21st Century Public Health threats. The nations preparedness and response capabilities. We will hear from the assistant secretary preparedness and response at the department of human health and services. Chapter at the centers for Disease Control and prevention. And doctor Scott Gottlieb commissioner for the fda. This is the first of two hearings we plan to have on this topic. The second will be noticed for tuesday, january 23rd. Senator murray and i each have an opening statement. Then i will turn to senator alexander and casey for opening remarks they might have. After that will introduce the panel of witnesses and we will hear their testimonies and then each member will have up to five minutes for any remarks and questions. First i would like to welcome the chairman and thank him for giving me the opportunity to hold the devil today. This hearing discusses a topic that is critical to the National Security and has seen many years of bipartisan work in this committee and in this congress. Together we have developed and strengthened the grammar to ensure that we are prepared for chemical, biological, radiological and other Nuclear Threats with the potential to jeopardize the health of all americans. The pandemic and preparedness act of 2006 crater framework which is grown and changed as we have learned from each Public Health experience we have been through. We should be a part of the accomplishments under the progress made over the last decade. Our work has resulted in strong partnerships with state and local counterparts. Creating greater certainty and accountability to bring forward medical countermeasures and established a Clear Strategy with which we can combat the full range of Public Health threats we face today and thus we may encounter in the future. Despite this progress, we are not fully prepared and more work remains to accomplish our goal. The Blue Ribbon Study Panel on bio defense stated in 2015 report that i quote serious gaps in inadequacies continue to leave the nation vulnerable to threats from nature. And terrorists alike. As we move forward, and revisiting the successful and bipartisan law, i want to make it very clear to my colleagues that this is reauthorization of a National Security bill. I look forward to working with each of you on this important issue. The threats we face continue to evolve. And it is critical that we bring with this discussion, the vigilance, urgency and resolve this mission demands. We are in an unprecedented era of advancement. In november 2016 the president S Advisory Council in Science Technology warns that and i quote while the ongoing growth of biotechnology is a great moment for society also holds a series potential for destruction or destructive use by both states and technically competent individuals. And encourage the Us Government passed ways of thinking and organizing to meet biological threats needs to change to reflect and address this rapidly developing landscape. For this reason, it is critical that fostering and advancing innovation, particularly in the development of medical countermeasures, is top of mind and that we work through this reauthorization process to ensure cdc, fda, have what they need to keep pace with these rapidly changing and evolving threats. This committee has worked to push the federal government and hss in particular, to meet the challenges. An hhs fosters innovation and development of medical countermeasures and across the framework provides the greatest hope to ensure the safety of the American People. The witnesses that we have before us today, will be able to provide insight into the urgency of this mission. And a promise innovation holds it properly leveraged. Look forward to hear from each of you about the progress that we have made. And where we can continue to improve policies and programs to realize their full potential to save americans lives. I would like to turn to senator murray for any comments. Thank you very much. Thank you to all of you for joining this hearing on our nations preparedness to combat Public Health threats as we look towards now reauthorizing the pandemic and preparedness act later this year. I especially want to thank senator casey and senator burr for their bipartisan efforts on this issue. Papers show why this discussion is so important to families across the country. With headlines like, flu deaths and cases increasing in pierce county. And flu outbreak and a county kills five, 15 hospitalized. A bad flu season can be a nightmare for families and too often ends in horrible tragedy. Just as we must continue to improve the Public Health response across the board to prevent those tragedies on the local level, we have to also make sure we are vigilant against pandemics on a global scale. A pandemic can affect happily in people. More than the entire population of the United States. That is not speculation. It happened 100 years ago. The 1918 influenza epidemic was a tragedy more deadly to the human race than world war i. And today the threat of pandemic flu is joined by new threats. What have we learned in the last century . Are we better prepared for the next catastrophe . When you consider ebola and how the centers for Disease Control and prevention and summary partners supported nigeria, as they instituted evidencebased policies and track the path of that disease and contained it when the outbreak reached after words answers clearly, yesterday we consider our Strategic National stockpile which can deliver 50 tons of emergency medical supplies anywhere in the us in 12 hours, the answer is clearly, yes. Many consider the fdas approval of new medical countermeasures to combat anthrax and flu and radiation and plague, the answer is clearly yes. However our track record is far from perfect. We still can do better. We can do better than the president s way to slow response in puerto rico and the Us Virgin Islands after Hurricane Maria. The storm left Many Americans without access to clean water and electricity and healthcare for months. We can do better than the administrations response to the opioid epidemic. President trump declared that christ is a Public Health emergency 83 days ago and has taken little meaningful actions. I am glad this committee will continue the bipartisan work to address the Opioid Crisis in another hearing soon. We can also do better than our slow response and combating zika virus in 2016. The World Health Organization declared zika virus a global Health Emergency in february. Instead of a Fast Response, the response that politicized around some republicans who pushed to undermine womens healthcare and access to contraception which was a key requirement to prevent this from causing devastating birth defects. As a result it took Congress Nine months has Emergency Funding for a Public Health crisis that endangered mothers and babies and families across the world. It harmed people and families in ways they will carry for the rest of their lives. So we have to do better. We are most successful at protecting our families against pandemics threats when we respond with quick bipartisan action. We need decisions based in science. An expert medical opinion. Not ideology. Especially when it comes to womens health. We need federal, state and local agencies to hire the people and capacity and have the funding they need to protect communities. Hiring freezes and funding cuts make us less prepared, not more. We need to plan for everyone. We cannot overlook the young for the elderly. We cannot forget pregnant women or individuals with disabilities or those fighting chronic diseases like diabetes. We need innovative, medical countermeasures to protect us from todays threats like a universal flu vaccine and antibiotic to combat resistant bacteria. We must continue strong partnerships with industries that will allow us to rapidly respond to new threats. We need to stop fear and uncertainty before they create panic by giving families helpful and Accurate Information from sources that they trust. We cannot allow anyone to undermine the science of Proven Solutions like vaccines. We need to respond to Global Health crisis abroad before they travel here to home. Diseases are not stopped by borders or walls or bands. This is a place with the United States can and should leave. We should continue to see the International Partners that we are focused on these issues and will be there ally in preparing for and addressing Public Health threats. Congress has a strong bipartisan track record of addressing these challenges which strengthened the nations Public Health preparedness and created new roles and programs with authorities proposed Emergency Response. Reauthorizing the act in 2013 we built on the record. When has medical surge capacity. We modernize bio surveillance capabilities. We increased focus on atrisk individuals. I am hopeful we can continue that progress with legislation that focuses on the signs and evidencebased policies we know work. To mitigate Public Health crisis. Consider the needs of everyone and puts families in women before politics. Reports state and local Public Health officials and joes communities do not spend months waiting for emergency resources and enables us to respond to the next crisis with foresight rather than with hindsight. We do not know what the next Public Health threat will be. We do not know where, when or how. But we do know that being prepared starts now. All of you here today have a Critical Role to play in keeping our communities healthy and safe. The fda help facilitate the development and review of medical countermeasures and grants emergency use authorizations for products needed on the front lines. The assistant secretary preparedness and response guides the nations preparedness planning. Help ensure the Healthcare System is ready to face any emergency. An investor medical countermeasures, pipelines to Biomedical Advanced Research and development authority. The centers for Disease Control and prevention is on the frontline. Supporting state and local Public Health departments. Overseeing the national Strategic National stockpile. Gathering and analyzing key data and serving as a trusted source of information to the public. Im interested to hear from all of you today about your work to fulfill these Important Roles and keep our country safe. Mr. Chairman, i do want to say im frustrated that director fitzgerald is once again unable to join us today. Due to conflict of interest presented by investment the cdc director still has to recuse herself on some of the Important Health issues that we face. Including issues related to Data Collection and information sharing. Which are very relevant to the conversation we are having today. I am concerned that she still cannot give her full attention to all of the pressing Health Threats we face and hope that these conflicts of interest will be resolved soon. Thank you doctor stephen redd for joining us in her place and i look forward to hearing from you. Senator alexander. Thank you, senator. And thank you for your willingness to chair this hearing. On march 2013, president obama signed into law the bipartisan pandemic and hazard preparedness and reauthorization act. This became law in 2006 that worked with many senators on this committee. Both democratic and republican. I think im all for that. Replacing senator franken who was at the table member of the committee. Senator jones from alabama is also a new member of the committee. We welcome him. He replaced senator y. Ted who was a very valuable member of the committee, i mean whitehouse and who was taken a lesser assignment on the finance committee for some reason. But we will miss sheldon and his work on this committee. Mr. Chairman i am going to withhold my comments although what i would like to do is call on senator isakson for one minute just to make some comments and then we will go to senator casey. Thank you mr. Chairman. I wanted to reference some statements made by Ranking Member senator murray. As chairman of the Ethics Committee i have gotten her in touch with the appropriate people to deal with the issue. She is forthrightly dealing with it to the best i can determine and im working expeditiously to get it done as quickly as possible so she will not have any conflicts of testimony as well and thats her desire as well. Thank you very much senator burr. Grateful for this hearing and grateful to be working with you on this reauthorization and i commend your work on this for many years. They also want to thank the chairman, chairman alexander and Ranking Member murray for this bipartisan hearing on the nations preparedness and response capabilities in advance of the reauthorization of a pandemic all hazards and response act. I will give you one story, one brief story about how important preparation is. This is a good example of preparedness infrastructure that it supports. In this case in the aftermath of the tragedy a Train Derailment that occurred in philadelphia of may of 2015. The train was carrying 238 passengers when it derailed. Eight people lost their lives. Over 200 were injured in that derailment. Fortunately through funding from the Hospital Preparedness Program which we know by the acronym hbp Regional HealthCare Coalition had long been working together for emergencies that did cause a surge in patients. When the train derailed systems for tracking bed availability in local hospitals and provided information in real time to Emergency Responders helping them to effectively triage patients sending them to the hospitals that have the capacity to accept additional patients so they could again to receive the care they needed. Because these systems were in place before the train derailed they were ready to protect and help save lives one seconds literally seconds counted. Health security threats are increasing in frequency and intensity due to a combination of factors including newly emerging Infectious Diseases, extreme weather events and our aging infrastructure so now more than ever we must continue to build our nations resiliency by investing in Countermeasure Development surveillance supporting state and local partners to reduce the impact of Health Events in the country. Id like to think todays witnesses for their service and its important to mention your service to the country as well as your commitment to protecting the americans Public Health. I look or to the hearing and grateful for the work we can do today at this hearing. Thank you mr. Chairman. Thank you and thank you for your continued help and work on this issue. Let me just remind members that this is the start of the reauthorization of popup. Having been in congress 24 years i realize when you get in involvement hhs legislation theres always the temptation to fix other things. I want to encourage you to fight the urge. Lets keep this focused on perfecting its been successful. We still have work to do but if we become distracted in create a fight over changes within fda or somewhere else because the sheer geography that pappa allows us to get into we will lose the focus of what we are doing in trying to make pappa even more effective in the future so with that id like to introduce our witnesses which will each have up to five minutes to give their testimony. Im pleased to welcome today dr. Robert kadlec. Dr. Kadlec is the assistant secretary for preparedness and response of the secretary in health and human services. If he doesnt like the title he was the one who created it. It was dr. Kadlec that created pappa to establish a clear line of support. Hes solely responsible for leading and coordinating the federal medical and Public Health preparedness and response effort across all the agencies within hhs including fda and cdc cdc. Delighted to have you back today. Next we will hear from. Terry stotts gotlieb. Dr. Kadlec exist the commission or the food and drug administration. The fda plays a Critical Role in our Emergency Preparedness and response capabilities through its review of medical countermeasures including drugs, vaccines diagno