Exit interview: FDA Commissioner Scott Gottlieb

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I come before. You today humbled by the realization that the lives and futures are families like minor affected by the decisions made by FDA. Should you? Choose to confirm me, I'll make it my mission to fight for those families every single day and ensure that the FDA puts their interests first in everything we do. I'm Dan diamond this pulse. Check. And that was Scott Gottlieb testifying in April twenty seventeen about why he wanted to be FDA Commissioner two years later as godly prepares to leave the agency. How has the reality of running FDA compared to his early goals on Wednesday? I watched the Commissioner's office to ask him as part of a wide ranging conversation about his priorities legacy and unfinished business, you know, when you're at a think tank looking at things in the abstract is very different than when you're running regulatory agency, and you have public health obligations, you'll hear from God leave in a moment. But just reminder that if you like political pulse Jack new can help us by rating, reviewing the show on your favorite podcast app. Just search for politico Halse check, he should also check the show notes where we linked to stories previous episodes with Commissioner God lead and other items that we reference. During the conversation. And now, let's get to that conversation with Commissioner. Scott Gottlieb Commissioner Scott Gottlieb. Welcome back to politico. Pulse. Check. Thanks for having me. We weren't expecting you back. So soon the secret to cut the line is just to announce it your resigning it worked here. You are one of your colleagues. I was asking around trying to figure out what what to ask you today. One of your colleagues said I should ask if you don't love America anymore. If that's why you're leaving the FDA feel free to weigh in on that sometimes, you know, sometimes a pipe just a pipe. And you know, the reason I'm leaving the reason I gave this got really difficult commuting from Connecticut and being away from my family, basically for two straight years. So my kids on Saturday, but you know, it'd be home late Friday night. And I'd be back in Washington Sunday and mostly working all day Sunday. So two years of that with with three young kids got hard reporters. Like me, my colleague, Sara Carl Smith's are over m-. All others have been. Trying to figure out the reasons behind your departure. Do you understand why that has been such a source of curiosity? I don't understand why has been source of curiosity. You know, obviously, I love this job. And I'm very unhappy leave it I would have liked to have done for longer. And it was a difficult decision in the week after I resigned motionless. It was very difficult. I was thinking whole week. What did I do was this right decision? But you know, I've been in two years, and I worked this job one hundred and fifty percent, I think that that was largely apparent to people on the outside. This was really a twenty four seven job. I I didn't work from home Fridays. I was home late Friday night again, which spent part of Saturday with my kids. Go out my wife, Saturday night and Sunday be back at work two straight years that difficult. I think in retrospect had had I do it over again. I would have moved my family down here at the outset. But I didn't speaking on behalf of journalists. I think one reason it is such a source of curiosity is there. It could be a reason that you're leaving that could be of interest to the American people, for instance, if you push too hard on tobacco, and that was an issue or if the White House had a different vision for the FDA that would seem to be of interest to well on the tobacco. I understand the proximity of when I announced on that Tuesday versus there was reports that I had been at the White House that Friday a briefing on tobacco meeting. But the reality is, you know, there was always going to be something immediately before I resigned and something coming up immediately after I resigned as always things happening here every week. I think with respect to the tobacco issue in particular. I would hope we put that to rest with the announcement made last week where not only did weed Vance a policy that we intended to. But you know, we got strong support the secretary put out a statement. I had a White House fact sheet issued the White House press secretary re tweeted some of the statements Kellyanne Conway over the weekend re tweeted some of these statements with respect to that that announcement you had to chief-of-staff, Mick Mulvaney and had. Domestic policy council. Joe Rogan both affirming that there was going to be steps taken to address a youth the youth addiction to to nicotine in e cigarettes and additional tobacco relation coming. So I think the strong statements and the administration which we would have had regardless. But I would think that's strong. That's strong statement from the administration, in fact that we got that policy out in time for him that we that we intended to would would put those rumors to rest vaping has been a major subject of of your tenure. It has been something you've weighed in on quite a bit. I don't want to spend too much time on it. But the Washington Times a conservative paper has an editorial today Wednesday morning saying that your resignation quote comes at just the right time. And they specifically criticize you for pushing vaping regulations and suggest you became an quote avenging angel for the nanny state with the Scott Gottlieb of three years ago who worked for conservative thinktanks like a and argued against regulations from the FDA with that Scott Gottlieb have recognized the description of Commissioner Gottlieb or remember the. Golly of two years ago. Probably always a recipient of editor Oriels. I mean in the Washington Times that applauded me for pushing off the application deadlines on on the electric cigarette products to allow them time to come through an appropriate series of regulatory gates at the time that we propose to regulate nicotine and combustible cigarettes to render the minimally not addictive with vision that we would be able to more more rapidly migrate adult smokers off of traditional cigarettes onto modified risk products like e cigarettes, potentially which would pose far less health risks. That was the vision we embraced it that was out plan. But what changed our mind was when Mitch Zeller the head of the tobacco center came into my office on August thirty first twenty eighteen with data from the twenty eighteen nationality tobacco surveys showing epidemic use of e cigarettes. And they just want to jump in. Because you've you've said some of these things about the vaping strategy before. I am curious about is Scott. Golly. The regulator versus galley booze outside the FDA thinking that this agency was doing too much for exam. Apple response letters to drug companies when when drug companies would apply and have their approvals turned down. When you read you argued that those response letters should be public now that you're Commissioner those letters mean separate issue. I mean, I still I still would argue that there should be more transparency where we can have more transparency. I think the Scott Gottlieb who's running a regulatory agency needs to weigh how I allocate agency resources against public health considerations. And ask is trying to increase transparency around complete response is the best use of the public. They've finite public health resources. I have whether it's the lawyers or the people in cedar who would have to redact those letters. And that was the that was distrustful that we had internally. You know, when you're at a think tank looking at things in the abstract is very different than when you're running a regulatory agency, and you have public health obligations, and what what I had to make decisions against first and foremost, my public health applications, I don't have the luxury in these jobs of thinking about things in an abstract fashion. All the time you have set of obligations, and you need to carry out the mission of the agency, and I feel very comfortable that we made decisions against a good set of public health considerations. And did what was right through multiple settings and multiple tough decisions. So Scott leave on the outside looking in a wrong, Scott, golly. Bunny outside riding up as at the American Enterprise Institute, which were largely consistent with you know, my how I executed the mission on the inside. And I'm proud of proud of the eight hundred articles that I wrote on the outside. They only know that number because his Senate managed to pull them all during my confirmation process. But as you're very prolific colleagues to shame for your productivity. But you know, there's a lot of difficult practical considerations on the inside. That don't always just hue to a particular sort of regulatory ideal ideology, they have they important public health considerations. And things that this agency has to do to protect consumers that sometimes put us in places where we are. Yes. We are impacting competition. We are impacting the free flow of information all the things that as a conservative you want to you want to try to promote you try to there's sometimes a hard balancing against public health considerations. Speaking of communications tragedy from the day, you were confirmed to today FDA put out press announcements on virtually everything hand sanitizer, heart valves, milk cheese. Do you want to guess how many press announcements FDA put out under your tenure? I would suspect us a little more than one a day. It's exactly that it's four hundred eighty one. I think you've been in seat about four hundred and sixty five days not counting weekend or government holidays that's much faster than the Obama administration. Why was that a focus of your time? Here what was the strategy behind being? So proactive not just with press announcements. But you're doing interviews with me other folks, you're you're always available. What was the rationale? Why think that can -cations policy communications is a very important part of effective policymaking. I think that you know, it's not just that we have to explain what we're doing very clearly so people understand what the goals are of the agency. But I think in order to advance the policy it's very clear that people have a they accurate vision of what we're trying to achieve so we can get broad consensus. Brought by and and so that was the goal. I mean that was really the the thinking behind trying to be communicative trying to put out very clear statements around the rules. We put out the guidance we put out so people understood what what the vision was. And how the different things that we were doing fit into a broader public health vision. Why don't more Trump officials follow yearly? Well, I think there are agencies that do, you know, part of it is that it's a it's resource intensive in its time. Intensive I would spend my Sundays probably clearing between six and twelve documents and writing some of those documents writing so on my own speeches, you know, drafting statements. This was a extremely resource intensive endeavour not just for me. But but for the entire staff here, our office of media fares people in the senators who drafted some these statements, but I think, you know, looking back I think it didn't able us to advance things in a way that allowed them to be enduring you've kind of become known as the tobacco Commissioner, not only. Have there been all these actions? You just referenced this has been a major focus of press attention. I'm curious when we look back at your tenure at FDA. What do you think your major accomplishment was on medical devices? Well, look, I think with spectra medical devices. I think it's, you know, taking a fresh look at the five ten k approval process and looking to modernize that and reeducate how we. How we look at the product process. Trying to way I see the five ten K processes. It's very backward. Looking you know, people who are bringing new devices forward to try to try and find predicates to compare the devices to constantly looking back at old predicates? And I think we need to have a forward-looking process with people have the potential to create new predicates through the D-I-N-O-V-I-T-E process, which we try to create more efficiencies around creating going through the D-I-N-O-V-I-T-E process as well as reeducate some of the old predicates. And so we started down a path of creating a policy framework that could allow the agency to reeducate some of the existing predicates. I think that conceptually is a very important sort of policy advanced to step into I think more discreetly in terms of discrete policy reforms I would point to some of the things we did on digital health where we move towards a whole different paradigm of regulation moving towards a firm based approach. I think that that kind of frameworks going to going to be something that we can use an other other context of of. New technology. And then in terms of the unfinished business the stuff that we opened the door to. But but remains unfinished I would point to the legislation trying to look towards a modern framework for in vitro diagnostics, the IV C T legislation, which we obviously advanced substantive ta to the hill, and that will that will continue to move forward on Capitol Hill. I had a call today about it. With some members of congress have some meetings about it. That's one of the things I wanna take a little bit further before before I leave this giant in the two weeks. You have to have left. You just went through a number of different priorities. Both things that you're working on things that might have been finished. I wanna take those apart as as much as we can in our time getting back to device safety. There have been a lot of questions about device safety in your time here at FDA some driven by investigative journalism. Documentaries. Some your own statements to it does seem like there's a new development every week with device safety. What what does he need to do in the next few years specifically after you are gonna make sure that devices are safer? Well, I think I think. Vices are safe. And I think the process is very rigorous. A lot of the questions have surrounded a small subset of devices. Will we frankly have taken significant action when you look at Eastshore shore? We that product is effectively been taken off the market. We took a strong action against certain other women's health devices. You know, I think that the the device review process is rigorous overall. I think with the questions have been historically, and this is over a long period time is around five ten K process and people people from the outside looking in believing that devices should be regulated like drugs and everything should be a PM application devices should go through you know, randomize perspectively randomized placebo controlled trials. There's reason why we don't do that, you know devices. The device statute itself is a much more modern statute that allows us to adjust our level of regulatory touch to be commensurate with the risk of the device. Not every device proposes same kinds of risks page. And implantable device could be much more risky than, you know, at a device at just a tool in the hands of a physician being used to help assist them surgery. So the five ten K process allows us to regulate lower risk devices differently than we would regulate higher risk devices. I think if you look at what's happened over time and even the time period, I've been here the five ten case gotten much more complex, the the length of five ten case has grown significantly. There's much more clinical data and five ten K. So I think the process over time has gotten more rigorous, but the fundamental architecture of the device review process where we have this more titrate approach that allows us to adjust our level of regulatory touch to the perceived risk of the device with known risk the device, I think is fundamentally sound. But when you say, you know, devices device safety has been under assault over period time. I know this weren't your exact words. I those words I think which really being criticized is the the framework and people who who are arguing this is what I hear that, you know, certain devices shouldn't be going through a process like the five ten k. Process that's much longer debate. And I think fundamentally that process is very sound. The FDA's budget proposal does seek to left a provisionally approved devices. So essentially moving devices to market with less data. How do you reconcile that with this focus on device safe while the the the budget proposal builds in number things, and I think one of the most fundamental things in in what we didn't a budget. What we've done even administratively, and we've allocated more resources from my office to this function is trying to move towards a more active surveillance system when it comes to medical devices. And so this is another paradigm change in terms of how the agency looks at device safety where the the long term goal, and we got money in twenty twenty budget for this. We also got money in the twenty nineteen budget. So it's actually been appropriated as well. As some money, we've been we've Riach allocated internally to try to move towards a system where we use data derived from traffic health records to engage in more active surveillance of medical devices in the post market, we've never had that capability anywhere. Really in the agency. We have it a little bit in a central system when it comes to drugs, but mostly we use claims data to do retrospective analyses of safety questions, particularly on the drug side. We've never really been able to move towards more active surveillance system using HR date. I think the first place it we're gonna fundamentally be able to do that on a broad basis is going to be in the device space. And this is really the vision of what we've been trying to do with respect to with respect to device safety the goal in two thousand twenty budget proposal, we put voters to get ten million lives. EH our lives into a database. I would allow us to do active surveillance in the post market, you mentioned digital health at it seems difficult to regulate this field because in many cases to harm to patients might not be clear. I normally wear an apple watch. It took it off because it was interfering with the microphone that I'm speaking into. But that apple watch has engaged Bilton. And I think the worst thing that can happen as it gives me falls data about my heart rate that's different than say contaminated lettuce or a drug that's linked with. He shouldn't deaths. Do you worry about the the products getting ahead of the evidence when it comes to some of these very hyped digital health innovation? I think you're not when you say the worst thing that can happen is the watch can give you false data. That's the worst thing that can happen dot com report an outcome. That's not actually occurring. I think what what what you hear people expressing angst about more often, isn't what you just said. But, but but people worrying that the devices are going to be able to report data that might not have clinical significance. Make it would reporter, you know, proximal fibs, so an intermittent arrhythmia that might not be clinically significant. But you actually had the arrhythmia my view is that if device can otherwise report information that could be actionable could help inform you about your health could help prompt you to see a physician we as regulators should earn aside of trying to allow patients to have access to tools, otherwise inform them as long as it's informing them accurately. It's not up to us to decide whether or not that information is immediately actionable whether or not. The patients should should it shouldn't have access to it. That's the decision to be made by the patient by the provider. But if a tools as long as the tools, providing reliable information accurate information, if a if a patient wants an information, I think they should have access to it. And the other thing I would say also is that if you look at the history of digital tools, more broadly and lets about from digital health tools, but just digital tools. More broadly. The use cases have always evolved over time. In tools have been introduced with a with with us one use for them when one use case, but what we've seen is once they were available application, developers others came along and figured out other app. Other ways to use these tools once they got into the hands of consumers and once enough consumers had them that. There was a business case to be made think of the think of the camera in the back of your phone when that was I put it in the back of your phone. It was a camera now it's a sensor now shoes for all different kinds of functions. I think you're gonna see the same thing with digital health tools, which is once we are able to. Create a framework with these come onto the market for one specific use people are going to create applications that once the hardware is in the hands of consumers that are going to have much broader set of uses, and that's gonna create a create a whole new set of opportunities. But if we withhold these digital hell, tools, these these hardware platforms until all the use cases of worked out. I don't think you're ever going to see the investment in the kind of software that can unlock the full capabilities of these tools. I'm trying to use the time. I have with you to run down the list of priorities. A you yourself have established going back to your first speech to FDA in may of twenty seventeen in your opening remarks. You said quote, our greatest immediate challenge is the problem of opioid abuse. And yet a few months ago FDA approved Subbiah a synthetic opioid hundreds of times more powerful than morphine. Why approve this powerful new drug amid an opioid couple things with with the Suva. I mean, the headline is that it's one hundred times more powerful than morphine actually what to SUV. Is is it's a very small amount of a powerful of formulation of of an opioid. And the reason why you'd want to formulate something like that is because it's designed for sub will administration it's designed to allow the opioid to be put under the tongue and get in the blood very quickly. And if you took a a less potent opioid and designed it for that purpose, it would be a very large pill, and it would never be absorbed. And so the only way to create something that could get absorbed quickly into the blood through sub lingual administration would be to use something that was very potent. But it's actually an amount of opioid that's quivalent to fifteen milligrams of morphine, which isn't a trivial amount of morphine. But it's an amount of morphine NAT is commonly prescribed in emergency situations for someone who might need a bedside procedure, for example. And I've been in many situations as a physician, you know, where I've been bedside with a patient where I needed to do an emerging procedure you think of a place in a test tube where you couldn't get IV access. And so you couldn't administer intravenous. Pain sedate sedation in that setting and having a sub lingual administration that could provide enough analgesic in that setting could could could be life, saving the other thing to remember what the Suva is. You know, this was on. I talked about the time we did enter into you know, an arrangement with the Pentagon we committed to prioritize products that they felt were priority products for the battlefield and four frontline soldiers and their priority. Lists isn't thirty products. It's not fifty products. It's about ten and the movie was one of them. And we we worked out that arrangement as, you know, a compromise for an effort that was underway to try to strip FDA all authority to approve products that were intended for frontline show soldiers for the battlefield because we felt that it was important to have FDA review products intended, for the battlefield what we committed to do was give products that they prioritize which is a small list breakthrough like Thai. Touch within the agency. So there was a there was an imperative with respect to disprove that did factor into how the agency at least the process by which it was developed not by which was reviewed and non how we assess for specific. But certainly the process which was developed. I think the larger question though, it to SUV, and I said this at the time, and I'm going to be saying this again before I leave isn't the question of disprove per se. I think these questions come up with the respect to every time we approve a new opioid. That's you know, perceived as powerful which is and it's a fair question. Which is why is FDA proving another opioid your yet another opioid that has the potential to be diverted in abusing the setting of an opioid crisis. And that's a reasonable question. And it's a question of whether or not we should have a comparative superiority standard when it comes to the approval of new opiates. I think we need to address that question. I don't I don't like addressing the question litigating it in context of individual proves, I think it's a broad policy question that we ought to consider wholesale. And we are considering it and considering whether or not the agency needs. Different authorities when it comes to opioids to put in place, some kind of comparative superiority standard to say that if new opioids coming to the market that has the potential diversion abuse. Should it be differentiated in a way that is offering some advantage over the existing therapeutic or material? And I would I would argue that if we had such a standard to SUV, you would probably meet it because it is differentiated way can be used in clinical settings where other drugs aren't available. But we should we should ask the question, and a broader setting the last thing, I'll say, and you open the door to I'll just say it the issue of whether or not Subbiah is a drug that could be abused. It does have risks associated with it. It does have a risk of diversion and abused. But I think it's a risk that is gonna be significantly mitigated in terms of how this drug is administered where it's administered the risk really is a risk of diversion by healthcare professionals because it's drugs going to be administered in inpatient settings. It's going to be tightly controlled and pick systems. That's how it's going to be delivered in inside a healthcare. Setting. And so the risk. You worry about is will healthcare professionals try to divert it in no settings and abuse it and we've seen that that does happen happens much less. Now there's much tighter controls, but it does happen. But that's really the risk you talking about. I think the way this was portrayed. Somehow this drug is going to be available. You know, lock prescribed an outpatient settings by general practitioners, and it's going to become a street drug or a choice drug of abuse. You're talking about there's a risk of diversion and abuse here. But it's narrow this administration pushed the right to try Bill, which led patients, essentially, go around FDA to get on approved drugs is roundly opposed by cancer organizations, HHS curling conducting a review of its fetal tissue research scientific organizations. Don't like that either before he came into office. This president was allowed critic at times of vaccinations, you're seen as a champion of science. What would you say to the general public and to staff who are concerned about your departure in the feet of science administration? Why think? That this this agency has been very rigorous in terms of how we've approached public health issues. I think we have affirmed the importance of science based decision making. I don't see any departure from how this agency makes decisions, you know, when I would obviously quibble with your underlying sort of statement and assumption upfront, but which part all the parts, but just in terms of just in terms of looking at FDA, I'm very confident in the process that's underway here in and, you know, the the decision making process in FDA isn't just sort of consequence and the result of things that I did over the last two years. It's the consequence of what how this agency has gone about its work over decades. And I think this agency the rigor by which we make decisions the importance of the decisions we make the way they impact people's lives. I think that we we have really infirm d- over a long period of time the importance of science based decision making in regulation and policy thinking about. Who's taking over for you Ned sharp less head of the National Cancer Institute. Why pick him as your successor as far as I know. He's never worked in FDA. You had a track record here before you came back. He's only been in government about a year and a half. What did you see in Dr sharp us? Well, I didn't pick them. The secretary did secretary as secret that you favor him. Well, I I made no secret that that I think he's highly capable and very competent. I think he has a very good ethic to be running this agency. And so why why do I like net because I've worked with him because I think he's a deeply public health minded because I think he understands the mission of the agency he's done work with FDA. He plays basketball with FDA reviewers. And I think is underlying ethic and is underlying approach to public health issues is very consistent with with the way this agency thinks about its mission. We've talked about your priorities. What would you have started? If you had been here for say another year started more recently. That's interesting. It's an interesting question. I think that a lot of what we a lot of what we did really reflect the things that I came in thinking about the things I got generated during during the time that I was here. I think some of the things that I might have pushed on that. I was looking at doing were some things around food safety where we were looking at implementing brought in Frank Janas, the head of food safety at at WalMart. And we are looking at technology that will allow the agency think differently about how it does track and trace with respect to the food supply chain and produce in particular, those are things that will get underway that I haven't been long enough to to get started. There's a couple of other things like that that are in process. I want to leave some some of that work for you know, Dr shoplift make decision whether whether and how he takes him forward. The other thing that I I would have liked to pushed further along were the implementation of some of the authorities that we got under the support act where we got we worked on over very long time and got some substantially with Ari's with respect to dealing with yoga. Crisis. And I won't be here to see all goes through and get implemented. But I'm very confident they will be for example, the one that probably going to narrowly miss the opportunity to announce that was very important to me was requiring the immediately so points to be put in blister packs. I think that fundamentally changes how providers prescribe I are formulations of opioids like vicodin and Percocet requiring them to be in one or two day ballista backs. It's gonna push much more the prescribing towards one or two day dispensing as opposed to a bottle of thirty pills that will get out. That's certainly going to get out. But I worked very hard on out. And who would like to have been here to get through the finish line? Last question. You did two separate stints in George W Bush administration. You're right FDA. He left the government you came back. What are the odds? The you will come back to government serve Halley that to you at side. That's your your life your career. Look, I would love an opportunity to serve in the government. I don't know. I don't know whether that will come to fruition. I think every time I've stepped out of one of these jobs. I accept the fact that might be my last time in the government and that last time, I I left the role as deputy Commissioner I said to myself, this is the best job I'm gonna ever have. And I might never be back in the government. I needed to make a decision to do that for personal reasons. The time I was undergoing treatment for cancer. I've had that conversation with myself in my in my head this time again that I'm walking away from you know, a tremendous opportunity, perhaps the best job will ever have. And it may be my last job in the government. Well, we will see we will see you around. Hopefully, thank he's gonna Gottlieb. That's it for pulse. Check this week. My thanks to Doug Andreas. And of course, Commissioner Scott Gottlieb at FDA for time for the interview as well as Jenny meant and Sarah Carlin Smith at politico for making this conversation happen to if you like politico pulse. Check helpless by rating, reviewing the show on your favorite podcast app. If you have suggestions for future episodes. Find me I'm a diamond politico dot com by Email and you'll find a new episode of politico pulse. Check in your podcast player next week.

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