Supercharging a New FDA: Marty Makary on Science, Power & Patients

Summary

FDA Commissioner Marty Makary sits down with David Friedberg at the JP Morgan Healthcare Conference to discuss his first 10 months leading the agency. Makary outlines 42 major reforms implemented under his tenure, including streamlining drug approval processes from 10-12 years down to potentially weeks in some cases, reducing clinical trial requirements from two pivotal trials to one, eliminating unnecessary animal testing, and modernizing the agency’s approach to AI and wearables. He emphasizes the competitive threat from China, where phase one trials can be completed in 4 weeks compared to much longer US timelines.

The conversation covers major policy changes including the new food pyramid focusing on protein over refined carbohydrates, modifications to the vaccine schedule reducing recommended doses from 72 to 38, and efforts to lower drug prices through most favored nation pricing and faster biosimilar approvals. Makary discusses the expansion of over-the-counter medications, reforms to pharmaceutical advertising enforcement, and new pathways for cell and gene therapies. He shares his perspective on medical dogmas that have been proven wrong over time, including saturated fat guidance and peanut allergy recommendations.

Throughout the interview, Makary emphasizes patient-centered reform, citing his experience as a cancer surgeon at Johns Hopkins breaking bad news to patients with incurable conditions. He expresses optimism about breakthroughs in type 1 diabetes, ALS, PTSD treatments, and cancers where tumors can be eliminated without surgery or chemotherapy. The commissioner calls for more research funding into root causes of disease, microbiome health, and environmental factors rather than solely focusing on genetic treatments.

Highlights

”Why does it take 10 to 12 years for a new drug to come to market?”

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“Why does it take 10 to 12 years for a new drug to come to market? We’ve become so lukewarm and passive accepting that horrible timeline that it has just become the status quo.” — Marty Makary, 4:49

”My number one priority is not to censor Americans”

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“The number one priority of the commissioner that preceded me was to fight misinformation. My number one priority is not to censor Americans. It’s to deliver more cures and meaningful treatments faster to the American public.” — Marty Makary, 7:06

”I met a guy whose job was to change the ink cartridge on one fax machine”

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“I met a guy whose job was to change the ink cartridge on a fax machine… on one fax machine. Healthcare has single-handedly kept the fax industry alive.” — Marty Makary, 32:56

”We have drugged our nation’s kids at scale”

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“We have drugged our nation’s kids at scale. It’s wrong. It needs to stop. We have to reexamine the root causes.” — Marty Makary, 35:55

”Biden FDA sent zero enforcement letters - I sent 1,500”

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“The Biden folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out zero. I sent out 1,500 enforcement letters.” — Marty Makary, 70:35

Key Points

• 42 Major FDA Reforms (4:33) - Announced 42 major reforms in 10 months including new priority reviews, pilots, and transparency measures like making rejection letters public

• China Competition (7:51) - US has 3-year window to keep up with Chinese biotech innovation; Chinese companies went from 5% of licensing deals in 2022 to 42% in 2025

• Phase One Timeline Crisis (10:10) - China doing phase ones in 4 weeks, Australia in 6 weeks, while US IRB approval for a simple survey took a year and a half at Johns Hopkins

• One Pivotal Trial Policy (14:15) - Changed from requiring two pivotal trials to one, saving companies $100-300 million and allowing twice as many drugs through trials

• Reducing Animal Testing (14:41) - Eliminated chimpanzee studies for monoclonal antibodies (typically 144 chimps per drug); 90% of drugs passing animal studies fail in humans anyway

• Bayesian Statistics Approval (20:22) - Now allowing Bayesian statistical evaluation for continuous real-time efficacy monitoring instead of waiting for scheduled committee meetings

• 55-Day Drug Approval (17:20) - First medication approved in 55 days under new pilot program with 18 products having vouchers for accelerated review

• Vioxx Learning (22:44) - Vioxx may have killed 38,000 people before safety signal identified 5 years later; now implementing real-time big data postmarket surveillance

• Right to Try (25:51) - Signed 100% of right to try requests; believes in both letter and spirit of the law for patients wanting experimental treatments

• Cell/Gene Therapy Reform (26:53) - Reduced manufacturing requirements for cell and gene therapies; customizing requirements to drug and population rather than one-size-fits-all

• Baby KJ Gene Therapy (28:49) - Infant received gene editing therapy and went home; created “plausible mechanism pathway” for bespoke therapies

• China CAR-T Shutdown (30:30) - Discovered Biden administration approved shipping American cells to China for gene editing; immediately shut down the practice

• FDA Modernization Shocks (31:12) - Found employee whose job was changing ink cartridge on one fax machine; boxes being hand-carried between buildings because centers couldn’t email each other

• Food Pyramid Overhaul (33:13) - Flipped pyramid upside down focusing on protein; 38% of kids have pre-diabetes/diabetes; 60-70% of child calories are refined carbohydrates

• Nutrition Science Corruption (33:53) - Called nutrition science “one of the most corrupted fields”; medical establishment’s saturated fat focus led to carbohydrate epidemic

• Peanut Allergy Mistake (37:10) - Avoiding peanut butter until age 3 was wrong for 16 years; early exposure creates immune tolerance and reduces allergies

• GLP-1 Benefits (43:51) - Mimics natural hormone; reduces insulin resistance and inflammation; seeing benefits in addiction, cardiac health across 60+ indications

• NIH Funding Reality (45:33) - No dollars cut from NIH or Medicaid; 14% of NIH grants were going to DEI research; reallocating to root causes of disease

• Vaccine Schedule Changes (49:54) - Reduced from 72 doses to 38 core essential vaccines age 0-18; US was international outlier; aims to increase vaccination by meeting parents where they are

• Hepatitis B Questioning (50:01) - Both Friedberg and Makary declined hep B vaccine for newborns when mother tested negative; vaccine prevents sexually transmitted infection not relevant at birth

• Drug Pricing Reform (59:40) - GLP-1 costs $1,300 in US vs $88 in London; implementing most favored nation pricing bringing GLP-1 to $149 for first 3 months

• Biosimilar Acceleration (61:30) - Reduced biosimilar approval from 5-8 years and $300M to 2.5 years and $100M+ savings; biologics are fastest growing drug spend

• Over-the-Counter Expansion (63:51) - Moving more drugs OTC to enable price transparency and bypass PBM money games; brought new leadership to non-prescription office

• Pharma Advertising Crackdown (70:04) - Biden FDA sent zero enforcement letters; Makary sent 1,500 including 100+ cease and desist letters for misleading ads

• AI Medical Guidelines (72:30) - New guidance at CES on AI decision support and wearables; deregulating consumer devices but requiring validation for “medical grade” claims

• GRAS Loophole Closure (75:28) - Closing “generally recognized as safe” loophole that allowed companies to self-declare chemical additives safe; 1000+ chemicals in US food not allowed elsewhere

• Autism Research (78:57) - 1 in 12 California boys diagnosed with autism; exploring autoimmune and microbiome hypotheses; 90% of body’s serotonin made in gut

• Microbiome Impact (83:07) - Modern life “tortures” microbiome through C-sections, formula, antibiotics; average 2-year-old has had 2.5+ antibiotic courses

• Heart Disease Dogma (84:31) - Three large studies failed to show saturated fat-heart disease link; Minnesota heart study suppressed for 16 years showing opposite result

• Future Goals (85:27) - Wants cures for type 1 diabetes, ALS treatment, universal flu shot, and PTSD therapy (7,000+ veterans lost to suicide annually)

Mentions

Companies

• Pfizer (8:26) - $1.25B upfront/$6B total licensing deal with 3S Bio from China
• Novo Nordisk/Eli Lilly (59:40) - GLP-1 drugs pricing discussed ($1,300 US vs $88 London)
• Humira/AbbVie (62:38) - Example of biologic with limited biosimilar competition
• Froot Loops/Kellogg’s (77:06) - Makes different formula for Canada (no petroleum dyes) vs US

Products & Technologies

• CAR-T Therapy (29:39) - Editing T-cells to target cancer and autoimmune conditions; costs $500K-$1M
• Organ on a Chip (15:47) - Technology to test drugs on lab-grown liver/heart cells instead of animals
• Bayesian Statistics (20:22) - Statistical method now approved for continuous trial monitoring
• GLP-1 Drugs (41:29) - Incretin mimetics being tested for 60+ indications beyond obesity
• Leucovorin (78:48) - Methylated folate that bypasses blocked receptors; potential autism treatment

People

• Marty Makary (0:02) - FDA Commissioner, former Johns Hopkins cancer surgeon, 350+ publications
• David Friedberg (0:02) - Interviewer, All-In Podcast co-host
• President Trump (2:30) - Implemented price transparency in first term; gave charge on most favored nation pricing
• Dr. Mehmet Oz (56:05) - CMS administrator, 400 scientific publications, former Columbia surgery vice chair
• Jay Bhattacharya (49:34) - NIH reform leader, MD-PhD
• Tracy Beth Hoeg (56:27) - MD-PhD epidemiologist involved in vaccine schedule reform
• Robert F. Kennedy Jr. (78:45) - HHS Secretary, discussed leucovorin for autism
• Francis Collins & Tony Fauci (46:48) - Former NIH leadership criticized for gene-centric funding focus
• Gary Taubes (87:32) - Science journalist who exposed suppressed Minnesota heart study

Institutions

• Johns Hopkins (1:20) - Makary’s former institution; School of Public Health and clinical practice
• JP Morgan Healthcare Conference (0:10) - 120,000 attendees; biggest biotech conference globally
• Wuhan Lab (49:14) - NIH funded gain-of-function coronavirus research
• UCSF/Stanford (27:14) - Can develop cell/gene therapies in academic labs under new rules
• Consumer Electronics Show (73:42) - Where AI and wearables guidance was announced

Surprising Quotes

“Why does it take 10 to 12 years for a new drug to come to market? We’ve become so lukewarm and passive accepting that horrible timeline that it has just become the status quo.” — 4:49

“The number one priority of the commissioner that preceded me was to fight misinformation. My number one priority is not to censor Americans. It’s to deliver more cures and meaningful treatments faster to the American public.” — 7:06

“I met a guy whose job was to change the ink cartridge on a fax machine… on one fax machine. Healthcare has single-handedly kept the fax industry alive.” — 32:56

“We have drugged our nation’s kids at scale. It’s wrong. It needs to stop. We have to reexamine the root causes.” — 35:55

“The Biden folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out zero. I sent out 1,500 enforcement letters.” — 70:35

Transcript

0:02 Marty Makary, commissioner of the FDA. Welcome to San Francisco. Great to be here, Dave. Good to be with you. Yeah, thanks. It’s JP Morgan Healthcare Conference this week in San Francisco. Considered, I think, probably the biggest most important biotech conference globally. Very important week. So, you’re visiting this week for the conference. Yeah. 120,000 people, great conversations. You hear from everybody. Just not enough time to meet with everybody you want to meet with, but it’s a great time.

1:10 Well, thanks for sitting down with me. You and I have gotten to know each other a little bit over the last year or so and I’m really excited to hear a little bit about how things are going. It’s been almost a year since you’ve been in the role. I think maybe for our audience you could share a little bit about how you got this role. How did you get involved with this administration? How did you get connected with them? And maybe we can go all the way back to your very outspoken views during the COVID pandemic and maybe how that brought attention to you and your philosophies that drove this role.

1:42 Yeah. So my interest in academia, I went to graduate school for public health and served on the faculty of the Johns Hopkins School of Public Health as I also had a clinical practice in GI and cancer surgery at Johns Hopkins. And my interest was always in the root causes of our healthcare system problems from quality, transparency, and price. And in the work on price, I led sort of a national effort to try to get more price transparency of hospital prices. I wrote a book on it that did very well. It took me to the White House where they had read the book, invited me in, and in that first Trump administration, we had a lot of great conversations and then they implemented the idea and I was so impressed.

2:30 This makes sense. You know, we want competition. We want to put the person out there, the consumer, at the center of what we do in healthcare and trust them with information and then they invited me back to serve this time to head up the FDA. And I’m so appreciative. I love. I love the mission and I love what we’re doing. We have a great team and we hit the ground running. I was working before I was confirmed through the transition team on the ideas that I wanted to implement. I had them all ready to go on a sheet, and when I got confirmed, my first morning when I was still going through the uh orientation, I summoned leaders. I said, can you come into my office? My supervisor were in the room.

4:33 And so we’ve been running with these ideas. We have announced 42 major reforms in my 10 months in office at the FDA and it has challenged the status quo of doing things. But we have to I mean why does it take 10 to 12 years for a new drug to come to market? We’ve become so lukewarm and passive accepting that horrible timeline that that has just become the status quo. We’ve got to challenge these deeply held assumptions. And we’re doing it. We are doing it with new programs, new priority reviews, new pilots, new forms of transparency.

5:10 We made our rejection letters public so that if the FDA does not approve a drug, the public deserves to know why. And it creates accountability. And that was not the case before. They talked about it for 30 years and we got it done. They talked about banning one food diet for 35 years. Within weeks of coming into office, we took action to remove all nine artificial petroleum based dyes. So, we’re getting stuff done. We’re not afraid to move fast.

5:35 And in that role, some people have left the FDA and then they’ve been outspoken critics of yourself. Maybe you can respond to some of the criticisms that it’s chaotic, that there’s a lot of turmoil. I’ve worked at many startups. I know that when you move fast, things feel or they may feel too busy or they may feel like there’s too much going on. It’s overwhelming at times, but at the end of the day, progress is what matters.

6:08 There were 2,000 HR people at the FDA just before I got there. There were 1,500 IT people. And so, for a staff of how many total? 20,000 employees just before I got there. And so there was a goal to say, hey, we’re going to go back to 2019 staffing levels and the cuts are not going to be to scientists or reviewers. No scientific reviewer was laid off. But there were significant consolidations in HR, procurement, IT, and the duplicative services that were out there.

6:48 Now, anytime you do something in government, you take headline risk, but we felt it was the right thing to do. And so I came in right after that massive sort of change. And since then we’ve had a great culture. We’ve had more teamwork. We have new leaders. And they believe in this new vision. The number one priority of the commissioner that preceded me, he said, was to fight misinformation. Well, my number one priority is not to censor Americans. It’s to deliver more cures and meaningful treatments faster to the American public and healthier food for children.

7:25 And I think every employee at the FDA knows that mission. We have incredible teamwork. Our turnover rate is at the baseline 5 to 7% that has been there for the last 10 years at the agency. So there’s no exodus, there’s no mass departures. We are actually hiring 1,500 new scientists because we have very ambitious goals on our new pathways, accelerated type pathways. And so we’re building up capacity to have a whole new line of pathways so that we can deliver faster for the American people.

7:51 Great. Well, look, let’s start with a framing. The framing is the US versus China. I want to read this report that came from the Congressional National Security Commission on Emerging Biotechnology. We’re here at a biotech conference. So, I figured we could start here because everyone’s talking about China and the race against China. The US, according to this commission, has a three-year window to act to keep up with Chinese innovation and the speed in biotech.

8:18 In 2022, Chinese companies were just 5% of licensing deals. 2025, 42%. And recently, one of the biggest licensing deals ever was 3S Bio 1.25 billion up front with a $6 billion total with Pfizer. China had 10 years ago only 50% of published scientific papers to the US. Today they’re 50% more than the US. So I just want to walk through your view on US biopharma innovation as it relates to China. Is there a race and if so what are the priorities for the administration in helping American biotech industry remain competitive?

8:59 There is a race and when we came to office we were losing that race. We were behind. We were getting clocked by China, by Australia and other countries that were doing things more efficiently with less red tape and we made it a massive priority to say we need to retain our number one position in life sciences and biomedical research and we’ve got to think innovatively so we can come up with some protectionist strategies but ultimately what we need to do is be more competitive with what’s going on with phase 1’s and INDs overseas.

9:35 So that means we need to rethink our entire phase one process. We have to convene hospitals who are so part of the problem is outside of the walls of the FDA. When hospitals have IRBs, that is the institutional review boards that approve research that meet monthly and you know at Johns Hopkins I had a study took a year and a half to go through the IRB. It was a survey. What are we worried about? It was a survey. It was a nutrition survey and at the end of a year and a half it was not approved.

10:10 That kind of stuff is intolerable when we’re competing with China where they’re doing phase ones in 4 weeks with Australia that’s doing phase ones in 6 weeks. And so we need to have more centralized IRBs and we need to streamline the hospital contracting because right now if you want to do a trial each hospital wants to negotiate their margin of what they want and sure they have to customize the contract because every study is different has different requirements and resources that are needed. But you go to Australia and they say sure sign here on the dotted line you have access to these 14 hospitals or so.

10:49 And so we have got to have more centralized contracting and a centralized IRB in order to compete. Those are big priorities. And we also have to reduce the red tape and regulation on our own INDs phase ones. And the entire process, you know, when we came in, it took 60 days for the FDA just to tell you whether or not they were going to consider a supplemental application. I mean, that kind of stuff is intolerable in the modern world. It took and you know some often still takes 60 days just for the FDA to tell you that your application is complete. We’re going to get that down to one day. We’re going to use AI.

11:26 So we’ve got to modernize the agency and be more competitive, not just talk about protectionist strategies. As you think about those work streams in improving the efficiency, turnaround time, how much can you do this on your own versus how much do you need Congress to act to pass legislation to support those changes? And are there priorities that you’re working with Congress on to try and accelerate drug approval timelines that are necessary?

11:51 So, right now we have user fees, which means if you submit an application, there’s a fee associated with it because there’s an unknown number of applications each year. So, it’s a system that’s been around for a while. And so, I’d like to see those user fees much higher if your phase one is done overseas. And if it’s done in the United States, it’s going to be a lower user fee. That’s what I’d like to see. It’s an America first policy. I’d love Congress to do a bunch of stuff, but we’re not going to wait for them. Congress is slow. We’re moving incredibly fast.

12:23 You know, our number one goal was to make sure that the morale was good, the culture is good, and the trains are running on time, coming in right after the restructuring. I’m proud to report this year in 2025, this past year, we hit 100% of our user feed target dates, that is the trains were all running on time, that every accept or reject decision by the FDA was consistent with the accept or reject decision by the primary review team. That is, we’re not doing secret deals. We’re not messing with things. We are standing by our scientists.

12:59 And last month we had a record number of drugs approved by our center for biologic cell and gene therapies and other nine drugs. And so we want to keep going hard and strong and innovate. But the first goal in the first nine months was to make sure the trains are running on time and that we are strong. And I’m happy to report the FDA is strong and is going to continue to be strong.

13:17 And going back to this point about cutting down on timelines for phase 1 2 3 maybe you can just for the audience that may not work in this industry very briefly explain phase 1 2 3 and then where we think there’s the biggest kind of call it excess regulatory burden that’s causing these extended timelines on drug approvals just to kind of frame it up a little bit.

13:38 Sure. So there’s something called the IND investigational new drug registration process. That’s step one. Most of those are actually filed by academics and I think people forget that we still have a lot of great innovation in our academic spaces. It’s not just the pharma labs. Then you try a drug in healthy subjects. That’s called a phase one trial. Typically a small number, a handful. And then you give the drug to subjects with the condition and that’s a phase two. It’s a limited study. And then phase three is a large randomized control trial. We call it the pivotal trial.

14:15 We announced just last month that we are going to go from a baseline default requirement of two pivotal trials for a drug to one pivotal trial for a drug. It’s just math. You can achieve the same statistical power if you design one good clinical trial properly with a good control group. And so that by the way that saves like a hundred million to $300 million for some companies. Shortens the time.

14:38 We’re reducing animal testing. That’s the pre-IND or pre-phase one work, that is how does it work in animals? We are eliminating a lot of animal testing requirements. We have a roadmap. You no longer officially have to submit chimpanzee studies for monoclonal antibodies. That was announced two months ago. We said typically 144 chimpanzees are used for a monoclonal antibody.

15:05 By the way, you’re making me sick because this has always been from my point of view one of the most troubling bioethical concerns I’ve had about the industry because you don’t get a lot of statistical power or benefit from doing this and it’s just awful that we do it. But you actually get misleading information sometimes. Some say aspirin would not have been approved today if we had the old animal testing requirements to species because drugs that have safety concerns in animals may not have safety concerns in humans.

15:34 So we may miss out on cures and vice versa. 90% of drugs that pass animal studies do not pass safety and efficacy in humans. So what are we doing? We have computational modeling now. Computer can look at a drug and actually make better predictions and we have something called organ on a chip technology where you grow say the liver cells or heart cells in a lab administer the drug and then look for any enzyme leaks or disturbances. These are modern techniques. We’ve got to modernize the agency. It’s a massive goal.

16:01 And they’re doing it in China. They’re doing it in China. And if we don’t, then we’re also putting our industry at risk. We’ve got to be more competitive, 100%. And so what does this do? It compresses the time for approval. It allows R&D to be done at a lower price point, translating into lower drug prices for everyday Americans. More drugs can be evaluated. I mean, I had one pharma executive tell me, “Hey, I love you’re going from 2 to one pivotal trials. That means we can run twice as many drugs through large pivotal trials.” That’s what we want. We want to see more.

16:32 Look, I’m coming in with a bias. We all have our biases. I have a bias and it’s just a matter of recognizing your biases when we talk about reforms. My bias is being at the bedside breaking bad news to people with incurable conditions or being at the bedside in the ICU. And when you do that, it has a profound impact on your brain and your soul, and you think about what can we possibly do to give this individual some hope.

17:03 And so when I see a 10 to 12 year time period of bringing a drug to market, I think in the modern world it makes no sense. Just think about the advances in science and technology. So I’m committed to that mission. And we’ve got a new pilot program now to get decisions out in weeks. It’s unheard of. It’s unprecedented.

17:26 We have the first medication we just announced after 55 days. We have a lot to change in the workflow to get that time frame down. But we have I think 18 products that have vouchers for this new pilot program. If you’re going to do something new, you have to pick criteria. You can either do it randomly or you can pick criteria. So the criteria we chose are drugs in line with our national priorities, an unmet public health need. Say a new amazing cure for cancer 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 actually giving you a real example. We gave those companies a voucher.

18:10 If you’re bringing manufacturing back to the United States, that’s a national security issue. And if you are going to make the drug affordable, that’s an access issue. And that’s a massive priority for this president is lowering drug prices. So, we have this pilot underway and it’s going extremely well. So, the drug company gets a voucher if they qualify under one of those three criteria and that gives them a fast track. That’s right.

18:31 Yeah. And when will we get a readout on how that program’s going and whether it becomes standard? So, internally it’s going great. I mean, I’ve got employees at the FDA tell me, gosh, I love this. It makes sense. And the reason we haven’t done it before is that we farm out the application to a dozen offices and everybody has until the target date to get their final reports in. Well, the target date is about a year.

18:54 So if you are an expeditious scientist or you have the ability to go do your work expeditiously and in two weeks you have your result. Well, it doesn’t matter because the farm talks person or whoever else is another part of that has until the day before. Guess when they’re going to submit it? The day before. So, we are changing the incentives internally, the bonus structure. We’re changing the alignment. We’re changing the culture. And our goal is to streamline that process.

19:21 Going back to the computational point, we are collecting more data, digitizing that data on patients than ever before. That data should generally be accessible. Is there a world where we can transition from phase one, phase two, phase three trials into a phase one, phase two slash three by taking into account all of this additional data? Some people have talked about the idea of using AI plus other health data that’s collected and allowing the phase 3 to kind of roll into phase 2 and create a much more expedited computationally assisted approval process. Is that something that’s on the road map or is discussed?

20:00 Absolutely. There has been tinkering of combining phase one and two, phase one, two hybrid trials, phase two and three hybrid trials, approving something with sort of a preliminary approval after phase two if the results are really promising. And those are all steps in the right direction, but I think of something much bigger. Can we move to continuous trials? Can we use Bayesian statistical evaluation which we announced this week? We are now going to allow Bayesian statistics to be used.

20:32 So now you can if something works instead of having a committee meet twice a year to do a cut of the data and print it out and everybody looks at it. I mean I was literally on those committees. Why can’t we in real time with AI tools figure out when there’s a safety signal or efficacy established and then call it at that point allowing more people to get the drug as soon as we know it works.

20:59 And is there more continuous tracking that’s also possible to look for risks and issues that start to emerge in certain populations? Because this is something that it’s almost like the approval happens and then you find out years later that well maybe there was an issue that we should have caught sooner. And if you move to a more data-driven continuous observational system, can you both have faster approvals but also faster recognition of safety concerns for specific populations?

21:22 Yeah, I love the way you’re thinking. So we I want to see continuous trials with endpoints in the cloud so that the reviewers are looking on to the endpoint. You don’t do your freshman year of college and then submit a giant 50,000-page application to start your sophomore year and then do your sophomore year and start another 50 page to start your but that’s what we’re doing at the FDA. Now look, it had good intentions, but we live in a modern world. We’re using computers now, not stone tablets. And so we can run more continuous trials. That’s the goal.

21:53 And we can use Bayesian statistics, which we announced this week a big new milestone with that. And I want to see us continue to have eyes on a drug after approval. So approval is sort of a point where we say hey the world can use it with a fair degree of confidence on the safety efficacy tradeoff but why did we learn 5 years after Vioxx was approved that it may have killed 38,000 people? Well in the modern world with big data we can have eyes on a drug as it’s being used in real time to call out that safety signal immediately and let people know.

22:29 It may be a subgroup of people that are affected. There may be a drug drug interaction. You know, you think about the opioid epidemic, 15 years of prescribing it, having no idea. And I was I’m guilty. I was doing this. I was prescribing it. My patients were getting addicted, coming back for refills. I thought it was kind of a one-off thing. You know, a lot of people come back, ask for refills. No, it was a national pattern we should have identified in big data.

22:57 And so we’re going to do postmarket surveillance in a way like we’ve never seen before using big data. And if we get it right, if we get it right and there’s a big priority, it can actually change the threshold of approval because you know you’re going to have eyes on a drug immediately. For people in the general audience to understand this begs the question and I think people will bring this up as a critique of absolute safety.

23:19 I always talk about the example of you put the Waymos or the autonomous cars on the road, they cut down on fatalities by 95%. But as soon as one person gets killed by a Waymo, the media goes crazy and says these autonomous cars are killing people. You know, and this begs the question about the understanding of safety and risk versus the benefit that can occur.

23:57 You know, I was sharing with you about a family member who had to wait a long time to get a certain therapeutic and I was thinking about the thousands of people that died in that same period of time. Fortunately, he was able to get the therapeutic, but all the people that died because they couldn’t get access to this drug. How do we convey to the general population the idea that speed matters in saving lives and this question about absolute safety and absolute risk around drug approval? This is really important when you talk about risk to a general audience. How do you convey that second order effect?

24:33 That’s right. So safety is our number one priority. We are to safeguard the public. But having 8 months of 144 chimpanzees undergoing studies has risks to the general public. You may be holding back a curative medication for 8 months. Not identifying the efficacy in a trial with Bayesian statistics early enough has risks because that extra lag period is time when patients like the patients that I treated at Johns Hopkins are told sorry we don’t know of anything out there so time delays that are unnecessary have risks and I think that is something we don’t think about enough at the FDA.

25:19 We think oh we have this concern let’s sleep on it okay well you get a night to sleep on it not 9 months. So I want to give a flip to this. The right to try law gives patients access to drugs when they’re in a certain condition, they can access the drug before it’s gone through full approvals. What’s the current state of right to try? Where do you view that going? And does the threshold for right to try change over time, giving patients and their doctors more rights and more access sooner or does the FDA still have to hold firm? How do you think about that over time?

25:51 So, I believe in both the letter and the spirit of right to try. It’s an amazing achievement of President Trump in his first term and I have signed 100% of right to try requests that come across my desk. Of course, the companies have to agree to make the medication available, but it’s a great program and like we don’t want people getting spun up on snake oil that doesn’t work, that’s cost $3 million where their churches are doing GoFundMe campaigns when we know a drug does not work. So, we do have a responsibility and we have to be good stewards of the Medicare program. They’re using taxpayer dollars to fund things.

26:31 But if there’s a signal that something works and somebody wants to try a drug, who are we to say you can’t? So, we look at safety, but beyond safety, we are, you know, have to be as flexible as possible with our regulation. And we announced just this week that we are getting rid of some of the regulatory requirements for cell and gene therapy. Now those are used for a lot of rare diseases, but we had requirements uh what we call PPQ runs for batches of it’s part of the manufacturing requirements for cell and gene therapies.

27:05 We were holding them to the same standards we were for say mass manufacturing of a pill. Well, a cell or gene therapy can be developed in a lab at UCSF or Stanford. And are we going to require that they use the same manufacturing broad standards to do multiple batches when you’ve got a scientific platform that works, a vector platform that works and you’re basically doing surgery on the human genome just in different locations? So, we made that announcement earlier this week.

27:33 So, let me just understand that one. I’ve spent a little time in the space. Does this mean that I will not need to go through a GMP or good manufacturing practice facility to bring those therapeutics to a broader set of patients? And does it also mean that once I’ve got a system that works, I can use it for different indications? And maybe help understand a little bit about where this goes because there’s many patients that today are looking at papers on cell and gene therapies, early data, and they’re saying, “When can I get access? I’m at risk.” This matters a lot to patients and maybe you can help contextualize how this translates into speed and access.

28:09 Yeah. So, the announcement that we made on Sunday was that we’re going to customize the manufacturing requirements to the drug and the population being treated. So, there’s a number of flexibilities including the ones you mentioned, but it’s no longer going to be this hard and fast. You have to do it this way. For example, the three batch runs that have been required, those ingredients are expensive. I mean, those ingredients could cost $100,000 for just one ingredient. And so, we have to use common sense.

28:41 I mean, when you see something perform, you know, something magical to a kid with no help right in front of your eyes, you’ve got to say like, what are we doing getting in the way? We just had early in our time there, baby KJ go home from the hospital, right? So this infant got gene editing therapy. You can’t do a randomized trial on that. There’s not enough kids who have it. So these bespoke therapies. We created essentially a novel pathway for them. Dr. Vani Prasad described it in the New England Journal of Medicine. It’s called the plausible mechanism pathway and it’s basically combining gold standard science with common sense.

29:19 Right. And what about for CAR-T therapy? So there’s this blossoming class of therapeutics in CAR-T that’s historically been used exclusively for oncology for cancer. Increasing discussion about using it for autoimmune conditions. Does this help with the CAR-T therapy pathway and enabling faster routes to market and more access and lower cost? It can. And by the way, CAR-T is amazing. CAR-T is amazing. I’m not here to promote any one class of drugs but I mean it the stuff that we have seen is mind-boggling. So yes.

29:52 And just for folks to understand when they take T cells edit them and put them back in the body and those T cells go after targets in the body and destroy those targets and many blood cancers are now seeing extraordinary results with these CAR-T therapies and now they’re going after autoimmune conditions. But it definitely seems to be that there needs to be a faster path to market, lower cost because the pricing is half a million to a million dollars still.

30:16 Yeah. It’s amazing. We’re essentially activating your own immune cells to have a very clear path and target something in your body that needs to be targeted. So it’s now we did find that there was in the Biden administration approval to have the cells of Americans for CAR-T therapy shipped to China where the Chinese did the gene editing and then ship back to the United States to infuse in Americans. When I found out about that, we shut that thing down so fast. Yeah. So, we have to do things carefully.

30:48 What else have you discovered since you’ve been in the FDA that shocked you? Just go on a side for a second. I’m curious to know what are the biggest shocks that you’ve uncovered. I mean, you’ve now been there for some time, you mentioned before we sat down that you’re actively digitizing millions of files that historically have not been digitized, and I’m assuming you can now use AI and other tools to go read through them very quickly. What’s been shocking to you?

31:15 Where do I start? I mean, somebody was carrying a box from one building to another building with a drug file in it. And it turns out that the lawyers said they couldn’t email the information to the other center because, you know, each center was like their own secret government before we got there. Each center of the FDA. Same agency. Yeah. Same agency. Seven centers. It was like, you know, they had their own boundaries and territories and, you know, lawyers. They had their own communication staff put out their own releases, their own press releases, did their own legislative affairs with, had scheduled their own hearings. And the commissioner was out of the loop sometimes.

31:57 And so, we restructured the entire agency. Now, we centralized those services. But in the days of this sort of siloed world of the agency, by the way, it was a nightmare for developers that had a drug device combination. I mean, it was like gerrymandered lines of what was included in one center versus another center based on infighting. And, you know, people had served long terms there. You know, they’d serve terms like President Mugabe of Zimbabwe who’d been there, you know, forever. These people just were there forever, right? It was just their way.

32:32 And, anytime there was an opening in leadership, 19 times out of 20 it went to an internal candidate. So, you didn’t have a lot of fresh new ideas. We have a lot of fresh scientists coming in there. I mentioned the 1,000 new scientists. We’re onboarding right now 450 of them. 50 of them already just started.

32:52 But I’ve met a guy who his job was to change the ink cartridge on a fax machine on one fax machine. Like healthcare has single-handedly kept the fax industry alive. Wow. The guy’s job was the ink guy on the fax machine to swap out the machine. There’s a lot of that. There’s a lot of that.

33:15 Well, let’s shift over to food. Maybe I’ll just give you a moment to share what you changed in the food pyramid in the announcement last week. Why you made those changes and why weren’t they made before? Yeah. So, we have had decades of medical dogma and corruption putting together food pyramids that make no sense. People can tell. I mean, the open secret was that they make no sense. They’re scientifically inaccurate and they were often times curated by the food industry or the food industry’s influence on academia.

33:53 Nutrition science may be one of the most corrupted fields in all of science. And it gave us the dogma that we had to focus on saturated fat and just eradicating natural healthy fats from the US food supply. Ignoring that you replace fats with refined carbohydrates which are not healthy. And we have this carbohydrate heavy diet now for American children. And guess what? 38% of kids have pre-diabetes or diabetes. Is that a surprise? The rise has paralleled the shift from saturated fat or regular food to pumping refined carbohydrates and added sugar.

34:35 60 to 70% of the calories of a child in America today are refined carbohydrates. No one has talked about it. It’s been in a blind spot as the medical establishment has had this myopic focus on the boogeyman of saturated fat. And so we had a food pyramid that was entirely backwards. And so we flipped it upside down using good science talking about a previously ignored area of nutrition. And that is the importance of protein. We’ve been getting about half the protein that we need.

35:08 The protein levels in the previous dietary guidance was really just to prevent withering away. We want our American kids to thrive, right? And look at the status of kids today. Low in protein, muscle wasting, weakness, underperforming in school, high in refined carbohydrates and added sugar, giving them that kind of sugar sort of coma, food coma after a refined carbohydrate breakfast. Again, we hit them hard in the afternoon. They get very little or no natural light exposure.

35:48 They’re told to sit at a desk still for 7 hours a day. They can’t do it. And what do we do? Tragically, we have drugged our nation’s kids at scale. It’s wrong. It needs to stop. We have to reexamine the root causes. And so, flipping this food pyramid upside down, focusing on protein is the first step. And so, I’m very proud of what we were able to do.

36:27 What have you uncovered now that you’ve been inside the organization and you can see paperwork related to the legacy of how the old food pyramid was constructed and maintained for so long about the motivations who was involved in setting that food pyramid when you mentioned the corruption of nutrition science? Help us understand the root of that.

36:49 So, I wrote a book just before coming into office where I had a chance to do a deep dive and do some investigative journalism, if you will, to learn how this dogma of what to eat we got so wrong. And I think it was a lot of group think just like we saw with opioids are not addictive. Medical establishment got that wrong for 15 years. Young kids should avoid peanut butter until they turn three. We got that wrong for 16 years. Tragically wrong. Igniting the modern-day peanut allergy epidemic because peanut butter exposure in infancy reduces there’s something called immune tolerance, right?

37:34 And it reduces the risk of peanut allergies. We’re the only country in the world that has high rates of peanut allergies along with UK and a few other European countries that fell for our dogma based recommendation to avoid peanut butter till the kid turns three. And so we got that 180 degrees wrong. And so there are dogmas in the medical field that take on a life of their own and you’re not allowed to question them.

38:00 And we saw a little bit of it during COVID if you recognized natural immunity and may not need to be fired from your job because you have circulating antibodies to COVID, but they were just antibodies that the government did not recognize. This dogma can take on a life of its own. And so we’re trying to get back to gold standard objective science.

38:33 It is crazy that the fundamental premise of science is you ask a question and then you test whether there’s one answer or another. And the idea that you can’t ask questions indicates that it’s not science from my point of view. All standards should be challengeable. That you should be able to ask the questions and fundamentally if they hold truth or they hold ground then great. Let’s maintain them. And if they don’t we should be able to change.

39:07 And then they use the word science or historically the word science has been then used to justify not testing something. That’s right. It’s it’s crazy to me. What are the roles that food companies have played? What are the roles that folks that might have an economic incentive in keeping the food pyramid as it was played historically in this? And is that permanently changed at this point or is it changed while this administration is here and it’s going to change again next cycle?

39:44 Well, I think the industry did what the medical field told them to do and that is to address the risk of mass starvation and deal with food insecurity and that calories in equals calories out regardless of where those calories come from. That was the dogma and sort of the mandate to the food industry. So they did what they were told to do and so they moved to refined carbohydrates. They stripped the grains of fiber to mass-produce them. They would even chop them up which made them increase your glycemic index. That is it basically functions like sugar.

40:20 So you have cereals, breads, pastas functioning like sugar. And so we ushered in a generation of kids and you and I were the first generation who were part of this the first generation in human history with massive insulin spikes day-to-day in our normal everyday life. We’ve never seen insulin spikes to that degree. And of course that drives something called insulin resistance. That is the organs in your body that do important functions are trying to block out all this extra glucose. And so they kind of change the configuration of the insulin receptor to just try to resist all this sugar coming in.

41:03 And it is at the root of almost every chronic disease. Insulin resistance, general body inflammation. And we never talk about these things. Never. So we talked about them front and center in our new guidance. The types of grains matter. It’s not calories in equals calories out. It’s not you can have this if you sit on the treadmill for this amount of minutes. We’ve got to talk about the soil that food comes from and the farming techniques that animal products come from and the cleanliness and chemical-free waters that seafood comes from and the importance of protein and the value of whole grains and what we call real food. And so the website is realfood.gov.

41:49 My only criticism is the lack of vegetarian protein in the top of 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, I’ll talk to Joe Gibbia about it. It could. No, it could. I think the New York Times had a conception about the blueberries. The blueberries. I think it was disproportionately disturbingly large. Disturbingly large blueberries. That was the criticism. Okay, that wasn’t one that bothered me.

42:26 Let’s talk about the adult population. I think 40 to 60% depending on how you measure it are obese clinically obese in this country and these incretin mimetics GLP-1 drugs and others have really taken the market by storm taken our population by storm. So I realize that much of this is in response to an obesity epidemic that we’re facing in this country. But it turns out that these incretin mimetics may actually have other systemic benefits and they’re now I think there’s 60 indications that they’re being tested against including kidney neurological cardiac.

43:07 I mean there seems to be a lot of benefit potentially in using them for other disease indications. Can you speak a little bit about your view on where this market where this class of therapeutics is headed? Is this something that some people have estimated or 60% of Americans are going to be on? And if it is the case, does that mean we failed with our food system?

43:42 Well, first of all, we have failed with our food system. Look at the fact that 40% of American kids have a chronic disease. Between the lines in the medical textbooks in medical school was kind of a blaming of children for not having the discipline. And it’s not a willpower problem. This is highly addictive chemicalized foods that are ultraprocessed that are put in front of kids and they want more and you put these vibrant colors in them from the petroleum based dyes.

44:14 And so this is something adults have done to kids. And so I think that we have failed. We’ve given people the wrong information. The calories in equals calories out, this demonization of fat and all that stuff we talked about. GLP-1s are mimicking a natural hormone in the body. And so when you get a supplementation of that, it’s doing the job of increasing satiety, slowing down GI motility, and it has a profound impact on a number of conditions because you are also reducing insulin resistance and general body inflammation.

44:51 And so that’s why we’re seeing so many other benefits. Plus, you feel better. When you feel better, you’re going to have benefits you don’t even we haven’t even appreciated yet because there’s an incredible value this sort of positive thinking. We’ve seen it in a lung cancer study from Mass General. They randomize people to palliative support versus chemotherapy and the palliative support did better even though chemo drug is more effective than standard of care.

45:20 So, you see this incredible value to sort of positive thinking and maybe that’s one of the reasons we’re seeing reductions in addiction. Maybe we’re, you know, we’re seeing cardiac benefits. So, we’ll see. I mean, we’re, you know, as a regulator, we’re a referee and we want to see products come to market quickly and safely, but I think we’re at a pretty interesting time.

45:41 Yeah. Just to go back on the China point because we did talk about competitiveness with respect to speed, but the other piece I wanted to address was funding of research. So that biotechnology council I mentioned recommended a $15 billion kind of rushed investment in research. When I meet with scientists, there’s a view that the Trump administration is anti-science, is defunding a lot of research institutions in the United States that are going to save people’s lives and develop amazing cures.

46:14 Why are they doing this? There’s this council that recommends that even in the face of China, they’re putting out tremendous funding to support research scientists coming up with those next set of molecules or therapeutic modalities that are going to change lives and improve lives. Maybe you can comment a little bit on are we funding through the government enough scientific research? What’s the right steady state for us? And how do we address the points about the Trump administration being anti-science?

46:41 Yeah. Well, look, we live in partisan times now where people get spun up and they’re in sort of a toxic polarization. And the truth is, if we want to know the facts, is that in the Trump administration, we have not cut $1 of NIH funding. We have not cut $1 to the general Medicaid budget. That is the overall Medicaid fund. And the proposal for the future is to increase Medicaid by $200 billion.

47:09 So you hear all the time, oh, Trump cut Medicaid, Trump cut the NIH. No, what we want to see is reallocating money at the NIH from just chemotherapy and proton beam therapy work to study food as medicine and school lunch programs and the microbiome and gut health. We’ve got to start talking about school lunch programs, not just putting every six-year-old on Ozempic.

47:39 We’ve got to talk about the quality of sleep as it is a cause of high blood pressure when you sleep poorly instead of just throwing people on anti-hypertensive medications. We’ve got to talk about environmental exposures that cause cancer, not just the chemo to treat it. And so, we want to see funding go to root causes of diseases. And that is something that has been unfortunately in a blind spot because the culture of the NIH is the culture of Francis Collins and Tony Fauci and the group for the last 50 years.

48:10 And I’m going to oversimplify it. The gene is responsible for our health problems and the gene can solve all of our health problems. Well, look, I believe in gene therapy and we’re doing amazing stuff with that. But where’s the research on why one in six girls today will develop an autoimmune disease? What’s triggering that antibody response? What of the many exposures in the life of a child is causing their bodies to be triggered?

48:41 These studies can be done. It’s not that difficult to model the antibody that’s involved in type 1 diabetes or MS and exposures in the environment to see if it is triggering that same configuration that the antibody binds to. But no one’s been interested in it because everything has been about coming up with a, you know, treatment when we have to look at causes.

49:04 Right? And the scientists on the ground see their funding go away. They complain. They get media attention. There’s a lot of amplification of those stories. So is that not the fundamental truth because the money is being reallocated to other scientists and other research institutions?

49:22 Correct. So 14% of NIH funding went to DEI research. 14% of NIH grants went to DEI research. And NIH grants are about 40 billion a year. Does that sound it’s a little over 20 billion in terms of grants that go out the door but about 47 billion for the entire NIH budget because they run their own hospital and clinical center and others.

49:49 So if you think and and by the way I’m all for anything that reduces health disparities. Yeah, and increases access. But these grants were not doing it. It was just describing health disparities. Well, it’s we already know there are health disparities. Simply describing them with another 50 studies in JAMA does not help people who are suffering from these health disparities.

50:13 So, we’ve seen money shifted to root causes 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 value of hormone replacement therapy for post-menopausal women. Something the NIH demonized for the last 22 years, saying that women shouldn’t take it because it causes cancer.

50:36 When we came in, the NIH was a mess. Almost all the money was going to genetic research, which then becomes the priority of every academic institution. They’re not studying causes and food and the microbiome and cutting edge areas of science. And they just had this myopic focus on one area. It’s an important area, but it’s one area. They were funding the Wuhan lab to, you know, get bat coronaviruses and insert a furin cleavage site so it could infect humans. What are you doing? It’s a bunch of mad scientists. And 14% of grants were going to DEI. So the NIH when we came in was a mess. And under President Trump, it is massively being reformed. And Jay Bhattacharya is doing a great job.

51:16 Okay, let’s shift over to vaccines. Our wives had kids around the same time. Hope yours is doing well. Great. He’s great. Thanks for asking. Yeah. And we talked about the Hep B vaccine, which we declined on the day he was born. Because I started going very deep on what’s the origin of the Hep B vaccine the day that the child is born. Why is this being given to them? We have no Hep B exposure in our household. We don’t need it. Doesn’t protect anyone else.

51:45 What are we doing this for? You end up going down these rabbit holes and a lot of again what you mentioned earlier, you take for dogma and you recognize, wait a second, there may be some unfounded principles at play here. I should not be doing this. And we make a difficult decision against the tide and the recommendations and suddenly you’re in the social conflict with people around you, right? And it was very hard.

52:04 You guys recently made some big changes to the vaccine schedule. I’d love to hear a little bit about how those changes were made, what were the big changes, and then, you know, kind of what got us to this point where when you look at the data, you’re like, “Wait a second, right?” That may not make as much sense.

52:21 Yeah. I’m just laughing as you talk, Dave, cuz you do, you know, you just ask some good questions like, “Does my newborn on the in the first hour of life need to be injected with a hepatitis B vaccine when the mom is hep negative?” And within a matter of weeks of having broader conversations, you feel like you’re a fugitive of the law, like you’ve done something, you know, terribly wrong for choosing not to vaccinate.

52:55 We went through the same thing and you know, being a part of having a kid is so special. You know, we were talking about that. So, yeah, we just went through this. Our son was born about 6 months ago and, you know, we were offered the hepatitis B shot. Now, maybe they figured out who I was and didn’t push it as hard as some of my friends have had that it pushed on them and we declined.

53:23 You’re preventing with hepatitis B an infection that is a sexually transmitted infection or can be get it from a bloodborne pathogen exposure. So that’s not going to happen until they’re a teenager at least or further down the road. But when you ask the question immediately you get this sort of antivax label or you have to qualify that’s right I’m not an antivaxer but I’m asking this what right what’s going on here.

53:57 This sort of McCarthyism around this schedule which by the way the United States vaccine schedule was an international outlier with 72 doses recommended between the ages of zero and 18. So, President Trump asked us to review the international landscape of vaccine recommendations and we looked at 20 other developed countries and found that not only are we the international outlier in how high the number of doses we recommend is but that there’s a consensus of a group of core essential vaccines.

54:34 And we wanted to put that in front of the American people to say look all vaccines are still recommended by the CDC but here are a list of core essential vaccines. So we gave them a list that constitutes about 38 doses from age 0 to 18. And the idea is to increase vaccination rates among children that have been dropping because of a loss in public trust by saying here’s a hierarchy of what we believe to be a list of core essential vaccines.

55:03 I don’t want to see someone because you know a doctor’s pushing the sixth COVID booster in a young healthy 12-year-old girl. I don’t want to see the mom say, “Well, I’m not going to get the measles shot in my next with for my next child because I am something’s not right about this.” 38 is better than zero. You can still get them all. They’re all paid for, but we have a hard time in the medical culture, and this is part of the sort of the sociology of medicine, meeting people where they’re at.

55:35 For example, as a cancer surgeon, I would see women tell me they don’t want to get a mammogram. I disagree. I think they’re safe, but a woman may be concerned about the radiation, the discomfort, the inconvenience. 40% of women who are candidates for a mammogram are not getting a mammogram in the United States today. Showing you the massive disconnect between the medical field and where people are at.

56:02 Now, you know what we should be doing is we should tell those 40% of women, how about an ultrasound? It picks up 90 to 95% of the lesions that a mammogram would pick up. But doctors don’t recommend an ultrasound because you’re violating the gold standard and there’s liability and there’s, you know, and you’re practicing substandard care and women may tell other women that they can also get an ultrasound and we don’t want women getting an ultrasound instead. The paternalism that results in this disconnect is hurting people in the United States today.

56:37 And so with identifying the list of core essential vaccines, we are trying to meet people where they are at to see more vaccinations because childhood vaccines have declined over the last four years because people have lost trust in the dogma of the cloth masks for toddlers and vaccine boosters in perpetuity and you have to fire a teacher if she already had COVID. Ignore natural beauty. You have they have to be fired from their job. That absolutism has caused tremendous damage and we’re trying to rebuild public trust.

57:07 What’s frustrating to me to observe is there are now states like California and the California DPH that are saying we’re going to set our own vaccine schedule. We’re not going to listen to the FDA, to the HHS anymore because they don’t know what they’re doing because they’re Trump admin. They’re not doctors. They’re not scientists. Clearly, this is all political.

57:39 And is there a process of engagement that you and your organization go through to try and bring some of these other folks along with you? Because I think the point you just made can’t be a point that they can fundamentally disagree with. What is what is the process by which we can break the political rancor around things like vaccines and just take a very clear-cut scientific approach and get people aligned around this? Do you do engagement on this stuff?

58:08 I don’t. Look, I think it’s sad we have this toxic polarization that’s crept in. It’s in society, but it’s now crept into medicine and it’s a lot of character attacks. I mean, it was put together by doctors with impeccable credentials. Tracy Beth Hoeg, MD-PhD, phenomenal epidemiologist who is deep on the science on this stuff. You know all of us Jay Bhattacharya MD-PhD, Mehmet Oz vice chair of surgery at Columbia University.

58:40 I mean these impeccable credentials 400 scientific publications I’ve published 350 scientific peer-reviewed publications in my career at the Harvard School of Public Health at Georgetown at Johns Hopkins on the faculty tenure national academy of medicine. Didn’t matter all the impeccable credentials you can put in front of people there’s this sense of we just have to say the contrarian thing to whatever they are saying because of this sort of mantra of all vaccines are good regardless and you cannot have an honest conversation.

59:23 I talked to doctors and they’ve never heard of a vaccine they didn’t love. Anthrax vaccine was a disaster. H3N3 killed people. It was a disaster taken off the market. Rotavirus vaccine in 1999 taken off the market because kids were dying from intussusception. Rotavirus is not in our core essential vaccine schedule in the United States. Overseas it’s a little different but in what we put out it’s not in there.

59:56 After mass vaccination with rotavirus the number of deaths per year went from 3 to 1.6 or round it up let’s say two went from three to two with mass vaccination and the vaccine that was used up until 1999 was taken off the market for safety concerns. So when you have a parent ask a question about the necessity or we cannot respond with absolutism, American medicine needs to show some humility.

60:28 When I had a patient asked me a question I didn’t know the right answer, I don’t know. Maybe I’ll look into that. Maybe one of my colleagues knows during COVID, the right answer many times was we don’t know. Do you find that there’s a path forward? I hope so. So, I mean, we’re hoping to restore gold standard science and just talk objectively about it.

60:59 We’ve had universities cancel crush censor railroad doctors that, you know, pose different ideas about things. And I’m not talking about the political hot button issues. I’m talking about the fact that ulcers were not caused by stress. They were caused by a bacteria called H. pylori. Well, that guy was, you know, railroaded. His research was rejected from the national meetings and then he gets the Nobel Prize because he ends up being correct. So it’s not good for science. Most great scientists start out as heretics just to be clear by the way. That’s right.

61:35 Yeah. So Marty, one of the other big challenges that we talk a lot about in this country is the cost of drugs. Healthcare today costs roughly 15% of our GDP. That’s an insane statistic and it is rising year after year in the United States and it’s such a complex issue. By some measurements though, the price of drugs in the United States is almost three times what it is outside the United States.

62:03 So I’d love to hear a little bit about the specific role of pricing drugs. What sort of actions have you guys taken and can you take to help bring down the price of drugs for patients, for care providers, for insurance companies, and ultimately for the economy?

62:18 It’s been the great American ripoff. You could buy a GLP-1 drug for $1,300 in the United States and go to London, it sells for $88. Or you go to Germany or France and buy any of the drugs that cost a lot of money in the United States and they’re half a third or a quarter the price. And so, President Trump has given us a clear charge and he says, “Look, we’re the largest purchasers of drugs. We want the best price in the developed world. It’s called most favored nation status pricing.”

62:48 And thanks to Dr. Oz and Chris Clamp and others at CMS, we did our part at the FDA to be a part of this. We’ve gotten drug companies to the table and we’ve got them to agree to most favored nation status pricing. That’s going to radically lower the price of drugs. With the GLP-1 example, for example, it’s going to come down to $149 for the first three months.

63:09 Other countries are going to pay more. We have been financing 60% of the R&D cost to pharma companies. Other countries need to pay their fair share. And when it comes to this president, would be it NATO membership fees or whatever, he wants to see other countries paying their fair share. And so, we’re getting that delivered.

63:27 Another big way in which we are going to lower drug prices is by cutting the red tape at the FDA for biologic drugs. So most 51% of the so let me back up for a second. The fastest area of healthcare spending growth is drug price spending growth. And the fastest area of drug price spending growth are a class of medications called biologics which means you need a cell line to manufacture them.

63:55 And so these are typically the 60,000 $100,000 $150,000 medications. They have generic versions called biosimilars. But the FDA red tape to get a biosimilar approved has been so long and arduous it takes 5 to 8 years and $300 million or so. We have changed the requirements so that we use the same principles we use for small molecules. If you are structurally the same as a small molecule branded drug, we’re going to approve you with some other stipulations.

64:33 And so we are reducing the cost of R&D of biosimilars by a hundred 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 we’re going to see a whole new class of biosimilars come out in this administration that are going to finally compete with the biologics.

64:55 Now Humira is one of the most famous biologics. It took years after that patent market exclusivity for a biosimilar to come out and when one did come out you didn’t see the price of Humira come down that much almost sort of an implied price collusion. We need a lot of biosimilars to come out and we’re going to see the floodgates open up on biosimilars.

65:17 And then a final point, why are a lot of drugs requiring a prescription in the United States? What are we worried about? Somebody overdosing on anti-nausea medication or somebody picking up a prostate medication without a prescription. And we’ve got this is the paternalism in medicine again coming out. The same paternalism that blocked women from having home pregnancy tests because you know women can’t handle that information. They have to come in and we have to share it with them.

65:50 It’s this paternalism you see and by the way it happened again with COVID testing. We saw it well home COVID testing. We fought this battle. We wanted home COVID testing and the establishment was like no no we have to tell them they can’t have this information. What are why are drugs not over-the-counter? And we are going to so we are going to get more drugs over the counter.

66:12 And let me tell you why that lowers drug prices. Because when a drug is on the shelf in a store, there’s a price underneath of it. And there is something magical with competition and people who shop. Even if a small segment of the consumer market is shopping on price, it keeps prices in check for everybody. And so you will enable price transparency and you will bypass the crazy money games of PBMs, pharmacy benefit managers.

66:47 When you pick up something behind the counter, they ring you up. You have no idea the shell game that’s going on behind the scenes. Your employer is getting ripped off and your PBM is making money on this and the broker who sold the PBM to the employer group could be making $6.50 cents on every prescription sent for what? For the PBM just to tell you what your co-pay is going to be and set the co-pays. All of those money games disappear with the disinfectant of sunlight and a price on the shelf.

67:22 We want to see a mass transition to more nonprescription drugs. We have new leadership that I brought in at the office of non-prescription drugs at the FDA. We want to see companies request to be non-prescription and it’s going to have very simple criteria. If your drug does not have abuse potential, if your drug is safe, if your drug does not require laboratory testing, which doctors, you know, we often need to check your liver function tests. It does not need to be closely tracked.

67:58 It should be able to be over the counter. If you’re not going to use the drug in some meth lab to make some dangerous street drug, if you meet those basic criteria, the drug should be nonprescription. Think about the number of useless ER visits out there. The whole medical industrial complex cha-ching every time you need a refill. Like I got pink eye from my kids and it was such a headache to get the drops to get my pink eye to go away. Like I mean I can’t I spent so much money just getting a few drops of antibiotics to put in my eye.

68:35 But if I were able to buy that medicine the antibiotic drops over the counter or and I could just pick it up the shelf. How do I get my insurance to pay for it? How does that process work? Just explain to the everyday consumer what that’s going to look like.

68:52 So we need insurance companies to modernize how they reimburse for medications. And we’re having these conversations internally as well because they had this old construct of here’s our reimbursement scheme for prescription drugs and here’s our reimbursement scheme for non-prescription drugs. Well, they got to modernize. We’ve got to come up to the 21st century. And remember, the insurance companies own the PBMs a lot of times. So, we’ve got to be honest. We got to all come to the table. President’s bringing them all to the table and having very frank conversations. And he’s been successful.

69:37 I’ve got to imagine at 15% of GDP, this is a giant ship you’re trying to reset and redirect. Can you get this done in this administration? Can you make the changes of moving many of these medications over the counter and get them to fit under insurance reimbursement plans?

70:00 It’s a massive priority this year for me. One of my big 2026 goals is that we want to see more drugs move to nonprescription. If writing a prescription by a physician like myself is supposed to regulate and serve as a way to administer drugs judiciously, then history would show we failed. Opioids and Oxycontin 60% of antibiotics prescribed in the United States are unnecessary. That study has been done over and over again 10 different ways. Most antibiotics people take they should not be prescribed.

70:40 So, we have to talk about educating people, trusting people, and get away from the paternalistic model of medicine. Yeah. And well, I mean, look, if you guys get it done, I think it’ll be a profound change for America for the price of healthcare, which I think is really challenging a lot of people day-to-day.

71:04 One of the other things that’s been a little bit of a hot button is pharmaceutical advertising on TV. Yeah, some people have claimed that the pharmaceutical companies have significant influence over media because of the money they spend. They’re one of the biggest spenders. I spoke to a pharmaceutical CEO about advertising. He said the ROI is incredible. We’ve never been able to influence media, so it doesn’t make a difference to us in that sense, but fundamentally the reason we do it is because it gets awareness out there for therapies that patients might not know are available to them.

71:43 And he said this interesting statistic to me which is that half of US physicians never see a representative to learn about new drugs that are coming to market and two-thirds of physicians report never reading a journal article or going to a conference in the past year. So they’re not aware of some of the new medicines that have come to market or coming to market.

72:05 You’ve been a physician, you are a physician, you understand how this might go. You’re busy. You’re treating patients. You have a lot going on. Maybe you’re not up to speed on the newest medicines coming to market. What’s the administration? What’s your view on advertising, pharmaceutical advertising on TV? Where are things headed?

72:19 Well, raising awareness, as your friend mentioned, is a good thing, but creating a misleading impression and creating a massive storm of demand where patients come knocking on our door, insisting and begging that they get certain medications that are not indicated for them is a problem. And the drugs that they are advertising non-stop on TV and they’re always singing and dancing, right? Always singing and dancing or marching from some fake town to another. I don’t know where they’re going, but it’s always this sort of idea that life is great once you take this medication.

73:07 It’s the biologics that they’re advertising. And because they charge so much on the biologics, and look, they do cost a lot more to make, but because some of these biologics have been so expensive, that’s where they’re seeing this big ROI. So, we are lowering drug prices, and I think that’s going to affect whether or not it’s worth it for them to advertise.

73:26 We have a duty at the FDA to enforce two regulations that were not enforced in the Biden administration and that is that ads cannot create a misleading impression and that there has to be a quote unquote fair balance of information. There’s also a loophole called the adequate provision loophole which says you don’t have to list all the risks or side effects. You can put it somewhere else like on a website. We’re closing that loop. We’re changing the regulation to close that loop.

74:10 The Biden folks in the year before I came to the FDA sent out zero enforcement letters. A department of about 35 people in charge of sending out enforcement letters sent out zero enforcement letters. I sent out 1,500 enforcement letters, including over a 100 cease and desist letters for ads that were creating a misleading impression, including online pharmacies that are advertising drugs without the same side effects that pharma companies list when they do the ads.

74:44 And so we are cracking down on it. We want free speech, but we also want fair speech. And this is part of our jurisdiction. So, we are taking this very seriously. I’d personally love to see pharmaceutical companies spend that 20 to 25% of their money that they spend on marketing, take some of that and use it to lower drug prices for everyday Americans.

75:17 Okay, great. Well, sounds like there’s some balance and change that’s required. One of the other things that we talk a lot about in Silicon Valley is this shift in AI and using AI to diagnose your condition. And so many stories have come out where people upload their lab data or an MRI image and they’re getting readouts that they weren’t getting from the doctor or more accurate readouts or they’re able to find care that they weren’t finding through the traditional physician process.

75:52 What’s this administration’s view on these AI tools? Are they a supplement, a replacement? And then how do we allow them to proliferate if they’re good? And do they need to be regulated? Or are we going to end up regulating these AI doctors, these AI medical systems?

76:11 Well, first of all, AI is producing information at a rate that no one can keep up with. And so, if we use the traditional regulatory mindset to say we have to make sure the information is accurate, then you wouldn’t be able to do a Google search because you’re going to get a hit that’s going to give you something that’s not accurate. And so, what are we doing? What road are we going down?

76:32 We can’t outrun this lion. We have to use common sense and demarcate information that you’re getting from AI that automatically triggers some health intervention that is sort of automated AI. And so last week at the Consumer Electronics Show, I outlined new guidances on AI decision support and wearables. And it creates a clear consumer lane.

77:09 But if you’re making medical claims of a medical blank, then that’s something we’re going to want to take a look at and that’s something you’re going to want the FDA’s seal about. So, it creates predictability because developers tell me all the time they just want predictability from the FDA. Markets want predictability, developers want predictability, and investors want predictability.

77:38 So wearables meaning heart rate, blood pressure. That’s right. Glucose monitors, those sorts of things get deregulated, more accessible, lower price, and so on. That’s right. They’re going to be deregulated. So you can give those results of any physiologic parameter. But if you say that it’s a quote unquote medical grade blood pressure, then we are going to want to see the data to make sure that it’s validated with the gold standard blood pressure readings. We don’t want people redosing their blood pressure medications on something that claims to be medical grade when it is not medical grade.

78:11 Got it. Okay. One other area I’ve spent some time in my career is in alternative proteins. And this is something that your agency regulates. So making animal proteins, eggs and cheese and milk and so on using bacterial or yeast cells rather than making them from the animal. You get the same protein and you just use a different mechanism of making that protein or cellular meat where they’re actually growing the chicken breast or growing the beef.

78:39 There’s historically been a system called GRAS are generally recognized as safe that a lot of the companies have relied on as they’ve developed these techniques and these protocols. You’ve made a few changes. Maybe you can kind of highlight the balance between innovation because the benefit of these systems, lower cost, less energy, and you take the animal out, less cruelty. There’s an ethical driver for some of us. Yes. But I’d love to hear the view on balancing those benefits against the risks to consumer health.

79:09 And there’s an incredible amount of lobbying pressure from ranchers and animal agriculture against these systems that I’m assuming is starting to kind of make its way into DC. We’ve seen it make its way into states where they’ve banned it outright banned cellular meat in some states. So, I’d love to hear your view on this kind of alternative protein market and the changes you’ve made in GRAS and looking out for consumers against the benefits.

79:30 You’re making me hungry because I love eggs and I didn’t get my egg breakfast this morning because we’re out here at a bunch of meetings. But, I’ll get you some eggs afterwards. Great. And not egg white only. I do 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 ultimate epitome of the old dogma.

79:53 And by the way my uncle he came to the United States. He had eaten eggs every morning and he loved eggs. It was his livelihood is the morning eggs. And he came to the United States in his 30s and his doctor said no eggs. You know found out he was eating eggs and just you know wagged the finger and you know stopped. And so for 30-some years, he had this miserable life without eggs until we finally got to him and said, “It’s okay. Two eggs in the morning is okay. It’s a good source of protein. Don’t worry about the saturated fat.” He’s now 95 years old, I believe, in Florida. A happy man. Happy man eating his eggs every morning. I’m a two to three egg a guy as well. So oh, you are? Okay. It’s a great source of protein.

80:40 Yeah. So on GRAS, so GRAS for those who may not know is a way in which companies have created chemicals or brought in chemicals from the environment, added it to food and they could self-declare them as safe. And so it’s kind of a unique thing in the United States and it was started with good intentions so that the FDA wouldn’t regulate you know salt and butter. You know what are we doing regulating salt? I’m sure some people may want to, but we’re, you know, we’re not going to regulate salt.

81:08 So, GRAS was created for those sort of things like salt, but then over time it got abused. So, all of these engineered chemicals would just get a free pass. And we’ve said, look at where we are today. You turn over the packaging of some of these ultraprocessed foods and there’s 40 ingredients. Nobody knows what they are.

81:32 And in Europe they have basic principles of introducing chemicals. Basically it’s sort of if you will guilty until proven innocent that is you have to demonstrate safety to be introduced. In the United States we have this you know innocent till proven guilty. So we have basically said we have a thousand chemicals plus in the US food supply that are not allowed in other food supplies.

81:58 Froot Loops was making cereal for Canada where the petroleum based dyes were banned and a different Froot Loops for the United States for American kids. And so we’ve said we have to close the loophole on GRAS. We started the regulatory process to do that. And then we have to think about creatively those situations you mentioned where there may be ways to get more amino acids in some of these foods. And we know that kids are low in amino acids and protein because of this myopic focus on fat as the boogeyman.

82:29 We have not gotten the protein that we need. And part of that was also flawed studies approximating how much protein your body needed that used urea nitrogen levels that massively underestimated the amount of protein metabolism in your body. And every food has different levels of protein bioavailability and amino acid bioavailability. So that’s why you said you’re vegetarian. You have to think a little differently about the protein requirements.

82:55 So all fun topics but the cellular meat industry you don’t think is doomed. There’s a potential for the industry and it’s going to continue to evolve. We’ve seen under my time at FDA we’ve seen new cellular food products come not just beef but seafood. Yeah. And it happens at the state level and the FDA actually does not have jurisdiction over what somebody creates but we do ask for a registration in a sense to be in the loop.

83:17 Okay. So what is causing autism in the United States? Yeah, there was a conference a few weeks ago. You and Secretary Kennedy talked about Leucovorin as a new line of treatment for autism patients, but some people have since debated the merits of the data. Are we seeing rising autism rates in the United States? And what are the core drivers? What have you learned? And is this an ongoing process?

83:42 Well, there is more diagnosis for sure. But one in 12 boys in California now being diagnosed with autism. I mean, that you didn’t see that two generations ago. You didn’t see the repetitive ticks and the self harm and the you didn’t see that. You still don’t see people in their 60s and 70s with those symptoms at the rates that you do in young kids today. So, something’s going on for sure.

84:08 Now, what’s causing it? I don’t know, but there’s some interesting hypotheses. One is that for some kids it may be an autoimmune phenomena triggered by something where the antibodies are binding to the folate receptors preventing folate from entering the blood brain barrier. Folate is necessary for neural development. And so some doctors report and they’re I mean these are experts in the field been studying this their whole lives and see a lot of patients.

84:35 They have observed that if you give leucovorin as an example which bypasses the blocked receptor allowing methylated folate to get into the blood brain barrier they have seen clinical improvement. There’s one study that’s looked at the microbiome which we now know produces a lot of molecules involved in brain health. 90% of your body’s serotonin which is involved in mood is made by your gut.

85:03 And we’re just recognizing this giant frontier of the microbiome. And so when we in the modern world, we just torture the microbiome. I mean, so many things. Some things are necessary like C-sections, not good for the microbiome. Infant formula instead of breast milk, not good for the microbiome. Antibiotics used like candy. The average 2-year-old has already received over 2.5 courses of antibiotics. It’s carpet bombing your microbiome in certain places.

85:33 And what results is bacterial overgrowth, less biodiversity, and you have more inflammation later in life. And when you have inflammation of the gut, most the most painful thing in medicine is when a tubular structure stretches. A kidney stone supposedly is the most painful thing. I’ve never had one. Patients say it is. It’s not the stone scraping along the lumen. It is the blockage causing distension proximally stretching the ureter that’s what hurts gallbladder pain stretching the gallbladder that’s what hurts like crazy.

86:11 And the GI tract with low levels of inflammation is irritating that lumen and also causing this sort of discomfort at a low level and for a kid it may manifest as feeling sad or depressed and so we give kids all these chemicals and ultraprocessed foods. We alter their microbiome and we change the production of what comes out of the microbiome cells normally. That is certain vitamins, hormone regulation, serotonin. And what are we doing? We’re ignoring this physiologic cause and we’re drugging our nation’s kids at scale.

86:51 So, we’ve got to talk about the value of the microbiome. And I would not be surprised if we had the research on that instead of just the DEI stuff we talked about and study the microbiome the same way we were funding the Wuhan lab to study coronavirus you know manipulation. I think we could finally understand this great frontier of medicine that may be involved in autism.

87:16 One study has found that if you give a certain protease it’s a randomized trial. I couldn’t believe it when I saw it because and you know sometimes the studies are not reproducible in JAMA our most widely circulated medical journal a randomized trial giving a protease to kids with autism and noticing an improvement now again it needs to be replicated I don’t know if it’s real but maybe there’s something to the microbiome so I don’t know what causes autism but we have some clues and this is something worth studying not just is there a genetic cure for autism.

87:55 Yeah. And the underlying environmental contributors, there’s just so much going on that’s different in our environment, in our food system that are also being addressed that over time hopefully will result in maybe less of the general health effects caused by call it an adverse environment.

88:11 Yeah. Yeah, I mean the number of proteins that we ingest that are denatured in some way. The number of chemicals or molecules that do not appear in nature that go down the GI tract. What’s happening is you’re getting an inflammatory response, but it’s not a sudden acute inflammatory response. It’s a low-grade response and it may be causing general body inflammation.

88:33 And the one thing I wish I would have learned in medical school is that most chronic diseases are from general body inflammation and insulin resistance. Heart disease, for example, most common cause of death in the United States. We thought it was just saturated fat. Three large studies failed to show that association. The Minnesota heart study was supposed to be the end-all randomized trial in the 1960s. It showed the opposite of what they thought. The low-fat diet group, these are 9,000 Minnesotans randomized. Low-fat group had more heart attacks, not less.

89:12 They suppressed the results for 16 years. When Gary Taubes asked the senior author before he died, why didn’t you publish this for 16 years? He said, we just the results just didn’t turn out the way we expected. Well, other large studies failed to find this clear association between saturated fat. We’re talking about normal saturated fat intake, not massive overdosing. Normal saturated fat and heart disease. And so anyway, so there are these things that we have to re-evaluate.

89:41 Okay, last question. What’s most exciting to you in the frontiers of science in human health? You know, we at the FDA try to be referees. So we see different technologies competing. For example, sickle cell disease. There are monoclonal antibody treatments and there are gene therapy treatments. Now, we tend to get excited about one over another, but the reality is we don’t know which horse is going to win that race and so we want to be the referees.

90:09 I would like to see in the Trump administration during our term a cure for type 1 diabetes or some meaningful treatment for type 1 diabetes. A powerful treatment for ALS. Treatments for certain kinds of cancer where we’ve seen now PD-1 blockers and KRAS inhibitors melt the tumors away so you don’t need surgery or chemo. You talk about a health reform, that’s more powerful than a lot of the health reform ideas we have out there. You don’t need surgery or chemo or radiation. I mean, think about the reduction in expenditures.

90:46 We’d like to see a universal flu shot so we’re not guessing every year, something that gives you lifelong protection against future strains because it targets a different part of the influenza virus. And I would like to see something powerful for PTSD. A lot of Americans are still suffering from PTSD, some from having served in a war. These are young people oftentimes who stood up to serve their country and, they are suffering.

91:16 We are still losing 7,000 plus veterans a year to suicide. So the wars are over, but our men and women keep dying and many of these wars were unnecessary. I think we owe it to them to deliver a powerful treatment for PTSD if the data supports that there’s something out there. So that’s one of my personal goals.

91:32 You’re optimistic about the pipeline you’re seeing there? Very optimistic. I mean, we’re just seeing really interesting stuff. It’s been published in part, so I’m not sharing anything here that’s not public, but we’ve seen phase two trial results that are promising. And I go, you know, I go Dave to the scientific reviewers at the FDA. Without their bosses, just one-on-one, and I ask them, are you seeing anything early on that looks amazing? Are you seeing anything in the pipeline, anything in animal studies that’s actually working in animals that could extrapolate to humans in a way that could be a game-changer?

92:13 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 example, but every now and then somebody will tell me, “Yeah, there’s this mechanism. It’s creative. It’s different. And if it works, it’ll be amazing.” And we’ll often issue that company a priority voucher.

92:31 A treatment came out for a certain type of congenital deafness. It’s a gene therapy device combination. It came out in the New England Journal of Medicine. We read the article because we love to read these articles. That’s our nature. And we called the company and we confirmed about a dozen kids got it. A couple had normal hearing. I mean, that’s amazing. And so we immediately issued them a voucher.

92:57 A new treatment for multiple myeloma that was a game-changer. Three times better than anything out there now. 80% remission free survival I believe it was at a couple years out. There’s nothing like that on the market. We called that company. We had internal discussions within 24 hours of that abstract being printed in the pre-conference materials for the American Society of Hematology. We had been in touch with that company and issued them a voucher.

93:23 What are we waiting for? Right? What are we worried about? We have got to move at the speed that my patients demanded, not at government speed. So, we are streamlining and modernizing the FDA. And we are not wasting time. We’re getting stuff done.

93:37 Well, for that, I don’t know how anyone could disagree with the sentiment, the intent. Thanks for the service. Thanks for the work, Marty. It’s been great chatting today and thanks for being with me. Great to be with you, Dave. Thanks so much. I’m going all in.