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FDA Commissioner Scott Gottlieb


The bottom line is that if we are creating a whole pool of kids addicted to nicotine through e cigarettes some proportion than we're gonna become long-term uses of combustible tobacco that otherwise might never have initiate tobacco and all the great gains that we've made in his country, reducing smoking rates. And you saw the data that came out today showing smoking rates continue to come down and also stigmatizing smoking among young people. So that we're reducing the pool of future smokers all of that will be reversed or lost. If we can address the youth use of cigarettes. I'm Dan diamond this pulse. Check and that was FDA. Commissioner Scott Gottlieb vowing to crack down on e cigarette. Sales to young Americans. I just sat down with the FDA Commissioner, right? As news was breaking about the FDA's plan to widely banned sales a flavored e cigarettes in an effort to curb teen. Use now Commissioner Gottlieb couldn't comment on news reports, but he did detail with the agency is thinking what he's called an epidemic ahead of a formal announcement next week, but someone who can break down the latest news and t- up white. You're about to hear from Commissioner Gottlieb is my colleague, sir overhaul who's been covering the e cigarette beat get to both of those conversations in a moment. But first reminder, if you like pulse check, if you like being able to hear us put questions directly to Commissioner leave and other top officials. You can help us by keeping the podcast going every rating review on itunes. It's help. And please send suggestions to you. Can find me a D diamond politico dot com by Email and check the show notes for time cues an additional information about the topics we discuss in with that. Here's my conversation with Sarah over m- all politico health reporter. Sarah. How are you? Good big day. It was widely expected that the FDA was going to issue. Some moves to crack down on his cigarette sales. But what is actually going to happen? When news reports have suggested is that the ban is going to be fairly widespread. And where these cigarettes will be easy. Cigarettes will be sold. Did the cigarette makers see this coming? I think to a certain extent, they did especially the focus on flavored vapors and the teen appeal of them the FDA last week had released a summary of its conversations with e cig makers where banning flavored products had come up Altria also had preempted them about by about a week announcing that they would voluntarily pull their flavored is gets off the market. And so you could kind of see that as a bellwether another thing that Altria had announced last week was that they were going to back raising the age to buy all tobacco products to twenty one which even surprised if you other people in the tobacco market. It in each market. So you could see that even as something that they are potentially intimidating as well and just to to key in on that raising the age limit from eighteen around the country to twenty one is opposed by the tobacco industry. Historically. Right. Exactly. I don't smoke. I don't understand all the specifics here. Why would the FDA leave out menthol flavors in its pending actions? Well, so the the FDA has already banned flavored cigarettes, but they have left menthol cigarettes on the market. And that is something that Commissioner Gottlieb has talked about wanting to be visit. But in the meantime, they haven't done that. So the issue is if you ban menthol e cigarettes are you there for making traditional cigarettes more attractive again to smokers. Maybe some that have quit maybe some that are trying to quit. So it's about striking a balance they recognize that there's a really big problem in teen news, but they want to make sure that traditional smokers and people that have quit stick to ease. Which everyone agrees are healthier than traditional tobacco products. There's one ISA lobbyist who wants told me, you wouldn't give a recovering alcoholic whisky flavored drink so you don't want to just leave recovering smokers with just a tobacco flavored product. And these products the balance Gottlieb and others are trying to walk is to make them appealing enough for the recovering adult smokers, but not so cool that younger smokers want to switch on and in our earlier podcast with a top jewel executive Tevi. Troy, we talked about how cool some of these products, actually, look, and why that can be a difficult balance a strike because they need to be somewhat cool. But not so trendy is to get teenagers hooked on them too. FDA Commissioner Gottlieb has teased a formal announcement next week. You're a reporter here. What are you watching for? Well, I think that there is definitely going to be more in that announcement than the flavored products ban. Like, we said Altria has already sort of prompted with some things that they want to see. So maybe we will see something about age limits in next week's plan. Also, we have to remember that this is a very quick reaction to a very specific issue teen use. But like you said they want to strike a balance for adult smokers as well. They have pushed back actually formally regulating the industry until twenty twenty two. So they've got a few more years to outline what it can look like from this point onwards. How flavored products can come back to the market and how they are going to make sure that adult smokers continue switching I would note that on Thursday the same day that this announcement came out the CDC released figures. Saying that smoking is an all time low. I think that the FDA wants to make sure that that trend continues and they're going to be looking at e cigarettes as a part of that in the future. We'll we'll be looking at your coverage of the pending. He cigarette announcement next week and sir over multi queue for joining political pulse. Check making your debut, first time caller longtime listener, we're glad to have you. And now you'll hear my conversation with Commissioner godly by sat down with him for about an hour at each headquarters in Washington DC on Thursday, you'll hear we get to cigarettes pretty quickly in our talk. But also hit on topics like his leadership of FTA how he thinks about balancing science and politics in this administration opioid policies that he is leading and much much more. Remember to use the show notes to find time cues to locate parts of the conversation, and now here's Commissioner golly. In one of your last interviews with politico at our pro summit, you made the comment that quote, an almond doesn't lactate. This was part of your broader push to move away from terms like almond, milk, and soy milk. You made that point before. But it really blew up. Now that comment is a t shirt late night hosts mocked the idea and ran clips, by the way, the first person to seamlessly work the phrase and almond doesn't lactate into their wedding, vows and. Sends me a video gets. I don't know what t shirts. Were you surprised by that reaction? I was surprised by the reaction you go on Tomasson dot com, and you type in that phrase, and there's a lot of a lot of paraphernalia sold with with the phrasing dozen lactate, including mugs and t shirts. I'm glad that. I I've started a small business industry and help grow the economy with that phrase. But yeah, it caught me by surprise. There is a serious question though, here dairy farmers want to move away from terms like, cashew cheese, or soy milk FDA's trying to thread, the needle, well, you know, there is a regulatory obligation. If they see has with respect to our standards of identity, we have standards of identity that do articulate what food needs to constitute in order to be to have a certain phrases associated with it. So for example, what are you? What does it mean to be up how much tomatoes genie to have in order to have ketchup, and how many tomatoes do you need? I don't know. But, but you know, these these standards of identity have public health importance because people. Due impute certain nutritional content based on the nomenclature being used to describe a food product. And if a food products being described with the nomenclature, what people think they're getting a nutritional content that they're not that could have an adverse health impact. So in the case of milk. We know milk is fortified with calcium and vitamin d and has other nutritional value. If something is calling itself milk, and doesn't doesn't have those nutritional derivatives someone could substitute and their diet, not beginning that nutritional content and suffer adverse consequences than in fact, we've seen cases in the medical literature where parents, for example, that fed their children rice milk. There was some there was some public health implications of that some clinical equality, so one of the things we're asking is whether or not the use of the term milk needs to be be correlated with a certain nutritional value. So, you know, manufacturer might be able to meet those standards, for example, by fortifying the product there's going to be constitutional issues on whether or not we couldn't. Forbid a nut manufacturer from calling on beverage almond milk. Because if you look at the dictionary, the first term of milk relates to electing animal, the second term of of milk is something derived from a nut. So there is a speech issue here that said if we have data demonstrating that consumers think they're getting a nutritional value than a not by the use of the term milk. That's someplace where we might choose to enforce the existing standard of identity differently. And that's the kind of data. We're looking for. That's the process we're going to be going through in terms of evaluating whether or not we should change the way we enforce that existing Senate of identity your agency has been working with the department of agriculture on oversight of lab. Beast me lab lab grown meat. There's been somewhat of a public turf or here. Republicans wanted to give all the authority essentially to US DA. Yes, or no does the house flipping democrat. Make it easier to achieve dual oversight dual jurisdiction. We'll call. Cultured meat now. So lexicon has changed. But I think that I've been working very closely with USDA meeting with meeting with the deputy secretary the secretary we've had other discussions. I think we are very close to having a proposal on how the two agencies are going to work together, very closely insured jurisdiction here in a way that makes policy sense. And in a way, that's gonna make scientific sense in terms of the different processes involved in developing these products, and which agency has expertise in different areas of how these products are developed. So I feel very good that we're on. We're in the final stages of having a joint framework to agencies can work on together. And my hope is that if if we go out publicly, you know, with some some robust proposal on how we're going to approach this going forward that congress would give deference to the agencies to work out the fine print on how we would implement that. And if it requires legislation down the road to fully codify that if congress wants to come. In god. If I what we do, obviously. I'd welcome the input from congress. But I would hope that congress would give us the opportunity to work out these details. This is very new science. It's it's complex, and I think it's best work through by the agencies, and then we can be in a better position to inform congress if they want to legislate here. So I just to translate because they didn't hear yes, or no, you think congress, regardless of who controls what chamber should be deferential to the agency on something of this matter. Well, I think this is I think this is a very new area of technology. We're often in a position of having to to figure out how to regulate an industry after the fact the industry get started products route in commerce, and then we come in and try to regulate it after the fact this is an an example of where we're trying to lay out the regulatory parameters in advance of these products actually being available. So I think we have time to work this out what I'm saying is I think I'm going to be in a much better position to to inform congress on what I think a proper framework should look like and be an agreement with the secretary Bagley. Culture, go forward with a joint proposal to congress that then they can come in and make a judgment whether or not they agree with us. They wanted they want to legislate in a slightly different way. I think right now anyone who acts including congress on trying to legislate around. This is going to be acting in the absence of of a fuller understanding of what this process looks like because we're still developing it, you know, and if we if we the sort of experts in this will working through these issues are still trying to come up with what their framework looks like I think we have a better better opportunity to inform congress, you know, six months from now three months from now than we do do today. Attorney general Jeff Sessions has departed the Trump administration HHS secretary, Alex as our has been rumored as a possible replacement. I should say that his office has denied that he is interested. But you never know if secretary as ours tapped to be attorney general would you want to be secretary? Well, I'm not going to engage in hypotheticals on hypotheticals other than to tell you what. I told you before when you asked me this question about a year ago, which is I'm very happy and the job I'm in and I will say beyond that. I think I'm in the job that I'm best suited for. I mean, this is the place where I think I'm going to, you know, deliver the best work for the administration and for the public health. You referenced our conversation on this podcast about a year ago. I asked you at that time to give a headline for what you thought the agencies work was if you were picking the headlines as a as a newspaper editor you responded with more of an essay than a headline. But that's just a quibble if you were picking the headline for twenty eight teen with the you're almost over. What would that be for FDA? You know, the headlines ends up being issue specific, I think that we've done some pretty bold things and things that are going to have a pretty broad impact on public health in a couple of different areas. I think that work that we've done in in tobacco is notable, frankly. And I think it's going to have a meaningful impact in perpetuity. I think the things that we've done to try to shift the agency. Orientation to the opioid crisis and think differently about what roll is with respect to that crisis are going to have a lasting impact. I hope they will. And I think some of the work we've done to try to promote competition are also going to have lasting impact. I look at it from the from the standpoint, if you're asking me what I think of the most notable things that we've done I look at it from the standpoint where I feel that we have changed the agency's relationship to important issues and with the agencies now thinking differently about its mission with respect to those issues, and those are three areas with agencies now thinking differently with respect to those issues through the work that we you know, that we've done together that that I've done with the leadership of the centers. Is an essay. It's the headline and the first couple of paragraphs of historic. We'll give you credit for over achieving and delivering more than than the editor asked for. Let's let's go through those interns who tobacco and even beyond tobacco Easter 'grats. And what the FDA is is doing in that area. This is a real life problem in a way that say Medicare payment regulations might not be I get emails from readers who say I am. I am worried about my teenage son or daughter using jewels vaping and in school. I don't get that same level of urgency around like the discrete regulations that are happening. You've said that FDA has data showing that use of of ping devices among teenagers, isn't ethnic. What do you know? And when will we find out about it is going to be coming up very soon? We're going to announce action next week. The first stages of our action next week in terms of what we're going to do to try to address the epidemic of teen use of cigarettes. And I've already said the data shows a greater than seventy five percent increase in the use of cigarettes. Year-over-year from twenty seventeen to twenty eighteen among high school students and about a fifty percent increase in the use of cigarettes among middle school students in this comes from the national youth tobacco survey. This is early data from the national youth tobacco survey where we looked specifically at the east cigarette. Use based on concerning trends that we spotted you know, and and it's not just that uses gone up, but but regularly uses gone up. So typically in the past the argument was well kids are experimenting with these cigarettes. But they're not using it all the time. But the rate of use of regular use of cigarettes, which means using it twenty out of the last thirty days is also gone up. Thirty percent. I think the important thing to remember here. And why we're so concerned is this is not these are not kids who would have smoked cigarettes. But now they're using cigarettes. These are kids who would never have initiated on nicotine and had survey data shows that in fact, the companies owned data shows that they've told us that. And we also now have data that shows that kids who initiate on nicotine through e cigarettes. Proportion of them a gonna end up being smokers of combustible tobacco. So all the great game. Worship. What proportion you have to look at different studies. The rand study found reported on some Monday numbers national academies of medicine study reported numbers I own path study has reported numbers. So there's different studies that have reported different numbers with respect to what that proportion is. But the, but the bottom line is that if we are creating a whole pool of kids addicted to nicotine through e cigarettes some proportion than we're gonna become long-term uses of combustible tobacco that otherwise might never have initiated on tobacco and all the great gains that we've made in his country, reducing smoking rates. And you saw the data that came out today showing smoking rates continue to come down and also stigmatizing smoking among young people. So that we're reducing the pool of future smokers all of that will be reversed or lost. If we can address the youth use of cigarettes. I believe the steps that we're going to take gonna be robust. They're going to be an initial set of steps if we don't start to. See these trends come down. We'll take additional actions, but we're going to be stepping into this market. And I'll just say, I'll give one more minute. If I may, you know, we said less when we announced a comprehensive policy we saw an opportunity for these non combustible products to be away to migrate adult smokers off of combustible tobacco onto products that didn't pose all the same risks. And we put nicotine at the center of our regulatory efforts. And we we were accommodated to the east cigarettes insofar as we gave him extra time to come in with applications because we we wanted to we wanted to help promote this opportunity for adult currently addicted adult smokers, but we said then, and we said all along that it cannot come at the expense of addicting a whole generation of young people on nicotine threes cigarettes. And that's exactly what's happening. We warned the companies we told them that we wouldn't tolerate it. And we're not going to be tolerating. You mentioned the moves that your agency has made last year FDA decided to push the deadline for regulatory review of the e cigarette products to August twenty twenty two almost four years from now. So putting that in plano. English e cigarettes can hit the market without approval from FDA. Why did you make that decision? And or you re thinking that while it was e cigarettes that were on the market as of two thousand sixteen can continue to stay on the market until that date, if I hadn't changed that date, the applications would have been do about a month ago or two months ago, and there's the potential that these products would have had to come off the market a year from now. I still think we are trying to strike the right balance between trying to more rapidly migrate adult smokers off of combustible tobacco by regulating the nicotine levels in in combustible cigarettes to minimally a non indicative levels while still providing an opportunity for adults who want to get access to satisfy levels of nicotine to do through products that are less harmful. That means nicotine replacement therapy. The least harmful form of nicotine delivery, things like, you know, gums and patches that you might be able by a pharmacy without a prescription. And we've put out new policy to try to promote development of those products. But it also could mean things likely attrac- nicotine delivery systems like he cigarettes. And if you if we could switch every adult smoker who's currently addicted to combustible cigarettes onto cigarettes, we will dramatically reduce overall bidding mortality these e cigarettes are not risk free. They have risks associated with and we have to fully characterize them. But we know they're less risky than smoking combustible product. The what what happened in twenty eighteen in terms of the? The rapid rise in e cigarette. Use would have happened regardless. If I never changed the policy because nothing would have changed the applications would have been due in August. The products would have remained on the market for at least another year probably longer than that. So I don't think there was anything. We did by extending those deadlines at had the immediate impact. What we couldn't foresee was the dramatic rise in popularity among these e cigarettes among kids and particularly one brand of cigarettes among kids. That's what is driving this increase rate of us. But you know, I feel that we are going to be stepping in quickly enough with action to try to reverse these trends, I'm hopeful that we're going to be able to start to reverse these trends, not immediately. It's going to take time, but we're going to act forcefully. And what what we intend to do within the next week is just going to be a first step if we don't start to see aggressive action on the part of the sponsors themselves. And if we don't see our own action having an impact on these. Where we we're willing to step in with additional measures to try to reverse this. We cannot allow the rate of use that we're seeing among kids to continue, and we cannot allow fully now twenty percent of all American teams to be users or be cigarettes, which is is close to where we're going to be at when his data fully comes out. What are the additional measures that you could use? Well, I think the question I is what are we contemplating? That's the first question you should've asked me. And then and then the next question would have been what else are you considering? But I'm happy to ask those questions. If that will listen were information what what additional actions, are you contemplating? Well, where we have an issue of a problem with access and appeal these products to accede to kids and their too appealing to kids. So we're going to be taking some measures to limit accessibility of these products to kids looking in particular at sales of these products in retail establishments. You know, gas stations convenience stores where tobacco products are traditionally sold and considering taking the flavored. Products out of those establishments and making and making the flavored products only available in adult only establishment. So things like the ten thousand vaping stores in in the country were differentiating between cartridge based systems and open tank systems the open tank systems by and large used by adults. It's the cartridge based systems that are being used by the kids. And so we would we would look to differentiate between those two products. And we would also look to take action to, you know, limit a cocktail online sales unless the online sites are adhering to certain measures that restrict the ability of kids to be buying those products on online simplest being obviously age verification, perhaps adults signature on delivery. Like you do for wine when you order wine online right now, very small percentage of the cigarettes were actually sold online. Most of them are being sold in retail establishments of the convenience stores. And we think most of the places where the kids are getting access to these products are those those. Stablishment? It seems to me and this is a little bit of I'm surmising little bit. But it does seem that that convenience store clerks who understand it's not appropriate to sell a combustible tobacco product to two kids. There's there's less of you know, an inhibition about selling an e cigarette product kids, and so you see more sales. So we see establishments where we don't see violations on the combustible side. But we're seeing violations on e cigarette side. And so we have to look at that channel that channel is a place with these kids getting axes products and the flavors are one of the primary elements that are making these products attractive to kids the fruity flavors. You're talking about online sales being a small percentage here. Can you give a sense for how small yeah, I think you should talk to the individual manufacturers? But generally, and and we don't we don't necessarily collect data on that. I'm getting my information from the manufacturers. And I want to be careful not to reveal their confidential commercial confidential information. But generally, it's less than ten percent of their overall sales are coming through the online channel and for some of the. It's quite small. So most of the sales are in brick and mortar establishments. You've mentioned meeting with these manufacturers meetings are available on your public calendar. I'm curious if they have said anything in your meeting, specifically that have changed what you are going to do in terms of enforcement, and he positive ideas that they've contributed. I don't think that the com- the conversations have been helpful because they've informed me about things where we didn't have where maybe we didn't have full insight before they've they have come forward with with data that that has been helpful. For example, you know, some of the data that that kids who are initiating on e cigarettes aren't kids who would have initiated on combustible tobacco actually comes from some of the manufacturers. They they have some survey data they've discussed that with us. So I've I've gotten some additional helpful insights in terms of understanding the public health parameters of the problems. I think we have a good sense of what we're gonna do. I think that there's areas of agreement with some of the manufacturers about what would be most impactful. So there's elements of what we're gonna do that some of the manufacturers have, you know, said we think these are good ideas. Are we are we are going to voluntarily take steps that that comport with what the kinds of things are you talking about? So I've I've been pretty public about where we're looking to try to take action. So I don't think that there's been there's going to be a surprise with the manufacturer with respect to what we ultimately do. They've been constructive conversations. I can't I can't say that. It's informed. What we're going to do in so far as we heard a good idea now implementing it, I think it's I think it's validated that the kinds of things we're looking at also the kinds of considerations. They're making insofar as you know, they share some of these concerns I think that they recognize now I've been saying all year. But I think they recognize now that this is an existential threat to them because even if FDA were not take robust action, and we will take robust action. It's more than likely congress would step in here. So this is an. Essential threat to this business segment. They're not griping though, that you've sent mixed messages that that perhaps initially by cracking down on traditional tobacco and encouraging the shift to lure risk products like e cigarettes that now you've changed tuned too much by cracking down. But it's not miss it. It's not mixed messages. My message has been consistent all along. I see the cigarettes is not pretending to transition currently addicted adult smokers. I don't see it as not between two dick generation at young people nicotine, and I told him all along at the outset. And I said this at my very first speech when I announced our original policy vis cannot come at the expense of addicting, a whole generation of young people on nicotine. And I remember those words because I've much have said that dozens and dozens of time so this isn't a change in tune. I am still of the mind, and we are still the minded FDA that these products represent a potential opportunity for adult smokers. We don't want to foreclose this channel entirely. I don't wanna take action that's gonna shut the cigarette. Industry down. We see this is not between. But in order to close the on ramp for kids. We are going to have to narrow the off ramp for adults in order to make it much harder for kids to get access to these products. We are going to have to take action that will put some speed bumps in the way of adults as well. That's that's just the reality. There's no way to do this without also. So creating some measures that's gonna make it a little harder for adults to get access to all the products that they want, but quite frankly, I think most adult smokers, and I know most parents of teenagers are going to be willing to see us take action that makes that accommodation if it means closing down the level of youth use that we're seeing right now. So you've talked about manufacturers being helpful. But you've also taken pretty aggressive moves. You rated the office of jewel the dominant veep product. Why did you do that? If the company came to the table to discuss plants, well, look, they're two separate issues. We have an industry segment problem in terms of the east cigarettes being too appealing to accessible to kids, and we have company specific problems in terms of certain products being more widely used by children and jewel is one of the products that's being very widely used by children. And we want to understand why we have our own internal estimates onto proportion of sales of their products that are going to kids. It's very high. Hi, it's a high percentage of their overall sales that are going to kids, and we want to understand that we want to understand whether their marketing practices or aspects of that product that are making it more appealing to kids. And that was part of the information that we were trying to collect in those in those actions, you know, and I said that the companies have been helpful. They've been helpful in terms of answering questions and bringing information, I think to date, and I think they are starting to take measures that are going to address aspects of this problem, but up until recently, they have not been helpful. I don't think that they've recognized that this is an existential threat. I think they could've stepped into the market with more forceful action much earlier in the year. Are they are they starting to take actions right now, I believe they are you saw some actions recently, we believe some companies are going to take some additional voluntary action. So I think they recognize it. I think they know where serious I think they know we're deeply concerned. I hope they share those concerns and our public health mindedness. Guard. But, but this has been only recently that we've started to see a change in behavior and more vigorous action on the part of the manufacturers. And that's why you know, this isn't going to be something that I leave up to voluntary action. We're going to step in. We're going to put in place regulatory actions. That can be enforceable. That are vigorous. I'm not leaving this up to voluntary action on the part of sponsors Tevi. Troy who runs jewels government and policy affair shop was on this podcast ruler this year. I asked him a version of the question. I'm going to ask you you to our friends. You wrote articles together you worked in the Bush administration together. Now, you are regulating him at jewel. Do you think any differently about tabby, Troy, no, of course, not and I'm not regulating Tevi, Troy, I'm regulating jewel, and and you know, Tevi has been very Phidias about not having conversations with me about about these issues, you know, my interactions with jewel have been through the meetings that I've had with them the on the record. Would meetings that I've had with them. I would never second. Guess someone's decision to seek employment in a legal, you know, in a legal area of commerce in five years. You'll be able to write very interesting co bylined articles like, hey. Hey, less romantic, Mary, Madeline, James Carville. I I want to shift to other questions about the administration while we have time, and when would be held this administration views science there have been widespread concerns that the Trump administration has been too receptive to the antiabortion movement at just wrote a headline on politico pulse. Our newsletter about H E S. Making more moves to curb access to abortion for customers of the Affordable Care Act exchanges. There have been studies on teen pregnancy prevention that have been canceled. There's an agency wide review on fetal tissue research. And I've talked to officials political appointees career staffers who've said there's a there's a war at times between being pro-life and being pro science. Do you share those concerns, and if not do you understand why staff would have them? Well, I think with respect to the FBI look at the FDA, and I'm not I'm not following all the headlines that you are on all these other issues. I think with. Respect to the FDA. We've been very consistent and adherence to good science based decision making. I think my interactions with people in his administration have demonstrated not only an appreciation for the importance of that principle, but in a preoccupation for the unique mission of FDA. And I think impart why I've, you know, believed that I've been able to advance a robust policy agenda cross a lot of different areas that I believe is public health minded, advancing, you know, initiatives and programs that are gonna have a public health impact. Like what we've done on tobacco. Like what we've been able to do with respect to some of the changes made terms of how we regulate opioid drugs is because there's people in key positions of this administration, including secretaries are whoever deep understanding of FDA deep respect for its mission a deep respect for the science based decision making at the agency. And the secretary has been exceedingly supportive of the agency an exceedingly supportive of my Bill. To make independent decisions, you know, working with the professionals at at the FDA, and is one of the things I think I talked about the last time we spoke and one of the lessons. I learned when I work with Mark McClellan Moi's that it's very important that the the decision making and the ideas come out of the career staff FDA is not an agency where you can engage in top down policymaking where I can sit in my office with a Kabbalah people writing guidances and policy documents and try to impose it on on the, you know, the workings of the agency my job is to set out, you know, broad goals parameters public health goals that we're I think we should be investing our time try to get those resource, but the ideas in terms of how we're going to achieve them half to come from the professional staff, and it's my my job to work to make sure they get implemented. There was a recent survey by the union of concerned scientists that under the Trump administration many government science. Tests have been unhappy at places like EPA that is not the case FDA if anything happiness has been up under under your leadership one concern that some scientists have brought up to me is what the president has said at times about vaccines. You've been an unflagging champion Commissioner of the value vaccines. President Trump at times as questioned the Rafic ac- before being elected after being elected floated the idea of of vaccine safety commission. Have you ever spoken with the president about vaccines? I have not what would you tell him while I continue to speak privately about the things. I speak publicly. I don't think that my advice, privately is private and private is any different than my advice in public. I, you know, support support the role of vaccines. I think it's one of the greatest public health achievements of of humankind. Our ability to develop vaccines for vexing infectious diseases. I think that the, you know, the high vaccination rates that we've been able to achieve historically against pediatric diseases in particular have been one of the profound chievements of of modern. Medicine and to see those those gains reversed by fears that I don't think grounded in science and am talking particularly about some of the criticism around the MR vaccine would receive vaccination rates declining. And we see local communities putting in place ordinances allow people to choose not to vaccinate the kids on rationale that doesn't comport with science doesn't doesn't isn't directly related to health concerns. Those are all deeply concerning to me, and you know, out continue to be outspoken, and and trying to promote higher vaccination rates and trying to continue to support, you know, the safety of vaccines and regulatory process that overseas at one of, you know, one of the things that I think I can do to try to affect this debate is just to reassure people that we are aggressive in continuing to look at the safety net. See vaccines, and when we we learned something we make it known publicly, no products completely safe. There are side effects associated with vaccines. They're very rare. But there there are side effects. We need to speak honestly about that. Since we're talking about the president. I wanna talk about some of his other priorities that bring in your agency fighting the opioid crisis and this month. You teased a new approach to proving some opioid medications. Can you be more specific about the timeframe and the details of what that approach will declare? We're going to announce a public meeting very soon where where it's going to be sort of the first step towards trying to develop that framework and gather public input on what that would look like. And you know, this is a regulatory process takes time to unfold, you would have we we're gonna start it with a part fifteen hearing and put out a series of questions and open a dock and try to gather information. But the essence of it is that you know, we we've had criticism around the approval of selected opioids, and you've covered some of those criticisms, I think that underlying those criticisms isn't a question of whether this drug should have been approved of that drugs should have been approved. I think that what underlies those concerns our concerns from people who say in the throes of an opioid epidemic a massive opiates epidemic. Why do we need yet? Another opioid drug and is this drug going to be differentiated in some way that is going to provide additional public health benefits on top of all the available therapy. Or is it just another drug that could lead to addiction and abuse and misuse now setting that said supply doesn't create demand simply having more opioid drugs on the market isn't going to create more addiction. But if you have more opioid drugs on the market that have that a more likable or have more potential for abuse misuse that could drive more more addiction. But I think we have an obligation from public health standpoint to tackle the underlying question of should we have more opioid drugs. And if so what should the standard be and what I've proposed is asking the question of whether or not we should have a public health standard around the approval of new opioids where when we approve an opioid. We're looking at it against the overall therapeutic or Metareum and asking the question whether or not is differentiated providing some additional benefit over the existing drugs or whether or not it has a risk of. Being misused or abused a diverted because of the features that drug but looking at it in the context, not just that individual approval, which is generally how we look at drugs. Now, we look at an opioid drug against itself. But looking at it against all the other drugs within the category, and whether or not it's going to have a role in the overall therapeutic approach to the treatment of pain. That's a much different approach. That's a different standard Fowley would look at this. But I think congress has told us they want us to be thinking about opioid approval and controlled substances in a different way, the controlled substances act is the clearest expression from congress that they want. They want agencies to be thinking about the approval of these products differently. And we've got formation of that in a recently enacted opioid legislation with congress gave us a very specific set of authorities on how they want us thinking about opioid drug approvals that don't apply to any other therapy class. So I think we have an obligation to try to tackle this question. Head on. I don't wanna be having these debates in the context of this approval and that approval and people criticizing the individual drug approvals. What I wanna do is. Have an open honest debate about what I think is the underlying question is why another opioid drug in a setting of an addiction crisis shifting from opioids to drug pricing. It's been about four months since secretaries are recommended that you form a working group on drug importation industry groups have been resistant to this idea. Some Republicans have been critical like Orrin Hatch. Also seems like HHS hasn't been especially enthusiastic about this idea. Is that wrong? Well, I don't I'm not tracking all the criticism. You probably have a better handle on that in terms of what you hearing. Then then may we are we are moving forward with trying to look at a framework on how he would do this. Remember, this this applies to off patent off exclusivity drugs that are in that are so source drugs where they don't face competition where you have a price increase that creates an access dislocation that that forestalls access for certain patients. So we are looking for Justice summarize what you just said it's a very narrow. It's an it's a narrow. It's a narrow set of circumstances where? You have a drug that's off patent where there's something that happens in the market with respect to the price that makes it harder for patients who need the drug to get access to it. So there was a there is a bottom line public health concern in the setting of where we would employ this, and we are actively working through what that framework, look like how we would do it how we would make the legal certification to operationalize it on how we would apply a rationale to look at the drugs that we would seek to import in a very closed fashion. So we can ensure end to end the end to end integrity of the drug as it comes into the United States. This would not be free for all importation. This would be a closed system would be working with an intermediary to import the drug to make sure that we can secure the supply chain as the drug moves from a foreign market here. But look at the same time that I've done this. I've also put forward policies to try to create a global globally harmonized approval process for generic drugs to make it easier for generic drug companies to file what will hopefully eventually be a global applications. So if you're a European if you're a small European generic manufacturer, and you're manufacturing in in France, we wanna make it easy for you to follow the same application to US and bring that drug into the US market that I think will be hopefully in the long run a bigger opportunity to get more competition into this market than trying to do, you know, one off import Titian when these situations arise I want to prevent the situations where we have these sort of sole source drugs where you can have a speculator come in and take a big price increase and try to play. What I say what I call regulatory arbitrage hoping that they can sustain the price in the market long enough to return a profit before we can approve the next generic drug and bring in competition. So understanding that those are goals. I still don't think that there's been a lot of public information here, can you share who the members of the working group are for instance, who are working with the leadership of HHS. And you know, we're pretty far along. I think that we're we're pretty far along in mapping out. What the what the framework would look like, I can't give you a timeframe in terms of when we would, you know? Bounce a final framework when we might seek to import drug, but in terms of working through the the mechanics of how this would work what the legal issues are we've been spending a lot of time on this. You know, it seems like a long time to you from the date that we initially announced this two now, and I forget when we announced bobbly three or four months ago, but in July nineteen July, but in terms of government on top of your head. The. Terms of government policy making working through, you know, difficult issues. That's not a time. You know, these things do take time to put in place, and as a reason why they should take time because we're changing policy, and we want to be delivered about it. We need to be careful. I mean FDA is a is a complex agency with a complex statute. And there's a lot of implications. If we get something wrong in terms of the public health. Your time is precious. So I'd like to close this podcast with a lightning round of questions. Quick answers. If that's okay, I'll try to be as brief as I can be. It's a mandate. Secretary as ours said, I think he he's said this directly to reporters before that every time he talks to President Trump the president asks about drug pricing. Is there something that the president always brings up with you? You know, I I don't have as many opportunity to talk to the president. When I do it's usually about specific issues. And so the the the handful of opportunities that I've had time to be in the Oval Office and speak with the president's usually been the concepts and briefing among something very specific. What's the public health issue that you wish reporter like me spent more time writing about? That's a good question. I think nutrition I think that the stuff that we're doing on the food side of our house and with respect to trying to promote trying to reduce the burden of chronic disease through through better nutrition, sometimes gets shorter shrift. I think the the food policy has a profound impact on public health. You know, if we can have we can have small public health gains on an individual basis through our food policy. The the sort of distributed impact of that once you aggregate it over the entire population is enormous will here you go. Here's a nutrition question much of the nutrition work that you have pursued has been in line with what the Obama administration wanted to do in some ways, you even gone further with the consumer education. For instance, do you think a democratic house will give you more backup on the nutrition changes that you wanna see well, I haven't had any challenges implementing the policies that we've pursued. I mean, we we inherited a set of statute and and policies that would mid. Stream from the prior administration. We follow through a net. We felt that. There was strong public health rationale for the new nutrition facts label for menu labeling, and so we've continued to implement those policies and we've been able to fully implement those policies. I think now what I'm doing is looking at what is the next set of nutrition policies. You saw has put out nutrition plan our action plan about six months ago, and that encompassed a lot of the things that we want to do both individual policies as well as the medically where you're going to see more policies from us trying to use labelling trying to use information that we would make available to consumers as a way to help reduce the overall burden of chronic disease. So there's more that we want to do. But I can't say that. I've I feel that I've been impeded impede it in any way in terms of achieving what I wanna do on attrition agenda. Reporters like me spend, a lot of time focusing on you secretary as our administrator Verma who's the government health official that we should be giving more of the spotlight to well. When I think of when I. Think of FDA an an and I think about FDA a lot. I think that the the folks who really make things happen that are very important to the agency. Everyone is important to the agency and went you when you walk through the agency, and you look at division, directors and medical reviewers. They're the ones who are making things happen on day to day. But I think the center directors really are the senior experts there might chief scientists I I make sure that I meet with them each one individually every week and those interactions or where the policy gets done. Those are the hours that I enjoy the most every week of someone who said what's the best part of the job. It's meeting with the Senator actors they are experts in their field. And I think that's sometimes not fully recognized how impactful they are. So I should interview interview and investigate the Senator actors got it. Well, you kind of you them and speak to them nicely and ask them respectful questions. You don't need to investigate them. I always ask respectful. Nice questions. Here's a version of a question. I've heard asked of your female colleagues how do you balance being a working dad with the job of being FDA Commissioner, it's very hard. I'm away from my family during the weekend. It's very hard so hard as part of the job is is the fact that I'm away from my family, and even when I'm home on weekends. You know, I spent one whole day working. So I don't think I'm balancing very, well, did you balance it better in some way? Given the demands of this job. It's hard these twenty four seven jobs, and I think I think, unfortunately, that's the only way to do these jobs. Well, there's going to be a new planned community next door to FDA. I saw you with the groundbreaking. I watch video of you with Maryland governor, Larry HOGAN, could you buy a home in that next community that community will be fully erected? I think in sometime like twenty twenty five. So I'm not making long-term plans out that far. Last question when I sat down with CMS administrator Andy Slavic at the time in two thousand sixteen I think it was the first episode of this podcast. He made a comment like I need to do something on drug pricing. If I don't the next guy who comes in the next person who comes in. We'll say what the heck was slab thinking, what is the thing that you need to accomplish that if the next FDA Commissioner comes in and it hasn't been done. You will feel like the work was unfinished. Well, look, I feel good about what we're doing our job in the pro drug pricing debate is to try to bring more product competition to the market. I feel like we're doing that successfully. In terms of the reforms will make making the generic drug side. I think there is there is not as much recognition as the obstacles that branded companies face bringing follow on innovation to the market and some of these these drugs targeting on medical needs. We you see companies maintaining monopolies for longer periods of time and sometimes in perpetuity for drugs targeting unmet, medical needs, and that lack of competition against branded drugs is maintaining higher prices for long appear. As of time we have data demonstrating this. Now, I'm gonna be publishing a study that we did our own analysis showing that when we look at a cohort or drugs from the early two thousands to the current cohort of drugs over five or ten year period is taking much longer to get the second and third to market drug to the market now than it did ten years ago, and there's reasons for that. And I think there's things we can do to address it. But if that if that trend continues, and if you see venture capitalists and companies pulling out of the market, if they don't think that they can be first to market we're going to have significant challenges going forward, keeping these drugs affordable. The other thing that I'm going to be focused on in two thousand nineteen is looking at ways to try to improve the overall economics of generic drug development. I think that that industry is facing some pressures a lot of more commercial pressures that we can't affect. But I think some of them are regulatory. I think the multiple cycles of review are very costly to the industry. I think there's things we can do to make it less expensive and more efficient to file generic applications and get more generic companies into the space. See more competition, and we're going to be very focused on some of those reforms also making high value opportunities available to share companies that means you know, what we can do in biosimilars what we can do on drugs that have Rhames associated with them. What we can do in hard to formulate drugs to make it easier to genera size those drugs. Well, that's a lot of stuff to finish. No wonder you're working sixty's a week. Really could be working seven. But we will let you get back to your work. Commissioner Scott Gottlieb. Thank you for joining politico. Bolster thanks for having me. That's it for pulse. Check this week. My thanks to Commissioner, Scott Gottlieb and his team for making time and space for this interview. And my colleagues are over mall for making her long way to debut on politico. Pulse. Check as always thanks to producer Mikhail Rodriguez for touting her equipment. Enter time all over Washington DC on Thursday, confined pulse. Check on all of your favorite podcasts players. Can find me at Di diamond politico dot com, and you can find a new episode of pulse. Check coming to you very soon.

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