FDA Commissioner Dr. Marty Makary & U.S. Tourism 7/30/25

0:00Bring in show music, please. Hi, I'm CNBC producer Katie Kramer. Today on Squawk Pod. The health of healthcare. The head of the FDA, Dr. Marty Makkari, joins us. Drug safety, innovations, and yes, vaccines. The best way to prevent measles is through vaccination. Do tariffs impact travel? Booking.com CEO Glenn Fogel on consumer choice and the geopolitical baggage. We see Canada, U.S., way down, but Canadians are still traveling. We see them going to Mexico. Plus, the latest on a tragic Midtown Manhattan shooting, the tsunami warnings in paradise, and Eamon Javers wraps the U.S.-China trade talks led by the Treasury Secretary.

0:44The rhythm and tone of the negotiations is good. They're beginning to find a rapport with the Chinese side. But will we get the deals we want? It's an age-old question. That's one of the great questions, chicken and an egg. As far as I know, it still has not. We don't know. We just, we may never know which came first. It's Wednesday, July 30th, 2025. Squawk Pod begins right now. Stand Becky by in three, two, one. Cue it, please. Good morning, everybody. Welcome to Squawk Box right here on CNBC. We're live from the NASDAQ market site in Times Square. I'm Becky Quick along with Joe Kernan and Andrew Ross Sorkin.

1:23Meantime, investigators are looking into why the suspect in Monday evening's Midtown Manhattan shooting targeted the building at 345 Park Avenue. authorities say security video shows 27-year-old Shane Devon Tamaru of Las Vegas getting out of a double park car carrying what police described as a AR-15 style assault rifle. Officials familiar with the investigation telling NBC News that he left a note suggesting his mental illness may be linked to CTE from having played football. The NFL is one of the tenants of the Park Avenue building. Law enforcement authorities in Nevada say that he had two mental health incidents in roughly the last three years, also learning more about the victims of the shooting.

2:05Blackstone identified 43-year-old Wesley Lepartner. She was a senior managing director and a member of Blackstone's real estate investment committee. Also 36-year-old, Deidre Islam was the police officer who had been with the NYPD for almost four years. He was working off duty as a security guard at the time of the shooting and 46 year old Alan Ateen was a security officer who was also killed. His labor union remembered him as a New York hero and Julia Hyman was identified as the fourth victim by the New York City Chief Medical Examiner's Office. She was an associate at Rudin Management which owns and has offices in that building.

2:49They own that building. She was a first year by the way, a Cornell grad, and the whole thing is just so tragic. I know so many people. It's like one degree of separation with all of these people in so many ways. A very close friend who happened to be very close with the Blackstone executive, Josh Kushner, who, by the way, worked with her. Worked with her when he was an associate at Goldman Sachs. You can go down the list. So this for those on Wall Street, this this feels this, I think, touches a lot of folks. I would also say from a security perspective, I don't know how many people you spoke with yesterday, but I would say most business leaders were huddling with their own security teams trying to figure out, OK, do you harden the buildings?

3:39What do you do? Do you have to change your whole thing? And are we now into a whole new place? And I don't know if we are in a different place between what happened last year and what happened now. So, you know, I think a lot of people last year with United Health, with United Health. I think a lot of people used to say CEOs and others would have security. And some people said, oh, do they really need the security? They would say, do they need the security? Maybe they do. And maybe it's maybe it's different. The Department of Health and Human Services says that the FDA's chief medical and science officer has left his position after just three months on the job.

4:15Dr. Vinay Prasad led the center that oversees the regulation of vaccines, gene therapies, and other biologic drugs. He's faced criticism amid the controversy over the FDA's handling of Sarepta Therapeutics Duchenne muscular dystrophy drug Elevitus. The FDA halted shipments of that drug after the deaths of some recipients, but it removed the suspension earlier this week. In a statement, Health and Human Services said Dr. Prasad did not want to be a distraction to the great work of the FDA and the Trump administration. and has decided to return to California and spend more time with his family. We thank him for his service and the many important reforms he was able to achieve in his time at the FDA.

4:54We're going to be speaking with FDA Commissioner Dr. Marty McCary. We'll talk to him about this and a lot of other things that the FDA has been working on. Tsunami waves hitting parts of the U.S. following one of the most powerful earthquakes ever recorded. The 8.8 magnitude earthquake struck Russia's Far East. Earlier this morning, the National Weather Service said on X that waves had reached the California coast and waves of nearly six feet were recorded in Hawaii. The alert level there downgraded to a tsunami advisory. That's just about an hour ago. No substantial damage has been reported, though.

5:27Authorities in Russia and Japan said several people were injured. And before I'd gone to bed last night, the president had put out a post warning folks in Hawaii to be careful. And it was, I think it's been a tough, tough 10 hours. It's a big deal. Jane Wells is there, former reporter at CNBC. She filed a report kind of suggesting that all of them got out of there and everybody's listening because of what happened in Lahaina. My daughter has friends who are there and they all moved to higher ground as well. Everybody wants to take this pretty seriously. The initial waves have not been bad as the worst case scenario, but it's all the Oprah stuff.

6:03You can mess around with it. The Oprah stuff, right? No. She bought up half of Maui and there was a private road, her road, that was closed and people weren't able to evacuate. But then it was open later. But, you know, the usual suspects are crowing about that. Right now for the latest on this week's U.S.-China trade talks, Eamon Javers. He's in Stockholm, Sweden, with more on his conversation with Treasury Secretary Scott Besant. And Eamon, this was pretty interesting yesterday. You managed to get some pretty significant news from the Treasury Secretary about what actually happened yesterday.

6:44Yeah, Becky, that's right. We sat down with the Treasury Secretary just after he got off the phone with President Trump, briefing the president on the state of talks here in Stockholm with the Chinese side over two days. The bottom line is that they did not come to a deal, at least yet, right? The Treasury Secretary said he's got to go back to Washington today to meet in the Oval Office with President Trump. And President Trump will be the one who decides on that key threshold, which is whether or not to push back that August 12th deadline for Chinese trade negotiations. If he doesn't do that, those tariffs will snap back, the Treasury Secretary said.

7:20But if he does, we could look at another 90-day truce period where they simply set up another negotiation somewhere else in the world, possibly Portugal, the Treasury Secretary suggested yesterday. So we'll see through the day today what the president decides to do. The Treasury Secretary also told me that he pushed the Chinese side on their purchases of Iranian oil. The U.S. doesn't want the Chinese to continue doing that. I asked him what the Chinese response was to that pressure, and here's what he said. They said they're a sovereign nation and that they have security needs, energy needs, and that it would be based on their internal policies.

8:02We have sanctioned what are called teapot refineries. They are private refineries, not state-owned. And so we have sanctioned those refineries. The owners and some of those owners may have assets in the U.S. Now, I also asked the Treasury Secretary about that EU deal earlier in the week that was agreed to on Sunday. One of the pieces of that deal was that the Europeans would purchase$600 billion worth of product from the United States. But after the deal was announced, the Europeans came out and said, well, actually, those products purchases are going to come from private European companies. And we as the government can't really guarantee that those companies will do that.

8:43So I asked the Treasury Secretary if the U.S. side feels that that$600 billion commitment is real. Here's what he said. I think that's going to be closely monitored. I think President Trump believes that this is a good deal. I mean, on paper, this is a deal of the century. And I would be surprised over time if the EU doesn't hold up their end of the bargain or the 15 percent tariff rate could change. So, Becky, not a whole lot of specifics coming out of this sit down here in Stockholm. I asked the Treasury Secretary, you know, is there any specific agreement that you guys came to with the Chinese side?

9:26He didn't really point to anything specific, but he said that the rhythm and tone of the negotiations is good. They're beginning to find a rapport with the Chinese side and they're beginning to set sort of a framework for these talks. He kept talking about the arc of the negotiations. So this is setting up to be a long one indeed, Becky. And maybe what we're looking at now is a series of 90 day extensions until at some point Xi Jinping and Donald Trump can sit down in the same room and finalize a grander bargain between these two countries. At this session, though, the Treasury secretary told me there was no conversation about a Xi Jinping Donald Trump meeting anytime soon.

10:02Guys, back over to you. Although the speculation is that could happen as early as October. Yeah. Yeah, that is the speculation. And a lot of folks thought that this would be teeing up that. But the Treasury Secretary said no discussion of that here, at least in this context. Eamon, when you asked the Treasury Secretary about some of the things like Iranian oil, and his answer was, well, they said that they're a sovereign nation, basically. Like, we'll make our own decisions on that. That's the headlines on it. But it does feel like there is progress being made. I mean, it sounds like it between the lines.

10:38As you said, there's nothing concrete you can point to. but it feels like things are moving that direction from everything we read and hear. Yeah, I think that's right. I mean, the body language was very positive. The Treasury Secretary was in a great mood. He was, you know, joshing around with our crew and everything as we were setting up the cameras and the chairs and all that in a back room at a Swedish government building here. So he was in high spirits. You know, if I was a betting person, Becky, I would guess that the president will do that extension later today after he meets with Besson.

11:10And I would imagine that would be Besson's recommendation to him. But, you know, these things are unpredictable and you can never say for sure. But I think it's in nobody's interest right now for those tariffs to snap back right now. I also asked the Treasury Secretary, by the way, about Friday's deadline. Remember, August 1st is the deadline for all the tariffs on all the other countries around the world who haven't come to a deal with the U.S. so far. All those tariffs will snap back. The Treasury Secretary, I asked him what his message to American business is on those tariffs. And he said, well, look, it wouldn't be the worst thing in the world if those tariffs snapped back, at least for a period of time.

11:44Yeah, meaning that maybe just days or weeks before another negotiation can be kind of carried out. I think the idea is that those countries would then be under pressure to negotiate. Right. It seemed like his message, though, was to try and not have the markets freak out if those snap back. Right. Kind of the idea that this would be a temporary thing. I mean, that's one of any Treasury Secretary's major jobs, right, is to manage market freakouts and sort of telegraph a little bit what's coming. And I think he was sort of giving a soft warning to markets that we may see that big snapback on Friday.

12:18It's funny. You know, there's a lot of different ways you can sort of parse the details of the deal. yesterday, Aime, and the Wall Street Journal's criticism of crowing about the$600 billion in energy deal was that that was already in the works, that Europe had already decided it was going to wean itself from Russia. And, you know, they were going to do$600 billion easy. So, you know, so that was a way of saying, ah, it's not a big deal because they're already going to do it. Now the question mark is whether they are going to do it. So I guess if it's economically in their interest to do it, they'll end up doing it, whether it's a, you know, whether there are some implied threats or whether it's part of the deal or not, they may be just headed to that just from the economics of the energy needs that Europe has.

13:11Yeah. And look, that's a big criticism of a lot of the corporate announcements as well, when the president will bring in CEOs who announced we're going to open a major factory or something like that. People will say, well, you know, that company was going to do that anyway. And they're just trying to get political points for doing the thing that they were going to do in their economic interest no matter what. And you can't really separate the chicken and egg there. Right. I mean, you know, how much of this is inspired by the new economic conditions created by the president? How much of this was happening anyway?

13:40And people are just trying to give the president some credit and get a photo op out of it. And, you know, there's probably a mix of both of those in there. But the administration is, you know, key to take credit when they can, as any administration would be. Yeah. That's one of the great questions, chicken and an egg. And as far as I'm as far as I know, it still has not. We don't know. We just we may never know which came first. I mean, the top scientists have been working on it for generations. Generations. They haven't come up with an answer. No, no. And we're not going to. Eamon, thank you.

14:13Do you have a strong feeling? It had to be a chicken who sat on the table. You always come up with that, but it had to be. But then, I don't know. It's kind of like the sound of one hand. It's an age-old one. We're not going to answer it. It's the sound of one hand clapping. Cheese will be next. Coming up on Squawk Pod, FDA Commissioner Dr. Marty Makari on what's changing at the FDA under his watch. You can't possibly do a randomized controlled trial and have these rigorous standards when you have 50 or 100 people in the world that have a rare condition. And we've got to have regulatory flexibility.

14:49So we are working on a new pathway called the plausible mechanism pathway, by which we may not even need to see a study. Plus, what's staying the same? To be clear, there were no reductions in force or layoffs of scientific reviewers or of inspectors at the FDA. There have been some who have left voluntarily after the departure of Peter Marks. We'll be right back.

15:17This is Squawk Pod from CNBC. I'm producer Katie Kramer. Last night, the night before, the FDA commissioner was set to join us here on Squawk Box. The agency announced the resignation of its chief medical and scientific officer, who was also the head of the Center for Biologics Evaluation and Research, the body overseeing vaccines and biologic medicines. Dr. Vinay Prasad was a controversial figure during his three months on the job, including his position on a Sarepta Therapeutics gene therapy that treats Duchenne muscular dystrophy. Dr. Prasad argued against continuing use of that drug when patients in a clinical trial died and oversaw a recent halt of its shipments.

15:56Then came the backlash. The Wall Street Journal's editorial board called the FDA's decision to ask Sarepta to halt sales of the therapy, a, quote, mugging that would chill investment and innovation. Just two days ago, the FDA reversed course and okayed the continuation of Sarepta's drug shipments. And then Dr. Prasad announced his departure. Now, let's get back to Becky, Joe, and Andrew. Becky kicks things off. FDA Commissioner Dr. Marty McCary is in New York City today on a listening tour. He's going to be meeting with CEOs of major pharma and biotech companies. Dr. McCary joins us on set before he does that.

16:33And welcome. It's great to see you. Great to be with you all. So let's talk a little bit, first of all, why you're here in New York City. Who are you going to be speaking to? What's the point? Or I guess listening, not speaking. Yeah, so look, there's a lot of things we need to do at the FDA. And so to inform us, we want to meet with executives, with pharma leaders, and we want to hear from them. Because I believe in listening, and we've got to understand where in the user interface is the system broken. We're trying to ask the big questions. Why does it take over 10 years for a drug to come to market?

17:05Why do we have idle steps in the entire approval process? Do we really think if you have the cure for breast cancer, there should be long waiting periods where the application is sitting on a desk? Why do we apply? Why do we have people apply after every phase, preclinical, IND, phase one, phase two? Can we run more continuous trials? So when we listen to the CEOs, we learn so much. Like one of the big pieces of feedback that's come up in the other four CEO listing sessions has been communication. If they can have a couple 15-minute calls with the scientific team, that can save them a year of guesswork.

17:41So we don't want the FDA to be a black box. That's why we're releasing all of our decision letters so people can see exactly how the review team thinks. because markets want predictability and the companies want predictability and the drug makers and scientists want to know how to design drugs knowing what the review team is going to think. I mean, I think that's so important and it's definitely something we hear from industry as well. There have been some concerns in the last month, though, about the complete response letters that were issued for two drugs, Repulmune and Capricor. Both those companies said that they were caught off guard, that it seemed like things were changing, standards were changing at the FDA.

18:18They thought they were following the guidance they were given. Can you explain what happened there and maybe how that gets fixed? So I can't discuss any individual product or individual decision of the FDA. But look, the process should be transparent. And it's not always perfect. Sometimes the reviewers act in their own sort of autonomy and independence. We're trying to create more standardization and create a culture where we have common standards. For example, sometimes we still require routine animal testing. when a drug's already been approved in humans and used in thousands of people in Europe.

18:51It makes no sense whatsoever. Because that slows down the process a lot. That slows down the process. We want to speed up the process, streamline it, modernize it. We're using AI now in our scientific reviews as an organizing tool. And, you know, these applications are gnarly. They're like, can be 100 ,000 pages. So we're going to introduce a radical concept called a page limit, you know, just like college applicants have. and we want to allow drug makers to get more predictability and insight. I think about the way the private sector does things and the way the government does things. And I think about DMV or take your pick.

19:27And I'm just wondering, do you need, does the FDA need more money? Is that always the answer? I think public schools, more, money keeps coming in, doesn't make it better. How do you private sectorize the FDA to do more, all the things you're talking about, streamline it but without just throwing money at it and you know how bureaucracies work they don't yeah and every time there's a problem in government the answer is always the same more money more authority more people but there is criticism that you don't have enough right now so there's always going to be that criticism my job is to do an assessment and look i came in right after a reduction in force and so my job is to make sure that all the scientific scientists and inspectors and we have about 300 law enforcement officials with guns that go around and check out things like vape stores in our ports to make sure we're safe.

20:18We've got to make sure everyone has all the resources. To be clear, there were no reductions in force or layoffs of scientific reviewers or of inspectors at the FDA. There have been some who have left voluntarily after the departure of Peter Marks, and there's been some pushback from industry that says, wait a second, these were the people who were helping us streamline the process before. Now what? Yeah, so look, I think the FDA does not rest on any one individual, and no one person makes or breaks a scientific division. There's over a thousand scientists in that division. I've met with the leadership, the team.

20:51They're phenomenal. They're going to be strong. The FDA is going to meet all of its targets for reviewed decisions this year. I think we're going to reduce the average time. We may hit a record number of approvals this year. And so the trains are running on time. The FDA is strong, and it's going to continue to be strong. It's one of the greatest brands in the world. So we have a lot to live up to. And you see the pride in the institution. It doesn't matter what political party is in power. You see a tremendous pride among the scientists there. There was big news just last night with the departure of Dr.

21:26Vinay Prasad. He had been there as the director of the FDA Center for Biologics Evaluation and Research. He was only there for three months. There was a lot that had happened, I would say, just over the last three or four days where he took some incoming, not the least of which was from the Wall Street Journal in an op-ed that they put out just saying that he was stopping innovation. He was opposed to some of these things. What can you tell us about that? Yeah, the irony about that Wall Street Journal piece is that some of the drugs they criticized him for were not even in his center. He had nothing to do with them.

21:58And he did a tremendous amount of implementation of new policies in the time that he was at the FDA. I think the guy's a genius. He's published 550 scientific peer-reviewed studies in his career. He's 42 years old. So he gave us some of his time. Look, he's got family in California. The commute was brutal. And then when he saw some of these sort of smear pieces, he didn't want to be a distraction. So we're going to continue to talk to him. But we've got tremendous leadership there. Our top drug regulator, by the way, was not that role. Our top drug regulator is filled by this new guy, George Tidmarsh, MD, PhD, double fellowship trained in neonatology and oncology and led La Jolla Therapeutics.

22:47So he is a drug developer himself. I think seven different drugs he developed himself. He knows the FDA from both sides, and he's an academic with impeccable credentials from Stanford. What will happen? Who's going to be coming in to replace Dr. Prasad? So, look, we have a lot of interest from talented people, so we'll take a look at that interest. But we've got George Tidmarsh right now that sits as our top drug regulator. Dr. McCary, part of this was, you know, there's been so much focus on Sarepta, and it's something we watch closely because the stock was so massively impacted. But it was big news in the rare disease world as well, because this was a gene therapy that the FDA asked them to pull after there were two deaths with non-ambulatory patients from Duchenne's muscular dystrophy.

23:33They were pulling it from the non-ambulatory people, the boys who were further along in that disease and maybe more fragile. The FDA asked them to pull it from the ambulatory boys as well. And that was where the company pushed back and the families pushed back and said, wait a second, this is the only drug we have to fight a disease that is definitely killing our children. Yes. What happened? I know that the FDA has reversed course. Yeah, so that was a very temporary hold on the ambulatory population, which has since been restored. The scientists at the FDA wanted to look at that safety signal after some deaths.

24:09So I stood behind them. I think the company is pleased with where things are. I can't discuss really any details of our conversations, but we are committed to that rare disease community because you can't possibly do a randomized controlled trial and have these rigorous standards when you have 50 or 100 people in the world that have a rare condition. And we've got to have regulatory flexibility. So we are working on a new pathway called the plausible mechanism pathway by which we may not even need to see a study. We may just need to see a plausible mechanism and computational modeling suggesting that something is a safe molecule.

24:46And so you kind of saw that with a baby KJ example at University of Pennsylvania. Yeah. Gene editing in a newborn. That was just earlier this year. Yes. A few months ago. Yeah. So I think that was a great moment for the FDA. Doctor, let's say that we see another powerful variant of COVID or even hopefully, God forbid, a new novel pathogen. messenger RNA technologies is like can be upgraded. You can do it very quickly and you can come out with something that it could probably, in my view, I think it was, it saved our bacon to some extent last time. Are you comfortable with that technology? If there's another pathogen that needs to be dealt with in the future, would we use it?