This morning we have a hearing the preparedness and response capabilities we will hear from the assistant secretary for preparedness and response hhs and the director of the office of Public Health preparedness and response for health at cdc and dr. Gottlieb commissioner of the fda. This is the first of two hearings we plan to have on this topic. The second tuesday january 23. Senator murray and i each have been openingng statements or any opening remarks they may haverk after that we will introduce our panel and hear their testimony then each minute member has up to five minutes for any remarks or questions. First welcome to the chairman for giving me the opportunity to have this hearing that discusses the topic critical to National Security and has seen many years of bipartisan work in this committee and congress. We have developed strength in the name work with and other Nuclear Threats with the potential to jeopardize the health of all americans. This created a framework as we have learned. We should be proud of the accomplishments in the progress made over the last decade. Resulting in strong partnerships with our states inhi counterparts, create a greater certainty and accountability to bring forward medical countermeasures to establish a Clear Strategy with which we can combat the fullom range of Public Health threats we face today or encountering future. Despite this we are not fully prepared. The Blue Ribbon Study Panel stated in the 2015 report that there are serious gaffes of inadequacies that continue to lead the nation vulnerable from threats from nature and terrorist alike. As we move forward to revisit the successful and bipartisan law to make it very clear to my colleagues that this is the reauthorization of the National Security will i look forward to working with each of you on this issue. The threat we face continue to evolve it is critical to vigilance urgency and resolve this mission demands. In the unprecedented era of technological and biomedical innovation and advancement. The president S Advisory Council warned while the unknown growth of technology is a great boon for society it holds serious potential for distraction or use bible states and competent individuals i urge the u. S. Government ways to think and organize the biological threats it needs to change with this landscape it is critical to foster and advance innovation with the development of countermeasures to work through the reauthorization process to have what they need to keep pace with this rapidly changing and evolving threats. And to meet these challenges to foster innovation with countermeasures across the framework to provide theew greatest hope to ensure the safety of the American People. S and to provide insight into mission iy of thiss look forward to hear from you about the progress we have made in continuing to improve policies ande programs to realize full potential to save americas lives and now we turn to senator murray. Thank you to all of you for joining this hearing to combat Public Health looking at the pandemic and preparedness act later this year. With their bipartisan work on this issue showing why this is so important families across the country with headlines like cases are increasing in Pierce County and flu outbreak kills five and 50 hospitalized. It could be a nightmare often ending in tragedy. Just as we were improving our response across the board we have to also make sure we are vigilant against pandemics on a global scale it could affect half 1 billion people more than the entire population of the United States and that is not speculation it happened 100 years ago in 19 and the epidemic was more deadly to the human race than world war i in that thread is joined by new threats. What have we learned . Are we better prepared . When you consider a bola and cdc so many supported nigeria as they instituted evidencebased policies to track the path and contained that the answer is yes. When you consider a strategic stockpile to deliver 50 tons of emergency medical supplies anywhere in 12 hours the answer is yes with the fda approval of countermeasures to combat anthrax and the plague the answer is yes but our track record is far from perfect we can do better than of the response of puerto rico in the Virgin Islands after Hurricane Maria this left Many Americans without access to clean water and electricity from we can do better with the Opioid EpidemicPresident Trump declared a Public Health emergency 83 days ago but has taken little action sent but it will continue its work in another hearing. We can also do better to combat t3 from 2016 it is a global Health Emergency in february and instead of a Fast Response it was politicized around some republicans push to undermine healthcare and contraception which was a key requirement from causing devastating birth defect lung defects it took Congress Nine months tos pass a test emergency funding that hurt people and harmed families so we have to do better we are most successful to protect our families against pandemic threats when we respond with quick bipartisan action and webi need an expert medical opinion not ideology with south federal state and local agencies to hire the people have the funding they need to protect communities funding cuts make us less prepared. Not more preparing for everyone we cannot forget pregnant women or individuals with disabilities or fighting chronic diseases innovative medical countermeasures to protect us from the threat like that universal flu vaccine and we must continue strong partnerships to allow us respond to new threats. We need to stop fear and certainty by giving families Accurate Information from sources that they trust. We cannot allow anyone to undermine those solutions. We are not stuck. This is the place the United States can and should be showed International Partners we are focused on these issues to be there ally addressing Public Health threats. There is a bipartisan tax record to strengthen the Public Health compared this but then we have been a surge capacity. I am hoping we can continue that progress with legislation based onon evidence or policies that continues of women in storage and then they dont spendwa enabling us to respond to the next crisis we dont know with the next Public Health threat will be there when or where or how it will start. But to be prepared starts now. All of you here today have a Critical Role to keep communities healthy and safe fda helps to facilitate the development of medical countermeasures for products needed on the front line. If this guides the nations preparedness planning. And raise to face on dash to make at least it is on the line are we seeing the i am interested to hear from all of you these keep her country safe to make i am frustrated that do to conflicts of interest. But the cdc director has to recuse herself on his Health Issues including related to Data Collection and information sharing which are very relevant to the conversation we are having today. She cannot give her all attention and hope that they willre be resolved. I look forward to hearing from you. Senator . Thank you for your willingness tor share this hearing. On march and then to have the reauthorization and that he worked with many senators craddick but senator for chairing the hearing i thank him for that. I would also like to welcome senator smith from minnesota joining our committee and senator jones but for some reason on the finance committee but we will miss him on work i would like to come on senator isakson for one minute. Thank you mr. Chairman just reference the Ranking Member senator moore murray yesterday the chairman i was in touch with theth appropriate people f and to the best i could determine now i am working expeditiously so you will not have any conflict to testify whatsoever. That is her desire as well. Grateful for this hearing and working with you. Again on this reauthorization and i commend your work on this. Also the chairman and for this bipartisan hearings on the nations capabilities in advance of the reauthorization of the pandemic all hazards and response act. One brief story about how preparation is this is a good example so in this case in the aftermath of the tragedy that trained real mint that occurred may 2015, it was carrying 238 passengers when it derailed. Eight people lost their lives in over 200 injured. Fortunately through fun funding through the pahra Preparedness Program the Pennsylvania Department of health and the Regional Healthcare coalition and long working together to prepare local Healthcare Systems for emergencies that could cause the surgeon patients. When the train derailed they were tracking bed availability at local hospitals to provide information hoping to effectively so they could begin to receive the care that they did. I they were ready to protect health but the health to increase 710 city with a combination including newly emerging Infectious Diseases and extreme weather events and aging infrastructure. We must continue to build our nations resiliency by investing in Countermeasure Development to support state and local partners to reduce the impact to the country. Thank you for todays witnesses it is important to mention your service to the country as well as your commitment to Public Health and forward to the hearing and grateful for the work we can do today atou this hearing. Thank you for your continued help and work on this issue. Let me just remind members this is the start of the reauthorization of pahra. Being in congress 24 years i realize getting involved in hhs and fda there is always intimidation to fix other things. I want to encourage you to fight that urge and lets keep this focused on perfecting pahra. We still have work to do but if we become distracted with nothing related to this the sheer geography that just pahra allows us to get into we will lose the focus of what we are doing and we are not trying to make it even more effective for the future. I would like to introduce our witnesses each having up to five minutes to givepl testimony. T12 the assistant secretary for preparedness and response at hhs he was the one who created the title and that we created the position to establish a clear line in the event of a Public Health emergency. To make them with the coordinated preparedness and response effort across all agencies within hhs including fda and cdc. I am delighted to have you back today. Next we hear from doctor gottlieb is the commissioner of the fda that plays a Critical Role in Emergency Preparedness of the medical countermeasures vaccine and diagnostic tests to ensure ar countermeasures. The reauthorization of pahra with regulatory certainty and predictability for those countermeasures under review while also providing you with additional authorities to support Rapid Response to Public Health emergencies. We are delighted to have you here and in that position at the fda. Finally dr. Redd the office of preparedness at the cdc it serves a number of rules under the framework building a strong relationship with state and local Public Health departments to prepare for and responding to emergency Public Health threats. Cdc works to make sure we have the information we need in advance of the Public Health emerged. It houses an expansive Epidemiology Laboratory with Data Collection activities. We welcome all of you. Let me say at the beginning that i believe the hurdle in our way is not innovation. The hurdle is government. Clearly defining what it is and the certainty of a pathway for getting the approvals that we need for those to be deployed i keep along i hope you keep those in mind in the roles that you carry out to understanding on the front line to make this happen. Good morning. Distinguish members of the committee i assumed this role right before Hurricane Harvey struck texas it is been an interesting experience i appreciate the opportunity to appear before you today this champion the bipartisan effort thank you for your continuing commitment to this endeavor. I am proud to have played a part to acknowledge the vision and knowledge i will share my perspective on the National Security and my visions for areasne of so to be our way of life. The strength as well as the capabilities to coordinate a National Response so with those responseg capabilities is the national imperative. But the 21st century environment is complex but having recently left my job at the Senate Select committee on intelligence organizations are determined to attack United States since the actors threaten the homeland of Nuclear Weapons and have the means to employ chemical and biological weapons. Decrease frequency with naturally occurring disasters to currently monitor purchase diseases to cause a pandemic such as the new the influenza strain circulating in china. Whatever happens American People expect the government to be readyy to respond to save lives. A decade ago to answer a simple question who is in charge of response functions . To create the unified combat command. By the entire way of the Public Health assets to support state and local activities and responses to help americans in distress. So the key priorities are first coordination that threaten the National Security. The National DisasterHealthcare System and advocate for the sustainment of a Public Health the enterprise with the healthcare readiness and countermeasures enterprise and to be highlighted during the Hurricane Season after her nd harvey and berea in the Public HealthResponse Recovery activities from the National Response framework. And then to start with healthcare along with the deity assets. So then to update the command at the point of the medicalye capabilities as well as ancillary support across the country. Un that was a private sector enterprise to effectively engage. In this consequences of the 21sy century threats based on existing local healthcare coalitions and trauma centers. All of those includingde federal assets with the fine line of the response capabilities. And then those integrated measures of preparedness so with the medical enterprise i am grateful for those behind me and establishing to bridge the valley of death without late stage dos development as my parts fail. And for those two advanced development to stockpile fda approval. And then for the purposes of responding to disasters to the credit of doctor bright and his predecessors. Opportunities will further improved by streamlining the decisionmaking process finding new ways to support invasion and increasing and also must work closely to enhance the capabilities quickly to dispense countermeasures we have the opportunity to further improve response capabilities alike forward to working with you and yourd staff thank you again for your bipartisan support committed to National Security i will be happy to answer any questions you have. Senator and Ranking Member and members of the committee, thank thank you for your invitation to testify today. Facing those Public Health challenges and will face additional challenges in the future thankfully our ability to respond of the original enactment and each is unique with threats with the Technology Without diabolical purposes to become more ubiquitous so we face new and preventive so to be exposed by Natural Disasters which cause significant devastation they tasted long tested the capabilities to respond i will focus my remarks were the actions we are taking for product shortages impact of Hurricane Maria shows the importance of puerto rico with that fragile nature of the supply chain so to focus on the complexities of the shortage because of the system and many of you are learned about the situation are only a small number of primary manufacturers even lowering production there is stress on the entires one of the largest manufacturers the primary site located in puerto rico struggling to regain