The Exchanges

Q measurements, though, the price of drugs in the United States is almost three 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, for care providers, for insurance companies, and ultimately for the economy?

A It's been the great American ripoff. You could buy a GLP one drug for 1300 dollars in the United States and go to London. It sells for 88 dollars. Or you go to Germany or France and buy any of the drugs that are cost a lot of money in the United States and they're half a third or a quarter of the price. And so 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 Status Pricing, and thanks to Dr. Oz and Chris Klopp and others at CMS, we did our part at the FDA to be a part of this. We've gotten drug companies to the table, and we've got them to agree to Most Favored Nation Status Pricing. That's gonna radically lower the price of drugs. With the GLP-I example, for example, it's gonna come down to a 149 dollars for the first three months. Um, other countries are gonna pay more. We have been financing 60% of the R&D cost to pharma companies. Other countries need to pay their fair share. And 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 bio, biologic drugs. So most, 51% of the, so let me back up for a second. The fastest area of h…

AI assessment note: “we've got them to agree to Most Favored Nation Status Pricing”

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

A You know, we at the FDA try to be referees, so we see, um, different technologies competing. For example, sickle cell disease. There are monoclonal antibody treatments, and there are gene therapy treatments. Now, we tend to get excited about one over another, but the reality is we, 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 one diabetes or some meaningful treatment for type one diabetes. Uh, a powerful treatment for ALS. Um, treatments for certain kinds of cancer where we've seen now PD one blockers and KRAS inhibitors melt the tumors away. So you don't need surgery or chemo. You talk about a health reform. That's, that's more powerful than a lot of the health reform ideas we have out there. You don't need surgery or chemo or radiation. I mean, think about the reduction in expenditures. Um, 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. And I'd like to see something powerful for PTSD. Um, a lot of Americans are still suffering from PTSD, some from having served in a war. Uh, these are young people oftentimes who, Stood up to serve their country, and they're suffering. We are still losing 7000 plus veter…

AI assessment note: “treatments for certain kinds of cancer where we've seen now PD one blockers”

Q phase two, phase three trials into a phase one, phase two slash three by taking into account all of this additional data? Some people have talked about the idea of using AI plus other health data that's collected and allowing the phase three to kind of roll into phase two and create a much more expedited computationally assisted approval process. Is that something that's on the roadmap or is discussed?

A Absolutely. There has been tinkering of combining phase one and two, phase one, two hybrid trials, phase two and three hybrid trials, approving something with sort of a preliminary approval after phase two, if the results are really promising. And those are all steps in the right direction, but I think of something much bigger. Can we move to continuous trials? Can we use Bayesian statistical evaluation Which we announced this week. We are now going to allow Bayesian statistics to be used. So now you can, if something works, instead of having a committee meet twice a year to do a cut of the data and print it out and everybody looks at it. I mean, 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.

AI assessment note: “Absolutely. There has been tinkering of combining phase one and two”

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

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

AI assessment note: “we flipped it upside down using good science, talking about... the importance of protein”

Q when they're in a certain condition, they can access the drug before it's gone through full approvals. What's the current state of right to try? Where do you view that going? And does The threshold for Right to Try change over time, giving patients and their doctors more rights and more access sooner, or does the FDA still have to hold firm? How do you think about that over time?

A So I believe in both the letter and the spirit of Right to Try. It's an amazing achievement of, um, 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, and, like, we don't want people getting spun up on snake oil that doesn't work, that's cost three million dollars, where their churches are doing GoFundMe campaigns, when we know a drug does not work. So we do have a responsibility, and we do, we, we have to be good stewards of the Medicare program. They're using taxpayer dollars to fund things. But if there's a signal that something works and somebody wants to try a drug, who are we to say you can't? So we look at safety, but beyond safety, we, you know, have to be as flexible as possible with our, uh, regulation. And we announced just this week that we are getting rid of the, some of the regulatory requirements for cell and gene therapy. Now, those are used for a lot of rare diseases. But we had requirements, uh, what we call PPQ runs for batches of, um, it's part of the manufacturing requirements for cell and gene therapies. We were holding them to the same standards we were for, say, mass manufacturing of a pill. Well, a cell or gene therapy can be developed in a lab at UCSF or Stanford, and are we going to require that t…

AI assessment note: “I have signed 100% of Right to Try requests that come across my desk.”

Q And so, sorry, for a staff of how many total?

A 20,000 employees just before I got there. And so, there was a goal to say, hey, we're going to go back to 2019 staffing levels, and the cuts are not going to be to scientists or reviewers. No scientific reviewer was laid off, but there were significant consolidations in HR, procurement, IT, and the duplicative services that were out there. Now, anytime you do something in government, You, you take headline risk, but we felt it was the right thing to do, and so I came in right after that massive sort of change, and since then we've had a great culture, we've had more teamwork, we have new leaders, and they believe in this new vision. The number one priority of the commissioner that preceded me, he said, was to fight misinformation. Well, my number one priority is not to censor Americans. It's to deliver more cures and meaningful treatments faster to the American public and healthier food for children. And I think every employee at the FDA knows that mission. We have incredible teamwork. Um, our turnover rate is at the baseline five to seven percent that has been there for the last 10 years at the agency. So there's no exodus. There's no mass, uh, departures. We are actually hiring 1050 new scientists Because we have very ambitious goals on our new pathways, accelerated type pathways, and so we're, um, building up capacity to have a whole new line of pathways so that we can deliv…

AI assessment note: “20,000 employees just before I got there.”

Q the face of China, they're putting out tremendous funding. To support research scientists coming up with those next set of molecules or therapeutic modalities that are going to change lives and improve lives. Maybe you can comment a little bit on are we funding through the government enough scientific research? What's the right steady state for us? And how do we address the points about the Trump administration being anti-science?

A Yeah, well, look, we live in, ah, partisan times now where people get spun up and they're in sort of a toxic polarization And the truth is, if we want to know the facts, is that in the Trump administration, we have not cut one dollar of NIH funding. We have not cut one dollar to the general Medicaid budget, that is the overall Medicaid fund. And the proposal for the future is to increase Medicaid by two hundred billion dollars. So you hear all the time, oh, Trump cut Medicaid, Trump cut the NIH. No, what we want to see is reallocating money at the NIH From just chemotherapy and proton beam therapy work, to study food as medicine, and school lunch programs, and the microbiome, and gut health. We've got to start talking about school lunch programs, not just putting every six-year-old on Ozempic. We've got to talk about the quality of sleep as it, 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, and so we want to see funding go to root causes of diseases, and that is something that has been unfortunately in a blind spot because the culture of the NIH is the culture of Francis Collins and Tony Fauci and the group for the last 50 years that, and I'm going to oversimplify it, the gene is responsible for Our h…

AI assessment note: “in the Trump administration, we have not cut one dollar of NIH funding.”

Q mean, there's, there seems to be a lot of benefit potentially in, uh, 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 are 60% of Americans are gonna be on? And if it is the case, does that mean we failed with our food system?

A 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 kind of a blaming of children for not having the discipline, and it's not a willpower problem. This is highly addictive, uh, chemicalized foods that are ultra processed, that are put in front of kids, And they want more, and you, you put these vibrant colors in them from the petroleum-based dyes, and so this is something adults have done to kids, and so I think that we have failed. We've given people the wrong information. The calories in equals calories out, this demonization of fat, and all that stuff we talked about. Um, GLP-I's are mimicking a natural hormone in the body. And so when you get a 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 general body inflammation. And so that's why we're seeing so many other benefits. Plus you feel better when you feel better, you're going to have benefits. You don't even, we haven't even appreciated yet because There's an incredible value, this sort of positive thinking. We've seen it in a breast, in a lung cancer study from Mass General. They randomized people to palliative support versus chemotherap…

AI assessment note: “Well, first of all, we have failed with our food system.”

Q from the doctor, or more accurate readouts, or they're able to find care that they weren't finding through the traditional physician process. What's this administration's view on these AI tools? Are they a supplement, a replacement, and then how do we allow them to proliferate if they're, they're good, and do they need to be regulated, or are we gonna end up regulating these AI doctors, these AI medical systems?

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

AI assessment note: “I outlined new guidances on AI decision support and wearables, and it creates a clear”

Q And NIH grants are about forty billion a year, does that sound?

A Uh, it's, it's a little over twenty billion in terms of grants that go out the door. But about forty seven billion for the entire NIH budget because they run their own hospital and clinical center and others. So, um, so if you think of, and by the way, I'm all for anything that reduces health disparities and increases access, but these grants were not doing it. It was just describing health disparities. Well, it's, it's, 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. So, um, we've seen money shifted to root causes and areas of research that we need to study that we have not 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. Um, When we came in, the NIH was a mess. Almost all the money was going to genetic research, which then becomes the priority of every academic institution. They're not studying causes and food and the microbiome and cutting edge areas of, of, of science. And 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, you know, get back coronaviruses and insert a furin cleavage site so it could inf…

AI assessment note: “it's a little over twenty billion in terms of grants that go out the door.”

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

A So right now we have user fees, which means if you submit an application, there's a fee associated with it because there's an unknown number of applications each year, so it, it's a system that's been around for a while. And so, ah, I'd like to see those user fees much higher if your phase one is done overseas. And if it's done in the United States, it's gonna be a lower user fee. That's what I'd like to see. It's an America first policy. I'd love Congress to do a bunch of stuff, but we're not gonna wait for them. Congress is slow. We're moving incredibly fast. You know, our number one goal was to make sure that the morale was good, the culture is good, and the trains are running on time, coming in right after the restructuring. I'm proud to report this year, in twenty-twenty-five, this past year, we hit a hundred percent of our user fee target dates, that is, the trains were all running on time, that every accept or reject decision by the FDA was consistent with the accept or reject decision By the primary review team. That is, we're not doing secret deals. We're not messing with things. We are standing by our scientists. And last month we had a record number of drugs approved by our center for biologic cell and gene therapies and other nine drugs. And so we want to keep going hard and strong and innovate. But the first goal in the first nine months was to make sure the trends…

AI assessment note: “I'd love Congress to do a bunch of stuff, but we're not gonna wait”

Q was able to get the therapeutic, but all the people that, that died because they couldn't get access to this drug. How do we convey to the general population the idea that speed matters in saving lives? And this question about absolute safety and absolute risk around drug approval. This is really important when you talk about risk to a general audience. How do you convey that second order effect?

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

AI assessment note: “Time delays that are unnecessary have risks, and I think that is something we don't think about”

Q around you. Right. And it was very hard. You guys recently made some big changes to the vaccine schedule. I'd love to hear a little bit about how those changes were made. What were the big changes? And then, you know, kind of what got us to this point where when you look at the data, you're like, wait a second. Right. That may not make as much sense. Yeah.

A I'm just laughing as you talk, Dave, because you do, you know, you just ask some good questions. Like, does, does my newborn on the, in the first hour of life need to be injected with a hepatitis B vaccine when the mom is hep B negative? And within a matter of weeks of having broader conversations, you feel like you're a fugitive of the law. Like you've done something, you know, terribly wrong for choosing not to vaccinate. We went through the same thing and, and, and, you know, being a part of having a kid is so special. You know, we were talking about that. So, yeah, we just went through this. Our son was born about six months ago and, you know, the, uh, we were offered the hepatitis B shot and 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. Um, you're preventing with hepatitis B an infection that is a sexually transmitted infection or can be, uh, get it from a, uh, bloodborne pathogen exposure. Uh, so that's not going to happen until they're a teenager, at least, or further down the road. But when you ask the question immediately, you get this sort of anti-vax label or, um, Or you have to qualify. That's right. I'm not an anti-vaxxer, but I'm asking this, what, what, right? What's going on here? This sort of McCarthyism around this, uh, schedule, which by the way, the United States vaccine schedul…

AI assessment note: “president Trump asked us to review the, um, international landscape of vaccine recommendations.”

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

A So I meet with folks at the FDA, and if you meet with them with their bosses and everybody in the room to get a briefing on a topic, then they give you one glowing story. But if you meet with one individual scientific reviewer and give them the safety of anonymity and say, look, I want to hear how is it going on the ground, or what big ideas do you have that you've always wanted to do but not been able to do? Four out of five people, or sometimes more, will, will not, not really give you anything interesting. But then somebody will say, you know, it makes no sense that we do it this way, and we could do it better, and we could do it this way. Something they, they wouldn't feel comfortable offering if their supervisor were in the room. And so we've been running with these ideas. We have announced 42 major reforms in my 10 months in office at the FDA. And it has challenged the status quo of doing things, but we have to. I mean, 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, ah, timeline that, that has just become the status quo. We've got to challenge these deeply held assumptions, and we're doing it. We're doing it with new programs, new priority reviews, new pilots, new forms of transparency. We made our Our rejection letter is public, so that if the FDA does not approve a drug, the public deserve…

AI assessment note: “And so we've been running with these ideas. We have announced 42 major reforms”