promising treatments that is potentially promising. Of course, we have to wait for the final clinical trials that I get to see in this job that is really cool. you get to see things in the pipeline and there are potentially promising flu shots that are universal flu shots that is you don't have to come in every year where we guess what the strain might be and the flu shots you know are rarely more than 50% effective. Uh, so we'd love to see American invention, ingenuity, innovation, and pharmaceutical development thrive. And we'd like to cut the red tape so that decisions can be made promptly and without cutting any corners on safety. And I think we can do that. I think there are a lot of things that we can do to try to uh foster the thriving and the success of companies in the United States and companies that do business in the United States to deliver more meaningful treatments for Americans. That's my goal and that's what I'd like to see. Our goal is pretty simple. More cures for Americans and healthier food for children. And I think in the first 100 days, we've been able to do a lot and we're just getting started. Well, Dr. Marty McCary, it's such a pleasure to have had you on. Great to be with you, Yan. Thank you all for joining FDA Commissioner Dr. Marty McCary and me on this episode of American Thought Leaders. I'm your host, Yana Kellik. [Music]