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Marty McCary, commissioner of the FDA. Welcome to San Francisco. >> Great to be here, Dave. Good to be with
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you. >> Yeah, thanks. It's JP Morgan Healthcare Conference this week in San Francisco.
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Considered, I think, probably the biggest most important biotech conference globally. Very important
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week. So, you're visiting this week for the conference. >> Yeah. 120,000 people, great
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conversations. You hear from everybody. Just not enough time to meet with everybody you want to meet with, but
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it's a great time. >> Well, thanks for sitting down with me. You and I have gotten to know each other
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a little bit over the last year or so >> and I'm really excited uh to hear a
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little bit about how things are going. It's been almost a year since you've
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been in the role. I think maybe for our audience you could share a little bit about how you got this role. How did you
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get involved with this administration? How did you get connected with them? And maybe we can go all the way back to your
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very outspoken views uh during the COVID pandemic and maybe how that brought attention to you and your philosophies
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that that drove this role. >> Yeah. So my um interest in academia, I um went to graduate school for public
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health and served on the faculty of the Johns Hopkins School of Public Health as
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I also had a clinical practice in GI and cancer surgery at Johns Hopkins. And my
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interest was always in the root causes of our healthcare system problems from quality, transparency, and price. And in
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the work on price, uh, I led sort of a national effort to try to get more price transparency of hospital prices. I wrote
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a book on it that did very well. It took me to the White House where they had read the book, invited me in, and in
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that first Trump administration, we had a lot of great conversations and then they implemented the idea and I was so
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impressed. This makes sense. You know, we want common sense ideas. And so we got the hospital price transparency
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executive order signed by the president. That's where I developed some of the
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relationships and got to know the folks. And then when uh President Trump got reelected, he gave me a call days after
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the election and I was very honored to be offered this role. So, it's been awesome. Uh co, you mentioned CO, it was
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a crazy time. I mean, the sort of sociology of medical dogma is a fascinating historical thing and we
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still suffer from it. paternalism, the sort of suppressing ideas that are not the legacy ideas, the sort of
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sacrificing the basic principles of science to question everything to have no sacred cows. And you saw the worst of
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that bad behavior during co cloth masks on toddlers for 3 years, vaccine mandates for young college
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students, recommending COVID boosters with such absolutism and young healthy children. you the um ignoring natural
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immunity. One of the most uh scientifically dishonest things a scientist could possibly say about the
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with the virus and the and the immunity and um shutting kids out of school for nearly two years which I fought tooth
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and nail along with Jay Bachari and others starting in the fall of 2020. We initially we were okay just doing stuff
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while we didn't understand it but once the data emerged we made a strong case
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to reopen the schools and to some degree I feel like we lost that battle but people now see that the data has caught
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up with public health officials and so I'm proud to be in office now to be a
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part of an effort to rebuild public trust in our health institutions and you must be having a lot of conflict then
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because you really are fundamentally trying to rewrite the way these institutions operate have operated and
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in some sense you are degrading the success and the career and the authority that some have vested themselves over
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time in those roles. How has that been and and what's the push back been like
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as you've kind of gone through this exercise? >> So I meet with folks at the FDA and if
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you meet with them with their bosses and everybody in the room to get a briefing
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on a topic then they give you one glowing story. But if you meet with one individual scientific reviewer and give
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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
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that you've always wanted to do but not been able to do four out of five people
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or sometimes more will will not not really give you anything interesting but then somebody will say you know it makes
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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
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feel comfortable offering if their supervisor were in the room. And so we've been running with these ideas. We
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have announced 42 major reforms in my 10 months in office at the FDA and it it has challenged the status quo
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of doing things. But we have to I mean it why does it take 10 to 12 years for a new drug to come to market? We've become
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so lukewarm and passive accepting that horrible uh timeline that that has just become the status quo. We've got to
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challenge these deeply held assumptions. And we're doing it. We are doing it with
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new programs, new priority reviews, new pilots, new forms of transparency. We made our our rejection letters public so
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that if the FDA does not approve a drug, the public deserves to know why. And it
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creates accountability. >> And that was not the case before. They talked about it for 30 years and we got
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it done. They talked about banning one food diet for 35 years. Within weeks of coming into office, we took action to
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remove all nine artificial petroleum based diet. So, we're getting stuff done. We're not afraid to move fast. And
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in that role, some people have left the FDA and then they've been outspoken critics of yourself. Maybe you can
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respond to some of the criticisms that it's chaotic, that there's a lot of
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turmoil. I've worked at many startups. I know that when you move fast, things
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feel or they may feel too busy or they may feel like there's too much going on.
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It's overwhelming at times, but at the end of the day, progress is what matters. Maybe you could just comment on
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some of the reports made by employees that have quit the FDA, left and and and provided some comments on how things are
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going. >> There were 2,000 HR people at the FDA just before I got there. There were
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1,500 IT people. And so, for a staff of how many total? >> 20,000 employees just before I got
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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
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going to be to scientists or reviewers. No scientific reviewer was laid off. But
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there were significant consolidations in HR, procurement, IT, and the duplicative
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services that were out there. Now, anytime you do something in government, you you take headline risk, but we felt
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it was the right thing to do. And so I came in right after that uh massive sort of change. And since then we've had a
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great culture. We've had more teamwork. We have new leaders. And they believe in
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this new vision. The number one priority of the commissioner that preceded me, he
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said, was to fight misinformation. >> Well, my number one priority is not to
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censor Americans. It's to deliver more cures and meaningful treatments faster
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to the American public and healthier food for children. And I think every employee at the FDA knows that mission.
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We have incredible teamwork. Um our turnover rate is at the baseline 5 to 7% that has been there for the last 10
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years at the agency. So there's no exodus, there's no mass uh departures.
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We are actually hiring 1,50 new scientists because we have very ambitious goals on our new pathways.
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accelerated type pathways. And so we're um building up capacity to have a whole
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new line of pathways so that we can deliver faster for the American people. >> Great. Well, look, let's start with a
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framing. The framing is the US verse China. I want to read this report that came from the Congressional National
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Security Commission on Emerging Biotechnology. We're here at a at a biotech conference. So, I figured we
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could start here because everyone's talking about China and the race against
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China. The US, according to this commission, has a three-year window to act to keep up with Chinese innovation
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and the speed in biotech. In 2022, Chinese companies were just 5% of licensing deals. 2025, 42%.
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And recently, one of the biggest licensing deals ever was 3S Bio 1.25 billion up front with a $6 billion total
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with Fizer. China had 10 years ago only 50% of published scientific papers to the US. Today they're 50% more than the
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US. So I just want to walk through your view on US biioarma innovation as it relates to China. Is
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there a race and if so what are the priorities for the administration in helping American biotech industry remain
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competitive? >> There is a race and when we came to office we were losing that race. We were
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behind. we were getting clocked by China, by Australia and other countries that were doing things more efficiently
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with less red tape and um we made it a massive priority to say we need to uh retain our number one position in life
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sciences and biomedical research and we've got to think innovatively so we can come up with some protectionist
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strategies but ultimately what we need to do is be more competitive with what's
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going on with phase 1's and INDs overseas. So that means we need to rethink our
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entire phase one uh process. We have to convene hospitals uh who are um so part of the problem is outside of the walls
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of the FDA. When hospitals have IRBs, that is the institutional review review boards that approve research that meet
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monthly and you know at at Johns Hopkins I had a study took a year and a half to
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go through the IRB. It was a survey. What are we worried about? It was a survey. It was a nutrition survey and at
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the end of a year and a half it was not approved. That kind of stuff is intolerable when
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we're competing with uh China where they're doing phase ones in 4 weeks with
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uh Australia that's doing phase ones in 6 weeks. And so we need to uh have more
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centralized IRBs and we need to streamline the hospital contracting because right now if you want to do a
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trial each hospital wants to negotiate their margin of what they want and and sure they have to customize the contract
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because every study is different has different requirements and resources that are needed. But you go to Australia
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and they say sure sign here on the dotted line you have access to these 14 hospitals or so. And so we have got to
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have more centralized contracting and a centralized IRB in order to compete. Those are big priorities. And we also
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have to reduce the red tape and regulation on our own IND's phase ones. And the entire process, you know, when
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we came in, it took 60 days for the FDA just to tell you whether or not they were going to consider a supplemental
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application. I mean, that kind of stuff is intolerable in the modern world. It took and you know some often still takes
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60 days just for the FDA to tell you that your application is complete. We're
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going to get that down to one day. We're going to use AI. So we've got to
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modernize the agency and be more competitive, not just talk about protectionist strategies. As you think
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about those work streams in improving the efficiency, turnaround time, how much can you do this on your own versus
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how much do you need Congress to act to pass legislation to support those changes? And are there priorities that
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you're working with Congress on to try and accelerate drug approval timelines
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that are necessary? >> So, right now we have user fees, which means if you submit an application,
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there's a fee associated with it because there's an unknown number of applications each year. So, it it's a
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system that's been around for a while. And so, uh, I'd like to see those user
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fees much higher if your phase one is done overseas. And if it's done in the
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United States, it's going to be a lower user fee. That's what I'd like to see.
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It's an America first policy. I'd love Congress to do a bunch of stuff, but
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we're not going to wait for them. Congress is slow. We're moving incredibly fast. You know, our number
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one goal was to make sure that the morale was good, the culture is good, and the and the trains are running on
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time, coming in right after the restructuring. I'm proud to report this year in 2025, this past year, we hit
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100% of our user feed target dates, that is the trains were all running on time,
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that every accept or reject decision by the FDA, was consistent with the accept or reject decision by the primary review
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team. That is, we're not doing secret deals. We're not messing with things. We
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are standing by our scientists. And last month we had a record number of drugs approved by our center for biologic cell
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and gene therapies and other nine drugs. And so we want to keep going hard and strong and innovate. But the first goal
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in the first nine months was to make sure the trains are running on time and that we are strong. And I'm happy to
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report the FDA is strong and is going to continue to be strong. And going back to
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this point about cutting down on timelines for phase 1 2 3 maybe you can just for the audience that may not work
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in this industry very briefly explain phase 1 2 3 >> and then where we think there's the
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biggest kind of uh call it excess regulatory burden that's causing these extended timelines on drug approvals
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just just to kind of frame it up a little bit. >> Sure. So there's an something called the
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IND investigational new drug registration process. That's step one. Most of those are actually filed by
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academics and I think people forget that we still have a lot of great innovation
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in our academic spaces. It's not just the pharma labs. Uh then you uh try a drug in healthy subjects. That's called
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a phase one trial. Typically a small number, a handful. And then you give the drug to subjects with the condition and
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that's a phase two. It's a limited study. And then phase three is a large
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randomized control trial. We call it the pivotal trial. We announced just last month that we are going to go from a
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baseline default requirement of two pivotal trials for a drug to one pivotal trial for a drug. It's just math. You
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can achieve the same statistical power if you design one good clinical trial properly with a good control group. Uh
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and so that by the way that saves like a hundred million to $300 million for some
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companies. Shortens the time. We're reducing animal testing. That's the preend or prephase one work. that is how
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does it work in animals? We are eliminating a lot of animal testing requirements. We have a roadmap. You no
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longer officially have to submit chimpanzeee studies for monoconal antibodies. That was announced two
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months ago. We said um so typically 144 chimpanzees are used for a monoconal antibbody. By the way, it's it's
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>> you're making me sick because this has always been from my point of view one of
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the most troubling bioethical concerns I've had about the the industry because
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you don't get a lot of statistical power or benefit from doing this and it's just
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awful that we do it. But >> you you actually get misleading information sometimes. Some say aspirin
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would not have been approved today if we had the old animal testing requirements
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to species because drugs that are uh have safety concerns in animals may not have safety concerns in humans. So we
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may miss out on cures and vice versa. 90% of drugs that pass animal studies do not pass safety and efficacy in humans.
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So what are we doing? We have computational modeling now. Computer can look at a drug and actually make better
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predict predictions and we have something called organ on a chip technology where you grow say the liver
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cells or heart cells in a lab administer the drug and then look for any enzyme leaks or disturbances. These are modern
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techniques. We've got to modernize the agency. It's a massive goal. So >> and they're doing it in China. They're
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doing it in China. And >> if we don't, then we're also putting our
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industry at risk. >> We've got to be more competitive, 100%. And so what does this do? It compresses
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the time for approval. It allows R&D to be done at a lower price point, translating into lower drug prices for
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everyday Americans. More drugs can be evaluated. I mean, I had one pharma executive tell me, "Hey, I love you're
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going from 2 to one pivotal trials. That means we can run twice as many drugs through large pivotal trials." That's
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what we want. We want to see more. Look, I'm coming in with a bi. We all have our
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biases. I have a bias and it's just a matter of recognizing your biases when
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we talk about reforms. My bias is being at the bedside breaking bad news to people with incurable conditions or
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being at the bedside in the ICU. And when you do that, it has a profound impact on your brain and your soul. and
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you think about what can we possibly do to give this individual some hope. And so when I see a 10 to 12 year time
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period of bringing a drug to market, I think in the modern world it makes no sense. Just think about the advances in
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science and technology. So I'm committed to that mission. And we've got a new
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pilot program now to get decisions out in weeks. >> It's unheard of. It's unprecedented. Uh
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we have the first uh medication we just announced after 55 days. Um we we have a
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lot to change in the workflow to get that time frame down. But we have I think 18 products that have vouchers for
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this new pilot program. If you're going to do something new, you have to pick
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criteria. >> You can either do it randomly or you can pick criteria. So the criteria we chose
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are drugs in line with our national priorities. a unmet public health need. Say a a new amazing cure for cancer
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where the tumor shrinks in front of your eyes and you don't need surgery or chemo. That's a real thing. That's I'm
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actually giving you a real example. We gave those companies a voucher. Um if you're bringing manufacturing back to
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the United States, that's a national security issue. And if you are going to
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make the drug affordable, that's an access issue. And that's an a massive
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priority for this president is lowering drug prices. So, we have uh this pilot underway and it's going extremely well.
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>> So, the drug company gets a voucher if they qualify under one of those three
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criteria and that gives them a fast track. >> That's right. >> Yeah. And when will we get a readout on
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how that program's going and whether it becomes standard? >> So, in internally it's going great. I
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mean, I've got employees at the FDA tell me, gosh, I love this. It makes sense.
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And the reason we haven't done it before is that we farm out the application to a
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dozen offices and everybody has until the target date to get their final reports in. Well, the target date is
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about a year. >> So if you are a expeditious scientist or you have the ability to uh go do your
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work expeditiously and in two weeks you have your result. Well, it doesn't matter because the farm talks person or
00:19:05
whoever else is another part of that has until the day before. Guess when they're
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going to submit it? The day before. So, we are changing the incentives internally, the bonus structure. We're
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changing the alignment. We're changing the culture. And our goal is to streamline that process.
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>> Going back to the computational point, we are collecting more data, digitizing
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that data on patients than ever before. That data should generally be accessible. Is there a world where we
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can transition from phase one, phase two, phase three trials into a phase one, phase two slash3 by taking into
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account all of this additional data? Some people have talked about the idea of using AI plus other health data
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that's collected and allowing the phase 3 to kind of roll into phase 2 and create a much more expedited
00:19:51
computationally assisted approval process. Is that something that's on the road map or is discussed?
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>> Absolutely. There has been tinkering of combining phase one and two, phase one,
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two hybrid trials, phase two and three hybrid trials, approving something with sort of a preliminary approval after
00:20:09
phase two if the results are really promising. And those are all steps in the right direction, but I think of
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something much bigger. Can we move to continuous trials? Can we use basian uh statistical evaluation which we
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announced this week? We are now going to allow basian statistics to be used. So now you can if something works instead
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of having a committee meet twice a year to do a cut of the data and print it out
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and everybody looks at it. I mean I was literally on those committees. Why can't we in real time with AI tools
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figure out when there's a safety signal or efficacy established and then call it
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at that point allowing more people to get the drug as soon as we know it works. And is there more continuous
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tracking that's also possible to look for risks and issues that start to emerge in certain populations? Because
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this is something that it's almost like the approval happens and then you find
00:21:06
out years later that well maybe there was an issue that we should have caught sooner. And if you move to a more
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datadriven continuous observational system, can you both have faster approvals but also faster recognition of
00:21:18
safety concerns for specific population? >> Yeah, I love the way you're thinking. So
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we I want to see continuous trials with endpoints in the cloud >> so that the reviewers are looking on to
00:21:28
the endpoint. You don't do your freshman year of college and then submit a giant
00:21:33
50,000page application to start your sophomore year and then do your sophomore year and start another 50 page
00:21:39
to start your but that's what we're doing at the FDA. Now look, it had good
00:21:42
intentions, but we live in a modern world. We're using computers now, not stone tablets. And so we can run more
00:21:49
continuous trials. That's the goal. And we can use basian statistics, which we
00:21:53
announced this week a a a big uh uh sort of new milestone with that. And I want to see um I want to see us continue to
00:22:04
have eyes on a drug after approval. So approval is sort of a a point where we say hey the world can use it with a fair
00:22:14
degree of confidence on the safety uh efficac and efficacy tradeoff but uh why did we learn 5 years after Vio
00:22:24
was approved that it may have killed 38,000 people well in the modern world with big data we can have eyes on a drug
00:22:32
as it's being used in real time to call out that safety signal. immediately and
00:22:38
let people know. It may be a subgroup of people that are affected. There may be a
00:22:41
drug drug interaction. Um, you know, you think about the opioid epidemic, 15 years of prescribing it, having no idea.
00:22:50
And I was I'm guilty. I was doing this. I was prescribing it. My patients were
00:22:54
getting addicted, coming back for refills. I thought it was kind of a one-off thing. You know, a lot of people
00:22:59
come back, ask for refills. No, it was a national pattern we should have identified in big data. And so we're
00:23:04
going to do postmarket surveillance in a way like we've never seen before using
00:23:09
big data. And if we get it right, if we get it right and there's a big priority,
00:23:13
it can actually change the threshold of approval because you know you're going
00:23:17
to have eyes on a drug immediately for people in the general audience to understand this begs the question and I
00:23:24
think people will bring this up as as a critique of absolute safety. I always talk about the example of you put the
00:23:32
Whimos or the autonomous cars on the road, they uh cut down on uh fatalities by 95%. But as soon as one person gets
00:23:41
killed by a Whimo, the media goes crazy and says these autonomous cars are killing people.
00:23:47
You know, and and and this this begs the question about the the understanding of
00:23:52
safety and risk uh versus the benefit that can occur. You know, I was sharing with you about a family member who had
00:24:00
to wait a long time to get a certain therapeutic and I was thinking about the thousands of people that that died it in
00:24:07
that same period of time. Fortunately, he was able to get the therapeutic, but all the people that that died because
00:24:11
they couldn't get access to this drug. How do we convey to the general population the idea that speed matters
00:24:18
in saving lives and this question about absolute safety and absolute risk around
00:24:24
drug approval? This is really important when you talk about risk to a general audience. How do you convey that second
00:24:30
order effect? >> That's right. So safety is our number one priority. We are to safeguard the
00:24:35
the public. But having 8 months of 144 chimpanzees go undergoing studies has risks to the general public. You may be
00:24:46
holding back a curative medication for 8 months. Not identifying the efficacy in
00:24:52
a trial with basian statistics. um early enough has risks because that extra lag
00:24:59
period is time when patients like the patients that I treated at John's Hopkins are told sorry we don't know of
00:25:06
anything out there so time delays that are unnecessary have risks and I think that is something we don't think about
00:25:15
in the FD you know enough at the FDA we think oh we have this concern let's sleep on it okay well you get a night to
00:25:21
sleep on it not 9 months >> so I want to give a flip to this. The right to try law gives patients access
00:25:27
to drugs that uh when they're in a certain condition, they can access the drug before it's gone through full
00:25:32
approvals. What's the current state of right to try? Where do you view that going? And does the threshold for right
00:25:39
to try change over time, giving patients and their doctors more rights and more access sooner or does the FDA still have
00:25:46
to hold firm? How do you think about that over time? >> So, I believe in both the letter and the
00:25:51
spirit of right to try. It's an amazing achievement of U. President Trump in the
00:25:55
his first term and I have signed 100% of right to try requests that come across my desk. Of course, the companies have
00:26:03
to agree to make the medication available, but it's a great program and like we don't want people getting spun
00:26:10
up on snake oil that doesn't work, that's cost $3 million where their churches are doing GoFundMe campaigns
00:26:16
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
00:26:23
Medicare program. They're using taxpayer dollars to fund things. But if there's a
00:26:28
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
00:26:36
beyond safety, we are, you know, have to be as flexible as possible with our uh regulation. And we announced just this
00:26:44
week that we are getting rid of the some of the regulatory requirements for cell
00:26:49
and gene therapy. Now those are used for a lot of rare diseases, but we had requirements uh what we call PPQ runs
00:26:56
for batches of um it's part of the manufacturing requirements for cell and gene therapies. We were holding them to
00:27:03
the same standards we were for say mass manufacturing of a pill. Well, a cellar gene therapy can be developed in a lab
00:27:09
at UCSF or Stanford. And are we going to require that they use the same manufacturing broad standards to do
00:27:17
multiple batches when you've got a scientific platform that works, a vector platform that works and you're basically
00:27:24
doing surgery on the human genome just in different locations? So, we made that announcement earlier this week.
00:27:31
>> So, let me just understand that one. I've I've spent a little time in the
00:27:34
space. Does this mean that I will not need to go through a GMP or good manufacturing practice facility to bring
00:27:40
those therapeutics to a broader set of patients? And does it also mean that once I've got a system that works, I can
00:27:46
use it for different indications? And maybe help understand a little bit about where this goes because there's many
00:27:50
patients that today are looking at papers on cell and gene therapies, early data, and they're saying, "When can I
00:27:56
get access? I'm at risk." This matters a lot to patients. and maybe you can help
00:28:01
contextualize how this translates into speed and and access. >> Yeah. So, the announcement that we made
00:28:06
on Sunday was that we're going to customize the manufacturing requirements to the drug and the population being
00:28:14
treated. So, there's a number of flexibilities including the ones you mentioned, but it's no longer going to
00:28:19
be this hard and fast. You have to do it this way. For example, the three batch runs that have been required, those
00:28:26
ingredients are expensive. I mean, those ingredients could cost $100,000 for just
00:28:29
one ingredient. And so, we have to use common sense. I mean, when you see something uh perform, you know,
00:28:38
something magical to a kid with no help right in front of your eyes, you've got
00:28:44
to say like, what are we doing getting in the way? We just um had early in u our time there, baby KJ go from go home
00:28:52
from the hospital, right? So this infant got gene editing therapy. You can't do a
00:28:57
randomized trial on that. There's not enough kids who have it. So we these bespoke therapies. We created
00:29:04
essentially a novel pathway for them. Uh Dr. Vani Prasad uh described it in the New England Journal of Medicine. It's
00:29:11
called the plausible mechanism pathway and it's basically combining gold standard science with common sense.
00:29:17
>> Right. And what about for CARTT therapy? So there's this blossoming class of
00:29:21
therapeutics in CARTT that's historically been used exclusively for oncology for cancer. Um increasing
00:29:28
discussion about using it for autoimmune conditions. Does this help with the CARTT therapy pathway and enabling
00:29:35
faster routes to market and more access and lower cost? >> It can. And by the way, CARTT is
00:29:40
amazing. Carti is amazing. I'm not here to pro promote any one class of drugs
00:29:45
but I mean it the stuff that we have seen um is mindboggling. >> So yes >> and just for folks to understand when
00:29:52
they take tea cells edit them and put them back in the body and those tea cells go after targets in the body and
00:29:58
destroy those targets and many blood cancers uh are now seeing extraordinary results with these CARTT therapies and
00:30:05
now they're going after autoimmune conditions. But it definitely seems to be that there there needs to be a faster
00:30:10
path to market, lower cost because the pricing is half a million to a million dollars still.
00:30:14
>> Yeah. It's amazing. We're essentially activating your own immune cells to to
00:30:19
have a a very clear path and target something in your body that needs to be targeted. So it's now we did find um
00:30:28
that there was in the Biden administration approval to have the cells of Americans for CARTT therapy
00:30:36
shipped to China where the Chinese did the gene editing and then ship back to the United States to infuse in
00:30:41
Americans. When I found out about that, we shut that thing down so fast. Yeah. So, uh we have to do things carefully.
00:30:47
>> What else have you discovered since you've been in the FDA that shocked
00:30:50
>> you? Just go on a side for a second. I'm I'm curious to know what are the biggest
00:30:55
shocks that you've uncovered. I mean, you've now been there for some time, you
00:30:59
mentioned before we sat down that you're actively digitizing millions of files
00:31:05
>> that historically have not been digitized, and I'm I'm assuming you can
00:31:08
now use AI and other tools to go read through them very quickly. What's been
00:31:12
shocking to you? >> Where do I start? I mean, somebody was carrying a box from one building to
00:31:18
another building with uh with a um drug file in it. And um it turns out that the
00:31:25
lawyers said they couldn't email the information to the other center because,
00:31:30
you know, each center was like their own secret government before we got there. >> Each center of the FDA.
00:31:37
>> Each center of the FDA. >> Same agency. >> Yeah. Same agency. Seven centers. It was
00:31:40
like, you know, they had their own boundaries and territories and, you know, lawyers. They had their own
00:31:45
communication staff put out their own releases, uh, their own press releases, did their own legislative affairs with,
00:31:52
had scheduled their own hearings. >> And the commissioner was out of the loop
00:31:55
sometimes. And so, we restructured the entire agency. Now, we centralized those services. But in the days of this sort
00:32:02
of siloed world of the agency, by the way, it was a nightmare for uh developers that had a drug device
00:32:08
combination. Um, right. >> I mean, it was like gerrymandered lines of what was included in one center
00:32:14
versus another center based on infighting. And, uh, you know, people had served long terms there. You know,
00:32:20
they'd serve terms like, uh, President Mugab of Zimbabwe who'd been there, you
00:32:25
know, forever. These people just were there forever, right? It was just their way. And, uh, anytime there was an
00:32:32
opening in leadership, 19 times out of 20 it went to an internal candidate. So, you didn't have a lot of fresh new
00:32:38
ideas. We have a lot of a lot of fresh scientists coming in there. I mentioned the 1,000 new scientists. We're we're on
00:32:43
boarding right now um 450 of them. 50 of them already just started. But um I've
00:32:50
met a guy who uh his job was to change the ink cartridge on a fax machine on one fax
00:32:58
machine. Uh like healthc care has single-handedly kept the fax industry alive. >> Wow.
00:33:04
>> Um the guy's job was the ink guy on the fax machine. to swap out the
00:33:09
>> machine. >> There's a lot of that. There's a lot of that.
00:33:12
>> Well, let's shift over to food. Maybe I'll just give you a moment to share
00:33:17
what you changed in the food pyramid in the announcement last week. Why you made
00:33:21
those changes and why weren't they made before? Yeah. So, we have had decades of medical
00:33:31
dogma and corruption putting together food pyramids that make no sense. people can tell. I mean, the open secret was
00:33:38
that they make no sense. They're scientifically inaccurate and they were often times curated by the food industry
00:33:45
or the food industry's influence on academia. Nutrition science may be one of the most corrupted fields in all of
00:33:53
science. And it gave us the dogma that we had to focus on saturated fat and just eradicating natural healthy fats
00:34:02
from the US food supply. Ignoring that you replace fats with healthy with refined carbohydrates which are not
00:34:10
healthy. And we have this carbohydrate heavy diet now for American children. And guess what? 38% of kids have
00:34:18
pre-diabetes or diabetes. Is that a surprise? The rise has paralleled the shift from saturated fat or regular food
00:34:27
to pumping refined carbohydrates and added sugar. 60 to 70% of the calories of a child in America today are refined
00:34:35
carbohydrates. No one has talked about it. It's been in a blind spot as the medical
00:34:42
establishment has had this myopic focus on the boogeyman of saturated fat. And so we had a food pyramid that was
00:34:52
entirely backwards. And so we flipped it upside down using good science talking about a an previously ignored area of
00:35:02
nutrition. And that is the importance of protein. We've been getting about half
00:35:06
the protein that we need. The protein levels in the previous dietary guidance was really just to prevent withering
00:35:12
away. We want our American kids to thrive, >> right? and and look at the status of
00:35:18
kids today. Low in protein, muscle wasting, weakness, um underperforming in school, high in uh
00:35:28
refined carbohydrates and added sugar, giving them that kind of uh sugar um sort of coma, food coma after a refined
00:35:37
carbohydrate uh breakfast. Again, we hit them hard in the afternoon. They get very little or
00:35:43
no natural light exposure. They're told to sit at a desk still for 7 hours a
00:35:48
day. They can't do it. And what do we do? Tragically, we have drugged our nation's kids at
00:35:54
scale. It's wrong. It needs to stop. We have to reexamine the root causes. And
00:35:58
so, flipping this food pyramid upside down, focusing on protein is the first step. And so, I'm very proud of what we
00:36:04
were able to do. What have you uncovered now that you've been inside the organization and you can see paperwork
00:36:11
related to the legacy of how the old food pyramid was constructed and maintained for so long about the
00:36:17
motivations who was involved in setting that food pyramid when you mentioned the
00:36:21
corruption of nutrition science. Help us understand the root of that. So, I wrote
00:36:26
a book um just before coming into office where I had a chance to do a deep dive and do some investigative journalism, if
00:36:34
you will, to learn how this dogma of what to eat got we got so wrong. And I think it was a lot of group think just
00:36:45
like we saw with opioids are not addictive. Medical establishment got that wrong for 15 years.
00:36:54
Uh, young kids should avoid peanut butter until they turn three. We got that wrong for 16 years. Tragically
00:37:00
wrong. Igniting the modern-day peanut allergy epidemic because peanut butter exposure in infancy
00:37:08
reduces there's something called immune tolerance, right? And it reduces the
00:37:12
risk of peanut allergies. We're the only country in the world that has high rates
00:37:16
of peanut allergies along with UK and a few other European countries that fell for our dogma based recommendation to
00:37:23
avoid peanut butter till the kid turns three. And so we got that 180 degrees wrong. And so there are dogmas in the
00:37:32
medical field that take on a life of their own and you're not allowed to question them. And we saw a little bit
00:37:38
of it during COVID if you recognized natural immunity and may not need to be fired from your job because you have
00:37:44
circulating antibodies to COVID, but they were just antibodies that the government did not recognize.
00:37:51
This dogma can take on a life of its own. And so we're trying to get back to
00:37:55
gold standard objective science. It is crazy that the fundamental premise of science is you ask a question and then
00:38:03
you test whether there's one answer or another. And the idea that you can't ask
00:38:09
questions indicates that it's not science from my point of view. All standards should be challengeable. That
00:38:15
you should be able to ask the questions and fundamentally if they they hold truth or they hold ground then great.
00:38:21
Let's maintain them. And if they don't we should be able to change. And then
00:38:26
they use the word science or historically the word science has been then used to justify not testing
00:38:30
something. >> That's right. >> It's it's crazy to me. What are the
00:38:33
roles that food companies have played? What are the roles that folks that might have an economic incentive in keeping
00:38:41
the food pyramid as it was played historically in this? And is that permanently changed at this point or is
00:38:48
it changed while this administration is here and it's going to change again next
00:38:51
cycle? help us understand a little bit about you know the the the role that industry has in influencing some of this
00:38:59
regulatory process. >> Well, I think the industry did what the medical field told them to do and that
00:39:07
is to address the risk of mass starvation and deal with food insecurity and that calories in equals calories out
00:39:15
regardless of where those calories come from. That was the dogma and sort of the
00:39:19
the mandate to the food industry. So um they did what they were told to do and so they moved to refined carbohydrates.
00:39:27
They stripped the grains of fiber to mass-produce them. They would even chop them up which made them increase your
00:39:34
glycemic index. That is it basically function like sugar. So you have cereals, breads, pastas functioning like
00:39:43
sugar. And so we ushered in a generation of kids and you and I were the first gener who were part of this the first
00:39:51
generation in human history with massive insulin spikes daytoday in our normal everyday life. We've never seen insulin
00:39:58
spikes to that degree. And of course that drives something called insulin resistance. That is the the organs in
00:40:05
your body that do important functions are trying to block out all this extra glucose. And so they kind of um uh
00:40:14
change the configuration of the insulin receptor to just try to resist all this sugar coming in. And it is at the root
00:40:21
of almost every chronic disease. Insulin resistance, general body inflammation. And we never talk about these things.
00:40:29
Never. So we talked about them front and center in our new uh guidance. The types
00:40:34
of grains matter. It's not calories in equals calories out. It's not you can
00:40:37
have this if you sit on the treadmill for this amount of minutes. We've got to
00:40:42
talk about the soil that food comes from and the farming techniques that animal products come from and the cleanliness
00:40:51
and chemical-free waters that seafood comes from and the importance of protein and the value of whole grains and what
00:40:59
we call real food. And so the website is realfood.gov. My only criticism is the lack of vegetarian protein in the top of
00:41:05
the pyramid where as a vegetarian I eat eggs and dairy. It could use a few more nuts and beans up top, but you know,
00:41:12
I'll talk to Joe Gibbia about it. >> It could. No, it could. I think the New
00:41:15
York Times had a conception about blue the blueberries. >> The blueberries.
00:41:19
>> I think it was uh uh disproportionately uh disturbingly large >> disturbingly large blueberries. That was
00:41:27
the criticism. Okay, that wasn't one that bothered me. Let's talk about the
00:41:30
the adult population. I think 40 to 60% depending on how you measure it are obese clinically obese in this country
00:41:36
and these incretin mimedics GLP1 drugs and others have really taken the market by storm taken our population by storm.
00:41:42
So I realize that much of this is in response to an obesity epidemic that we're facing in this country. But it
00:41:48
turns out that these incretin mimedics may actually have other systemic benefits and they're now I think there's
00:41:54
60 indications that they're being tested against including kidney neurological
00:42:00
cardiac. I mean there's there seems to be a lot of benefit potentially in uh
00:42:04
using them for other disease indications. Can you speak a little bit about your view on where this market
00:42:10
where this class of therapeutics is headed? Is this something that some people have estimated or 60% of
00:42:15
Americans are going to be on? And if it is the case, does that mean we failed with our food system?
00:42:20
>> Well, first of all, we have failed with our food system. Look at the fact that
00:42:24
40% of American kids have a chronic disease. Between the lines in the medical textbooks in medical school was kind of
00:42:33
a blaming of children for not having the discipline. And it's not a willpower
00:42:39
problem. This is highly addictive uh chemicalized foods that are ultrarocessed that are put in front of
00:42:46
kids and they want more and you you put these vibrant colors in them from the petroleum based dyes. And so this is
00:42:52
something adults have done to kids. And so I think that we have failed. We've
00:42:57
given people the wrong information. The calories in equals calories out, this demonization of fat and all that stuff
00:43:03
we talked about. um GLP-1s are mimicking a natural hormone in the body. And so when you get a supplementation of that,
00:43:13
it's doing the job of increasing satiety, slowing down GI motility, and it has a profound impact on a number of
00:43:21
conditions because you are also reducing insulin resistance and general body inflammation. And so that's why we're
00:43:29
seeing so many other benefits. Plus, you feel better. When you feel better, you're going to have benefits you don't
00:43:34
even we haven't even appreciated yet because there's an incredible value this
00:43:40
sort of positive thinking. We've seen it in a breast in a lung cancer study from
00:43:45
Mass General. They randomize people to palative support versus chemotherapy and the palative support did better even
00:43:52
though chemo drug is is more effective than standard of care. So, um, you see this incredible value to sort of
00:44:00
positive thinking and maybe that's one of the reasons we're seeing reductions
00:44:04
in addiction. Maybe we're, you know, we're seeing cardiac benefits. So, we'll
00:44:08
see. I mean, we're, you know, as a regulator, we're a referee and we want
00:44:12
to see products come to market quickly and safely, but I think we're we're
00:44:17
we're at a pretty interesting time. >> Yeah. Just to go back on the China point
00:44:21
because we did talk about competitiveness with respect to speed, but the other piece I wanted to address
00:44:26
was >> uh funding of research. So that uh that bioh technology council I mentioned
00:44:33
recommended a $15 billion kind of rushed investment in in research. When I meet with scientists, there's a view that the
00:44:41
Trump administration is anti-science, is defunding a lot of research institutions
00:44:46
in the United States that are going to save people's lives and develop amazing
00:44:50
cures. Why are they doing this? There's this council that recommends that even
00:44:54
in the face of China, they're putting out tremendous funding to support research scientists coming up with those
00:45:00
next set of molecules or therapeutic modalities that are going to change lives and improve lives. Maybe you can
00:45:06
comment a little bit on are we funding through the government enough scientific research? What's the right steady state
00:45:14
for us? And how do we address the the points about the Trump administration being anti-science?
00:45:18
>> Yeah. Well, look, we live in uh partisan times now where people get spun up and
00:45:23
they're in sort of a toxic polarization. And the truth is, if we want to know the
00:45:28
facts, is that in the Trump administration, we have not cut $1 of NIH funding. We have not cut $1 to the
00:45:37
general Medicaid budget. That is the overall Medicaid fund. And the proposal for the future is to increase Medicaid
00:45:45
by $200 billion. So you hear all the time, oh, Trump cut Medicaid, Trump cut the NIH. No, what we want to see is
00:45:52
reallocating money at the NIH from just chemotherapy and proton beam therapy work to study food as medicine and
00:46:02
school lunch programs. and the microbiome and gut health. We've got to start talking about school lunch
00:46:09
programs, not just putting every six-year-old on ompic. We've got to talk about the quality of sleep as it as it
00:46:16
is a cause of high blood pressure when you sleep poorly instead of just throwing people on anti-hypertensive
00:46:21
medications. We've got to talk about environmental exposures that cause cancer, not just the chemo to treat it.
00:46:28
And so, we want to see funding go to root causes of diseases. And that is something that that has been
00:46:35
unfortunately in a blind spot because the culture of the NIH is the culture of Francis Collins and Tony Fouchy and the
00:46:45
group for the last 50 years that and I'm going to oversimplify it. The gene is
00:46:50
responsible for our health problems and the gene can solve all of our health problems. Well, look, I believe in gene
00:46:57
therapy and we're doing amazing stuff with that. But where's the research on
00:47:01
why one in six girls today will develop an autoimmune disease? What's triggering
00:47:07
that antibbody response? What of the many exposures in the life of a child is causing their bodies to be triggered?
00:47:15
These studies can be done. It's not that difficult to model the antibbody that's involved in type 1 diabetes or MS
00:47:25
and exposures in the environment to see if it is triggering that same configuration that the antibbody binds
00:47:32
to. But no one's been interested in it because everything has been about coming
00:47:36
up with a, you know, treatment when we have to look at causes, >> right? And the scientists on the ground
00:47:44
see their funding go away. They complain. They get media attention. There's a lot of amplification of those
00:47:51
stories. So is that not the fundamental truth because the money is being reallocated to other scientists and
00:47:56
other research institutions? >> Correct. So um 14% of NIH funding went to DEI research. 14%
00:48:05
>> 14% of NI NIH grants went to DEI research >> and NIH grants are about 40 billion a
00:48:11
year. Does that sound >> uh it's it's a little over 20 billion in terms of grants that go out the door but
00:48:17
about 47 billion for the entire NIH budget because they run their own hospital and clinical center and others.
00:48:23
>> So um so if you think and and by the way I'm all for anything that reduces health
00:48:29
disparities. >> Yeah. and increases access. But these grants were not doing it. It was just
00:48:35
describing health disparities. Well, it's it's we already know there are
00:48:39
health disparities. Simply describing them with another 50 studies in JAMAMA does not help people who are suffering
00:48:46
from these health disparities. So, um we've seen money shifted to root causes
00:48:53
and areas of research that we need to study that we've not studied. At the FDA, we have put a big emphasis on the
00:48:59
value of hormone replacement therapy for post-menopausal women. Something the NIH
00:49:05
demonized for the last 22 years, saying that women shouldn't take it because it
00:49:09
causes cancer. Um, when we came in, the NIH was a mess. Almost all the money was
00:49:16
going to genetic research, which then becomes the priority of every academic institution. They're not studying causes
00:49:23
and food and the microbiome and cutting edge areas of of of science. And they just had this myopic focus on one area.
00:49:30
It's an important area, but it's one area. They were funding the Wuhan lab
00:49:34
to, you know, get bat corona viruses and insert a furine cleavage site so it could infect humans. What are you doing?
00:49:41
It's a bunch of mad scientists. Um, and 14% of grants were going to DEI. So the
00:49:47
NIH when we came in was a mess. And under President Trump, it is massively being reformed. And Jay Bodyario is
00:49:53
doing a great job. >> Okay, let's shift over to vaccines. Our wives had kids around the same time.
00:49:58
Hope yours is doing well. >> Great. He's great. Thanks for asking. >> Yeah. And we talked about the HEP
00:50:03
vaccine, which we declined on the day he was born. >> Cuz I started going very deep on what's
00:50:11
the origin of the HEP vaccine the day that the child is born. Why why is this being given to them? We have no HEP B
00:50:18
exposure in our household. We don't need it. Doesn't protect anyone else. What
00:50:23
are we doing this for? You end up going down these rabbit holes and a lot of again what you mentioned earlier, you
00:50:28
take for dogma and you recognize, wait a second, there may be some unfounded principles at play here. I should not be
00:50:34
doing this. And we make a a difficult decision against the tide and the recommendations and suddenly you're in
00:50:39
the social conflict with people around you, right? And it was very hard. >> You guys recently made some big changes
00:50:44
to the vaccine schedule. I'd love to hear a little bit about how those changes were made, what were the
00:50:50
big changes, and then, you know, kind of what got us to this point where when you
00:50:55
look at the data, you're like, "Wait a second, right? >> That may not make as much sense." Yeah.
00:50:59
>> I'm just laughing as you talk, Dave, cuz you do, you know, you just ask some good
00:51:03
questions like, "Does does my newborn on the in the first hour of life need to be
00:51:10
injected with a hepatitis B vaccine when the mom is hep negative?" And within a
00:51:16
matter of weeks of having broader conversations, you feel like you're a fugitive of the law, like you've done
00:51:21
something, you know, terribly wrong for choosing not to vaccinate. We went through the same thing and and and you
00:51:28
know, being a part of having a kid is so special. You know, we were talking about
00:51:31
that. So, yeah, we just went through this. Our son was born about 6 months ago and, you know, the uh we were
00:51:39
offered the hepatitis B shot. Now, maybe they figured out who I was and didn't
00:51:43
push it as hard as some of my friends have had that it pushed on them and we declined. Um, you're preventing with
00:51:50
hepatitis B an infection that is a sexually transmitted infection or can be uh get it from a uh bloodborne pathogen
00:51:59
exposure. Uh, so that's not going to happen until they're a teenager at least
00:52:03
or further down the road. But when you ask the question immediately you get this sort of antivax label or um
00:52:13
>> or you have to qualify that's right >> I'm not an antivaxer but I'm asking this
00:52:18
what what right what's going on here this sort of McCarthyism around this uh
00:52:23
schedule which by the way the United States vaccine schedule was an international outlier with 72 doses
00:52:28
recommended between the ages of zero and 18. So, President Trump asked us to review the um international
00:52:37
landscape of vaccine recommendations and we looked at 20 other developed countries and found that not only are we
00:52:43
the international outlier in in how high the number of doses we recommend is but
00:52:48
that there's a consensus of a group of core essential vaccines and we wanted to
00:52:52
put that in front of the American people to say look all vaccines are still recommended by the CDC but here are a
00:52:59
list of core essential vaccines. So we gave them a list that constitutes about 38 doses from age 0 to 18. And the idea
00:53:06
is to increase vaccination rates among children that have been dropping because of a loss in public trust by saying
00:53:15
here's a hierarchy of what we believe to be a list of core essential vaccines. I
00:53:21
don't want to see someone because you know a um a doctor's pushing the sixth
00:53:26
COVID booster in a young healthy 12-year-old girl. I don't want to see the mom say, "Well, I'm not going to get
00:53:32
the measel shot in my next with for my next child because I am something's not
00:53:37
right about this." 38 is better than zero. You can still get them all. They're all paid for, but we have a hard
00:53:44
time in the medical culture, and this is part of the sort of the sociology of medicine, meeting people where they're
00:53:51
at. For example, as a cancer surgeon, I would see women tell me they don't want
00:53:57
to get a mammogram. I I disagree. I think they're safe, but a woman may have be concerned about the
00:54:04
radiation, the discomfort, the inconvenience. 40% of women who are candidates for a mammog are not getting
00:54:12
a mammogram in the United States today. Showing you the massive disconnect between the medical field and where
00:54:18
people are at. Now, you know what we should be doing is we should tell those 40% of women, how about an ultrasound?
00:54:26
It picks up 90 to 95% of the lesions that a mammogram would pick up. But doctors don't recommend an ultrasound
00:54:33
because you're violating the gold standard and there's liability and there's, you know,
00:54:38
and you're you're practicing substandard care and women may tell other women that
00:54:43
they can also get an ultrasound and we don't want women getting an ultrasound
00:54:46
instead of the paternalism that results in this disconnect is hurting people in the United States today. And so with
00:54:55
identifying the list of core essential vaccines, we are trying to meet people where they are at to see more
00:55:01
vaccinations because childhood vaccines have declined over the last four years of co because people have lost trust in
00:55:09
the dogma of the cloth masks for toddlers and vaccine boosters in perpetuity and you have to fire a
00:55:16
teacher if if she already had CO. Ignore natural beauty. You have they have to be
00:55:21
fired from their job. that um absolutism has caused tremendous damage and we're
00:55:27
trying to rebuild public trust. What's frustrating to me to observe is there
00:55:32
are now states like California and the California DPH that are saying we're going to set our own vaccine schedule.
00:55:37
We're not going to listen to the FDA, to the HHS anymore because they don't know
00:55:41
what they're doing because they're Trump admin. They're not doctors. They're not
00:55:45
scientists. Clearly, this is all political. And is there a process of engagement that you and your
00:55:51
organization go through to try and bring some of these other folks along with you? Because I think the point you just
00:55:56
made can't be a point that they can fundamentally disagree with. What is what is the process by which we can
00:56:03
break the political ranker around things like vaccines and just take a very clear-cut scientific approach and get
00:56:12
people aligned around this? Do you do engagement on this stuff? >> I don't. Look, I I think it's sad we
00:56:18
have this toxic polarization that's crept in. It's it's in society, but it's
00:56:23
now crept into medicine >> and it's a lot of character attacks. I mean, it was put together by doctors
00:56:30
with impeccable credentials. Tracy Beth Hogue, MDPhD, phenomenal epidemiologist who is deep on
00:56:37
the science on this stuff. you know all of us Jay Badacharia MDPhD memed Oz vice
00:56:43
chair of surgery at Columbia University I mean these impeccable credentials 400 scientific publications I've published
00:56:51
350 scientific peer-reviewed publications in my career at the Harvard School of Public Health at Georgetown at
00:56:57
John's Hopkins on the faculty tenure national academy of medicine didn't
00:57:01
matter all the impeccable credentials you can put in front of people there's
00:57:05
this sense of we just have to uh say the contrarian thing to whatever they are saying because of this sort of mantra of
00:57:15
all vaccines are good regardless and you cannot have an honest conversation. I talked to doctors and they they've never
00:57:21
heard of a vaccine they didn't love. Anthrax vaccine was a disaster. H3N N3 killed people. It was a disaster taken
00:57:29
off the market. Rotovirus vaccine in 1999 taken off the market because kids were dying from interception. Roto virus
00:57:38
is not in our core essential vaccine schedule in the United States. Overseas it's a little different but in in what
00:57:44
we put out it's not in there. After mass vaccination with roto virus the number
00:57:49
of deaths per year went from 3 to 1.6 >> or round it up let's say two went from
00:57:56
three to two with mass vaccination >> and the vaccine that was used up until
00:58:01
1999 was taken off the market for safety concerns. So when you have a parent ask
00:58:06
a question about the necessity or we cannot respond with absolutism, American medicine needs to show some humility.
00:58:16
When I had a patient asked me a question I didn't know the right answer, I don't
00:58:20
know. Maybe I'll look into that. Maybe one of my colleagues knows in co during
00:58:25
COVID, the right answer many times was we don't know. >> Do you find that there's a path forward?
00:58:33
>> I hope so. So, I mean, we're hoping to restore gold standard science and just
00:58:37
talk objectively about it. We've had universities uh cancel uh crush censor railroad doctors that, you know, pose
00:58:47
different ideas about things. And I'm not I'm not talking about the political
00:58:50
hot button issues. I'm talking about the fact that ulcers were not caused by
00:58:55
stress. They were caused by a bacteria called H. pylori. Well, that guy was, you know, railroaded. his research was
00:59:02
rejected from the national uh meetings and then he gets the Nobel Prize because he ends up being correct. So it's it's
00:59:09
not good for science. >> Most great scientists start out as heretics just to be clear by the way.
00:59:13
That's right. Yeah. So Marty, one of the other big challenges that we talk a lot
00:59:17
about in this country is the cost of drugs. Healthcare today costs roughly 15% of our GDP. That's an insane
00:59:26
statistic and it is rising year after year in the United States and it's such
00:59:31
a complex issue. By some measurements though, the price of drugs in the United States is almost three times what it is
00:59:39
outside the United States. So I'd love to hear a little bit about the specific
00:59:43
role of pricing drugs. What sort of actions have you guys taken and can you take to help bring down the price of
00:59:50
drugs for patients, for for care providers, for insurance companies, and ultimately for the economy?
00:59:56
>> It's been the great American ripoff. You could buy a GLP-1 drug for $1,300 in the
01:00:02
United States and go to London, it sells for $88. Or you go to Germany or France
01:00:06
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 the
01:00:13
price. And so, President Trump has given us a clear charge and he says, "Look,
01:00:17
we're the largest purchasers of drugs. We want the best price in the developed
01:00:22
world. It's called most favored nation status pricing. And thanks to Dr. Oz and
01:00:28
and Chris Clamp and others at CMS, we did our part at the FDA to be a part of this. Uh we've gotten drug companies to
01:00:34
the table and we've got them to agree to most favoration status pricing. That's
01:00:38
going to radically lower the price of drugs. With the GLP1 example, for example, it's going to come down to $149
01:00:47
for the first three months. Um, other countries are going to pay more. We have been financing 60% of the R&D cost to
01:00:54
pharma companies. Other countries need to pay their fair share. And when it comes to this president, would be it
01:00:59
NATO membership fees or whatever, he wants to see other countries paying their fair share. And so, we're getting
01:01:04
that delivered. Another big way in which we are going to lower drug prices is by cutting the red tape at the FDA
01:01:12
for bio biologic drugs. So most 51% of the So let me back up for a second. The fastest area of healthc care spending
01:01:23
growth is drug price spending growth. And the fastest area of drug price spending growth are a class of medic
01:01:31
medications called biologics. which means you need a cell line to manufacture them. And so these are
01:01:37
typically the 60,000 $100,000 $150,000 medications. They have generic versions called bioimilars.
01:01:47
But the FDA red tape to get a bioimilar approved has been so long and arduous it
01:01:52
takes 5 to 8 years and $300 million or so. We have changed the requirements so that we use the same principles we use
01:02:01
for small molecules. If you are structurally the same as a small molecule branded drug, we're going to
01:02:09
approve you with some other stipulations. And so we are reducing the cost of R&D of biosimilars by a hundred
01:02:16
million plus dollars and we are shortening the time frame from 5 to 8 years to 2 and 1/2 years or more. And so
01:02:24
we're going to see a whole new class of biosimilars come out in this administration that are going to finally
01:02:30
compete >> with the biologics. Now humumera is one of the most famous biologics. It took
01:02:35
years after that patent market exclusivity for a bio similar to come out and when one did come out you didn't
01:02:42
see the price of hum come down that much almost sort of an an implied price collusion. We need a lot of biosimilars
01:02:50
to come out and we're going to see the floodgates open up on biosimilars. And
01:02:54
then a final point, why are a lot of drugs requiring a prescription in the United States?
01:03:01
>> What are we worried about? Somebody overdosing on anti-nausea medication or
01:03:07
somebody picking up a prostate medication without a a prescription. And we've got this is the the paternalism in
01:03:15
medicine again coming out. the same paternalism that blocked women from having home pregnancy tests because you
01:03:22
know women can't handle that information. They have to come in and we have to share it with them. It's this
01:03:26
paternalism you see and by the way it happened again with COVID testing. We saw it well home COVID testing. We
01:03:32
fought this battle. We wanted home COVID testing and the establishment was like no no we have to tell them they can't
01:03:38
have this information. What are why are drugs not over- theounter? And we're going to so we are
01:03:46
going to get more drugs over the counter. And let me tell you why that lowers drug prices. Because when a drug
01:03:52
is on the shelf in a store, there's a price underneath of it. And there is something magical with competition and
01:04:00
people who shop. Even if a small segment of the consumer market is shopping on price, it keeps prices in check for
01:04:07
everybody. And so you will enable price transparency and you will bypass the crazy money
01:04:15
games of PBMs, pharmacy benefit managers. When you pick up something behind the counter, they ring you up.
01:04:22
You have no idea the shell game that's going on behind the scenes. Your with
01:04:26
your employer is getting ripped off and your PBM is is making money on this and the broker who sold the PBM to the
01:04:33
employer group could be making $6.50 50 cents on every prescription set for what? For the for the PBM just to tell
01:04:41
you what your co-ay is going to be and set the co-pays. All of those money games disappear with the with the
01:04:48
disinfectant of sunlight and a price on the shelf. We want to see a mass transition to more nonprescription
01:04:55
drugs. We have new leadership that I brought in at the office of non-prescription drugs at the FDA. We
01:05:01
want to see companies request to to be non-prescription and it it's going to have very simple
01:05:08
criteria. If your drug does not have abuse potential, if your drug is safe, if your drug does not require laboratory
01:05:17
testing, which doctors, you know, we often need to check your liver function tests. It does not need to be closely
01:05:23
tracked. It should be able to be over the counter. If you're not going to use
01:05:27
the drug in some meth lab to make some dangerous street drug, if you meet those basic criteria, the
01:05:35
drug should be nonprescription. Think about the number of useless ER visits out there. Uh the whole medical
01:05:42
industrial complex ch-ing every time you need a refill. Like I got pink eye from
01:05:48
my kids and it was such a headache to get the drops to get my pink eye to go away. Like I mean I can't I spent so
01:05:55
much money just getting a few drops of antibiotics to put in my eye. But if I were able to buy that medicine the
01:06:00
antibiotic drops over the the counter or and I could just pick it up the shelf. How do I get my insurance to pay for it?
01:06:05
How does that process work? Just explain to the everyday consumer what that's
01:06:08
going to look like. >> So we need insurance companies to to um modernize how they reimburse for
01:06:15
medications. And we're having these conversations internally as well because
01:06:19
they had this old construct of here's our reimbursement scheme for prescription drugs and here's our
01:06:24
reimbursement scheme for non-prescription drugs. Well, they got to modernize. We've got to come up to
01:06:28
the 21st century. And remember, the insurance companies own the PBMs a lot of times. So, we've got to be honest. We
01:06:35
got to all come to the table. President's bringing them all to the table and having very frank
01:06:39
conversations. And he's been successful. I've got to imagine at 15% of GDP, this
01:06:44
is a giant ship you're trying to reset and redirect. Can you get this done in
01:06:49
this administration? Can you make the changes of moving many of these medications over the counter and get
01:06:54
them to fit under insurance uh reimbursement plans? >> It's a massive priority this year for
01:06:59
me. My one of my big 2026 goals is that we want to see more drugs move to nonprescription. I if writing a
01:07:07
prescription by a physician like myself is supposed to regulate and serve as a way to administer drugs judiciously,
01:07:17
then history would show we failed. Opioids and Oxycontton uh 60% of antibiotics prescribed in the
01:07:25
United States are unnecessary. That study has been done over and over again 10 different ways. Most antibiotics
01:07:32
people take they should not be prescribed. Um, so we have to talk about educating people, trusting people, and
01:07:40
get away from the paternalistic model of medicine. >> Yeah. And well, I mean, look, if you
01:07:44
guys get it done, I think it'll be a profound change for America for the the
01:07:49
price of healthcare, which I think is really challenging a lot of people dayto-day. One of the other things
01:07:54
that's been a little bit of a hot button is pharmaceutical advertising on TV.
01:07:58
Yeah, >> some people have claimed that the pharmaceutical companies have significant influence over media because
01:08:03
of the money they spend. They're one of the biggest spenders. I spoke to a pharmaceutical CEO about advertising. He
01:08:08
said the ROI is incredible. We've never been able to influence media, so it doesn't make a difference to us in that
01:08:13
sense, but fundamentally the reason we do it is because it gets awareness out there for therapies that uh patients
01:08:20
might not know are available to them. and he said this interesting statistic to me which is that half of US
01:08:26
physicians never see a representative to learn about new uh drugs that are coming
01:08:29
to market and uh twothirds of physicians report never reading a journal article or going to a conference in the past
01:08:37
year. So they're not aware of some of the new medicines that have come to market or coming to market. You've been
01:08:42
a physician, you are a physician, you understand how this might go. You're busy. You're treating patients. You have
01:08:46
a lot going on. Maybe you're not up to speed on on the newest medicines coming
01:08:50
to market. What's the administration? What's your view on advertising, pharmaceutical advertising on TV? Where
01:08:55
are things headed? >> Well, raising awareness, as your uh friend mentioned, is a good thing, but
01:09:02
creating a misleading impression and creating a massive storm of demand where patients come knocking on our door,
01:09:09
insisting and begging that they get certain medications that are not indicated for them is a problem. and the
01:09:14
drugs that they are advertising non-stop on TV and and they're always singing and
01:09:19
dancing, right? Always singing and dancing or marching from some fake town to another. I don't know where they're
01:09:26
going, but it's always this sort of idea that life is great once you take this
01:09:31
medication. Um, it's the biologics that they're advertising. And because they
01:09:37
charge so much on the biologics, and look, they do cost a lot more to make, but because some of these biologics have
01:09:44
been so expensive, that's where they're seeing this big ROI. So, we are lowering
01:09:49
drug prices, and I think that's going to affect um whether or not it's worth it
01:09:54
for them to advertise. We have a duty at the FDA to enforce two regulations that
01:09:59
were not enforced in the Biden administration and that is that ads cannot create a misleading impression
01:10:06
and that there has to be a quote unquote fair balance of information. There's
01:10:10
also a loophole called the um uh adequate provision loophole which says you don't have to list all the
01:10:19
risks or side effects. You can put it somewhere else like on a website. We're
01:10:23
closing that loop. We're changing the regulation to close that loop. The Biden
01:10:27
folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge
01:10:36
of sending out enforcement letters sent out zero enforcement letters. I sent out
01:10:42
1,500 enforcement letters, including over a 100 cease and desist letters for ads
01:10:48
that were creating a misleading impression, including onlineies that are advertising drugs without the same uh um
01:10:56
side effects that pharma companies list when they do the ads. And so we are cracking down on it. We want free
01:11:04
speech, but we also want fair speech. And this is part of our jurisdiction. So, uh, so we are taking this very
01:11:10
seriously. I I'd personally love to see pharmaceutical companies spend that 20
01:11:15
to 25% of their money that they spend on marketing, take some of that and use it
01:11:19
to lower drug prices for everyday Americans. >> Okay, great. Well, sounds like there's
01:11:25
some balance and change that's required. One of the other things that we talk a
01:11:29
lot about in Silicon Valley is this shift in AI and using AI to diagnose your condition. And so many stories have
01:11:36
come out where people upload their lab data or an MRI image and they're getting
01:11:43
readouts that they weren't getting from the doctor or more accurate readouts or
01:11:47
they're able to find care that they weren't finding through the traditional
01:11:51
physician process. What's this administration's view on these AI tools? Are they a supplement, a replacement?
01:11:59
And then how do we allow them to proliferate if they're they're good? And
01:12:03
do they need to be regulated? or are we going to end up regulating these AI doctors, these AI medical systems?
01:12:08
>> Well, first of all, AI is producing information at a rate that no one can
01:12:14
keep up with. And so, if we use the traditional regulatory mindset to say we have to make sure the information is
01:12:20
accurate, then you wouldn't be able to do a Google search because you're going
01:12:23
to get a hit that's going to give you something that's not accurate. And so,
01:12:26
what are we doing? What road are we going down? We can't outrun this lion. We have to use common sense and
01:12:32
demarcate information that you're getting from AI that automatically triggers some health intervention that
01:12:41
is sort of automated AI. And so last week at the Consumer Electronic Show, I outlined new guidances on AI decision
01:12:49
support and wearables. And it creates a a clear consumer lane. But if you're
01:12:54
making medical claims of a uh medicalra blank, then that's something we're going
01:13:01
to want to take a look at and that's something you're going to want the FDA's
01:13:04
seal about. So, it creates predictability because developers tell me all the time they just want
01:13:09
predictability from the FDA. Markets want predictability, developers want predictability, and investors want
01:13:14
predictability. So wearables meaning heart rate, blood pressure, that's right. Glucose monitors, those sorts of
01:13:20
things get deregulated, more accessible, lower price, and so on. >> That's right. They're going to be
01:13:25
deregulated. So you can give those results of any physiologic parameter. But if you say that it's a quote unquote
01:13:33
medical grade blood pressure, then we are going to want to see the data to make sure that it's validated with the
01:13:39
gold standard blood pressure readings. We don't want people redosing their blood pressure medications on something
01:13:46
that claims to be medical grade when it it is not medical grade. >> Got it. Okay. One other area I've spent
01:13:51
some time in in my career is in alternative proteins. And this is something that your agency regulates. So
01:14:00
making animal proteins, eggs and cheese and milk and so on using bacterial or yeast cells rather than making them from
01:14:06
the animal. You get the same protein. and you just use a different mechanism of making that protein or cellular meat
01:14:12
where they're actually growing the chicken breast or growing the the beef. Um there's historically been a system
01:14:19
called grass are generally recognized as safe that a lot of the companies have relied on as they've developed these
01:14:26
techniques and these protocols. You've made a few changes. Maybe you can kind
01:14:29
of highlight the balance between innovation because the benefit of these systems, lower cost, less energy, and
01:14:36
you take the animal out, less cruelty. There's an ethical driver for some of
01:14:40
us. >> Yes. >> But I'd love to hear the view on balancing those benefits against the the
01:14:45
risks to consumer health. And there's an incredible amount of lobbying pressure
01:14:49
from ranchers and animal agriculture against these systems that I'm assuming
01:14:52
is starting to kind of make its way into DC. we've seen it make its way into
01:14:56
states where they've banned it outright banned cellular meat in some states. So,
01:15:00
I'd love to hear your view on this kind of alternative protein market and the
01:15:04
changes you've made in grass and and looking out for consumers against the benefits.
01:15:08
>> Um, you're making me hungry because I love eggs and I didn't get my egg
01:15:13
breakfast this morning because we're out here at a bunch of meetings. >> But, um,
01:15:16
>> I'll get you some eggs afterwards. >> Great. And not egg white only. I I do
01:15:21
not believe in egg white only. I mean that is what are we doing? Egg white only eggs. I mean that's sort of the
01:15:27
ultimate epitome of the old dogma. Um and and by the way my uncle um he came to the United States. He had eaten eggs
01:15:35
every morning and he loved eggs. It was his livelihood is the morning eggs. And he came to the United States in his 30s
01:15:43
and his doctor said no eggs. You know found out he was eating eggs and just you know wagged the finger and you know
01:15:50
stopped. And so for 30ome years, he had this miserable life without eggs until we finally got to him and said, "It's
01:15:58
okay. Two eggs in the morning is okay. It's a good source of protein. Don't
01:16:02
worry about the saturated fat." He's now 95 years old, I believe, in Florida.
01:16:06
>> A happy man. >> Happy man eating his eggs every morning. >> I'm a two to three egg a guy as well. So
01:16:11
>> Oh, you are? Okay. It's a great source of protein. Yeah. So um on grass, so
01:16:16
grass uh for those who may not know is a way in which companies have created chemicals or brought in chemicals from
01:16:25
the environment, added it to food and they could self-declare them as safe. And so u it's kind of a unique thing in
01:16:32
the United States and it was started with good intentions so that the FDA wouldn't regulate you know salt and
01:16:38
butter. You know what are we doing regulating salt? I'm sure some people want may want to, but we're, you know,
01:16:44
we're not going to regulate salt. So, grass was created for for those sort of
01:16:48
things like salt, but then over time it got abused. So, all the of these engineered chemicals
01:16:54
would just get a free pass. And we've said, look at where we are today. Uh, you turn over the packaging of some of
01:17:01
these ultrarocessed foods and there's 40 ingredients. Nobody knows what they are.
01:17:06
And uh in Europe they have basic principles of introducing chemicals. Basically it's it's sort of if you will
01:17:14
uh guilty until proven innocent that is you have to demonstrate safety to be introduced. In the United States we have
01:17:20
this you know uh innocent till proven guilty. So we have basically said we have a thousand chemicals plus in the US
01:17:29
food supply that do are not allowed in other food supplies. Froot Loops was making cereal for Canada
01:17:38
where the petroleum based diets were banned and a different Froot Loops for the United States for American kids. And
01:17:45
so we've said we have to close the loophole on grass. We started the regulatory process to do that. And then
01:17:51
we have to think about creatively those situations you mentioned where there may
01:17:56
be ways to get more amino acids in some of these foods. And we know that kids are low in amino acids and protein
01:18:03
because of this myopic focus on fat as the boogeyman. We have not gotten the protein that we need. And and part of
01:18:09
that was also flawed studies approximating how much protein your body needed that used ura nitrogen levels
01:18:16
that massively underestimated the amount of protein metabolism in your body. And
01:18:21
every food has different levels of protein bioavailability and amino acid bioavailability. So that's why you said
01:18:27
you're vegetarian. you have to think a little differently about the protein requirements. Uh so all fun top
01:18:33
>> but the cellular meat industry you don't think is doomed. There's a potential for
01:18:37
the industry and >> it's going to continue to evolve. >> We've seen under my time at FDA we've
01:18:41
seen new cellular uh food products come not just beef but seafood. >> Yeah.
01:18:46
>> And it happens at the state level and the FDA actually does not have jurisdiction over what somebody creates
01:18:52
but we do ask for a registration in a sense to be in the loop. >> Okay. So what is causing autism in the
01:18:59
United States? >> Yeah, >> there was a conference a few weeks ago. You and um Secretary Kennedy talked
01:19:05
about Luca Vorin as a new line of treatment for autism patients, but some people have since debated the merits of
01:19:12
the data. Are we seeing rising autism rates in the United States? And what are the core drivers? What have you learned?
01:19:17
And is this an ongoing process? >> Well, there is more diagnosis for sure.
01:19:22
Um, but one in 12 boys in California now being diagnosed with autism. I mean, that you you didn't see that two
01:19:29
generations ago. You didn't see the repetitive ticks and the self harm and the you didn't see that. You still don't
01:19:36
see people in their 60s and 70s with those uh symptoms at the rates that you do in young kids today. So, something's
01:19:45
going on for sure. Now, what's causing it? I don't know, but there's some
01:19:48
interesting hypotheses. One is that for some kids it may be an autoimmune phenomena triggered by something where
01:19:56
the antibodies are binding to the folate receptors preventing folate from entering the bloodb brain barrier.
01:20:02
Folate is necessary for neural development. And so some doctors report and they're I mean these are experts in
01:20:08
the field been studying this their whole lives and see a lot of patients. They have observed that if you give
01:20:15
f um lucavorin as an example which bypasses the blocked receptor allowing methylated folate to get into the bloodb
01:20:22
brain barrier they have seen clinical improvement. There's one study that's
01:20:26
looked at the microbiome which we now know produces a lot of molecules involved in brain health. 90% of your
01:20:34
body's serotonin which is involved in mood is made by your gut. And we're just
01:20:41
recognizing this giant frontier of the microbiome. And so when we in the modern world, we we just torture the
01:20:49
microbiome. I mean, so many things. >> Some things are necessary like C-sections, not good for the microbiome.
01:20:56
Uh infant formula instead of breast milk, not good for the microbiome. Um antibiotics used like candy. The average
01:21:04
2-year-old has already received over 2.5 courses of antibiotics. It's carpet
01:21:10
bombing your microbiome in certain places. And what results is bacterial overgrowth, less biodiversity, and you
01:21:16
have more inflammation later in life. And when you have inflammation of the gut, most the most painful thing in
01:21:22
medicine is when a tubular structure stretches. A kidney stone supposedly is the most
01:21:30
painful thing. I've never had one. Patients say it is. It's not it's not
01:21:34
the stone scraping along the lumen. It is the blockage causing distension proximally stretching the urer that's
01:21:43
what hurts gallbladder pain stretching the gallbladder that's what hurts like
01:21:47
crazy and the GI tract with low levels of inflammation is irritating that lumen and also causing this sort of um
01:21:58
discomfort at a low level and and for a kid it may manifest as feeling sad or depressed and so we give kids all these
01:22:07
chemicals and ultrarocessed foods. We alter their microbiome and we change the production of what
01:22:14
comes out of the microbiome cells normally. That is certain vitamins, um, hormone regulation, serotonin. And what
01:22:24
are we doing? We're ignoring this physiologic cause and we're drugging our
01:22:27
nation's kids at scale. >> So, we've got to talk about the value of
01:22:31
mic the microbiome. And I would not be surprised if we had the research on that instead of just the DEI stuff we talked
01:22:38
about and study the microbiome the same way we were funding the Wuhan lab to study corona virus you know
01:22:45
manipulation. I think we could finally understand this great frontier of medicine that may
01:22:52
be involved in autism. One study has found that if you give a certain protease it can it's a randomized trial. I
01:23:00
couldn't believe it when I saw it because and you know sometimes the studies are not reproducible in JAMAMA
01:23:07
our most widely circulated medical journal a randomized trial giving a protease to kids with autism and
01:23:14
noticing a an improvement now again it needs to be replicated I don't know if
01:23:19
it's real but maybe there's something to the microbiome so I don't know what
01:23:23
causes autism but we have some clues and this is something worth studying not just is there a genetic cure for autism.
01:23:32
>> Yeah. And the underlying environmental contributors, there's just so much going
01:23:37
on that's different in our environment, in our food system that are also being
01:23:41
addressed that over time hopefully will result in maybe less of the general health effects caused by call it an
01:23:48
adverse environment. >> Yeah. Yeah, I mean there the number of proteins that we ingest that are
01:23:53
denatured in some way. The number of chemicals or molecules that do not appear in nature that go down the GI
01:24:00
tract. What's happening is you're getting an inflammatory response, but it's not a sudden acute inflammatory
01:24:06
response. It's a low-grade response and it may be causing general body inflammation. And the one thing I wish I
01:24:13
would have learned in medical school is that most chronic diseases are from general body inflammation and insulin
01:24:20
resistance. Heart disease, for example, most common cause of death in the United
01:24:22
States. We thought it was just saturated fat. Three large studies failed to show
01:24:28
that association. The Minnesota heart study was supposed to be the endall randomized trial in the 1960s.
01:24:35
It showed the opposite of what they thought. The low-fat diet group, this these are 9,000 motans randomized.
01:24:42
Low-fat group had more heart attacks, not less. >> They suppressed the results for 16
01:24:48
years. When Gary Tobs asked the uh the senior author before he died, why didn't
01:24:54
you publish this for 16 years? He said, we just the results just didn't turn out
01:24:59
the way we expected. >> Well, other large studies failed to find this clear association between saturated
01:25:06
fat. We're talking about normal saturated fat intake, not massive overdosing. Normal saturated fat and
01:25:11
heart disease. And so um uh so anyway, so there are these things that we have to re-evaluate.
01:25:19
>> Okay, last question. What's most exciting to you in the frontiers of
01:25:22
science in human health? >> You know, we at the FDA try to be referees. So we see um different
01:25:29
technologies competing. For example, cickle cell disease. There are monoconal antibbody treatments and there are gene
01:25:35
therapy treatments. Now, we tend to get excited about one over another, but the reality is we we don't know which horse
01:25:41
is going to win that race and so we want to be the referees. I would like to see
01:25:46
in the Trump administration during our term a cure for type 1 diabetes or some meaningful treatment for type 1
01:25:54
diabetes. Uh a powerful treatment for ALS. um treatments for certain kinds of cancer where we've seen now PD1 blockers
01:26:04
and K Rass inhibitors melt the tumors away so you don't need surgery or chemo.
01:26:10
You talk about a health reform, that's that's more powerful than a lot of the
01:26:14
health reform ideas we have out there. You don't need surgery or chemo or radiation. I mean, think about the
01:26:19
reduction in expenditures. Um we'd like to see a universal flu shot so we're not
01:26:24
guessing every year. something that gives you lifelong protection against future strains because it targets a
01:26:30
different part of the influenza virus. And I would like to see something powerful for PTSD. Um, a lot of
01:26:37
Americans are still suffering from PTSD, some from having served in a war. Uh, these are young people oftentimes who
01:26:46
stood up to serve their country and, uh, they are suffering. uh we are still losing 7,000 plus uh veterans a year to
01:26:56
suicide. So the wars are over, but our men and women keep dying and many of these wars were unnecessary.
01:27:02
>> I think we owe it to them to deliver a powerful treatment for PTSD if the data
01:27:08
supports that there's something out there. So that's one of my personal goals.
01:27:11
>> You're optimistic about the pipeline you're seeing there? >> Very optimistic. I mean, we're just
01:27:14
seeing really interesting stuff. It's been published in part, so I'm not
01:27:18
sharing anything here that's not public, but we've seen phase two trial results
01:27:22
that are promising. And I go, you know, I go Dave to the re scientific reviewers
01:27:27
at the FDA. >> Yeah. >> Without their bosses, just one-on-one, and I ask them, are you seeing anything
01:27:34
early on that looks amazing? Are you seeing anything in the pipeline, anything in animal studies that's
01:27:40
actually working in animals that could extrapolate to humans in a way that could be a gamecher?
01:27:46
And I'd say 90% of the time they say nothing really that much of a leap. We do a lot of non-inferiority studies, for
01:27:55
example, but every now and then somebody will tell me, "Yeah, there's this
01:27:58
mechanism. It's creative. It's different. And if it works, it'll be amazing." and we'll often issue that
01:28:06
company a priority voucher. >> Um, a treatment came out for a certain type of congenital deafness. It's a gene
01:28:15
therapy device combination. It came out in the New England Journal of Medicine. We read the article because we love to
01:28:20
read these articles. That's our nature. And we called the company and we confirmed about a dozen kids got it. A
01:28:28
couple had normal hearing. I mean, that's amazing. And so we immediately issued them a voucher. a new treatment
01:28:34
for multiple myoma that was a gamecher. Three times better than anything out there now. Uh 80% remission free
01:28:41
survival I believe it was uh at a couple years out. There's nothing like that on
01:28:47
the market. We called that company. We had internal discussions within 24 hours of that abstract being printed in the
01:28:55
pre-conference materials for the American Society of Hematology. We had been in touch with that company and
01:29:00
issued them a voucher. What are we waiting for? Right? What are we worried about? We have got to move at the speed
01:29:06
that my patients demanded, not at government speed. So, we are streamlining and modernizing the FDA.
01:29:13
And we are not wasting time. We're getting stuff done. >> Well, for that, I don't know how anyone
01:29:17
could disagree with the sentiment, the intent. Thanks for the service. Thanks for the work, Marty. It's been great
01:29:23
chatting today and thanks for being with me. >> Great to be with you, Dave. Thanks so
01:29:26
much. I'm going all in.