The [inaudible conversations] good afternoon. Welcome to the National Press club, the place where news happens. Maybe andrea snyder, part of bloombergs 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 addin 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, aalpha 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 todays luncheon. Betsy fisher martin, laurie russo, Heather Lieber and press club staff liaison lindsey underwood. Thank you all. For cspan 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 farflung 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 20052007, dr. Gottlieb served as Deputy Commissioner for medical and Scientific Affairs and from 20032004 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 InformationTechnology 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 peoples lives. We are honored to have dr. Gottlieb here with us today to explain how hes 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 im very proud of their effort and deeply moved by dedication. I wouldve focused on the the efforts weve been undertaking when it relates to the medical Product Development process. Ive been in fda for six months as Agency Commissioner by some of you know im 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 fdas work inside the outside has shaped my approach to make her a role in shaped my vivid understanding of what i think inspires fdas 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. Theres a shared sense of Public Health mission that animates the agencys 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 havent fda at all. We havent 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 harms. 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 teambased approach. This approach will integrate people from different disciplines and across different stages of lifecycle products from postmarket 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 postmarket 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. Its the outcome that expresses why we do our work in the same commitment as directors before the product is approved are equally important after its made more widely available. We need each of our medical and scientific experts to have more opportunity to extend their expertise and leave their mark over the full duration of 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. Ill 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 teambased 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 teambased approach in its key the organizational structure support the surface but thats not always the case today. Instead the Current Organization often fosters intellectual and managerial silos. It splits premarket and postmarket functions into separate offices that dont 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 postmarket 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 its 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 Peoples Health. The central tenet of these new teambased approaches is to increase disciplinary collaboration principle is to make sure decisionmaking 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 isnt simply to mean a bowler to prove more novel products. It is to make sure we have meaningful impact of Peoples 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 fdas efforts to impact americas crises of addiction. This goal is clearly embodied in her new initiatives on regulation of tobacco and nicotine. The nicotine in cigarettes doesnt directly cause tobaccorelated 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 doctors prescription will be for Immediate Release formulation of an appealing drug. Sciencebased 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 preand postmarket review. As one part of th