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Welcome to the National Press club. The place where news happens. Im part of bloombergs breaking nouz desk. Im Vice President of the club. Before we get started, id like to remind everyone to please silence your phones. For our viewing and listening audience, please feel free to also follow the program on twitter using the hash tag npc live. Now its time to introduce our head table guests. Id like to ask you to please hold your applause until all guests are introduced. And guests id like each of you to stand briefly as your name is announced. From your right, we have sarah reporter for nature magazine. Tam ra hinten. Founder and chief strategist. Mcwilliams, seen your advisor to the fda commissioner. A washington correspondent with usa today. Jennifer rodriguez assistant commissioner for media affairs. Medicine and Health Editor for scientific american. Kath lean kwin, Senior Advisor to the fda commissioner. Here we have lisa matthews. Vice president of hagger sharp. And coleader of the National Press club headliners team. Skipping over the guest for a moment. We have bill pierce, senior director of app coworldwide. And the National Press club headliners member who organized todays event. Allison fits gerald cojack. Health policy correspondent for npr. Jim spencer. A washington correspondent for the minnesota star tribune. Reporter for midtech insight. And dr. Charles. Health and science correspondent for audio video news. Thank you all for joining us. Id like to take one moment to acknowledge additional members of the headliners team. Responsible for organizing todays luncheon. Betsy fisher martin, healthther weaver, thank you all. For our cspan and public radio audiences, please be aware that in the audience today are members of the general public. So any applause or reaction that you may hear is not necessarily from the working press. So, being a successful commissioner of the u. S. Food sdp Drug Administration requires a combination of skills that is not easy to find. The fda is an expert agency. It requires a expert in medicine and health. The fda is a government agency. So it requires someone who knows how to navigate the bureaucratic maze that is washington. The fda regulates business, and 25 of the consumer goods sold in the u. S. So it requires someone who knows how the private sector works. And the fda employs about 17,000 people. So it needs someone who knows how to manage a far flung and diverse organization. Doctor scott the 23rd fda commissioner is the man who is taken on this challenge. His experience checks a lot of boxes. First, he has known government from the inside. From 2005 to 2007, he served as fda Deputy Commissioner for medical and scientific afar fairs and from 2003 to 2004 he was senior add vie tor to the fda commissioner. In his work, he also worked on implementation of the medicare drug benefit. A seen your implementation of t drug benefit as the Senior Adviser of the centers for medicare and medicaid services. In 2013, dr. Gottlieb was appointed to serve on the federal Health Information Technology Policy committee which advises the department of health and Human Services on Healthcare Information technology. Immediately prior to his current appointment, dr. Gottlieb was a resident fellow at the American Enterprise Ips Institute which seeks to study how government can efficiently interact with the private sector. And he sv dollars as a clinical professor at the New York University school of medicine in manhattan where he practiced medicine as a hospital list physician. He has authored numerous comment tears on healthcare for publications including the wall street journal, forbes magazine, washington post, as well as scholarly journals. He also has a great deal of experience working with various Healthcare Companies over the years. Dr. Gottlieb graduated from mount cyanide school of medicine where he completed a residency internal medicine at mount sinai center. He undergraduate degree is from where he studied economics. The system should increase efficiency and consistency, address the opioid price crisis and increase composition as a mechanism to make pharmaceuticals more accessible. These and other matters for which the fda is responsible are issues that are crucially important to the country. The speed with which the fda determines drugs and therapies is safe and allows them to reach those who need them changes peoples lives. We are honored to have dr. Gottlieb here with us today to explain how he is feping the fda fulfill these responsibilities. Thank you, dr. Gottlieb. [ applause ] thanks a lot. I appreciate the opportunity to be here today. I want to start by extending my apologies for canceling my earlier appearance to the press club mitt to travel down to be puerto rico that day on urgent business to assess the impact of Hurricane Maria on swann san juan and on our staff and the people on puerto rico. I can tell you whey riverside at the fdas facility in san juan i witnessed the emotion of the assembled staff when one of the team members whom nobody had heard from since the storm showed up for our meeting, her colleagues had feared the worst. They were overcome to see that she was unharmed. She had been tending to her own destroyed home and her displaced family and it was her First Contact with the fda team. The destruction down there that i saw was profound and it the despair widespread. Stories i heard from fdas team made the ongoing hardships very clear to me. They all stood their post, however. Theyve been help working day and night to help the manufacturing get restarted. Even as their homes were destroyed and most of the island remained without power, our team has made win 30 firm vis its so far to help manufacturing sites get restarted. In 113 of the visits they were able to make contact with the firm and in 99 cases the firms were operational. This is a Monumental Task given the logistic cal challenges they face in moving around the island and the personal challenges that they face at home. Im very proufd their effort and im deeply moved by their dedication. I want to focus my remarks today on some of the ef fortsds weve been undertake at fda when it relates to our medical Product Development process. Ive been at fda for six months now as the agencys commissioner, but as some of you know im not new to fda. This is my third time serving at the agency. Ive held three different positions at fda during a span of almost 15 years. In between my roles as the fda i worked in the private sector and the chance to see fdas work from the inside and outside has shaped my approach to my current role and shaped my perspective and my understanding of what i think inspires fdas unique mission. From this Vantage Point now as commissioner, i can tell you with certainty that fda is a missiondriven organization motivated by a very unique core. Theres a shared sense of Public Health mission that an mates the agencys work. It might sound quaint in some quarters to say that your job is to protect and promote the Public Health, but at fda people voice this call to duty without a hint of irony. Its this spirit of mission that inspires us. When people want to know about the agency, they often ask how we achieve our mission and most go directly to try to understand the what. What is it that we do . But thats the wrong question to ask. The right question to ask, why does fda do what it does . I want to focus my remarks today on the why. Why fda does the work we do to describe the heart of our mission. To understand fda is to understand why we do what we do. But to answer the why, id start by asking why have an fda at all . We have an fda to help make it easier for people to be apparent or a caretaker and improve their lives. The fda exists to empower people to make choices and decisions about their own health and the health of their families, to give people access to safe and effective technologies that can provide them with meaningful choice whens they face serious illness, and to offer hope that they can cure an acute disease or more reasonably manage a chronic one and to be protect them from potential harms. That why also describes the foundation of american Public Health. Simply put, our mission and the mission in Public Health is to help people live up to their full potential. That why is to advance the health of our nation and this is essential to our flourishing the question of why we do what we do is on the policy reforms that were undertaken at fda. When it comes to our medical product review programs. I want to highlight one particular idea today, it brings to life a broader changes underway in our organizational approach to new mal product review. Were changing how we organize ourselves as part of the medical product review process and moving away from a structure that had people working in discrete organizational units that often operated as independent entities rather than an integrated team that functioned together to share best practices and knowledge. Instead, were evolving to a more teambased approach. This approach will integrate people from different disciplines and across different stages of the lifecycle of a product from the pre and post market phases were working toward a common Public Health goal. In most cases, that immediate goal will be the review of a new product. But the ultimate goal is to facilitate a fluid and Dynamic Team Environment that fosters a deep understanding of these products across a full continuum of the pre and post market phases. I believe that these changes will elevate the role of our clinical and scientific experts to take a more universal view of the products they evaluate. A role where they can take more stewed wardship of products over their entire life psych from the the initial product application touts review by fda, to the approval and safe use of a product by patients and providers. Our experts are our clinical and scientific officers. They must have a stewardship over the products they evaluate that extends throughout the product lifecycle. Thats their commitment to Public Health. The connection between the products we regulate and the lives we seek to improve over time is what first brought many to fda. The benefit that people ultimately derive from a new product after its approved and the risks they might encounter in the ordinary routine of clinical medicine is our shared responsibility and obligation. Its the outcome that compresses why we do our work and so the same commitments that stir our efforts before a product is approved for use are equally important after its made more widely available. We need each of our medical and scientific experts to have more opportunity to extend their expertise and leave their mark over the full duration of a products lifecycle rather than at just one stage. Part of our effort to modernize the structure of our review teams is as much a cultural change as it is an organizational one. Ill focus on these changes first as they relate to medical devices. With this modernization is imbodied in the creation of a total product lifecycle office in our kwies center. This new structure will consolidate many of the aspects of product review into a new teambased approach. Our clinical and scientific staff is comprised of some of the leading experts in their fields to maximize their effectiveness and efficiency and fully leverage and integrate their knowledge and expertise into product review. Were changing from an individual centric approach to teambased approach. Its key that our organizational structure supports that purpose, but thats knots alwanot always today. Instead the Current Organization often fosters intellect wail and managerial silos. It splits premarket and post market functions into separate offices that dont always talk to one another as much as they should. It places staff into hire arcual structures and management chain. This makes it more difficult to share information and to hand off work between offices. For example, between our compliance officers and our premarket experts, often expert input across different parts of the review function is sought through consults rather than an ongoing dialogue offered as part of an integrated review team. One of the key purposes of our new approach is to make information sharing easier. Reviewers, compliance officers, and other experts will look at the products total lifecycle rather than different staff looking at different devices at different stages of the development and commercialization. Regulatory oversight will span the continuum of pre and most market products. The aim is to make sure that the people with expertise and how our product works can inform those who are monitoring its continued performance after its approved for use by patients and viceversa. Were also pursuing similar organizational changes when it comes to new drugs. These modernizations have the same Public Health goals as those embodied in the new efforts related to medical devices. Under leadership of dr. Janet woodcock, is addressing the way new science is changing the nate tire of how drugs are developed. The center is piloting the creation of one common shared view memorandum. This will ensure early cross disciplinary interaction among scientists and clinicians who have Specialized Knowledge in disease. These interactions have become more critical because fields such as gentleman nome miks, human fact thattor alanalysis, and others have become integral parts of the drug review process. A single review memorandum will be much more accessible to the Biomedical Research community. At the same time were evam waiting the more disease offices as a morn afroch new drugs. The goalstor provide stakeholders with a single point of contact and allow synergies and surge capacities within offices. The Broader Community often measures fda productivity by its adherence to goals. These are the timelines that are imbodied by our deadlines negotiated as user fee agreem. These are important metrics for measuring our organizational efficiency and we intend to hit these commitments. But goal dates arent always good approximates for our Public Health impact. Our impact can be e best be measured by the completeness and quality of our clinical and scientific work before and after a new product say proved and by the safe and effective use of medical technology that we help facilitate and how we are advancing products that also help advance Peoples Health. The central tenant of these new teambased approaches is to increase cross disciplinary collaboration. The goal is to make sure Decision Making at every stage of a products review is more fully informed by scientists and cla nitions with very discrete and deep areas of expertise. This gets me back to the why of our mission. It isnt simply to meet a user fee goal or approve more novel products. Its so make sure were having meaningful impact on Peoples Health and positively imkt pag their lives. The impact of our work is becoming especially palmable as we see more products coming to market that have transformative and curative effects on vexing diseases. The why of our work is deeply expressed in a lot of other areas of our portfolio. The most prominent i believe are fdas efforts to impact americas kries sifs addiction. This goal is very clearly embodied in our goal. The nicotine and cigarettes doesnt directly cause tobacco related cancer, lung disease or heart disease. But the powerfully addictive nature of the delivery of nicotine in cigarettes makes tobacco use the leading cause of preventible death in the united states. So were putting nicotine at the snefr our strategy. Were taking steps to render combustible cigarettes minimally or nonaddictive. This could prevent future generations of kids from becoming addicted to significant lets, the deadliest form of nicotine delivery. We set that the goal to be regulated before the end of this year. At the same time were putting through an appropriate series of regulatory gates, new technology thats emerging that could deliver nicotine to those adults who still want or need satisfying levels of this drug but that enable them to get that nicotine through products that may pose far less risk than spoking combustible cigarettes. We need to make sure that these new products like electronic nicotine systems are properly regulated. For fex they claim the product modifies the risk to users, they must prove that they can slig reduce risk if they want to make those claims. Were also focused on another devastating addiction crisis in america, the addition to opioids. As you know, this is a top priority of the Trump Administration. The fda has an Important Role to play over every aspect of this crisis. But two of our key obligations are fdas influence on the rate of new addiction and our impact on the availability and the use of treatments that could help people live lives of sobriety. We know that many people who become addicted to opioids will be medically addicted and the first exposure will be a lawful prescription. For most people that first prescription will be for an Immediate Release of an opioid drug. Sciencebased evidence shows that the key to reducing new addition is to reduce the opioid prescriptions. This makes sure that fewer prescriptions are written and fewer duration of doses are dispensed the we released a federal notice that will begin a process at fda to implement steps to reduce exposure to opioids through our influence on prescribers. Some of the steps were evaluating are how we, i doctorstor educated, our role in how products are packaged and how doses are dismentioned on indication. Among other influences we believe we can have on bend being the rate of new addiction. As another part of our work to address the Opioid Epidemic, were looking at how we assess risk and benefit to make sure were take the best. Both as part of oufr pre and post market review thea as one part of that effort, we requested earlier this year that endo farm suit walz withdraw its reform lated opanna er from the market based on our analysis of the risks associated with that drugs elicit use. Now, ive read recent media reports that stated that endo is participating in a relaunch of the old version. This is the version of the drug that endo had previously withdrawn from the market when it launched its reform lated version of opanna because that older version didnt proport to have abuse deterrent features. I dont want to speak about our regulatory intentions with respect to any specific drug, but i do want to address oxy more phone products more generally. Fda previously commissioned a study to evaluate whether oxy morphine has qualities that make it more likely to be abused than other schedule two opioids ib clueding the elicit use of administration such as snorting and injection. Im announcing that study for the first time today. If the scientific results of this study demonstrate that this ingredient has qualities that make it more likely to be abused, fda will consider taking relevant laer to actions that could limit patient exposure to oxy more phone. In closing, the aim of the organizational policy changes i discussed today is to empower the scientific and Clinical Experts at fda with a primary objective in mind. Its to more fully engage and i spire their workday in and day out to solve similar Public Health challenges. Our goal is to make it simpler for our scientists and physicians to pursue and accomplish these goals by working as teams, by sharing different expertise, well are more closely aligned as an organization around a common ambition to enable people to have more opportunities to use diets and novel medical products to improve their lives. Thats the why of our work. Its the Common Thread that links our shared goals, and its the principle that underlies our Public Health mission. Thanks for the opportunity to join you today. [ applause ] thank you, dr. Gottlieb. We have some questions from the audience. One. Youve already implemented a lot of changes at the fda. To attempt to ease the drug and Device Development process. Are there more changes coming or have you already laid out most of your plaps . Weve talked a lot about trying to make the drug and medical Device Development process more efficient, so were not talking about f, a review times here. Fdas review process and review times are exceedingly efficient. We review the vast majority i think upwards of 90 of all emas are reviewed within the dates and these dates are aggressive in the a. Times we spend working a product application pirt think what we could all have an impact is trying to make sure that the clinical develop plont says itself related to new medical technologies is as efficient as possible so when were looking at Clinical Trials, were looking at the requirements that are being imposed on sponsors and investigators who are developing new products. Were incorporating good science into those, developing good trial methods to make it as not getting a return in terms of better assurance of safety and effectiveness. I do think there are things that fda can be since a lot of what Product Developers do in the clinical Development Process is driven by fda requirements, i think there are things fda can do in terms are of how it lays out its own guide liens. That can drive efficiencies in that process. And weve laid out some of those. Weve looked at issues of how we can improve the design at Clinical Trials, how we can better incorporate things like model and simulation, how we can use registries and Historical Data to model placebo in certain instances. Some of the scientific reforms that we can start to better incorporate into the Development Process. But were certainly going to have more to say on that. Theres more policies that we plan to lay out in the near now ture where we think there might be things we can do from both the standpoint of how the Agency Structures its review process but more importantly the guidance we give to Product Developers to make that pro skes more efficient. Were going to be mutting out a suit products specific guidances on the new drug side of the house shortly before the end of the year, about ten now guidances that are going to address different diseases and medical need that i think are going to lay out more important approaches to how people can develop products against those disease areas. Could you give ace small preview of the ten five of them are suite of guidances that are going to address various neurological disorders, many of which are unmet medical needs and others going to address discrete medical needs north areas. How is the chronic staff shortage impacting the goals youre trying to accomplish . We recently announced a hiring pilot within the office of the commissioner to try to address some of the challenges with onboarding people. Particularly when it comes to people with clinical and scientific expertise. The hr process can sometimes be slow, people who, you know, clinician whos have a lot of expertise who might have competing job offers might not wait six or eight months for fda to work through the process. And so the goal of the new hiring pilot is to try to make that process much more efficient so that we can move more quickly on new hires. So weve focused that initially on the user fee slots. And so these tend to be the medical review slots paid for by user fees. We felt that that was an area of sort of a discrete area where we could try out a new methodology with how were going to approach hiring. I think we made a lot of progress. Well be reporting on results soon. I have a blog ready to go out sometime next month to tell you about the progress weve made on the hie hiring pro pilot to the to the extent theyre successful were going to try to expand that agency wide. I would mention weve had a lot of new authorities particularly in the cures act that gave fda very targeted hiring authorities to bring on people with certain kinds of scientific expertise, including the ability to pay people additional salaries if they have expertise that is very particular to an area of science that fda needs. And one of the challenges i think we face Going Forward is that the kinds of products were being asked to evaluate are so complex that theres a small subset of people nationally who have the kind of expertise sometimes required. When you look at things like gene therapy or car t, some of the new platform technologies. So the ability to be have some Additional Resources that we can target to try to on board people with expertise in very discrete areas is going to be a real added value so were grateful for congress for designing that pathway. Excellent. On drug pricing, some members of congress have once again brought up the idea of importing cheaper drugs from canada. Has the fda taken a look at this since or does it plan to since the fda can make the decision to declare reimportation . As you know under current law the secretary of health and Human Services can make a declaration that drugs that would be imported in sort of a broad fashion can be imported so long as the secretary can certify that its not going to have an impablt on safety and its going to promote access. And the secretary, i dont know the exact sort of codified language around that, but its something to that effect. And no secretary has been able to make that determination through successive administrations both republican and democrat. We havent take ann look at that question recently. We certainly 0 would if we were asked to. I will say that the challenges that have faced fda in the past in terms of when its contemplated this question, particularly the issue around the security of the supply chain, the sophistication of counterfeit drugs have only grown in proportion and increased the challenge potentially to try to operationalize such a thing. But if we were asked to do it we would reevaluate the question as other fda administrations have through both republican and democratic administrations. Including the Bush Administration when i was at the fda. What have you heard so far from Tobacco Companies about the plan to eventually reduce nicotine levels in significant trots nonaddictive levels and whats a realistic timeline for thef for the . Well, i havent spoken directly to industry. Were going to be announcing soon so i might as well do it now that were going to be having meetings with stakeholders in this community. So thats going to include Public Health groups who, you know, are who have a long history working in tobacco control. Its going to include some of the trade association rares small subset of some of the Large Companies as well. So now that weve announced this process and were going through a rule making process, when we do do that, we will start to take meetings with stakeholders and hear from them. There will be listening sessions. That will be my first opportunity to hear directly from some of the companies. So all ive heard so far is what ive read in the press thanks to all the journalists in the room. I think in terms of a time frame, ill just say that when we when we announced this policy at the outset what we said our goal was to advance the advanced notice of proposed rule making addressing nicotine in combustible cigarettes before the end of this year, i am i believe we will stay on that schedule. My goal is to and my hope is that we will be able to publish an advance notice of proposed rule making before the end of this year. Great. In an oped a few years ago you crit sized an expansion of tobacco product regulation to the making of highhand rolled cigars saying it would be beyond what conkbres had envision and won threaten small businesses. Do you still believe there should be an exemption for regulation of premium cigars and if so how account agency make sure they are not regulated in the same way as cigarettes . Im not sure if thats selectively quoted. I vaguely remember the article, but ill let you have have that characterization in the oped. But i will say, and this isnt a cop out. We have you know, weve undertake ann process now where we said that were going to issue an advanced notice to reask questions around in particular around cigars, premium cigars. So the newly deemed products, all the regulations that apply to the newly deemed products continue to go forward. So the newly deemed products include things like hookah, Electronic Cigarettes and cigars. And theres a lot of regulations around them that once they were deemed they were subject to certain regulations, restrictions on sales to youth, requirements on label, they do inspection of facilities, were continue doing that. We pushed off product application deadlines for certain certain of the newly deemed products. In particular, to allow the ends to continue to advance while we got in place foundational regs that would define how we would, i product applications to come into the fda. Because the feeling was that at the same time that we are moving to render cigarettes minimally or nonaddictive and regulate nicotine in combustible cigarettes, we need to think about what the alternative is going to be to people who still want to get satisfying levels to nicotine. And the ends do offer one possible alternative that could potentially be safer. I say potentially impossible because it needs to be put through an appropriate series of regulatory gates and thats what we need to do through the product application process. The regulations were going to advance are going lay out what that process is. The foundational regulations for the tobacco Problem Program were never put in place and well take the time to put those in place so we have a Firm Foundation with which to regulate. With respect specifically to premium cigars as part of our announcement we said we were going to put out a promodes notice of chicago gar make about whether or not the use of premium cigars represents other forms of combustible tobacco. Were in the process of drafting that amprm. We plan to issue it shortly. We recently published some scientific analysis that the agency did with respect to this question that will be part of the amprm in helping form the questions that we ask. But i wont answer the question because were entering a rulemake process. Okay. All right. So opioid addiction or obesity epidemic, which one keeps you up at night. Excuse me the other part obesity epidemic. Sorry. Its hard to, you know, equate one dramatic Public Health challenge with another so i dont want to get into, you know, a position of trying to say this is worse than this. I think everything is horrible if youre the family thats suffering from one of these one of these Public Health challenges. By will say that i think that the Opioid Epidemic is a unique threat to the country and requires very dramatic action on the part of Public Health authorities to get in front of this. I think weve watched over a ten or 15year period this epidemic grow in proportion, even as we tried to take measures to intervene in various ways, the epidemic was always five steps ahead of us and always growing well out of proportion, i think, of what anyone anticipated. And so to try to get ahead of it now, i think we need to be willing to take much more dramatic action, be much more potentially intrusive than what we thought we might have to do and what would have been our comfort zone five years ago or ten years ago. Having failed to intervene hard enough, perhaps at times when we might have had an opportunity to quail this epidemic or at least stem its continued spread, i was at fda for part of this period of time and part of the people who were in government who were analyzing this and trying to consider what action would and wouldnt have been appropriate. But having failed to recognize how this epidemic was going to grow in proportion and take gig vigorous enough action, i think now we immediate to be far more vigorous so we dont continue to make that mistake. Youve squd that one opioid be pulled from the mar detective ket from its risk of abuse being higher than its benefit. Are you going to be asking more companies to do the same . Well, you know, obviously im not going to speak to individual productspecific issues. I will say that were looking much more closely that the question of elicit use as a component of how we look at risk b benefit. Im not going to try to relapt gate the agencys posture historically whether the agency o wasnt looking that the question. I will just tell you Going Forward this is going to be a more prominent part of how we think about risk benefit when it comes to opioids in particular, scheduled drugs but opioids in particular. And what made the decision to ask for the withdrawal, the market withdraw of opanna er unique was that it was based solely on a consideration of the risk of the elicit use. We found that the way that product was being abused to the way other products were being abused there was a risk. There was a product in its formulation that when it was injectsed when was reform late and abused and being injected it was causing autoimmune phenomena. And we believe that the product because of the way it had to be manipulated to be abused lent itself more towards abuse through injection routes. So the epidemiological pattern showed a higher proportion of abusing through to hepatitis c and hiv. That regulatory action was based solely on a consideration of the risks associated with the elicit use of that drug, not with the labeled use of that product. Okay. Thank you. You said youd be meeting with insurers to talk about limiting the number of opioid prescriptions that people can get, so how have those talks gone . Can we expect fda to add any guidance to opioid labels soon . Weve been having those discussions. Weve also been having discussions, i would note, with provider groups. Weve put out federal register notice requesting comment and advice and ideas on how we might take steps to try to better effect how drugs are dispensed. Theres different constructs that we could potentially pursue that relate to how we can change labels, how we change package. Let me give a hypothetical construct. I know its dangerous for me to give hypotheticals. Weve talked about the pack abling as one vehicle. So lets say we have a construct where Immediate Release formulations of opioid, so 90 of all opioid utilization is Immediate Release formulation, vicodin, percocet, about 190 million prescriptions each year. Most people their first procedure will be through an Immediate Release formulation. If they become adiktd often times theyll move on to hire dose formulation, stoortd manipulate them and then move on to the lowcost alternative which are street drugs. Think of a world where we might package these formulations in say three, six, nineday packs but have you blister packs like sometimes you take for your antibiotics, a steroid taper, so you might dispense opioids in packs that comport with clinical guidelines on what a proper dispensing should be. We work with the dental so he association, orthopedics and other groups on what proper dispensing should be for different kinds of procedures and then we incorporate into labeling and then we use that as a way to help manage what gets dispensed for different clinical indications. Thats a world where you could see trying to line up the way drugs are packaged with expert guidelines and what the proper dispensing should be in different clinical circumstances. Then you might mayor that i to an educational requirement that if a doctor wants to prescribe a 30day supply because theyre a doctor who sees patients with chronic pain conditions, maybe at that point require the mandatory education. You start to see how these Different Things that were thinking about, package, working with the provider groups to try to develop expert guidelines, working with groups that could help us think about educational requirements, how they start to marry up into a more comprehensive scheme, if you will, that i think might be able to get us to a place where we can better rational hoois the fda has available to it. The president passes an executive order mandating that each new regulation must be accompanied by removing two old regulations. How has this impacted the fda . Well, each new regulation that costs, i mean, weve been able to a lot of our regulations are deregulatory actually in terms of how they get scored because a lot of times when we issue regulation, were updating, you know, standards in a way that actually could potentially create efficiencies in the Development Process. We actually deregulate by regulate, by issuing regulationings, its something unique about fda. This isnt some magical construct weve adopted over six years, the last six months, this is basically our operating platform in the is alls the case that a lot of our regulation whens looked at from the basis of whether or not theyre regulatory and add to costs or deregulatory insofar ars they will help save money, a lot of our regulations historically have gotten scored as regulations that save. And so to the extent that we do have regulations that add to costs or where the costs outweigh the benefits, thats basically what youre looking at when do you the analysis, the economic analysis, i feel pretty comfortable that were going to be able to find ways to marry things that we might think are outdated and might want to potentially withdraw with things where we have to advance regulations that are going to cost money in terms of situations where the costs are going to outweigh the benefits of a regulation. But we believe theres an overriding Public Health purpose in advancing the regulation. We have a lot of regulations that are from the 1970s and 1980s that just really theyre not even relevant anymore and theyre just sort of ignored and not followed. And we have regulation, we regulate in areas where we might be able to create efficiencies where the fda might be able to rethink its whole paradigm. We publish literally hundreds of regulations that are standards of identity that are basically resspies for how you develop certain food. So we have a recipe for what Peanut Butter needs to be to be called Peanut Butter. What mayonnaise needs to be called mayonnaise. Some of those are important because they provide a foundational element for how products are made. If youre going to call something Peanut Butter it should have peanuts in it. But some things are like we have a regulation thats a standard or identity for cherry pie. Thats something that we might be able to look at. Im not sure fda as were grappling with all these other Public Health issues needs to be redefining the standard for what constitutes cherry pie. Some element of cherries is good, and there should be a crust, but i dont know. But does there really need to be a crust . Switching topics a little bit. Any thoughts on the gop tax bill, particularly on repealing the orphan drug tax credit . Yeah, look, im not going to drive outside my lane and as far as the orphan drug tax credit ive seen some of the reporting on it and its been a question thats been put to me. I havent taken a look at it in terms of what the specifics are and what what impact it could potentially have so im not going to comment. Okay. Birth control is over the counter in many countries. Why is the fda not approved in over the counter Birth Control dwrot ease access for women . This is a question thats come up in the past. You know, theres been present chal candidates on both sides of the aisle that have advocated otc Birth Control. As best i know, this question hasnt been put before fda where its gone to an advisory committee. I dont think that this is something thats been put forward in a way where its advanced to the agency. I know in the past some of the provider groups have been against . I dont know where they stand today, but, you know, like any other application, if we received a request on a switch woe would evaluate the same way we would evaluate anything else. As a policy, the fda currently does not comment on any product that is currently under review. As a result, the Company Behind the product is the only available voice on how their product is perform, which means that they can say the fda says it is promising or it will soon be approved and theres no way to verify that. How account fd, address this issue . Well, you know, the i think thats not entirely true because if a product is if a products investigational, whats relevant is from a Public Health standpoint whats relevant is that the investigators are made aware of information that could be relevant to the patients that are enrolled in a Clinical Trial as well as the irb. And the irb is kept in inform of the progress of the trial, has information made available to it. When the irb believes the investigator should be informed of something that happens. So theres a process in place that protects Patients Enrolled in the Clinical Trial. But theres a larger question, i recognize. Theres a question if a products under review and somethings happening in the context of that product that could inform a product thats on the market thats a similar product, shouldnt patients who are on a similarly marketed product know that something that was learned in the contemt of a product thats under review might tell them something important about a product that theyre using. And in that case, here again, we have the ability to inform the public. We could issue a Public Health advisory or some kind of notice if fda learns something in the context of a Clinical Trial that we think is relevant to a marketed product. Theres a third element to this with respect to investigators and i suspect the question came in that context that if a Company Makes claims about the performance of a product in a Clinical Trial to the investment community, you know, could investors be misled . And ill just say with that, here again, theres a construct in place that helps speak to that issue. Fda does have an mou, a memorandum of understanding in place with the fcc. Fda routinely has dialogue with the sec. That dialogue is sometimes initiated by representations that management will make to the Public Markets where fda will know theres a conflict or an untruth or, you know, purported untruth. And i know that there have been sec actions taken on the basis of referrals that have been made by fda. Okay. Heres a Company Specific question. Little tougher. How do you respond to people concerned that your ties to industry could give device makers and Drug Companies too much influence at the expense of patient protections . Well, i think i think my experience having worked on both sides of this, working in the Venture Capital community, helping to develop novel technologies, and a lot of my work was related to small companies, new technologies, as well as my, you know, my experience currently and in past working on the regulatory side has informed my perspective in ways that i think are helpful. I mean, others can judge that differently. I judge it in a certain way. I think it helps inform my view. I feel that i draw upon my experience in the private sector all the time in terms of how i think of challenges inside the agency. You know, as far as relationships and whether or not relationships in the past are influencing my current work, obviously, no, i, weve been vigilant about making sure if im recused from a company we respect the recusals. And i will tell you just as a matter of routine, its rare that i take its rare that i take meetings with individual counsels. Its rare that i would adjudicate or be involved in a product specific issue. Generally what i work with and what i think someone in this role should be worried about and working on, because there are a lot of things to worry about, ill tell you, is matters of broad and general poll say that can affect a lot of lives. And theres a lot of those. And, you know, i try to focus my attention on places where i can have the most impact to make sure im using my own personal resources efficiently just like im asking the agency to use its resources efficiently and thats generally where ive spent my time. On rekuhse cuesals you said would you recuse yourself from 20s e 20 companies youve had relationships with for one year. The question is why just one year . Why not for the whole time you run the fda . Well, the one year was out of the ethics pledge, as you know. Ive complied with the all the all the requirements that were asked of me, including the ethics pledge that the Trump Administration asked all senior political appointees to sign. So that was signed of a went through the whole confirmation process so you stein your first day on the job, as recusal requirements that exceed the one year. So i would encourage people look at that because i think its sort of a not fully informed. Because the new ethics requirement does place a higher burden on people. Okay. Do you believe fda should have authority to regulate prices of therapies as well as safety and effectiveness . Well, you know, this gets the question of drug pricing. Ive said i think fda display a role in this debate and ive said that i think issues of access and to the extent pricing affects issue of access are matters of Public Health concern that the agency ought to concern itself with. Where weve been on this debate is looking at ways we can try to promote competition in the market. Weve talked about the generic drug side to affect that. Theres going to be things we do on the new drug side to impact that, particularly looking at areas where theres Single Source drugs and are there things that we can do to help promote competition in those categories so that if you do have an area where theres a ma noly and company has a good therapy and brings it to market and ebb joys a period of monopoly of products, but you also twoonlt see competition enter those categories. To the extent we could look on the new drug side of our house as well in ways we can promote competition were, were going to be look those things as well. But a lot of our early work as focus on trying to promote more generic competition particularly around place wheres we see Branded Companies gaining our rules in ways that fore stahl intended competition. So situation wheres exclusivity has lapsed, you dont see Branded Companies have entered into certain tactics that keep the Generic Companies coming in. I see Branded Companies blocking access to Generic Companies get access to the doses that they need to apply for generic approval. Here we had a situation where Congress Said to the Generic Companies you have to do a bioequivalent study and file it will with the fda. They say well make those studies and make the investment, then they go out into the market with the cash and theyre willing to buy the branded drug and they cant get the drug because they adopt anticompetitive tactics to prevent them from getting access to those drugs. I think thats a real problem. Weve seen some of our own policies be used in ways to do that, to frustrate that. I believe the rehms is sometimes used for that. We impose that as way way as a safe use profit duct are being used to block that sale. And it takes anywhere between 2,005,000 doses of a branded drun to run a bioequivalent study to compare your drug to the biobranded drug. But the other place we see these activities dont fall within the direct pur view of the fda. We often times see them selling drugs to a tight supply shayne chain. They might tell stel through a single Specialty Pharmacy where they tightly control who the drug can be sold to and have, we believe, i believe, ill say i believe, they have rules in place that make it difficult for the pharmacy or the distributor, whoevers handling the drug, to actually make the sale to a Generic Company or a sale in bulk in a bulk fashion to a Generic Company. Were looking at things that we might be able to socialize because this wouldnt necessarily be directly in fdas pursu purview, but im willing to think in ways that we can collaborate with other agencies for example to try to address this. Because we obviously as an agency that tries to promote drug access and competition between the safe and epekttive use of drugs were we have an interest in seeing that the studies can get done. We Want Companies to come in and file those applications. If they come to us as many have and say we cant get access to the drugs do it even though were willing to pay full price, thats a problem. So weve talked about potentially allowing them go to europe to buy the drugs, but were going to look at that question very hard. Great. Some medical device ceos say potential cybersecurity vulnerabilities are the top issue that keeps them awake at night and analysts say its just a matter of time before someones seriously hurt or worse. Whats your take on this issue and what are you doing about it we just put out some information this week so i would encourage everyone to look at that time that summarizes a lot of the activity that were undertaking to address this. I think upwards of 90 of medical devices that are aroughed think there its probably pma devices have some component of a cybersecurity evaluation. So were, would with sponsors, weve laid out guidance on how they can evaluate this, the Network Security of devices, and we are encourage the sharing of information that can help inform how Product Developers can develop products that put in place safeguards to address this vulnerability. Were well aware of it, were concerned about it. You know, i think that weve been pretty proact any of trying to address it as a component of how we go about evaluating medical devices. Its not just people think its, you know, they watched homeland and they think its a pacemaker. A lot of times this relates to, you know, large medical equipment that might be in a hospital and it relates to issues of being able to bring down a device so its not available rather than just affect its performance, actually take it down if a device is net worked. Weve seen that in certain situations. So this this spans a pretty big continuum of potential concerns. Okay. Before the last question, i have one programming note. Sorry, im just going to reach across you very quickly. So at the National Press club wed like continue to variety to you please join us on monday. Well be hosting for a luncheon the u. S. Secretary of veterans affairs, david shul ken. So please put that on your calendars and join us if you can. I notice that david sold out. Theres a big red x over his face. At first i saw the red x and i said im glad i didnt get a red x but then i saw what it meant. People are curious. Well there are say very good crowd as well. This is great. All right. Last question. So you used to make your own syrup and now you raise chickens. Why is that . Are you manufacturing unregulated vaccines on the side . Well, so the maple syrup operation at my house isnt subject to fda regulation because i dont do it in an adjacent facility. If you look at the regulations. And with the with the eggs and the chickens, we dont we dont regulate the chickens and the egg we only regulate when its kraft. So i just want to you know ive complied with all the regular rules. Sonny perdue regulates most of what i do. We like fresh eggs ant kids like it and so its a lot of fun. Weve enjoyed it. Thanks. Before you leave were we would like to present you with our mug from the National Press club. Every speaker gets one. We hope that you use this in good health. Thanks a lot. Thanks very much. [ applause ] and that concludes our luncheon today. Again, thank you everyone for coming. The cspan bus is traveling across the country on our 50 capitals tour. We recently topped in jefferson city, missouri, asking foeths folks whats the most important issue in their state. Im kind of concerned about foreign policy. Weve had a big change in administration and its a little bit different than its been in the last year or eight years rather. So hopefully we can continue to go smoothly. Its been a little rocky at the start here, but cspan is what helps me keep up to date on this. Im really concerned about waens healthcare. It seems like its always under attack and i think in order for women to be truly equal we need too have free control of our bodies. My issue with what i think missouri needs is we need good paying jobs. We need people to be able to contribute to society, to contribute to their local area, and to help serve others. And one way you can do that is by having a really, really good job. Thats something id like to see from the state of missouri. I would like to see us try to help more of those that are the neediest in our communities. We have a project homeless connect. We have several other different significant events in our community. And were trying to make an impact and if that could be done statewide on every community i think it would make our state maybe one of the models for the nation. And i would love to see that. My issue is we need more leaders of the world war ii era, think. Im a little on the edge of that. And i just thought ive been listening to Winston Church hills and visiting his museum over in fulton, missouri, and they just the people of the 40s just did some wonderful things. Voices from the states on cspan. The house ways and Means Committee continues work opted gop tax reform bill tuesday and wednesday. Watch live coverage tuesday at 10 00 a. M. Eastern or cspan oregon or listen live on the free cspan radio app. The House Judiciary Committee recently met to debate and consider amendments to immigration legislation that would create a new visa classification or agricultural guest workers. The bill was introduced by Committee Chair bob good legality. This is just under

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