Transcripts For CSPAN3 FDA Commissioner Gottlieb At National

Talks about efforts to evaluate and approve new pharmaceutical treatments. And the fda role in combatting the nations Opioid Epidemic. This is an hour. Good afternoon. Welcome to the National Press club. The place where news happens. Im part of bloombergs breaking nouz desk. Im Vice President of the club. Before we get started, id like to remind everyone to please silence your phones. For our viewing and listening audience, please feel free to also follow the program on twitter using the hash tag npc live. Now its time to introduce our head table guests. Id like to ask you to please hold your applause until all guests are introduced. And guests id like each of you to stand briefly as your name is announced. From your right, we have sarah reporter for nature magazine. Tam ra hinten. Founder and chief strategist. Mcwilliams, seen your advisor to the fda commissioner. A washington correspondent with usa today. Jennifer rodriguez assistant commissioner for media affairs. Medicine and Health Editor for scientific american. Kath lean kwin, Senior Advisor to the fda commissioner. Here we have lisa matthews. Vice president of hagger sharp. And coleader of the National Press club headliners team. Skipping over the guest for a moment. We have bill pierce, senior director of app coworldwide. And the National Press club headliners member who organized todays event. Allison fits gerald cojack. Health policy correspondent for npr. Jim spencer. A washington correspondent for the minnesota star tribune. Reporter for midtech insight. And dr. Charles. Health and science correspondent for audio video news. Thank you all for joining us. Id like to take one moment to acknowledge additional members of the headliners team. Responsible for organizing todays luncheon. Betsy fisher martin, healthther weaver, thank you all. For our cspan and public radio audiences, please be aware that in the audience today are members of the general public. So any applause or reaction that you may hear is not necessarily from the working press. So, being a successful commissioner of the u. S. Food sdp Drug Administration requires a combination of skills that is not easy to find. The fda is an expert agency. It requires a expert in medicine and health. The fda is a government agency. So it requires someone who knows how to navigate the bureaucratic maze that is washington. The fda regulates business, and 25 of the consumer goods sold in the u. S. So it requires someone who knows how the private sector works. And the fda employs about 17,000 people. So it needs someone who knows how to manage a far flung and diverse organization. Doctor scott the 23rd fda commissioner is the man who is taken on this challenge. His experience checks a lot of boxes. First, he has known government from the inside. From 2005 to 2007, he served as fda Deputy Commissioner for medical and scientific afar fairs and from 2003 to 2004 he was senior add vie tor to the fda commissioner. In his work, he also worked on implementation of the medicare drug benefit. A seen your implementation of t drug benefit as the Senior Adviser of the centers for medicare and medicaid services. In 2013, dr. Gottlieb was appointed to serve on the federal Health Information Technology Policy committee which advises the department of health and Human Services on Healthcare Information technology. Immediately prior to his current appointment, dr. Gottlieb was a resident fellow at the American Enterprise Ips Institute which seeks to study how government can efficiently interact with the private sector. And he sv dollars as a clinical professor at the New York University school of medicine in manhattan where he practiced medicine as a hospital list physician. He has authored numerous comment tears on healthcare for publications including the wall street journal, forbes magazine, washington post, as well as scholarly journals. He also has a great deal of experience working with various Healthcare Companies over the years. Dr. Gottlieb graduated from mount cyanide school of medicine where he completed a residency internal medicine at mount sinai center. He undergraduate degree is from where he studied economics. The system should increase efficiency and consistency, address the opioid price crisis and increase composition as a mechanism to make pharmaceuticals more accessible. These and other matters for which the fda is responsible are issues that are crucially important to the country. The speed with which the fda determines drugs and therapies is safe and allows them to reach those who need them changes peoples lives. We are honored to have dr. Gottlieb here with us today to explain how he is feping the fda fulfill these responsibilities. Thank you, dr. Gottlieb. [ applause ] thanks a lot. I appreciate the opportunity to be here today. I want to start by extending my apologies for canceling my earlier appearance to the press club mitt to travel down to be puerto rico that day on urgent business to assess the impact of Hurricane Maria on swann san juan and on our staff and the people on puerto rico. I can tell you whey riverside at the fdas facility in san juan i witnessed the emotion of the assembled staff when one of the team members whom nobody had heard from since the storm showed up for our meeting, her colleagues had feared the worst. They were overcome to see that she was unharmed. She had been tending to her own destroyed home and her displaced family and it was her First Contact with the fda team. The destruction down there that i saw was profound and it the despair widespread. Stories i heard from fdas team made the ongoing hardships very clear to me. They all stood their post, however. Theyve been help working day and night to help the manufacturing get restarted. Even as their homes were destroyed and most of the island remained without power, our team has made win 30 firm vis its so far to help manufacturing sites get restarted. In 113 of the visits they were able to make contact with the firm and in 99 cases the firms were operational. This is a Monumental Task given the logistic cal challenges they face in moving around the island and the personal challenges that they face at home. Im very proufd their effort and im deeply moved by their dedication. I want to focus my remarks today on some of the ef fortsds weve been undertake at fda when it relates to our medical Product Development process. Ive been at fda for six months now as the agencys commissioner, but as some of you know im not new to fda. This is my third time serving at the agency. Ive held three different positions at fda during a span of almost 15 years. In between my roles as the fda i worked in the private sector and the chance to see fdas work from the inside and outside has shaped my approach to my current role and shaped my perspective and my understanding of what i think inspires fdas unique mission. From this Vantage Point now as commissioner, i can tell you with certainty that fda is a missiondriven organization motivated by a very unique core. Theres a shared sense of Public Health mission that an mates the agencys work. It might sound quaint in some quarters to say that your job is to protect and promote the Public Health, but at fda people voice this call to duty without a hint of irony. Its this spirit of mission that inspires us. When people want to know about the agency, they often ask how we achieve our mission and most go directly to try to understand the what. What is it that we do . But thats the wrong question to ask. The right question to ask, why does fda do what it does . I want to focus my remarks today on the why. Why fda does the work we do to describe the heart of our mission. To understand fda is to understand why we do what we do. But to answer the why, id start by asking why have an fda at all . We have an fda to help make it easier for people to be apparent or a caretaker and improve their lives. The fda exists to empower people to make choices and decisions about their own health and the health of their families, to give people access to safe and effective technologies that can provide them with meaningful choice whens they face serious illness, and to offer hope that they can cure an acute disease or more reasonably manage a chronic one and to be protect them from potential harms. That why also describes the foundation of american Public Health. Simply put, our mission and the mission in Public Health is to help people live up to their full potential. That why is to advance the health of our nation and this is essential to our flourishing the question of why we do what we do is on the policy reforms that were undertaken at fda. When it comes to our medical product review programs. I want to highlight one particular idea today, it brings to life a broader changes underway in our organizational approach to new mal product review. Were changing how we organize ourselves as part of the medical product review process and moving away from a structure that had people working in discrete organizational units that often operated as independent entities rather than an integrated team that functioned together to share best practices and knowledge. Instead, were evolving to a more teambased approach. This approach will integrate people from different disciplines and across different stages of the lifecycle of a product from the pre and post market phases were working toward a common Public Health goal. In most cases, that immediate goal will be the review of a new product. But the ultimate goal is to facilitate a fluid and Dynamic Team Environment that fosters a deep understanding of these products across a full continuum of the pre and post market phases. I believe that these changes will elevate the role of our clinical and scientific experts to take a more universal view of the products they evaluate. A role where they can take more stewed wardship of products over their entire life psych from the the initial product application touts review by fda, to the approval and safe use of a product by patients and providers. Our experts are our clinical and scientific officers. They must have a stewardship over the products they evaluate that extends throughout the product lifecycle. Thats their commitment to Public Health. The connection between the products we regulate and the lives we seek to improve over time is what first brought many to fda. The benefit that people ultimately derive from a new product after its approved and the risks they might encounter in the ordinary routine of clinical medicine is our shared responsibility and obligation. Its the outcome that compresses why we do our work and so the same commitments that stir our efforts before a product is approved for use are equally important after its made more widely available. We need each of our medical and scientific experts to have more opportunity to extend their expertise and leave their mark over the full duration of a products lifecycle rather than at just one stage. Part of our effort to modernize the structure of our review teams is as much a cultural change as it is an organizational one. Ill focus on these changes first as they relate to medical devices. With this modernization is imbodied in the creation of a total product lifecycle office in our kwies center. This new structure will consolidate many of the aspects of product review into a new teambased approach. Our clinical and scientific staff is comprised of some of the leading experts in their fields to maximize their effectiveness and efficiency and fully leverage and integrate their knowledge and expertise into product review. Were changing from an individual centric approach to teambased approach. Its key that our organizational structure supports that purpose, but thats knots alwanot always today. Instead the Current Organization often fosters intellect wail and managerial silos. It splits premarket and post market functions into separate offices that dont always talk to one another as much as they should. It places staff into hire arcual structures and management chain. This makes it more difficult to share information and to hand off work between offices. For example, between our compliance officers and our premarket experts, often expert input across different parts of the review function is sought through consults rather than an ongoing dialogue offered as part of an integrated review team. One of the key purposes of our new approach is to make information sharing easier. Reviewers, compliance officers, and other experts will look at the products total lifecycle rather than different staff looking at different devices at different stages of the development and commercialization. Regulatory oversight will span the continuum of pre and most market products. The aim is to make sure that the people with expertise and how our product works can inform those who are monitoring its continued performance after its approved for use by patients and viceversa. Were also pursuing similar organizational changes when it comes to new drugs. These modernizations have the same Public Health goals as those embodied in the new efforts related to medical devices. Under leadership of dr. Janet woodcock, is addressing the way new science is changing the nate tire of how drugs are developed. The center is piloting the creation of one common shared view memorandum. This will ensure early cross disciplinary interaction among scientists and clinicians who have Specialized Knowledge in disease. These interactions have become more critical because fields such as gentleman nome miks, human fact thattor alanalysis, and others have become integral parts of the drug review process. A single review memorandum will be much more accessible to the Biomedical Research community. At the same time were evam waiting the more disease offices as a morn afroch new drugs. The goalstor provide stakeholders with a single point of contact and allow synergies and surge capacities within offices. The Broader Community often measures fda productivity by its adherence to goals. These are the timelines that are imbodied by our deadlines negotiated as user fee agreem. These are important metrics for measuring our organizational efficiency and we intend to hit these commitments. But goal dates arent always good approximates for our Public Health impact. Our impact can be e best be measured by the completeness and quality of our clinical and scientific work before and after a new product say proved and by the safe and effective use of medical technology that we help facilitate and how we are advancing products that also help advance Peoples Health. The central tenant of these new teambased approaches is to increase cross disciplinary collaboration. The goal is to make sure Decision Making at every stage of a products review is more fully informed by scientists and cla nitions with very discrete and deep areas of expertise. This gets me back to the why of our mission. It isnt simply to meet a user fee goal or approve more novel products. Its so make sure were having meaningful impact on Peoples Health and positively imkt pag their lives. The impact of our work is becoming especially palmable as we see more products coming to market that have transformative and curative effects on vexing diseases. The why of our work is deeply expressed in a lot of other areas of our portfolio. The most prominent i believe are fdas efforts to impact americas kries sifs addiction. This goal is very clearly embodied in our goal. The nicotine and cigarettes doesnt directly cause tobacco related cancer, lung disease or heart disease. But the powerfully addictive nature of the delivery of nicotine in cigarettes makes tobacco use the leading cause of preventible death in the united states. So were putting nicotine at the snefr our strategy. Were taking steps to render combustible cigarettes minimally or nonaddictive. This could prevent future generations of kids from becoming addicted to significant lets, the deadliest form of nicotine delivery. We set that the goal to be regulated before the end of this year. At the same time were putting through an appropriate series of regulatory gates, new technology thats emerging that could deliver nicotine to those adults who still want or need satisfying levels of this drug but that enable them to get that nicotine through products that may pose far less risk than spoking combustible cigarettes. We need to make sure that these new products like electronic nicotine systems are properly regulated. For fex they claim the product modifies the risk to users, they must prove that they can slig reduce risk if they want to make those claims. Were also focused on another devastating addiction crisis in america, the addition to opioids. As you know, this is a top priority of the Trump Administration. The fda has an Important Role to play over every aspect of this crisis. But two of our key obligations are fdas influence on the rate of new addiction and our impact on the availability and the use of treatments that could help people live lives of sobriety. We know that many people who become addicted to opioids will be medically addicted and the first exposure will be a lawful prescription. For most people that first prescription will be for an Immediate Release of an opioid drug. Sciencebased evidence shows that the key to reducing new addition is to reduce the opioid prescriptions. This makes sure that fewer prescriptions are written and fewer