Timbre, founder and chief strategist, carly mcwilliams, Senior Advisor to the fda commissioner, waring, a washington correspondent with usa today. Jennifer rodriguez, dena, medicine and health editor, kathleen quinn, Senior Advisor to the fda commissioner. Here, we have lisa matthews, Vice President and coleader of the Headliners Team. We have bill pierce, senior director of the National Press club headliners who organize todays event. Allison, how policy for an pr, jim spencer, a correspondent to the star tribune. Doctor charles snyderman, health and science correspondent for audio video. Thank you for joining us. [applause] want to take a moment to acknowledge members of the Headliners Team responsible for organizing the luncheon, betsy, laura, heather, and lindsay. Thank you all. For cspan public radio audiences, please be aware that in the audience today are members of the general public. Any applause or reaction even here is not necessarily from the working press. So, being a successful commissioner of the u. S. Fda requires a combination of skills not easy to find. The fda requires experts in medicine and health. It is a Government Agency so require someone who knows how to navigate washington. They regulate business and 25 of the consumer goods sold. It requires someone who knows how the private sector works. Was about 17000 people, and need someone who knows how to manage a large and diverse organization. Doctor scott gottlieb. The 23rd fda commissioner has taken on this challenge. He is known government from the inside. From 2005 to may 2007 he served as the fda Deputy Commissioner for medical and scientific in 2003 to may 2004 he was a Senior Advisor to the fda commissioner. In his work he worked on implementation of the medicare drug benefit and a Senior Advisor. In 2013 he served on the Health Technology committee which advises the committee of health and Human Services immediately prior to his current appointment was a resident fellow at the American Enterprise institute which looks so government can efficiently and effectively interact with the private sector. His clinical professor in manhattan. He practiced medicine as a hospitalist physician. Many the of the issues are not new to him. Hes authored commentaries on healthcare for publications including the wall street journal, washington post, and scholarly journals. He has experience working with healthcare companies. He graduated from Mount Sinai School of residence. Center graduates from Wesleyan University where he studied economics. Kids said the agency should increase efficiency and consistency, adjust the opiate crisis and increase competition to make pharmaceuticals more accessible. These and other matters or issues crucially important to the country. The speed to which the fta deems drug safe and allows them to reach people who needed change peoples lives. Were honored to have him here with us today. Thank you. [applause] thank you, i appreciate the opportunity to be here. My apologies for canceling my earlier appearance. I had to travel to puerto rico that dan urgent business to assess the impact of Hurricane Maria on our facility in san juan the people of puerto rico. When i arrived there, i witness the motion of the staff. When a team member and nobody had heard from since the storm showed up for the meeting, the colleagues have feared the worst in their overtime to see that she was unharmed. She was tending to her own destroyed home and family. The distraction was profound and widespread. The stories i heard from the team is very clear, they also their purse, they been working day and night to help manufacturing get restarted. As homes were destroyed our team has made 130 visits to help sites get restarted. There are able to make contact and 113 cases. The Monumental Task given the challenges they face moving around the island of the personal challenges they face at home. Prodded their effort and moved by their dedication. I have been at fda for six months as the agency commissioner. I am not new to fda. This is my third time serving. I have held three different positions at fda during the past 15 years. In between my roast i worked in the private sector. The chance to see their work on the inside and outside shaped my approach and my perspective and understanding of what inspires fda submission. Now is commissioner fda is a Mission Driven organization, motivated by a very unique court. Theres a shared nice our claim to say that your job is to protect and promote the Public Health, at fda people process without a hint of irony. When people want to know about the agency they ask how we achieve our mission. They wonder what is it that we do. The right question test gives why does fda do what it does why does fda do the work that we do to describe the heart of our mission. To understand fda is to understand why we do what we do. We need to start by asking why havent fda at all. To help people to make it easier to be a parent or healthcare provider. To give people access to safe and effective technologies that can provide with meaningful choices when they face serious illness. And maybe they can manage a chronic disease protect from harm. It 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. This influence is essential to our worship. Why we do what we do essential to the organization of policy reforms. When it comes to medical product reviews i want to highlight some ideas that brings to life changes underway in our approach to new medical product review. Were changing how we organize herself and moving away from us structure that had people operated as independent entities rather than a team potion together. Instead, were evolving to a team based approach, will integrate people from disciplines across different lifecycle work product. In most cases, the goal be the review of a new product, the article is to facilitate a Team Environment that fosters a deep understanding of products across all phases. I believe the changes will elevate the role of our clinical scientific experts to take a universal view. I will from our stewardship from the initial product application to its review by fda, to the approval and safe use of a product. Our experts must have a stewardship over the products they value it that extends from the lifecycle. Is there commitment to Public Health. The connection between the products in the lives we seek to improve his or prop many to fda. The benefit they may get in the risk the main counter with medicine is our shared responsibility and obligation. The outcome that expresses why we do our work. The same efforts that stern efforts are equally important after its widely available. People to extend their expertise rather than just one stage. Part of the effort to modernize the structure is as much a culturalist changes citizen organizational one. A focus on these changes first. This is a structure will consolidate current aspects of product review into new team based approach. Our staff comprises some leading experts in the field. To maximize their effectiveness and efficiency and leverage into product review were changing from an individual centrics approach to a team based approach. Its key that organizational structure supports that. The current one often has different silos. It splits preand post market that dont always talk to each other. It places staff into hierarchical structures. Makes it more difficult to share information and handoff work. Between our compliance officers and premarket, information is sought through councils rather than on going dialogue. A key purpose of our new approach is to make information sharing easier. A look at the products total lifecycle. Regulatory oversight span the continuum of preand post market functions and product evolution. They missed to make sure people with expertise can inform those whose monitoring the performance after its approved use for patients. Pursuing changes when it comes to new drugs, have the same Public Health goals as those embodied in the new efforts related to medical devices. Evaluated a series of structural changes to address how scientists change the nature of how drugs are developed. Theyre piloting a creation of one shared memorandum. This will ensure interaction among scientists of Specialized Knowledge of diseases. These are important because these fields have become integral parts of the drug review process. Single review memo will be more accessible to the Biomedical Research community. At the same time the goals are to provide stakeholders with a single point of contact and allow synergies and search capacities and offices. The Community Offers this through its adherents goals. These are timelines embody buyer deadlines negotiated by these agreements. There are important metrics and we intend to hit these commitments. Hiring pet can best be measured by the completeness of our work, before and after a product is approved. By this technology and how were advancing projects that help advance Peoples Health. The central tenet is to increase cross disciplinary collaboration. To make sure decisionmaking at every stage is fully informed by scientists and clinicians with discrete areas of expertise. Our purpose is to make sure were having meaningful impact in Peoples Health and positively impacting their lives. The impact of our work is palpable as we see more products coming to market that have transformative and curative effects of vexing diseases. The most prominent, i believe in our efforts to impact americas crisis of addiction. This goal is embodied nicotine cigarettes doesnt directly caused tobaccorelated cancer, lung disease or heart disease, but the addictive nature of the delivery makes tobacco use the leading cause of preventable death in the united states. For taking steps to render combustible cigarettes minimally are nonaddictive. It could prevent future generation of kids from becoming addicted. We set our goal is to issue advance notice and rulemaking before the end of this year. Putting through new technology thats emerging that could deliver nicotine to those adults who still want or need satisfying levels of this drug but enable them to get that through products that could pose far less risk than smoking cigarettes. We need to make sure these products are properly regulated. If they claim it modifies the risk to users they must prove that. Also focused on the addiction to opiates. This is a top priority of the Trump Administration. The fda has Important Role to play. Two of our Key Applications they influence on the rate of new addiction and the impact on the availability and use of treatments that can help people live lives of sobriety. Many people who become addicted will become medically addicted in their first exposure will be through a lawful prescription. Science based evidence shows the key to reducing addiction is reduce the exposure to appear drugs. Making sure fewer are given. Coordinate evaluate and look at steps, some steps are evaluating are how we require doctors to be educated and how doses are dispensed. Its another part of our work to address the op at epidemic were considering how to address risk and benefit to make sure we have appropriate measure of the risk associated with the use and misuse of the drugs. As one part of that effort we requested that end of pharmaceuticals withdraw from the market based on the analysis of the truck solicit use. Recent reports say and does participating in a relaunch of the old version. This is a version they had previously withdrawn. I dont want to speak about regulatory intentions but i want to address some products more generally. Fda previously commissioned a study to see if oxymoron from an active ingredient has qualities to make it more likely to be abused including starting an injection. Ive seen the study for the first time. If the scientific results demonstrate the ingredients have qualities to make it more likely to be abuse. Fda will consider regulatory actions that could limit patient exposure. The aim of the organizational policy changes is to empower the scientists with the 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 to pursue these goals by working as teams sharing different expertise will be more closely aligned along a common ambition and to improve their lives. Thats the why of our work. The Common Thread that links our shared goals. Thank you for the opportunity to join you today. [applause] thank you. We have questions from the audience. Youve implemented a lot of changes that the fda to ease the development process. Other more changes coming . Talked about trying to make the drug a medical device process more efficient. When i talk about review times here. Review efforts to 90 the dates are aggressive in terms of the amount of time for the application. We can impact by trying to make sure the processes are as efficient as possible. Looking at requirements and were incorporating good science into those to make it as efficient as possible so are not adding cost and not getting a return in terms of insurance and effectiveness. Theres things the fda can do i think in terms of how it lays out its own guidelines. Played out some and looked at issues how we can incorporate things like modeling and simulation, holy case registries and data some of the scientific reforms we can incorporate, but will have more to say. Theres more policies we will lay out in the future. More importantly, the kind of guidance we give to make the process more efficient. Well put out products on the new drug side of the house shortly before the end of the year. New guidances will address new diseases and layout more modern approaches to how people can develop products against those areas. Five of them were just neurological disorders. Many of which are unmet medical needs. How is the chronic staff shortage impacting goals . We recently announced a hiring pilot to try to address challenges with on boarding people particularly when it comes to those with scientific expertise. Clinicians have a lot of expertise might now wait six or eight months for fda to work through the process. The goal is to make that process more efficient so we can quicker i new hires. Weve looked at the medical review slots, that was an area we could try out a new method, i think we pay progress and will be reporting our results soon. And to the extent that those are successful approaches tom boarding people will try to expand the agencywide. It had new authorities and a curious act that gave fda targeted hiring authorities to bring on people with certain kinds of scientific expertise, including being able to pay them extra if they have an expertise particular to an area that we need. One of the challenges we face is the products were being asked to evaluate her complex others a small subset of people who have the qualifications. So the ability to have resources to target and nonpoor people with expertise will be added value. Contract pricing, some members have brought up importing cheaper drugs from canada. Has the fda take a look at this or does a plan to since they can make that decision. The secretary of health and Human Services can make a declaration that drugs would be imported on the broad fashion can be imported if they can certify it wont have an impact on safety. I dont know the exact language around the. No secretary has been able to make that determination. We havent looked at that question recently, we would if we are asked to. The challenges that face hefty in the past when its looked at this question theyve only grown in proportion and increase the challenge to operationalize a thing. But certainly reevaluate the questions as others have including during the bush administration. What have you heard so far from Tobacco Companies about reducing nicotine levels in cigarettes to nonaddictive levels and when is the timeline . We will announce soon will have meetings with stakeholders in this community. Public Health Groups who have a long history working with tobacco control, some trade associations in a subset of the larger companies. Another wave announces process when we do look at the rulemaking will take meetings with stakeholders. Thats my first opportunity to hear directly from some of the companies. In terms of a timeframe, we announce the policy who said her goal is to it be as before the end of the year i believe we will stay on that schedule. My goal and hope is we can publish the rulemaking before the end of the year. A few years ago you criticized an expansion of tobacco product regulation to the making of highend cigars saying it would threaten small businesses. To believe there should be an exemption for premium cigars . And if so how can that agency make sure the regulated the same way. Already have a characterization, but i would say weve undertaken a process were going to issue an advance notice to re ask questions in particular around premium cigars. All the regulations that apply to the new products go forward. That includes things like Electronic Cigarettes and cigars solicited were deemed there have certain regulations fda does inspections of facilities. We pushed our product application deadlines for certain products. In particular, to allow bands to advance while we were defining how to require these. The same time were moving to render cigarettes minimally are nonaddictive, we need to think about what the alternative will be for people who still want satisfying levels of nicotine. The ends are one alternative. It needs to be put through a series selfregulatory gates. Regulations will advance layout with the application processes. Will take the time to put those in place. With respect to premium cigars as part of the announcement said put out an advance notice to re ask questions about if the use patterns replicate others. We will plan to issue thats shortly. We published a scientific analysis with respect to the questions we asked. The one answer the question comes were entering the rulemaking process. Circle. Injection obesity, which what keeps you up at night . Its hard to equate one dramatic Public Health challenge with another. I dont want to get into a position to send this is worse than this. Everything is horrible if youre the family suffering from one of these. The epidemi appeared epidemic ie threat to the country. Requires dramatic action. I think weve watched over ten or 15 your time this grow into proportion as we tried to intervene, it was always five steps ahead. And i was going out of proportion there would anyone anticipated. I think we need to be willing to take more dramatic action be more intrusive than what we thought we might and what will better comfort zone five or ten years ago. Having fields intervene hard enough i set fda for part of this time was part of the people in government analyzing considering what action wouldve been appropriate. Now we need to be far more vigorous so we dont continue that mistake. U. S. At one oh. Be pulled for the market for its risk of abuse being higher than the benefit. We be asking companies to do the same . I wont speak to specific issues. Looking closely at this question of illicit use. Im not to try to relitigate the posturing and whether or not they was or wasnt looking at the question. Going forward, it will be a more prominent part of how we think of riskbenefit. What may be the decision to ask for the market withdrawal it was very sorry a consideration of the use illicit use. The way the product was being abuseds creating unique risks. When it was injected and reformulated it was causing autoimmune phenomenon. We also believe because of the way the public had to be manipulated to be abused when sit more to abuse. That regulatory action was based solely on consideration of the risk associated with that truck now with a label use. Thank you. You said youd be meeting with insurers to limit the number four. Prescriptions a person can get. However those talks gone . Weve been having discussions with provider groups. We put out notices requested comments and ideas on how we could better affect how drugs are dispensed. Let me give you a hypothetical construct. Talked about the packaging is one vehicle. Lets say 90 of all opiate utilization at hundred 90 million prescriptions year as people if they become addicted though move on to higher dose and then go to street drugs. Think of old where we might package these and three, six or nine daypacks. He had blister packs and you might dispense the main packs that go with critical guidelines. Work with the dental association to develop expert guidelines what the dispensing should be. There were incorporate that into labeling and you said to help manage what gets dispense. See you can see how things should be. Then he might marry that to an education requirement if a dr. Wants a 30 day supply because of chronic pain conditions, maybe at that point you require mandatory education. So you start to see how Different Things were talking about, working with groups that can help us think about educational requirements and how they bury into more comprehensive scheme that make it a sir place where we can rationalize prescribing. Thank you. President has to do order saying each new regulation has to remove two old. Each new regulation that costs, a lot of our regulations are deregulatory because a lot of times when we issue regulation were updating standards in a way that potentially create efficiencies. This is in some magical construct, is basically our operating platform. Really look at our regulations and add to cost her deregulatory and help save money, a lot of the regulations have gotten scored as regulations that say. To the extent that we do have regulations for the cost outweighs the benefits, feel comfortable we will find ways to marry things we might think are outdated and will have to advance regulations that will cost money where the cost will outweigh the benefits. We believe theres an overriding regulation we have a lot from the 70s and 80s that are not even relevant theyre just ignored and not followed. We regulate areas where we could create efficiencies. We publish hundreds of regulations that are standards of identity that are recipes of how to develop certain foods. Some of these are important because they provide a foundational element to help rent products are vague, but some of them are things like we have a regulation for cherry pie. So something we might be able to look at. Not sure is for grappling with other Public Health issues we need to be looking at what constitutes cherry pie. Some elements of cherries is good. Switching topics, any thoughts on the gop tax bill particularly on repealing the tax orphan drug tax credit. As far as the tax credit ive seen some reporting on it. I havent taken of the look in terms of what the specifics are and what the impact it could potentially have. I will not,. Birth control is overthecounter in many countries why is the fda not approved this seas access to women. This is come up in the past. This been candidates on both sides that have advocated overthecounter birth control. I dont think this has gone to an advisory committee. Stop and put forward in a way where its advanced through the agency. Some provider groups have been against it, dont or they stand today. If we received a request we would evaluated same way we would anything else. As a policy the fta doesnt comment on any products under review. But the Company Behind the project is the only voice and how its performing. So the means they can say the fda said its a promising the but how can the fda address th this. Thats not entirely true. If a product is investigational, Public Health standpoint the investigators are made aware of it information on patients in a Clinical Trial. The irb is information to. When the irb think theres something they should know the Public Health is being protected but its a larger question. If a products under review and sums happening that come from a product on the market that similar, should it patients who are on a similarly marketed product no that one thats under review might tell them something important. We have the ability to inform the public. If we think its relevant to market product, a third element with respect to investors. If a Company Makes claims about the performance in a Clinical Trial to the Investment Community could investors be misled . Theres a construct in place that help speak to that. We do have an mou with the fcc. We routinely have dialogue with the fcc. That sometimes initiated by representations of the public market. Another has been actions taken the basis of referrals made by fda. Theres a Company Specific question, how do you respond to people concerned your ties to industry could give device makers too much influence. I experience having worked on both sides and helping develop technologies, a lot of my work was related to small companies, as well as my experience in the past working on the regulatory side it hasnt for my perspective in ways that i think are helpful. I judge it in a certain way and i feel i draw my experience in the private sector all the tim times. As far as relationships and whether or not relationships in the pastor influence in my current work, weve been good about making sure how things are going. Its very take meetings with an individual sponsor, generally what i work on in this role and what someone should be worrying about it and morning about this matters a broad and general policy that can affect a lot of lives. I try to focus my attention on places like that the most impa impact, just like im asking the agency to use their resources wisely. On recluses you said you would recuse yourself with 20 Companies Save had relationships. Why just one year . The one year was out of the ethics pledge, complied with all the requirements asked of me, including the ethics pledge the Trump Administration asked all senior political appointees to sign. The pledge was signed after i went through the confirmation process. You sign at the first and the job that has recusal accounts that exceed one year. The new ethics requirements does place a higher burden on people. To believe fta should have authority to regulate prices of therapies . This goes to drug pricing. I think fda does play a role in the debate. I think issues of access and the issues of pricing is a matter Public Health concern where we have been on the debate is looking at ways to promote competition in the market. We talked a lot about what were doing on the generic drug side to effect that. Theres also things will do looking at areas where theres a Single Source drug and other things we can do to promote competition those categories so theres an area of monopoly and enjoys profits because theyve done something breakthrough you want to see competition into those categories. To the extent will look on the new drug side as well will look at those as well. To apply for generic approval but now this system that congress created to get to the market to file then they say well do those studies and then they go out into the market and theyre willing to pay fair market value to buy that branded drug they think it is a drug with those tactics said it is a problem we have seen some policies so that we impose to place to provide for of the safety and compare that to the brand of drug but it but this doesnt fall under the purview of the fda to selling drugs to a very tight supply chain with a tightly controlled the could be sold to i believe they have a role to play that makes it difficult for a the pharmacy or distributor ended is something would be twos socialize but we are willing to think giveaways of addressing that. We had been interest in delaware kalb to us as many have and willing to pay full price that is a problem. So we look at this very hard. Some see that potential vulnerability. It is a matter of time before somebody is hurt or worse. What is your take . To summarize activity that is the pa native vice and the layout guidance with that Network Security devices period we are emerging the sharing of information to put in place the safeguards we are well aware and we are concerned about it we have been pretty proactive to address that how we go about evaluating. And that relates to the issues of what is available. So this is of those concerns. Before the last question i have one programming note. We would like to invite you to please join best for the u. S. Of Veterans Affairs mr. Shelton mark that on your calendar. If its is sold out. [laughter] but this is a great crop. [laughter] last question. Now you raise chickens why is that . Are deregulating vaccines on the side . [laughter] it is not subject to fda regulation so with the aids and chickens we dont regulate judkins sandy eggs just so you know we comply with all rules. But we like fresh eggs. [laughter] and the kids like it that is a lot of fun. So before you leave the with like to present you from the National Press club every speaker gets one. Use this in good health. [applause] [inaudible conversations] that includes a luncheon today thanks for coming. [inaudible conversations]. Tribes have sovereignty in preconstitutional existence and that is the position that the tribes take within their territory. So for example, of the ranch country that happens quite frequently. The 46 falls of is called for dakota that was to provide data marcions of safety and security. Were of one of the main thoroughfares in sioux falls, south dakota and named after one of the settlers. Takes us through the time lenovo the committee when the shot come mean it ways and Means Committee marked. The last four days they wanted to be done by thuray