the [inaudible conversations] >> good afternoon. welcome to the national press club, the place where news happens. maybe andrea snyder, part of bloomberg's breaking news desk and vice president of the club. before we get started, would like to remind everyone to please silence earphones. for viewing and listening ideas, please feel free to also follow the program on twitter using the hashtag add-in pc life. it seemed to introduce her head table guests. i would like to ask you to please hold your applause until all the guests are introduced and i would like each of you to please him briefly as was announced. from your right we have sarah riordan, reporter for a magazine. fatah chief strategist in npc have letters member, currently mcwilliams for the senior advisor to the fda commissioner, marine, washington correspondent with use site today, jennifer rodriguez, commissioner for affairs of the u.s. pa. the medicine and health editor, kathleen quinn, senior adviser to the fda commissioner. here we have lisa matthew, vice president of hager sharp and coleader of the national press club headliners team. skipping of our guests for a moment, and bill pearce, senior director of apco worldwide in the national press club headliners member who organized this event. alice insisted kojak, policy correspondent for npr. jim spencer, washington correspondent for the "star tribune", a-alpha rowe, reporter for the med tech insight and dr. charles snyderman, health and science correspondent for audio, video news. thank you all for joining us. [applause] i also like to take one moment to acknowledge additional members of the headliner team responsible for organizing today's luncheon. betsy fisher martin, laurie russo, heather lieber and press club staff liaison lindsey underwood. thank you all. for c-span and public radio audiences, please be aware in the audience today and members of the general public and he applies her reaction you may hear is not necessarily from the working press. 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 as an expert agency. it requires a sensitive and purging medicine and health. the fda as a government agency that requires someone who knows how to navigate the bureaucratic phase 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 in the fda employs about 17,000 people so it needs who knows how to manage a far-flung and diverse organization. dr. scott gottlieb is the man is taking on this challenge. his experience checks a lot of boxes. first companies and government from the inside. from 2005-2007, dr. gottlieb served as deputy commissioner for medical and scientific affairs and from 2003-2004 he was senior advisor to the fda commissioner. in his work at the fda company also worked on implementation of the medicare drug benefit for senior adviser to the administrator of the center for medicare and medicaid services. in 2013, dr. gottlieb was appointed to serve in the federal health information technology policy committee which advises health and human services on health care information technology. immediately prior to his current appointment, dr. gottlieb is a fellow at the american enterprise institute which seeks to study how government can efficiently and effectively interact with the private sector. he served as a clinical assistant professor at new york university school of medicine in manhattan were just a practice medicine a hospital physician. many issues and challenges facing the fda are not new. he suffered numerous commentaries on health care for publications including "the wall street journal," "forbes" magazine, "washington post" as well as scholarly journals. he also is a great deal of experience working with various health care companies over the years. dr. tranter graduated from sinai school of medicine where he had the internal medicine has been a pain in medical center pays undergraduate degrees 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 from address the acute crisis and increased competition mechanisms to make pharmaceuticals more accessible. these and other matters for which the fda is responsible our issues crucially important to the country. the speed with which the fda determines drugs and therapies is safe and a lot of them to reach those who need them changes people's lives. we are honored to have dr. gottlieb here with us today to explain how he's helping the fda develop these responsibilities. thank you, dr. gottlieb. [applause] i could tell you when i arrived at the fda facility in san juan, i witnessed the emotion of the assembled staff when one of the fta team members who nobody had heard from since the storm showed up for a meeting from her colleagues had feared the worst and they were overcome to see she was unharmed. she had been tending to her and destroyed home in her displaced family and it was her first contact with the fda team. the destruction down there i saw was profound and widespread. the stories i heard from the team made the hardships very clear to me. they all stood there post however. they been working day and night to help the product manufacturing get restarted. even as homes were destroyed in the island remained without power, to help sites get restarted with 113 visits to make contact with the firm and 99 cases the firms were operational. this is a monumental task given logistical challenges they face in moving around the island and a personal challenges they face and home and i'm very proud of their effort and deeply moved by dedication. i would've focused on the the efforts we've been undertaking when it relates to the medical product development process. i've been in fda for six months as agency commissioner by some of you know i'm not new to fda. this is my third time serving at the agency. in between my roles that fda work in the private sector and the chance to see fda's work inside the outside has shaped my approach to make her a role in shaped my vivid understanding of what i think inspires fda's unique mission. from this vantage point now is commissioner i can tell you a certainty that fda is a mission driven organization motivated by unique core. there's a shared sense of public health mission that animates the agency's work and it may cranked in some quarters to say that your job is to protect and promote the public health, but that fda people voice this call to duty without a hint of irony. it is the spirit of mission that inspires us. when people want to know about the agency can and they often ask how we achieve our mission and most go directly to understand the one that we do. that is the wrong question to ask at the right question to ask him the latest fda do what it does. i want to focus my remarks on why an 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 why i start by asking why haven't fda at all. we haven't fda to help make it easier for people to be a parent or caretaker and improve their lives. the ft 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 technologies that can provide with meaningful choices and they face serious illness and hope that they can cure disease or more reasonably management and protect them from harm's. that describes the foundation of american public health. simply put, our mission in the mission of public health is to help people live up to their full potential. that is to advance the health of our nation and this influence essential to our flourishing. the question of why we do what we do essential to the organizational policy reform we are undertaking an fda when it comes her medical product review programs. i want to highlight one idea today that brings broader changes underway in organizational approach to new medical product review. we are changing how we organize ourselves as part of the medical product review process in moving away from a structure that had people working in this organizational unit that operated as independent entities rather than a team that function together to share best practices and knowledge. instead we are evolving to a more team-based approach. this approach will integrate people from different disciplines and across different stages of lifecycle products from post-market phases working towards a common public health goal. in most cases that go will be the review of a new product with the ultimate goal is to facilitate a team environment with a deep understanding of these products across the full continuum of the trade 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 where they can take over stewardship of products over their entire lifecycle from the initial product to review by fda to the approval from safe use of a product by patients and providers. our experts are clinical and scientific officers. they must have a stewardship over the product they evaluate that extends throughout the lifecycle. that is their commitment to public health. connections between the products are regulated ones who seek to improve over time is what has brought many to fda. the benefit people drive to the new product effort and the risks they might encounter in the ordinary routine of clinical medicine is our shared responsibility and obligation. it's the outcome that expresses why we do our work in the same commitment as directors before the product is approved are equally important after it's 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 the product lifecycle rather than just one stage. part of our effort to modernize the structure of our review team is as much a cultural change as it is an organizational one. i'll focus on this changes first as they relate to medical devices with modernization embodying the creation of a total product lifestyle of the center to right center. this new structure will consolidate many current aspects of product review into a new team-based approach. our clinical and scientific staff is comprised to go experts in their fields to maximize their effectiveness and efficiency and fully leverage and integrate knowledge and expertise into product review and changing from an individual centric approach to a team-based approach in its key the organizational structure support the surface but that's not always the case today. instead the current organization often fosters intellectual and managerial silos. it splits premarket and post-market functions into separate offices that don't always talk to one another as much as they should. it places staffing to hierarchical structures and management chain. this makes it more difficult to share information and to hand off work between offices. for example between compliance officers and premarket experts often expert input across different parts of the review functions sought through consoles rather than ongoing dialogue offered as part of an integrated review team. one of the key purposes is to make information sharing easier. compliance officers and other experts will look at the total lifecycle rather than different staff in different devices that different stages of development and commercialization. regulatory oversight will span the continuum of premarket and post-market functions and product evolution. the aim is to make sure that the people with expertise in our product works can also inform those monitoring continued performance after it approved the use by patients and vice versa. also pursuing similar organizational changes when it comes to new drugs. modernizations have the same public health goals as those in a new effort related to medical devices. under leadership of dr. janet woodcock is structural changes to address the new science is changing the nature of how drugs developed. the sender is piloting the creation of one common share at review memorandum. this will ensure early disciplinary interaction among clay nations tendency is an important product review. these interactions have become more critical because genomics, human factor analysis, advanced modeling and others have become integral parts of the drug review process from a single review memorandum will be much more accessible to the biomedical research community. at the same time, value and encourage them or disease specific offices as part of a modern approach to the office of new drugs. the goals are to provide stakeholders to a single point of contact and allow synergies and search capacities within offices. the broader community measures product to relieve diet review goals. these are the timelines that embody our deadlines negotiated as part of the agreement. these are important metrics for measuring organizational efficiency and we intend to hit these commitments that they are know it's a good approximate for public health impact hitter and i can best be measured by the completeness and quality of our scientific work before and after a new product is approved in my safe and effective use of medical technology would help facilitate and how we advanced products that also hope that also hope it means people's health. the central tenet of these new team-based approaches is to increase disciplinary collaboration principle is to make sure decision-making in every stage of products review is more fully informed by scientist clinicians with discreet and deep areas of expertise. this gets me back to the why of our mission. it isn't simply to mean a bowler to prove more novel products. it is to make sure we have meaningful impact of people's health and positively impact their lives. the impact of our work is becoming especially palpable as we see more products come to market that has transformative curative effects of mixing diseases. the why of our work is deeply expressed in a lot of other areas of our portfolio. the most prominent i believe are fda's efforts to impact america's crises of addiction. this goal is clearly embodied in her new initiatives on regulation of tobacco and nicotine. the nicotine in cigarettes doesn't directly cause tobacco-related cancer, lung disease, but the power printer and powerfully than of combustible cigarettes makes tobacco use delete cause of death in the united states. putting nicotine that strategy in taking steps to render combustible cigarettes minimally nonaddictive to prevent future generations of kids becoming into cigarettes the deadliest form of nicotine delivery and we set our goal is to issue an advance notice of proposed rulemaking related to the regulation of nicotine before the end of this year. at the same time we put through an appropriate series of regulatory deep commitment technology emerging that can deliver nick team to those who still want or need satisfied levels of the drug or enable them to get nicotine through products that may pose a far less risk smoking combustible cigarettes. we need to make sure new products like electronic nicotine delivery systems are properly regulated. for example if they claim the product modifies the risk to users they must prove they can reduce risk if they want to make those claims. also focused on another devastating addiction crisis committee addiction to opioids. as you know this is a top priority of the trump administration. fda has an important role to play over every aspect of this crisis. two of our key obligations or the influence on the rate of new addiction and impact on the availability and use of treatments that can help people live life through sobriety. we know many people have become addicted to opioids will become medically addicted on their first exposure will be three lawful prescription. for most people doctor's prescription will be for immediate release formulation of an appealing drug. science-based evidence shows the key to reducing new addiction is exposure to appear drugs in a clinical section. an insurer durations of defense. we released a notice with the process of fda to evaluate and implement steps to reduce exposure to the opioids through prescribers. some of the steps evaluating or how we require doctors to be educated in regulating how products are packaged in doses makes an indication among influences we believe we can have unbending the rate of new addiction. as another part of our work to address the appear at epidemic, we reconsider how we address risk and benefit to make sure we take appropriate measure with risk and abusive appear drugs all part of our pre-and post-market review. as one part of the effort we requested early this year that endo pharmaceuticals withdraw this reformulated from the market based in her analysis of the risk associated with the use . they are participating in every lunch at the old version that endo had previously withdrawn from the market when the monster formulated version because the older version didn't support to have teachers. i know one mistake know one is fake about her regulatory intentions with respect to any drug, but i want to address oxymoron phone more generally. to firmly evaluate other oxymoron phone and not give ingredient in certain appear drugs make you more likely to be abused another scheduled to opioids including snorting an injection. i'm announcing a study for the first time today for the scientific results demonstrate this ingredient has qualities than make you more likely to be abused, fda will consider taking regulatory action that could limit patient exposure to oxymoron phone. in closing, the aim of the organizational policy changes i discussed today empower the efforts of fta with the primary objective in mind to fully engage and inspire their work day in and day out with similar public health challenges. our goal is to make it simpler for scientific permissions to pursue and accomplish these goals by working as teams by sharing different expertise will be more closely aligned as an organization for a common ambition to enable people to have more opportunities to enable products to improve their lives. that's the one of our work come in the common thread that links our shared goals is the principle that underlies our mission. thanks for the opportunity to join here today. [applause] >> thank you, dr. gottlieb. we have some questions from the audience. one company vardy implemented a lot of changes by the fta to ease the drug and device development process. the more changes coming or have your are doing out those plans? >> we've talked about the drug and medical device process more efficient. more of all enemies are reviewed within a day and these days in the amount of time we spend and we could all have an impact trade to make sure the process related to the medical technologies as efficient as possible. looking at medical trials come in the requirements that are being imposed on sponsors and investigators, we are incorporating good science into those conducting clinical trial methodologies to make it efficient as possible so we're not adding cost to the development process and not getting a return in terms of better insurance. the fda is driven by fda requirements. are things they can do and how it lays out its own guidelines that can help drive efficiencies in the process. we laid out some of those come elected issues on how we can improve the clinical trials and better incorporate things like registries and historical data. some of the scientific reforms we can start to better incorporate into the development process. we will have more to say on that. more policy would away out in the future but we think there might be things we can do it from the standpoint of the agency structures to review process to make that process more efficient. for example we'll be putting putting on a treated product and guidance is on the new drug side of the house pretty sure they before the end of the year to address different diseases and they think the layout more modern approaches to how people can develop products against those disease areas. >> could you give us a small preview? >> five of them will address various neurological disorders, many of which earned her medical needs of the others will address discrete diseases and other areas. >> okay, very good. >> how is the chronic shortages you are trying to accomplish? >> we recently announced a hiring pilot to try to address the challenges particularly when it comes to expertise that the h.r. process can sometimes be slow. clinicians who have a lot of expertise might now wait six or eight months for fda to work through a price tag. the goal is to try to rent the process much more efficient so we can move quickly on new hires. we focus that initially. we thought that was an area where we could try out a methodology with respect to how we would approach hiring. we've made a lot of progress and we will go out next month to highlight some of the progress we've made in to the extent that our successful approaches, we'll then tried to expand that. we've got a lot of new authorities they gave the fda targeted hiring authorities to bring on people with certain kinds of scientific expertise including the ability to pay people additional salaries that is particular to an area of science fda needs in one of the challenges we face going forward is the kind of products we are asked to evaluate are so complex that there is a smaller subset of people nationally to have the expertise sometimes required like jean therapy, some of the new technologies and the ability to have some additional resources we can talk her in very discrete areas will be a real added value. we are grateful for congress were designing the pathway. >> on drug pricing, some members of congress have once again brought up the idea of importing cheaper drugs from canada. has the fta taken a look at this answer doesn't plan to since the fta can make a decision to be clear on reimportation? >> undercurrent want from the secretary secretary of health and human services can make a declaration that drugs that would be reported in a broad fashion can be imported as long as the secretary can certify it will not have an impact on safety and promote access. it is something satisfactory at no secretary will make that determination both republican and democrat. we haven't taken a look recently. we certainly what if we were asked to. the challenges that are faced fta in the past in terms of what is contemplated this question particularly the issue around the supply chain of counterfeit drugs have only grown and increased the challenge to operational in such a thing. if we were asked to go we certainly would reevaluate the question through republican and democratic administrations >> thank you. what have you heard so far from tobacco companies about a plan to eventually reduce nicotine levels in cigarettes to non-decalogue and what is a realistic timeline for the effort? >> well come i haven't spoken to industry. we are announcing soon so might as well do it now that we are having meetings with stakeholders in this community, so that will include public health groups who have a long history working at tobacco control, some of the trade association, the a small subset of some of the large companies as well. no we are the rulemaking process when we do promulgate the rulemaking, we will start with stakeholders in here from the listening sessions, so that will be my first opportunity to hear directly from some of the companies. all occurred so far as what i've heard in the price thanks to all the journalists in the room. in terms of the timeframe, i will just say when we announced the policy at the outset of what we set our goal was to have areas notice of proposed rulemaking addressing nicotine and combustible cigarettes before the end of this year, i believe we will stay on schedule. michael lives in the hope is we will be able to publish an advance notice of proposed rulemaking before the end of this year. >> in an op-ed a few years ago he criticized the expansion of tobacco regulation to the making of high-end hand rolled cigars saying it would be beyond what congress had a vision and would threaten small businesses. do you still believe there should be an exemption for premium cigars and how can the agency make sure they are not regulated in the same way a cigarette? >> i vaguely remember the article. i'll let you have that characterization off the op-ed. this isn't a copout. we have said that we are going to issue an advance notice to ask questions in particular around cigars, premium cigars. the newly deemed products. all the regulations include things like electronic cigarettes and cigars. once they were deemed they were subject to certain regulations restrictions on sales to use such requirement on labeling, gmp facilities. we are continuing to do that. we pushed off product application deadline for certain products. in particular to allow the ends to continue to advance while we got the foundational regulations that define how we require product because the feeling was at the same time minimally or not addicted and regulate nicotine and people who still want to get access to nicotine and the ends do offer one possible alternative that could potentially be safer. i say potentially impossible because there needs to be put through a case of nuts and we intend to do through the product application process. the regulations will advance are going to lay out what the product application processes. the foundational regulation would never put in place and so we'll take the time to put those employees so we have a firm foundation on which to regulate. with respect specifically to premium cigars as part of our notes that, we suddenly put on demand notice to ask questions about whether or not the patterns. we plan to issue a shortly in the recently published an analysis the agency did with respect to the question part of the questions we asked, but i won't answer the question but the rulemaking process. [laughter] >> zero. edition for obesity epidemic. which one keeps you up at night? >> look, it's hard to equate one dramatic health public challenge with another. i know when they get into a position of trying to say this is worse than this. everything is horrible if you are the families suffering from one of these public health challenges. i will say video. epidemic is a unique threat to the country and requires very dramatic action to get in front of this. they think we watched over a 10 or 15 year. this epidemic growing proportion even as we try to take measures to intervene in various ways the epidemic was always five steps ahead of us and always growing well out of proportion to what anyone anticipated. to try to get ahead of it now i think we need to be willing to take much more dramatic action come and be much more potentially intrusive than what we thought we might have to do and what would've been her comfort zone five years ago or 10 years ago. having failed to intervene hard enough cover perhaps at times when we would have had an opportunity to call the epidemic and i was at fta for part of this time and was part of the people and government in a laziness to consider what action would've been appropriate appropriate, but having failed to recognize how would growing proportion of annuity to be willing to be far more vigorous and we don't continue to make that mistake. >> among those vigorous actions coming u.s. by 10. be pulled from the market for the risk of abuse being higher than its benefit. are you asking more companies to do the same? >> obviously i will not speak to individual products and specific issues. i will say we are looking much more closely at the question of the abuse of the component of how we look at risk-benefit. i'm not going to try to relitigate the agency's posture historically and whether it was or wasn't looking at this question. i will sort of tell you going forward this is going to be a more prominent part of how we think the risk benefits when it comes to appear in particular scheduled drugs, but appears in particular. what made the decision to ask for the withdraw unique was that it was based solely on a consideration of the illicit use and the way that was relative to the way others were being used was creating unique risks. its formulation when do is inject dave turner reformulated and abused it was causing ionian phenomenon and we chose to believe that product because of the way the products had to be manipulated to be abused on that software towards abuse through injection route. the epidemiological proportions had led tragically to outbreaks of hepatitis c and hiv. so that regulatory action was based solely on a consideration of the risks associated with the illicit use of that truck coming out with the labeled use of that product. >> thank you. you said you'd be meeting with insurers to talk about limiting the number of upgrade prescriptions people can get. how have those talks gone? you expect fta to have any guidance to appear at labels? >> they've also been having discussions with provider groups and i think we've put out register notice on how we might take steps to try to better effect how drugs are dispensed. there's different constructs we could potentially pursue too late to how we can change labels come in packaging. let me give you a hypothetical construct and know it's dangerous to give hypotheticals, though we talk about the packaging is one vehicle. but somewhere the construct were immediately formulation of opioid utilization is immediate release. vicodin, percocet. most people first exposure to opioids should be an immediate release formulation if they become addicted they will move on to start to manipulate them in line to an alternative which are increasingly street drugs. think of the world who we may package immediate release formulation and three, six to nine day packs like sometimes you take fort antibiotics or prednisone packs and so you might dispense opioids in packs the compartment clinical guidelines on what proper dispensing should be. we work with the dental association for other physician groups to develop expert guidelines on what dispensing should be for clinical procedures and incorporate that into labeling and then we used that as a way to help manage what gets dispensed to two indications. that's a world where you can see trying to line up the way drugs are packaged with expert guidelines on what the proper dispensing should be. then you might be able to marry that to an educational requirement that if a doctor once prescribed to see patients with chronic pain conditions. maybe at that point you start to see how these different things that we are thinking about packaging, working with provider groups to develop expert guidelines, working with groups that can have educational requirements to marry up into a more comprehensive scheme if you will that might be able to get us to a place we can do to rationalists prescribing to the tools. >> thank you as the president has an executive order mandating each deregulation must be accompanied by his regulations. how has this impacted the fta? >> each deregulation that cause. a lot of our regulations are deregulatory actually in terms of how they get gored that a lot of times when we issue a regulation, we are updating standards in a way that actually potentially create efficiencies and development process. wiki regulated by issuing regulations and something unique about it today. this isn't some magical construct. this is basically fda's case that a lot of our regulations let in the basis of whether or not the regulatory and add to costs are deregulatory insofar as they will help save money. a lot of regulations historically have gotten scored his regulations that save. to the extent we have regulations that add to cost for the costs outweigh the benefit, that's basically what the cow when you do the economic analysis. i feel comfortable we are going to be able to find ways to marry things that we might think are outdated and might want to potentially withdraw things with advanced regulations that are going to cost money with situations where the costs will outweigh the benefits are regulations that we believe there's an overriding public health purpose of advancing the regulation. we have a lot of regulations from the 1970s and 1980s they are not even relevant anymore and just sort of ignored and not followed. we regulate areas where we might create efficiencies where the fta might rethink its whole paradigm. we publish regulations probably hundreds of regulations or standards of identity basically recipes for how you develop certain foods. a recipe for what peanut butter needs to be to be called peanut butter, but mayonnaise needs to be to to be to be called mayonnaise. those are very important because they provide a foundational element for halliburton products are made. peanut butter has to have peanuts in it. some of them are things that have used this example before. we have a regulation for cherry pie. that is something we may be a look at. i'm not sure if he has a about this other public health issues needs to be redefined as a standard for what caused tickets cherry pie. some is good and there should be a crest. the >> but does there really need to be a crest? switching topics a little bit. any thoughts on the gop tax bills are particularly repealing the orphan drug? >> i'm not going to drive outside mailing. i've seen reporting on it. i haven't taken a look on what the specifics are. i'm not going to comment. >> birth control is over-the-counter in many countries. wife the fta not improved yet to ease access for women? >> this is a question that's come up in the past 10 presidential candidates on the side of the aisle that have advocated earth control. best i know this question hasn't been too advisory committee in. i don't think this is something that's been put forward in the way with advanced through the agency. they know the past provider groups have been against it. i don't know where they stand today, but like any other application if we received request bonus which we would evaluate the same they would evaluate anything else. >> as a policy cover the fta does not comment on any policy currently under review. as a result, the company behind the product is the only voice in how their product is performing which means they can say its privacy interest in the approved and there's no way to verify that. how can they address this issue? >> that is not entirely true because if the product's what is relevant from a public-health standpoint, what is relevant is the investigators are made aware of information that could be relevant to the patient involved in the trial as well as the irb in the irb has information made available to it when the investigation is informed of some feed us have been. there is a process in place that protects patients enrolled in clinical trial. there's a larger question i recognize. a question of if it products under review and have put it in the context of the product that could inform on the market that do similar product shows patient on a similarly marketed product know that and they learned in the context of a product under review might tell them something important about a product they are using. in that case again we have the ability to inform the public with the public health advisory that you learn something in the context of the clinical trial that is relevant to a market product. thursday start element to this with respect to investors and they expect the question came in that context they make claims about performance in clinical trial to the investment community could investors be misled. here again there is a construct in place to speak to the issue. cf. da routinely a dialogue with the sec. the dialogue is sometimes initiated by representation and management will make with reported untruth and i know that there have been fcc actions taken on the basis of referrals that have been made by fta. >> here is a company specific question. a little tougher. did he respond to people concerned that your ties to industry could give device makers and drug companies too much influence. >> my experience working on the venture capital community to develop and small companies come the new technologies as well as my experience currently and in the past working on the regulatory side has informed my dad in ways that i think are helpful. others can judge that differently. i judge it in a certain way. i feel that i drop on my experience of the private sector of the time in terms of how the challenges are inside the agent d. as far as relationships and whether or not relationships in the past are influencing the current work, obviously we been vigilant about respecting recusal than as a matter of routine, it is rare that i take meetings with individual sponsors. i think my public calendar demonstrates that it's wrote adjudicator be in the process of issue. generally what i work on in this broadway thinks someone in this role should be worried about and working on these matters of broad and general policy that can affect a lot of lives and there's a lot of them. i try to focus my question and make sure i use my own personal resources but that's very spent my time. >> you said you would recuse yourself with relationships with. the question is why just one year. why not for the whole time? >> well, the one year was out of the ethics pledge. i've complied with all the requirements soon be including the ethics pledge to turn the administration of saul political appointees to sign. the ethics pledge which was obviously signed after he went through the whole confirmation process because you site your first day on the job has recusal requirements that exceed one year. i would encourage people to look at the because it's so fully informed because the new ethics requirement does what it requires the people appeared to make you believe that he should have authority to regulate prices of therapies as well as safety and effectiveness? >> this gets to the question of drug pricing. i is that i think fta does play a role in this debate and i said that i think it should have access to the extent that pricing affects issues of access. i think i think the agency ought to concern itself with. we've been on this debate looking at ways we can promote competition and market. we've talked a lot about what we are doing on the jitter trunk side to affect that. also things we do of the new drugs impact that, looking at areas where there is a single source drug in things we can do to promote competition in those categories so if you have a monopoly in the company has an innovative therapy in the market that enjoys a period of monopoly profits because they've done something highly innovative company specially delivering to patients in need, but also competition in those categories. to the extent we can promote competition, we'll be looking at those things as well. a lot of our early work is focused on trying to promote more generic competition particularly around places where is the brady company is in ways that forestall competition. situations for exclusivity has generic competition entry the market because companies have adopted for tactics that prevent the competition from entering the market. the one i'm most concerned about a situations where a seabird companies taking steps to block generic companies from getting access to the doses to actually read their bio privilege studies to apply for generic approval. yet we have a system created with companies to get to the murky you have to approve the study and file it with fta and the company said it will do the studies and make the investment illegal it into the market with their own cash and they are willing to pay for market value to buy the drugs and run the comparison studies indicate that the drug if they adopt the tax base to prevent them from getting access to those drugs. i think that's a real problem and we've seen some of our own policies be used in ways to do that, to frustrate god. the risk management plan we impose and require companies to provide the safe use of a product being used also to block that and it takes anywhere between 2,005,000 doses to compare your generic drug to the brand of drug. the other place we see the effect to these don't follow through the direct purview of fta. we seabird that companies selling drugs to a very tight supply chain through single specialty pharmacy with a control that the drugs can be sold to it have we believe, i believe, let's say i believe they have rules in place that make it difficult for the pharmacy or the distributor, whoever it's easily the drug to make a sale to a generic company or sell at a bloke fashion a generic company. looking at things who might socialize that wouldn't be fta's purview, but i'm certainly willing to think in ways we could collaborate to address this. who he obviously has an agency that try to promote access and competition for the safe and affect these have an interest in saying we want companies to come to us and filed the application that if they come to us as many haven't said we can't get access to do it even though we are willing to pay full price, that is a problem. we've talked about allowing him to go to europe to buy the drugs, though we are going to look at this question very hard. >> great. some medical device esa potential cybersecurity is at issue in others say it's a matter of time before someone seriously hurt or worse. what is your take on this issue and what you're doing about it? >> we put out information that would encourage everyone to look at it. we are undertaking and to address this. upwards of 90% of medical devices. they have some component of the cybersecurity evaluation. we are working to sponsors and guidance of how they can evaluate the network security devices and we are encouraging the sharing of information that can inform how they could develop products that put in place safeguards to address this vulnerability. we are well aware of it, concerned about it. we've been pretty provide is trying to address it as a component of how we go about evaluating medical devices. they watch totally and with a pacemaker. a lot of times this relates to larger medical that may be in hospital and released two issues have been able to bring down a device so it's not available rather than just performance can actually take it down pete doocy that in certain situations. this spins a pretty big continuance of potential concerns. >> okay, before the last question i have one programming note. sorry, i reach across you quickly peered at the national press club we invite you to please join us on day. we will be hosting a luncheon at the u.s. secretary veterans affairs committee david chilton. so please put that on your calendar. >> i noticed that david sold out. a big red x over his face. at first i thought i read accidents that i'm glad i did get a red x, but then i saw what it meant. >> people are curious. this is a very good crowd as well. this is great. last question. so, you use to make your own syrup and now you raise chickens. why is that? are you manufacturing unregulated vaccines on the side? >> so common that maple syrup operation is it subject to fda regulation because they don't do it in a facility. if you look at the regulation. with the eggs to chickens, we don't regulate the chickens in the eggs we only regulate this i just want you to know i comply with all the regular tramples. we like fresh eggs in the kids like it so it's a lot of fun. we enjoy it. >> thank you. before you leave, we would like to present you with our mug from the national press club. every speaker gets when. we hope you use this in good health. [applause] thank you. >> thank you. >> and that concludes our luncheon today. thank you everyone for coming. [inaudible conversations] c-span, or history unfolds daily. in 1979 c-span was created as a public service by america's cable-television companies and is brought to you today by your cable or satellite provider. >> you are watching booktv on c-span2 with the top nonfiction books and authors every weekend. booktv, television for serious readers. >> it's thanksgiving weekend on booktv. this holiday you will see many recent book fairs and festivals including the national book festival and the brooklyn book festival as well as past in-depth programs with eric metaxas and lynn olson, last weeks national book awards. also this weekend on our afterwards program christopher bedford examines donald trump's leadership as a businessman, politics

Related Keywords

United States , Canada , Washington , America , Lynn Olson , Dave Turner , Heather Lieber , Kathleen Quinn , David Chilton , Andrea Snyder , Scott Gottlieb , Betsy Fisher Martin , Jim Spencer , Lisa Matthew ,