Cspan, where history unfolds daily. In 1979, cspan was created as a Public Service by americas Cable Television companies. That is brought to you today by your cable or satellite provider. Cspans washington journal, live every day with news and policy issues that impact you. Coming up wednesday morning, well talk about president trumps trip to asia and get the latest on republican tax Reform Efforts with California Democratic congressman john garumendi. And then well look at the results of governor races in virginia and new jersey with the Political Editor for national journal. And congressman rob whitman will offer his perspective on president trumps trip to asia and u. S. National security interests in the region. Watch washington journal live at 7 00 eastern wednesday morgue. Join the discussion. Up next, the head of the food and Drug Administration talks about efforts to evaluate and approve new pharmaceutical treatments. And the fdas role in combatting the nations Opioid Epidemic. From the National Press club, this is an hour. Good afternoon. Welcome to the National Press club, the place where news happens. Im andrea schneider. Im part of bloombergs breaking news desk and Vice President of the club. Before we get started, i would 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 npclive. Now its time to introduce our head table guests. I would like to ask you to please hold your applause until off of them are introduced. Guests, i would like each of you to stand briefly as your name is announced. So from your right, we have sarah reardon, reporter. Tamera hinton, founder and chief strategi strategist and npc headliners member. Carly mcwilliams, senior advise tore the fda commissioner. Maureen grapy, a washington correspondent with usa today. Jennifer rodriguez, assistant commissioner for Media Affairs at the usfda. Dina fine, medicine and health editor. Kathleen quinn, senior advise tore the fda commissioner. Here we have lisa matthews, Vice President of hager sharp and coleader of the National Press club Headliners Team. Skipping over our guests for a moment, we have bill pierce, senior director of Apco Worldwide and who organized todays event. Alison fitzgeraldcojack. And jim spencer, a washington correspondent for the minneapolis star tribune. Pedro alfaruk, reporter. And charles dr. Charles sneiderman, health and science correspondent for audio, video news. Thank you all for joining us. [ applause ] i would also like to take one moment to acknowledge additional members of the Headliners Team responsible for organizing todays luncheon. Betsy fisher martin, lori russo, heather weaver, and press club staff liaison lindsey underwood. Thank you all. For our cspan and public radio audiences, please be aware that in the audience today are members of the general public. Any applause you may hear is not necessarily from the working press. So being a successful commissioner of the u. S. Food and Drug Administration requires a combination of skills that is not easy to find. The fda is an expert agency. It requires a substantive 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 farflung and diverse organization. Dr. Scott gottlieb, the 23rd fda commissioner, is the man who has taken on this challenge. His experience checks a lot of boxes. First, hes known government from the inside. From 2005 to 2007, dr. Gottlieb served as the fdas Deputy Commissioner for medical and Scientific Affairs and from 2003 to 2004, he was a senior advise tore the fda commissioner. In his work at the fda, he also worked on implementation of the medicare drug benefit as a Senior Adviser to the centers of medicare and medicaid services. In 2013, dr. Gottlieb was appointed to serve on the federal Health InformationTechnology Policy committee, which advises the depth of health and Human Services on Health Care Information technology. Immediately prior to his current appointment, dr. Gottlieb was a resident fellow at the American Enterprise institute, which studies how government can effectively interact with the private sector. And he served as a clinical assistant professor at New York School of medicine in manhattan, where he practiced medicine. Many of the challenges facing the fda are not new to him. Hes authored numerous commentaries, including in the washington post, as well as scholarly journals. He also has a great deal of experience working with various Health Care Companies over the years. He graduated from mt. Sinai school of medicine where he completed a residency at the mt. Sinai medical center. His undergraduate degree is from Wesleyan University where he studied economics. Dr. Gottlieb has said the agency should increase efficiency and consistency in the review process of drugs and devices, address the Opioid Crisis and increase competition 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 with us today to explain how hes helping the fda fulfill feez responthese respon. Thank you. [ 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. I had to travel down to puerto rico that day on urgent business to assess the impact of Hurricane Maria on fdas facility in san juan and on our staff and the people of puerto rico. Ky tell you when i arrived at the fda facility in san juan, i witnessed the emotion of the assembled staff, when one of fdas team members, who 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 that i saw down there was profound and the despair widespread. The stories i heard from fdas team made the ongoing hardships where are clear to me. They all stood their posts, however, working day and night to help puerto ricos medical manufacturing get restarted. Our team has made 130 firm visits so far to help manufacturing sites get restarted. And 113 of the visits they were able to make contact with the firm. And in 99 of the cases, the firms were operational. This is a Monumental Task given the logistical challenges they face. In moving around the island and the personal challenges they face and im deeply moved by their dedication and proud of their effort. I want to focus on some of the efforts weve been undertaking at fda when it relates to our medical Product Development process. Ive been at fda for six months now as the agencys commissioner. As some of you know, though, im not new to fda. This is my third time serving at the agency. Ive held three different positions during a span of almost 15 years. In between my roles at 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,ky tell you with certainly that fda is a Mission Driven organization, motivated by a unique espirit de corps. It might say quaint 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 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, i start by asking why have an fda at all . We have an fda to help make it easier for people to be a caretaker or a parent 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 choices when they face serious illness. And to offer hope that they can cure a disease or manage a chronic one. That why also describes the foundation of American Public health. Our mission, and the mission of Public Health, is to help people live up to their full potential. That why is to advance the health of our nation. And this influence is essential to our flourishing. The question of why we do what we do is central to the organizational policy reforms undertaken at fda. For instance, when it comes to our medical product review programs, i want to highlight one familiar idea today. It brings to life a broader change under way in our organizational approach to a new medical product review. Were changing hour we organize ourselves and moving away from a structure that had people working in discrete units that operated as independent entities rather than a team that functioned together to share best practice and knowledge. Instead, were evolving to a more teambased approach that will integrate people from different disciplines and across different stages of a life cycle of a product, from t the ultimate goal is to facilitate and Dynamic Team Environment that fosters a deep understanding of these products across the 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 stewardship of products over their entire life cycle, from the initial product application, to its review by fda, to the approval and safe use of a product by patients and providers. Our experts are a clinical and scientific officers must have the stewardship over the products they evaluate that extends throughout the life cycle of the product. 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 drieriv from a new product after approved and the risks they might encounter is our shared responsibility and obligation. Its the outcome that expresses 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. 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 embodying the creation of a total Product Life Cycle in our device center. This new structure will consolidate many of the aspects of product review into a new teambased approach. Our clinical and scientific staff has comprised some of the leading experts this their fields to maximize their effectiveness and efficiency and expertise into product review. Were changing from an individual approach to a teambased approach. The Current Organization often fosters intellectual and managerial silos. It places staff into hierarchy structures and it makes it more difficult to share information and to hand off work between offices. Between our compliance officers and premarket experts, often expert input across different parts of the review function is sought through a consult rather than dialogue offered as part of an integrated review team. One of the key purposes to our new approach is to make information sharing easier. And reviewers, compliance officers and other experts will look at the total life cycle, rather than different staff looking at different devices, and commercialization. Regulatory oversight will spend the contimmium of product evolution. The aim is to make sure you can monitor the continued performance after its approved use for patients and vice versa. Were 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 the leadership of dr. Janet wood dock, the office is evaluating structural changes to address how new science is changing the nature of how drugs are developed. The center is piloting the creation of one common shared memorandum to ensure early cross disciplinary interaction among clinicians and scientists who have Specialized Knowledge in disease. These interactions have become more critical, because fields such as genomics and others have become a part of the review process. At the same time, were evaluating the creation of more disease specific audiences as part of a more modern approach. The goals are to provide a single point of contact and allow synergies and surge capacities within offices. The Broader Community off manages productivity by adherence to review goals. These are the timelines that are embodied by our deadlines negotiated as part of user fee agreements. These are important metrics for measuring our organizational efficiency. But goal dates arent always good proximates for our Public Health impact. Our impact can best be measured by the completeness and quality of our scientific work before and after a new product is approved. By the safe and effective use of medical technology that we help to facilitate and how we are advancing products that 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. This gets me back to the why of our mission. It isnt simply to meet a user fee goal or approve more novel products but to make sure were having meaningful impact on Peoples Health and positively impacting their lives. The impact of our work is becoming especially palpable as we see more products coming to market that have transformative and even curative effects on vaccine 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 crises of addiction. This is embodied in our new initiative on tobacco and nicotine. The nicotine and cigarettes doesnt directly cause cancer, lung disease or heart disease. But the addictive nature of the delivery of nicotine makes tobacco use the leading cause of preventable death in the united states. So were putting nicotine at the center of our strategy. Were taking steps to render combustible cigarettes minimally or nonaddictive. This would prevent generations of kids from becoming addicted to cigarettes. We said our goal is to issue before the end of this year. At the same time, were putting through 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 can enable them to get that nicotine through products that pose far less risk than smoking combustible cigarettes. We need to make sure these new products, like electronic nicotine systems are regulated. If they claim the product modifies the risk to users, they must prove that they can reduce risk it is they make those claims. Were also focused on another crisis in america, the addiction 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 the impact on the availability and the use of treatments that can help people live lives of sobriety. We know that many people who become addicted to opioids will become medically addicted, and their first e pocxposure will b through a lawful prescription. Science based evidence shows that the key to reducing new addiction is to reduce exposure to opioid drugs in a clinical setting, making sure fewer prescriptions are written. We released a federal notice that will begin a process to evaluate and perhaps implement steps to reduce exposure to opioids. Some of the steps are how we require doctors to be educated, and how doses are dispenlsed based on indication among other influences we believe we can have on bending the rate of new addiction. As another part of our work to address the Opioid Epidemic, were reconsidering how we address riveng ask and benefit e sure were taking appropriate measures. As one part of that effort, we requested earlier this year that pharmaceuticals withdraw its formula from the market based on our analysis associated with that drugs use. I read recent media reports that stated that endo is participated in a relaunch of the old version of the drug. This is the version that endo had previously withdrawn from the market when it launched, because the older version didnt purport to have abuse deterrent features. I dont want to speak about our regulatory intentions with respect to any specific drug, but i wanted to address it more generally. Fda previously commissioned a study to formally evaluate whether the active ingredient in certain opioid drugs has qualities to make it more likely to be abused than other schedule two opioid drugs. Im announcing that study for the first time today. If the results demonstrate that this ingredient has qualities that make it more likely to be abused, fda will consider taking regulatory actions that could limit patient exposure. In closing, the aim of the organizational policy changes i discussed today is to empower the Clinical Experts at fda with a primary objective in mind, to more fully engage and inspire their workday in and day out to solve similar Public Health challenges. Our goal is to make it simpler for our scientists to pursue and accomplish these goals, by working as teams, by sharing different expertise. Well be more closely allied as an organization, to enable people to have more opportunities to choose diets and novel medical products to improve their lives. Thats the why of our work. 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 process. Are there more changes coming or have you laid out most of the plans . We talked a lot about trying to make the drug and medical Device Development process more efficient. So were not talking about fda review times here. Fdas reviewed process and review times are exceedingly efficient. We review the vast majority, upwards of 90 of more of athem. I think what we can all have an impact is trying to make sure that the clinical Development Process related to new medical technologies is as efficient as possible, so were looking at Clinical Trials, looking at the requirements being imposed on sponsors and investigators developing new products, were a not getting a return in terms of better assurance of safety and effectiveness. So there are things fda can do, since a lot of what chronic developers do in the process is driven by fda requirements. There are things that fda can do in terms of how it lays out its own guidelines to drive that process. We have laid out some of those. We looked at issues of how we can improve the design and din cl Clinical Trials and how we can dwrus ruse registries and s the scientific reforms that we can start to better incorporate into the Development Process. But were going to have more to say on that. Theres more policies that we plan to lay out in the near future where we think there might be things that we can do from both the stand point of how the Agency Structures its review process and the kind of guidance we give the Product Developers. So well be putting out new guidances on the new drug side of the house before the end of the year that will address different diseases, different areas of medical needs and lay out more modern approaches to how people can develop products against those disease areas. Could you give us a small from e view . Five of them are guidances that address various neurological disorders. The others are going to address discrete diseases in other areas. Very good. How is the chronic staff shortage impacting the goals that youre trying to accomplish . Well, we recently announced a hiring pilot within the office of the commissioner to try to address some of the challenges, marly when it comes to people with clinical and scientific expertise, that the hr process can sometimes be slow. People who clinicians who might have a competing job offer might not wait six months for fda to work through the process. And so the goal of the new hiring is to make that process much more efficient to move much more quickly on new hires. So we have focused that initially on the user fee slots. So these tend to be the medical review slots paid for my user fees. We felt that was an area where we could try out a new methodology how to approach hiring. I think we made a lot of progress. I have a blog ready to go out in the next month to highlight some of the progress weve made. And to the extent those are successful approaches, i think well try to expand that more agency wide. I would also just mention that weve had a lot of new authorities, that gave fda targeted hiring authorities to bring on people with certain kinds of scientific expertise, including the ability to pay people additional salaries that they have expertise, that is very particular to an area of science. One of the challenges we face Going Forward is that the kinds of products were being asked to evaluate are so complex, that theres a smaller subset of people nationally that have that expertise required. When you look at gene therapy, some of the new platform technologies. So the ability to have some Additional Resources that we can target is going to be a real added value. So were grateful for congress designing that pathway. On direct pricing, some members of congress have brought up the idea of importing cheaper drugs from canada. Has the fda take an look at this since or does it plan to since the fda can make the decision to declare reimfortation . Current law, the secretary of public Human Services can make a declaration that drugs that would be imported in sort of a broad fashion that can imported, as long as the secretary can certify its not going to have an impact on safety and promote access. And no secretary i dont know the exact codified language around that understa, and no se has been able to make that determination. We havent taken a look at that question recently. We would if 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 security, the supply change of drugs have only grown. And increase the challenge to operationalize such a thing. But if asked to do it, we would reevaluate the question as other administrations have. What have you heard so far from Tobacco Companies about the plan to eventually reduce nicotine levels 2 s in cigaretto nonaddictive levels and what is a realistic timeline . I havent spoken directly to industry. Well be announcing soon that well be having meetings with stakeholders in this community. That includes Public Health groups who are who have a long history of working in tobacco control. Its going to include some of the trade associations, a subset of some of the Large Companies as well. So now that are going through a rule making process, when we do promulgate our rule making, well take meetings with stake holders. So that would be my first opportunity to hear directly from some of the companies. So all ive heard so far is what ive heard in the past thanks to all the youshli isjournalists i. When we announce this policy at the outset that what we set our goal for was to advance the advanced notice of proposed rule making, addressing nicotine and combustible cigarettes before the end of this year, i believe we will stay on that schedule. So my goal is and my open is well be able to public an advanced notice of rule making before the end of this year. In an oped a few years ago, you criticized an expansion of tobacco product regulation saying that it would be beyond what congress had envisioned and would threaten small businesses. Do you still believe that there should be an exemption for premium cigars and how can the agency make sure theyre not i vaguely remember the article, but i will say, and this isnt a cop out, we have undertaken a process now where we said were going to issue an advanced notice to reask questions around, in particular around cigars, premium cigars. So the newly deemed products, all these regulations that apply to the newly deemed products continue to go forward, including things like Electronic Cigarettes and cigars. Theres a lot of regulations around those products. We pushed off product application deadlines for certain of the newly deemed products. In particular, to allow the ends to continue to advance while we got to place foundational regs that would define how we would require product applications to come into the fda. The feeling was, 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 for people who want access to satisfying levels of nicotine. And the ends do offer one possible alternative that could potentially be safe. I say potentially and possible because it needs to be quicker and appropriate through regulatory gates and thats what we intend to do. So the regulations that were going to advance are going to lay out what that product application process is. The foundational regulation for the Tobacco Program were never put in place. So well take the time to put those in place, so we have a Firm Foundation which to regulate. With respect specifically to premium cigars, we said that we were going to put out an advanced notice of rule making to reask questions about whether or not the use patterns replicates other forms of combustible tobacco. We are in the process of drafting that amprm and plan to issue it shortly. We published some scientific analysis that the agency did with respect to this question. That would be part of it, to help inform the questions we ask. But i wont answer the question, because were entering a rule making process. Okay. So opioid addiction or obesity epidemic, which keeps you up at night . Look, its hard to, you know, equate one Public Health challenge to another, so i dont want to get into 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 Public Health challenges. But i will say that i think the Opioid Epidemic is a unique threat to the country. And requires very dramatic action on the part of authorities to get in front of this. I think we watched over a 10 or 15year period this epidemic grow in proportion. Its growing well out of proportion 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 in what we thought we might have to do, and what would have been our comfort zone five or ten years ago. Having failed to intervene hard enough, perhaps at times when we might have had an opportunity to quell this epidemic or stem the spread. I was at the fda for part of this period of time and part of the people in government who were analyzing this to try to consider what action would or wouldnt be appropriate. But having to fail to recognize how this epidemic was going to grow, i think now we need to be far more vigorous so we dont continue to make that mistake. Among those vigorous actions, you ask that one opioid be pulled from the market for risk of abuse. Are you going to be asking more companies to do the same . Well, obviously im not going to speak to individual products. I will say, though, that were looking much more closely at this question of how we look at rich benefits. Im not going to try to relitigate the agencys posture historically and whether the agency was or wasnt looking at this question. I will just tell you, Going Forward this is going to be a more prominent part of how we think about riskbenefit when it comes to opioids in particular. And what made the decision to ask for the market withdrawal unique was that it was based solely on a consideration of the risk of illicit use. We found the way that product was being abused relative to the way other products were being abused was creating unique risks. We believe that the product, because of the way the product had to be manipulated to be abused, leant itself more towards abuse through injection routes. So the pattern showed a higher proportion of these through injection and that led tragically to outbreaks of hiv and hepatitis c. So that regulatory action was based solely on a consideration of the risks associated with the illicit use of that drug, not with the labeled use of that product. Okay. Thank you. You said you would be meeting with insurers to limit the number of opioid prescriptions people can get. How have those talks gone . Can we expect fda to add any guidance to opioid labels . Weve been having those discussions and having discussions with provider groups. We have put out notice requesting comment and advice and ideas how to better affect how drugs are dispensed. So theres different constructs that we could pursue, that relate to how we can change labels and packages. Let me give you a hypothetical construct. We talked aboutaging as one vehicle. About 190 million prescriptions a year, most peoples exposure to an opioid would be through a prescription. If they become addicted, theyll start to manipulate them, then move on to the street drugs increasingly. Think of a world where we might have these formulations in say three, six and nineday packs. So you might dispense opioids in packs with things that comport to clinical guidelines. Say we work with a dental association, an orthopedist, to develop expert guidelines on what proper dispensing should be. And then we incorporate that into labeling. And then we use that as a way to help manage what gets dispensed. Thats a world where you could see trying to line up the way drugs are packaged with expert guidelines on what the proper dispensing should be in different clinical circumstances. Then you might be able to marry that to an educational aspect. Maybe at that point, you require the mandatory education. So you tart to see how these Different Things that were thinking about, packaging, working with the provider yous to try to develop expert guidelines, working with groups that can help us think about educational requirements, and how they marry up into a more comprehensive scheme, if you will, that might be able to get it to a place where we can getter rationalize prescribing the tools that the fda has available to it. Thank you. The president has an executive order mandating that each new regulation must be accompanied by removing two old regulations. How has this impacted the fda . Well, each regulation that costs. Weve been able to a lot of our regulations are deregulatory actually in terms of how they get scored. A lot of times when we issue regulation, were updating standards in a way that create efficiencies. This isnt something that we have some magical construct we have adopted over the last six months. This is fdas operating platform. This is always the case that a lot of our regulations, when looked at from the basis of whether or not theyre regulatory or addto costs or deregulatory, a lot of our regulations historically have gotten score as regulations that save. To sew so to the extent that we do have regulations that outweigh benefits, i feel pretty comfortable that well be able to find ways to marry things that we might think are outdated. You might want to draw with things where we have to advance regulation that cost money in terms of situations where the costs are going to outweigh the benefits. We believe theres an overriding purpose in advancing the regulation. We have a lot of regulations that are from the 1970s and ye 80s and theyre not relevant anymore and ignored and not followed. We have regulations where we might be able to create efficiencies where the fda might be able to think this whole paradigm. We public regulations, probably hundreds that are standards of identity that are recipes for how you develop certain foods. So we have a recipe for what Peanut Butter needs to be to be called Peanut Butter. Some of those are important because they provide a foundational element for how important products are made. Some of them are things like we have a regulation for cherry pie. So thats something that we might be able to look at. Im not sure fda, as were gr grappling these other issues, needs to redefine what standards ko constitute a cherry pie. Some elements of cherries are good. [ laughter ] any thoughts on the gop tax bill, particularly on repealing the orphan drug tax credit . Look, im not going to drive outside my lane. As far as the tax credit, theres been questions, and i havent taken a look at it in terms of what the specifics are and what impact it could have. So im not going to comment. Okay. Birth control is over the counter in many countries. Why has the fda not approved an overthe counter Birth Control to easy access for women . This is a question thats come up in the past. Theres been president ial candidates on both sides of the aisle advocated occ Birth Control. I dont think that this is something thats been put forward in a way where its advanced through the agency. I know in the past some of the provider groups have been against it. I dont know where they stand today. But like any other application, if we received a request on a switch, we would evaluate the same way we do anything else. As a policy, the fda does not comment on any product that its currently under review. As a result, the Company Behind the product is the only available voice on how their product is performing. Which means they can say the fda says that its promising or it will soon be approved and theres no way to verify that. How can the fda address this issue . Well, you know, the i think thats not entirely true, because if a product if a product, whats relevant from a public stand point, whats relevant is that the investigators are made aware of information that could be relevant to the Patients Enrolled in a Clinical Trial. And the irb is kept inform of the trial, and when the irb thinks investigators should be informed of something, that happens. So there is a process in place. Public health is being protected in that manner. But theres a larger question. A question of, you know, for products under review, and something is happening in the context of that product, that could inform a product thats not on the market thats a similar product might tell them something important about what theyre using and we are the ability to inform it public. Or issue some kind of notice if they learn something tat we think is relevant to a Market Product and i suspect it question came in tat context that if a Company Makes claims about the performance of a prod ktd in a Clinical Trial to the inhad vestment candidate, could if vestors be misled. Theyll just say with that there again theres a construct in place that epihads speak to that issue. Theres a memorandum of understanding in place with the fcc. Fda routinely has dialogue. That dialogue is sometimes initiated by representations that management will make to the public market. Where they note theres a conflict or an untruth or reported untruth and i know that there have been scc actions taken on the basis of referrals that have been made by fda. Heres a Company Specific question. A little tougher. How do you respond to people concerned tat your ties to industry could give device makers and Drug Companies too much influence at it expense of company protections. I think my experience having worked on both sides of this, working in the Venture Capital community, helping to devem novel technologies and a lot of my work was related to new technologies. As well as my experience currently and in the past 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 epihads inform my view. I feel i draw upon my experience all the time in terms of how i think about challenges inside the agency. As far as relationships and whether or not relationships in the past are influencing my current work, obviously weve been vigilant about making sure we respect the recusals and as a matter of routine, its rare that i take meetings with individual sponsors. I think its rare that i would adjudicate or be involved in a product specific issue. Generally what i work on and someone in this role should be worrying about and working on because there are a lot of things to worry about is matters of broad and general policy that can effect a lot of lives and theres lot of those. I try to focus my attention on places i can have the most impact to make sure im using my personal resources efficiently and thats generally where ive spent my time. On recusals u you said you would recuse yourself from 20 companies youve had relationships with for one year. The question is why not for the whole time youre on the fda . Well, the one year was out of the ethics pledge, as you know. Ive complied with all the requirements that were asked of me, including the ethics pledge that the Trump Administration asks all senior political appointees to sign. So that ethics pledge, obviously signed after i went through the whole conformation process. You sign it first job on the job has recusal requirements that exceed the one year. I think its not fully if formed. 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, this gets the question of drug pricing. Ive said i think fda does play a role in this debate and i said i think issues of access and to the extent pricing effects issues of access are matters of Public Health concern. Where w50eeve been on this deb is looking at ways to promote competition in the market. We talk a lot about the generic drug side to effect that. There will be things on the new drug side. Particularly where theres Single Source drugs and are there things we can help promote competition in those categories so if you have monopoly and a comp in a has an innovative therapy, brings it to market, enjoys monopoly profits because theyve done something very break through, especially when theyre delivering to patients. But you want to see competition in those categories. And ways we can promote competition, were going to look at those things as well. But a lot of our early work is focussed on trying to promote more generic competition, particularly around places where we see Branded Companies in ways that forstall competition. So congress intended for there to be generic competition. Branded companies have adopted certain tactics that prevent that competition from entering the market. It one im most concerned about are situations where i see Branded Companies taking steps to block Generic Companies from getting access to the doses of the drugs they need to run their bioequivalent studies to apply for generic approval. We have a system where Congress Said in order to get to the market you have to do a bioequivalent study and they say okay. Well do the if vestment and they go out in the market with their own cash and willing to pay fair market value so they can run the comparison studies and they cant get the drug because the Branded Companies use anticompattive tactics to prevent them from getting access to those drugs. Weve seen some of our own policies be used in ways to do that, to frustrate that. I believe sometimes used as a way do that. We require companies to place on their drugs as a way to provide for the safe use of a product and being yoozed to block that sale and takes anywhere between 2,000 and 5,000 doses around bioequivalent study to compare your drug to the branded drug. But the other places we see these activities dont always fall within the direct purview of fda. A lot of times we see Companies Selling drugs to a very tight supply chain. So they might sell to a specially branded pharmacy where they tightly control where it can be sold to and i believe they have rules in place that make it difficult for the pharmacy or the distributor, whoever is handling the drug, to actually make the sale to a Generic Company or in bulk fashion to a Generic Company. So were looking at things we might be able to socialize because this wouldnt necessarily be directly in fdas purview but im certainly willing to think in ways that we can collaborate with other agencies for example to try and address this. Because we, as an agency that tries to promote drug access through the safe and effective use of generic drugs, we have an interest in seeing that the equivalent studies be done and if they kp to us as many have and said we cant even get access to the drugs to do it, even though were willing to pay full price, tlarthats a proble. So weve talked about potentially allowing them to go to europe to buy the drugs. But were going to look at this question very hard. Some medical device ceos say potential Cyber Security vulnerabilities are the top issues that keep them awake at night and analysts say its a mat of time before someone is seriously hurt or worse. What are you doing about it . I would encourage everyone to take a look at it. That sums are as lot of the activity were undertaking to address this. I think upwards of 90 of medical devices that are approvaled. Have some component of a Cyber Security evaliation and so were working with sponsors. Weve laid out guidance on how they can evaluate the Network Security devices and were encouraging the sharing of information that can help inform how Product Developers can develop products that put in safeguards to address this vulnerability. Were concerned about it. I think that weve been pretty proactive in trying to address it as a component of how we go about evaluating medical devices. And its not just people think theyve watched homeland and think its a pace maker. A lot of times this relates to 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 effect its performance, take it down, if its networked. Weve seen that in certain situations. And so this spans a pretty big continuum of potential concerns. Okay. Before the last question. I have one programming note. So, that National Press club, wed like to invite you to please join us on monday. Well be hosting for a luncheon the yoois secretary of veterans affairs, david shulken. So please put that on your calendar and join us if you can. I have notice that dave sold out. A big red x over his face. At first i said im glad i didnt get a red x but then i saw what it meant. This is a 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 unregistered vaccines on the side . The maple syrup, i dont do it in a adjacent facility. And with the eggs and chickens, we dont regulate the chickens and the egg we only regulate when its cracked. I just want you to know i comply with all the relevant rules. Sonny perdue regulates most of what i do. We like fresh eggs. And the kids like it and so larlits a lot of fun. Weve enjoyed it. Thank you. Before you leave, wed like the introduce you with our mug from the National Press club. We hope you use this in good health. Thanks very much. Thank you. [ applause ] and that concludes our luncheon today. Again thank you everyone for coming. The committee will come to order and without objection authorized to declare recesses of the committee at any time. We welcome everyone to this mornings hearing on examining antisemitism on college campuses. Before i give my oop opening statement,