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[RUSH TRANSCRIPT BELOW] In this exclusive interview, I spoke with Dr. Marty Makary, commissioner of the U.S. Food and Drug Administration (FDA), about his first 100 days in office and how he is transforming the agency.

In this wide-ranging interview, we dive into his work to change food guidelines and drug approval processes, reduce supply chain vulnerabilities, and tackle conflicts of interest. We also address criticism of some of the FDA’s recent decisions surrounding vaccines.

Views expressed in this video are opinions of the host and the guest, and do not necessarily reflect the views of NTD.

RUSH TRANSCRIPT
Jan Jekielek:

Marty Makary, such a pleasure to have you back on American Thought Leaders.

Great to be with you, Jan.

100 days into your job, I’m going to ask you a bunch of questions. 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 obvious somehow? Or was it just figure it out as you go?

It was a range of emotions. I was in the operating room the day before my Senate confirmation hearing to become the FDA [U.S. Food & Drug Administration] commissioner. And when I walked into the FDA, there was a lot that surprised me, in both directions. I continue to be in awe of the regulatory authority of the agency. It regulates 20 percent of the U.S. 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 may think. And so drugs are 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 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 just want to do what’s right and do what’s good. 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 and 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 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 COVID vaccines. It’s because public health officials did one of the most dangerous things you can do as a physician, and that is to insist that people do things with an absolutism when the data was really not that definitive.

Over time, you do that again and again with insisting that kids, including toddlers, wear a mask for over three 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 mortality when the data didn’t support it. You do that over and over and over again, and you get yourselves into trouble.

That’s what happened with public health officials. They’ll say, well, we’re trying our best. No, they were insisting that soldiers, 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 walked into a situation where public trust was at record lows; it wasn’t just at the FDA. The NIH [National Institutes of Health] had 14 percent of its grants going to descriptive studies on health equity and diversity. Now, if those studies were reducing gaps in health inequity, 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?

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 cause cancer—not just the chemo to treat it? So we have had this myopic perspective in the medical establishment from our government over the 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 was basically written by industry, not because they had a sense of what was medically best for you to eat, but because they had a sense of what they wanted you to buy. And so it 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, 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. So we’ve done a lot in these first 100 days. Happy to chat about any one of those things, but we’ve been busy and we’re just getting started.

I want to talk about a great many of those things that you just mentioned. But as 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?

The FDA sat on data on myocarditis risk with the mRNA COVID vaccines in young men. They literally slow-walked any action on that data. 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.

So there was a lot going on, but I think also 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. We have inspectors, law enforcement officials, and thousands of scientists. And I think this is a good time for us to rehome and refocus on that core mission of the FDA.

Since you mentioned the mRNA product, this is one of the big contentious issues, right, that a lot of people have opinions on around me. Absolutely, and frankly, in very different directions. One thing that was surprising to many of the people I know who were involved in what would be called the MAHA movement was the authorization of spike vax for six-month-old to 11-year-old children, high-risk children. But if you could clarify what that situation is and also explain why this might be.

Yes, I’m glad you asked, Jan, because we are officially pivoting away from the blindly rubber-stamping COVID 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 do nothing, if you reject the COVID vaccines as they come to you for approval, then you have no leverage to be able to ask the company to do that. And those studies may never be done.

We don’t commission studies 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 pretest 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 immunosuppression from HIV and a cancer therapy with chemotherapy where they have an incredible immune susceptibility and their doctor feels like they would benefit from a COVID 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 in saying that we are going to be okay with the COVID vaccines and high-risk Americans, which is a much more limited indication, we now can ask the companies that this approval comes on the condition that you are 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 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, ACIP [Advisory Committee on Immunization Practices]  has already echoed the views of others in saying that we’re no longer going to push these COVID vaccines in healthy subjects.

There’s been a number of studies that have been done, and I think just observational at this point, that there appears to be something going on with these mRNA products and the immune system. I haven’t seen any definitive answers there. However, there seem to be all sorts of very concerning signals that people are pointing to, whether it’s an increase in rare cancers or maybe some sort of deregulation. Who knows? Have you been following this? And how does that fit into what you’re telling me here?

Yes, I do follow it, and the FDA does follow it. So 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. So this is a common situation.

The FDA and CDC [Centers for Disease Control and Prevention] have a very clunky database where you are supposed to go in there and say that you’ve been harmed by 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 website is just too gnarly. It’s too complicated. It takes too long. It’s not user-friendly. The interface is poor.

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 database, even though it’s a self-reported database? Well, people are giving up. They’re not capturing. You don’t have a good statistical capture of what’s happening. And we did our own analysis of myocarditis. And under my leadership, we just issued a strong warning label on myocarditis. But there are other things we have to look at, and we have to do it systematically.

Also, if people have reported injuries that were not injuries on that database, it’s very difficult 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 needs to trigger a more definitive analysis in big data. So we’re committed to that.

And I don’t want people to think that 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 COVID 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 these are the types of questions that people I’m hearing from are asking.

I think it’s good that people are asking this. 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 a clinical trial that is a randomized control trial and continue to have eyes on not just the COVID vaccines but any new FDA product in real time for an extended period of time.

We shouldn’t be learning 19 years after OxyContin was approved that it may have killed nearly a million people. We shouldn’t be learning about five years after Vioxx 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 COVID vaccines.

So look, we’ve taken action on warnings, on safety. 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, let opinions dominate this vacuum, this void of inadequate data. We want data to fill that void.

Let me touch a little more 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. There’s a whole movement of people, for example, React19 is, I think, the most prominent group that is acting to help people who have been injured or believe they have been injured. Is there any action being taken to try to help them? I know that as we’re recording here, there’s about to be another hearing related to the experiences of those people and the prospects of them getting help because in many cases, they were not given it.

Yes. First of all, vaccine injury is real. I do believe that. I also think there were some cases of long COVID misattributed to long COVID when 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 very angry when I learned that a friend’s father had died from the COVID vaccine. And look, we’re convinced it was causal until proven otherwise. You can always nitpick and say, well, this could have been a random event. But no, there are many reasons why we are confident that it was causal.

Now, when I say we, I mean not the FDA, but me and my circle of friends and loved ones who know this individual who lost their father. So people have a right to be angry. They have been deceived on different aspects of the COVID pandemic. 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.

Let’s jump to another question. What would you think is the most impactful thing you have been able to accomplish thus far at the FDA, 100 days in?

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 at predicting toxicity in humans. It turns out that 90 percent of drugs that pass animal testing do not pass in human studies on safety and efficacy.

So computational modeling now is getting more mature, where 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 promising, especially in certain areas of medicine like monoclonal antibodies. So we have a pathway; it’s a roadmap now on the FDA’s website to reduce animal testing towards an ultimate elimination of animal testing if we can get there.

Now, 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? There are things called organoids or mini-organs, and you can actually see whether or not the drug is causing some damage to the organ. And using both that technology and the computational modeling, you can actually get a toxicity predictive value that may be better than the animal testing.

We also found that animals were being used for drug testing when the drug was already approved in Europe and used in humans. We’ve got to use common sense. 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, 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 piloting a new pathway to get a decision out to companies a couple of weeks or several weeks after the final application is submitted to us instead of nearly a year. 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’s share of the application that talks about the manufacturing and the label and 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 do a step and submit an application, do another step, resubmit 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 severe neurodegenerative condition that’s otherwise hopeless, maybe they believe in the spirit of the 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.

Drug pricing is also something that’s been very important to the president. Maybe you can tell me where things have come with respect to this issue.

Yes, 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 we have a charge from the president to address this great American ripoff. And that means that Medicare and Medicaid under Mehmet Oz are 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 finance more research and development on drugs than any other country in the world. Are we subsidizing lower prices for other countries? I don’t even blame these drug companies. I blame these other countries that are trying to get a price that’s below what we are getting. And they’re shaking down these drug companies.

And so just like with NATO, just like with the WHO fees, just like with membership fees in any other international organization, other countries have not been paying their fair share, and this president would like them to pay their fair share. Research and development costs are about 20% to 25%, roughly, of the money that drug companies have in their expenditure. Well, direct-to-consumer ads might be more. They might be 25 percent 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 biosimilars. Biosimilars are basically generics for these biologic infusion drugs that you see on commercials running all the time. They’re always dancing and singing. And so those drugs have generic versions. We call them biologics. And so 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 one of the criteria for 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 [Organization for Economic Co-operation and Development] countries. Other criteria include companies or drugs that are meeting a large unmet public health need. Another criterion is the domestic manufacturing of drugs. We’d like to see more manufacturing in the United States. We’d like to see more APIs [Active Pharmaceutical Ingredients] in the United States. It’s a national security issue.

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 discovering, which is obviously a major national security issue. And by the way, I’m so glad to hear that you removed that gene editing or you stopped that gene editing arrangement, which we should have a whole episode about some other time. Before I jump to the pricing, I wanted to touch on one thing that you mentioned, which is direct-to-consumer advertising. This is something that HHS Secretary Kennedy, I understand, doesn’t think should exist. And 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. I’m sitting at home watching some of these ads. And by the way, it’s nonstop on some of these shows, nonstop. And it’s a big source of revenue from pharma to the media outlets.

And so, 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, skirting around the requirement to list side effects. There are drug ads now that don’t even mention side effects.

You just see people coming on and singing and dancing or just dancing. There’s no word spoken in the ads, and it just says the name of the drug. 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 want to watch nonstop advertisements on drugs where 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 discussed it in the past. The Chinese Communist Party actually did threaten to withhold products during the pandemic. It kind of gave us a taste, I think, of what it could do. The president has suggested dramatically increased 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 the prices. I don’t know. Color that picture for me. Where are we at with this? It’s something we’ve known about for at least a decade, I think, now at this point.

Yes. People have been talking about this for decades. And we got sort of a bite 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 a lot of things are happening.

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 hard to imagine more, in some ways, existential issues than, for example, the rare earths is another one where the Chinese regime has flexed its muscles. It shows us what it can do, what kind of leverage it can exert. So you have remanufacturing, as you said, plus dealing with the national security issue of having a country that says it’s waging a people’s war against America controlling precursors.

And then along those lines, Jan, 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 are 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 can be sort of disguised.

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 happened in the last administration. We learned 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, they’re laughing at us.

They would then take those boxes and bring them to another U.S. port. It’s called port shopping. And so essentially, our border has been entirely porous to these illegal vaping products. And so 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. We’re taking a broad approach throughout the administration to address this issue. Foreign manufacturing sites where pharmaceutical products have been made.

In the U.S., 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 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.

To qualify one thing, the 95 percent number I mentioned earlier about the drug components being made in China, that’s for generics.

And India, I think India and China both collectively consume the majority of generic manufacturing.

Correct. And then there’s, of course, this question of transshipment, which we’ve been learning is increasingly, increasingly a big issue. So from what I understood, I looked at some preliminary data from the Department of Defense looking at basically drugs that are being used there. And there are a lot of quality control issues that are coming up through their testing. I don’t think the final report has been issued yet.

But one of the things was that 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 kind of say, well, the FDA said it’s okay for us to bring it in. Are you aware of this situation? And if so, is there anything being done about that?

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