Transcripts For CSPAN2 Pandemic Preparedness Response 20180118

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 Epidemic President 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 Disaster Healthcare 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 Health Response 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 power and rose where the plans were disabled. Working in partnership with the department of Homeland Security in puerto rico authoritiessue to ensure they cn get back on the power grid a priority basis to stabilize production. Also working with other manufacturers to find other facilities to help supply the u. S. Until it is back up and running into shortage address. We work with manufacturers we work with manufacturers i land in mexico and brazil. When we import generally the manufacturer sends product u. S. But there is no increase of product now that those facilities are stable the power situation is fragile expect them to return to production to improveai the situation in anticipation of the crisis they also prioritize the approval of saline p p products by two manufacturers. Both should Start Productions t to soon to help increase the overall saline produced and distributed but this has another fax so to find work they put various strategies in place one has hospitals compounding product themselves causing the increased demand for the empty iv bags. This ise putting pressure to take steps. To address that situation for which could increase capacity if necessary. Every child to some personally inquire about that capacity increase if demand continues to increase. The scope of the flu outbreak added to the strain of the supplychain. The shortage of the impact underscores the need to elevate our preparedness. Already we have made key observations to detect device shortages since we lack authority we have to depend on manufacturers and distributors reaching out to fda proactively. That is an example of how they reacted to emergency situations at the same time with the development of countermeasures is a critical component weea have guidance on the vouchers that explains why we implement the program to incentivize and Development Bio logic countermeasures. Working with congress to increase readiness and i look forward to answering your questions. Senator, chairman alexander and ranking c members i am the director of the office of Health Preparedness andf response at cdc and i am pleased to talk with you today about the growth we play in Public Health preparedness and response including those for the all hazards preparedness act. I work to prepare and respond to emergencies from the day today work into particular areas the longstanding partnerships and number two the Scientific Program expertise. The three pillars of the Defense Strategy science and service. Cdc has unique set of expertise that we can identify agents causing illness whether it is caused by the infectious microbe or chemical radiation exposure. Readyn to ask one dash respond to smallpox or evil of or influenza. Playing a key role to emerging Infectious Diseases to identify pathogens quickly and more accurately. He for testing. But second it is surveillance as the collection analysis but basically making sure they are making the right decisions. Examples include and the global disease protection. Those that are the greatest natural Health Threat face and it would require a vigilance to these changes. Going out to every state and several major cities and ministries of health tohr conduct influenza surveillance and laboratory work. With the Surveillance Program cdc collects information on causes of emergency room, urgent care and hospital visits. With state and local Health Departments use the data to detect abnormal situations requiring assistance. The Operation Centers monitor and to assess the potential risk of the United States from these events. In addition the final pillar let me focus on fee programs. But with those initiatives and programs that the state and local Public Health for and goes that scientific expertise. The grant goes to every state to support staff and validate capabilities with the laboratory and communication equipment. The stockpile is a 7 billion dollar repository of pharmaceuticals and medical supplies andme equipment available for rapid delivery to us for responses for emergencies the Readiness Initiative enhances the 72 largest cities were 60 reside these files are used to develop test and maintain plans to receive countermeasures from the stockpiledi leaving the committee with three primary pointsts first it is the common sense of the country again tell threat and the preparedness work is built on the day today foundation with expertise and longstanding partnerships of the Health Authorities that are essential. Thank you for the opportunity to testify today. First the Ranking Member that in the order ofn attendance. So my first question is simple, arere we paired from the Public Health threat. It is for some but not all. But when the concept came up were anticipating a pandemic and just experiencing katrina but those were in the rearview mirror. S but quite frankly if you have to look at the nationstate or considering multiple nationstates willing to use weapons against us physical or cyberi think we are not prepared and quite frankly that is what keeps me up at night as well as a pandemic that could emerge from asia as well as that doctor gottlieb identified with tools to allow the various people to do unimaginable things eventually so we have a long wayab to go and have done very well in some areas as a compliment of state and local authorities and for those three hurricanes nearly consecutive that was a great commitment of effort by everyone but that is another respecttu two. Well i think the key thing is remember what the mission was. It was another critical element of thatheca formula of success o the manufacturers should they cross the finish line. We cant boil the ocean, quite frankly the resources that have been given today have been somewhat limited. We dont have the sustained local funding that would give great confidence that we would have an uninterrupted funding stream so arguably you could do more things with limited resources and if we focus on the National Security mission which is vital to the role we have to stick to the lane and highlight the defense analogy we are operating with the resources to do this mission to protect 320 Million People and that is a challenge. What challenges have you seen in the countermeasure pipeline . I came into the agency after it was implemented in 2002 and i think we are doing a better job with respect to bringing some of these technologies. There are challenges around the incentives and the prospect of commercializing something isnt enough of an incentive. We were developing countermeasures in the ways that we cannot fully anticipate the. The top priority was protecting individuals with disabilities and every Public Health emergency weve got to Pay Attention to people withue functional needs that put them particularly at risk and making sure there is adequate medical Countermeasure Development. The efforts to meet the needs of all people and what more can we do to ensure when it comes to Public Health preparedness we are prepared for everyone. Let me start with you if you can go down the panel. Our guidance requires that states have a plan for persons with functional needs so that is part of the planning process. We also work closely with the American Academy of pediatrics and the academy of obstruction of thobstetrics and gynecology o make sure their needs are being covered. The stockpile weve made progress for example there are 100,000 treatment courses targeted for children. Theres always more work to do. We need to make sure these plans are exercised and weve covered all the bases and that we are able to execute the plans that we made. I would just highlight that with treatment guidelines that can guide the applications particularly with respect to pediatric dosing. I think this is something we can continue to do better for better development. Other vulnerable populations allow us to have dosing guidelines t. Is there anything we can do to help improve the . It still needs further development for the Agency Resources and the discrete expertise as a result of the legislation that is a place we can continue to make more investment. We did some things around the disabilities. People who are dependent on the equipment we can provide very specific information. They were able to do a reverse call before any orders to the general public to advise them that they should consider leaving before things got worse. We actually used that data to identify people who were dialysis dependent and we were basically able to link with the teams and recover so theres that part of it. One of the limitations is that its only for the medicare data. We can do that if we have access to it so thats one area we can benefit from working with you all to see how we can have the states work collaboratively to use that information prospectively to count the points that were made by the other gentleman with look at specificsda and there are produs in the stockpile today to benefit both of those populationss. We like to take the Lessons Learned where we created a natural centers of excellence at the University Infectious disease and replicate at through other important disaster related areas like pediatrics. We think that would be a way not only can you create the necessary Critical Mass of expertise but also teach to provide support during disasters and a significant contributor hhs responded and took care of patientthe patients who providee to 21,000. Many of them were families of the beneficiaries and a larger number was the general public into so as it relates to the geriatric populations but is one of a the areas we can benefit in terms of using their expertise. Thanknk you very much. Thinks mr. Chairman. This is the 100th anniversary of the 1980 in influenza pandemic that killed an estimated 50 millionwi worldwide. According to the centers for Disease Control between 12,056,000 die as a result of seasonal flu. We heard last week that opioids kills more americans than Car Accidents and those statistics i just read would suggest that so could the flu. The National Institutes of health made the prediction before the committees if we keep if the investments in Biomedical Research with senator blunt the rest of us have been doing pretty well and we may have a universal flu vaccine as well as within the next decade. Doctor fauci said the method for protecting americans against another pandemic influenza is to encourage them to invest stockpiling of vaccines that will protect against the virus. The hospitals are filling up with people with the flu. So if researchers were any sort of partner with them discovery Platform Technology that can speed that its a tough the universal flu vaccine, what would they do to support the development of the technology and what is the fda ready to do to encourage that for the new Innovative Vaccines and there are three minutes. I will bewi very brief. Theres an integrated portfolio so once a product gets through thecl Clinical Trials that wille transitioned and take the development through to fruition to produce that in the emerging technologies. We already have universal flu vaccine that could achieve what youre outlining. We continue to provide advice to manufacturers looking at bringing those new technologies through. I would point to one place that we have adopted to address these threats that have been helpful for the manufacturing capacity particularly cellbased manufacturing that could provide a proper platform. This is a related matter i think you m told me one third of the economy has to do with medical technologies and cyber. And many of the facilities they were destroyed. Are they rebuilding in other places or do you know yet . We are very concerned for a number of reasons based on the scope and effect turning base and im happy to tell you all of the facilities we are w concernd about continued to remain offline and back on the grid so if they sustain a lot of damage in the power grid and infrastructure between to move in and off the island that once we are worried about still have such redundant electric generation capacity is we dont really have concerned about the products so the situation now looks a lot better than it did four months ago. Think my time is about up. I wanted to start with the reference i made earlier of an example of the good preparation. Part of that as its origin and the fact that it happened in an urban area not just resources but hospitals and Healthcare Infrastructure as well as by way of coordination so we have a lot of small towns and rural areas where you dont have the capacity necessary in the event of an emergency with other challenges so when you have this kind of gap where some communities may be in terms of thee hospital Preparedness Program counter those programs attempt to close the gap in preparedness for the states and regions . He the way we are structuring them right now is to promote health carhealthcare coalitionse collections of hospitals as well as other entities so you can build them regionally and we wouldat w like to expand that et so not only would it cover specific regions in the state to develop a much stronger backbone if you will to do this i think idea was worthy of reviewing because it highlights the Important Role not only for the routine activities but these Extraordinary Events not only in pennsylvania but the state of washington as an example to become aal central piece of tha. My interest is seeing how to leverage all the pieces together. It was a critical First Responder in Washington State so how do we basically forg forging Publicprivate Partnership for those that can basically strengthen its so not only do you have to transport mechanisms but also telemedicine that would be available from the specialty services, hospitals or level one hospitals like nebraska to deal with a rain of topical areas. This is an authorizing committee that i want to specifically ask in light of the question i pose are there additional authorities . We have a Health Care System for which we invest 250 million annually for preparedness and resilience. I think it highlights the kind of a drop in a bucket. I dont think its the role of the federal government to pay for the whole bill that we need to look at a variety of incentives whether that is through endorsements or tax benefits that would incentivize. Our conversations with some of the outside part is filled kind of big listening session with 35 stakeholders last week including hospital associations and we have hospitals volunteering to help i think they are just looking for the means to do this and maybin a way that is mutualy beneficial. We met with select it officials last spring for this exact question. Are there things we should be doing differently to support the Health Departments and the conclusion was a little surprising to me the capabilities that are needed for the districts are largely the same committee connection capability, communications or the structure to run responses but there are additional sort of layers of challenge of transport access to medical care. I think that this is an issue beyond the end its a great idea but its a question of how they make sure the communities have access to medical care during ann during emergencies. Thank you for the work on pandemics. Its very valuable to the committees and i appreciate the work that theyve done. The chairman of the Veterans Committee in the senate learned a lot of things about the Delivery System capabilities in terms of the health care which is the secondlargest employer in the government. They provide Significant Health care to seniors in virtue of the Delivery Systems and youre called out to them is appreciated. You have a control group of patients that do the Research Example and the Veterans Administration provides great service. Is it a part of the Emergency Preparedness as we have happened last week where we have a false alarhad a falsealarm on a missih was unsettling. That is an emergency grant where you get the wrong information at the wrong time. He concentrates a lot of that to protect ourselves from Bad Information getting out . I think that gets to one of the core requirements that we have which is to be sure information they are providing is as valid as it can be and we believe people need to know and we make sure that those caveats are expressed. It gets to some of the basic principles to tell people what we know and what we dont know if whatco we are givin doing tot those things. We worked on diseases that affect children into the first drug has been approved now. To expand the use to encourage the use of drugs that are costly to develop or hard tot develop s very important. How do you intend to use that in terms of new pharmaceuticals . It provides an additional incentive to try to develop products for these purposes so ithat is one of these tools contemplated to address some of the challenges. This isnt a typical market where you have the usual marketbased and sensitive to try to make the capital developments. Theres work gointhere is work k at what a petty and weve implemented the program and sell them in the secondary market as a way to recruit some of the cost of the investment. Ive had a personal situation when i was in the house and its a very difficult disease for which there is no cure but with the pharmaceuticals into specific parts of the body and brain in particular therthe bras hope and promise for that. You issued guidance letters to Research Hospitals or facilities and give them guidance on how they can test or develop to work on a breakthrough drug for a disease like that . I think one of the areas of the most promise right now when we look at the portfolio is with respect to the cellbased therapies and we have the ability to cure the disorders and they were nontradable just a short time ago. We are going to be putting out starting this spring maybe a little earlier products on how they can address certain disorders that we are going to work through some of these diseases to make sure they have a lot of clarity. Thank you very much for all of your testimony. Im so pleased to be able to serve on this committee thank you very much. I would like to come back to something several others have talked about which is the importance of local connections and support to publi publicheah organizations. In the past year in minnesota we felt with three infectious d disease outbreaks. All these outbreaks have required an Immediate Response as well as arc sustained approah as theyve gone forward and minnesota traditionally has been sure you know invested heavily in emergencycy preparedness and dealing with Infectious Diseases probably because of the history and agriculture more than anything. But indias particular situations returned to the cdc for support so we moved forward to pass an emergency Health Response account so we could respond quickly because speed is of the essence when you deal with these kind of outbreak. In what ways do you think an Emergency Response fund would strengthen efforts during an outbreak or after a disaster. I think the resources are critical in responding to an emergency. We had linked the delay is both in the response before funding became available and that hindered what we were able to accomplish. Theres been discussion in congress and the administration about how to do that but something along those lines would be helpful. One thing weve done specifically when the fundssp ae available we had a notice of the funding opportunity for the Public Health Emergency Preparedness that allowed them tohe apply that we have in unfunded gran grant mechanism sy dont get delayed in the federal level. It can be if you will distribution of the funds from that resource in the senate can be used across hhs or to find those that would be rapid. Would you like the medical equivalent of Disaster Relief fund that there would be a requirement to notify congress of those sorts of situations. I base this on the reporting in some occasions to make sure the funds are being spent. If such a song were to be made available, what would you advise in terms of the level of funding necessary to have this be workable . Bl what happened with the original pandemic influenza preparations which are on the order of 2. 5 to 3. 5 billion again, you need the opportunity for congress to weigh in a fully on the basis of time. It identified an appropriate level that would get us through the initial crisis to the point where congress can have the former judiciary responsibilities. It works well so i think it gives good food for thought when we consider how to respond as quickly as possible. Again we welcome you to the committee. Thank you, chairman. At the World Organization for Animal Health estimates that roughly 60 of known human disease is far transmitted from animals to people, the socalled origins every year an average of five human diseases appear such as ebola, hiv and new strains of influenza, three of which in my home state of indiana we suffered considerable losses in the widespread bird flu outbreak that led to the destruction of 400,000 turkeys and this followed 2015 in the outbreak with a loss of 38 million. So what are we doing now to prevent the spread of into transmission of diseases . I have to say that quite frankly we need to do more. The concept were outlining is an importantan one. Its not the only disease with pandemic potential. I think i need to really be for to talk about the role of the cpc and the surveillance because they are on the cuttingedge to recognize the events rapidly. We are working very closely with the usda on this issue and in particularly on influenza. We were joined at the hip in response to the importation of these Avian Influenza viruses. Our role was to make sure we understood the biology and if any human infections occur that they were rapidly detected and treated. You do the best you can with the resources and authorities have. How are we doing with respect to the tracking and responding to these situations and pairing for the next one and then speaking to any additional authorities or resources needed to optimize the efforts. I think that we are given the strategy we have which is a reactive one, i think we are doing well at containing. I think that predicate caused by inattention given our strategy is a reactive one. And i think the ability to prevent importation of the viruses that can be transmitted is very challenging and theres a lot being done on the Animal Health side i think it is a challenge into the basic strategy is identifying the flock in a small area to prevent human infections should the virus have the capability to be transplanted. Theres other kinds of creative policy approaches to make sure that this part of our approach as well. I will probably have some followup questions ive also met in writing. Incentives in the animal text i would like to pivot to the antibacterial resistance threats. Every year att least 2 Million People in the u. S. Apply your infections resistant to one or more type of antibacterial drugs however as i understand it there are companies that are developing new antibiotics. These additional action needed to incentivize the development of drugs to combat this global problem and if so, what might the new incentives look like. They created a number of new vehicles. I think this is an area to the point we need to think about what more we can be doing. I have two observations and concerns of the observation is base and some of you have alluded to this. One of the tasks of Emergency Preparedness is to prepare for attack. Senator isakson talked about these and i just want to say for the record and the public the prospect is being discussed within the frequency to a degree that i have not seen. Weve had a series delete a series of hearings open in the Korean Peninsula we have been Armed Services hearing recently where a witness volunteered in public about the likely cost of reconstructing and i noticed an article in the New York Times the cdc once to get people prepared for nuclear war and it was supposed to happen yesterday on january 16 they presented a workshop entitled publicHealth Response to the Nuclear Detonation for government officials and Emergency Responders and others who if they survive would be responsible for overseeing response to the attack. Would have devastating results and time to take steps despite surrounding such an Event Planning and preparation can last join us for this session to learn what publichealth programs have done on the federal, state and local level to prepare and learn how planning and preparation efforts are similar and different from other Emergency Planning efforts. The article goes on to say it includes the unthinkable and a roadmap to radiation preparedness and using decisions to drive response efforts. I understand the prescheduled and have a roundtable on the flu instead, but this sort of realistic discussion about the prospects adds to it the incident over the weekend where a state sent out a mass email telling people there was a Ballistic Missile in coming to hawaii and then on tuesday the state broadcaster put out a warning that north korea fired a and urgedssile japanese citizens to take cover and that was retracted within a very few minutes. Theres a lot of discussion and some very intentional and some frightened about the war thats happened in the process in the province of the agencies and i want to put that on the record that is sort of a normal area for discussion piece stays i find it frightening in the normality of that and the second observation this is a discussion about National Security involved in the budget today. The spending billions and one of the points of argument is whether we might find the defense accounts. You are about National Security depends and all of your agencier were from it through the accounts of the federal budget so any suggestion that we would increase the defenses budget in and putet nondefense agencies subject within fund the priorities that youre here about and thats something we have to wrap up with myy question. That is how world war i started and i know theres going to be a hearing later on in the week i know theres an investigation at the state level part of the responsibility and boos most ofs is directed to you part of the responsibility and that preparedness and response site is accurate communication and as a former mayor and governor it depends heavily on the state and local officials so as you approach this climate where things can be pretty tense how do you look at that coordination efforts especially as it deals atth communication and Accurate Information and blocking out inAccurate Information . The experience we had a pink highlighted some of the challenges that is not only information out of information in and i think the issues we need toin work with state and local authorities met with interest as of yesterday on how we integrate the efforts closer to have Better Information Exchange whether they are hurricane pandemics is one that quite frankly you need to think through so just to highlight one thing going back to please yourr cozy room its been a routine practice to exercise the idea of a Nuclear Detonation as a matter of improvised Nuclear Device is switched not necessarily new. But the context is different but the point to tort issue is that it does require our federal partners on these issues to make sure we have a horizontal flow of information as well as state and local select fro health andr peace and to begin work more seamlessly with our state colleagues. Thank you for letting me go over. I hope you will follow the investigation for your own purpose. For the purposes of having information i suspect there will be some lessons that will be relevant to other circumstances as well. I want to applaud you for your leadership in this area. More than a decade ago, we established a Port Security program that led to radiation monitors being installed at the major ports so that they could screen incoming and outgoing cargo tracks and individuals for radiologicalal materials and hih contrast that with what i perceive to be a real vulnerability to detect and quickly respond to an attack using biological or chemical agent. I would like you both to address the level of preparedness that we have to respond and detect a biological or chemical attack and respond to it. I would like specifically to t know whether cities have used federal funds that the admiral referred to two instant sensors that would detect these agents and they would also like you both to comment on the preparedness of the hospitals. I remember being in israel many years ago and being so impressed with t the preparation and abily to convert their hospitals to respond to that kind of attack. One of the issues the program pm and by the department of Homeland Security provides Area Protection for cities selecting this a real desire about the improvements we can make to the chemical and biological attack. The capabilities are Still Limited and primitive and there is a desire on the part between ourselves to basically view improvements to do that. Certainly the stockpile that can address many but not all of these suckers work to do in terms of some of the developments at one of the critical areas that collectively our office is considering some the last file of distribution is mentioned we can move the stockpile resources within 12 hours but the question is from that point forward to getting it into thefr hands and mouths of every person at risk is a significant challenge that collectively we need to work on. I think this is a really important question. The effectiveness of the response will depend on the speed and scale with which we respond. Ii think that the way that a biological attack would manifest itself would probably be different in aul chemical attac. That would require near instantaneous response. The National Stockpile has deployed anecdotes for nerve agents over a thousand different locations have these anecdotes are available to supplement the treatment that would be availablee immediately. We also have capability to determine exactly which talks in has been used so there is an element that they are responsible for. On the biological side, we have made Great Strides with the response network. Every state has at least one laboratory that is able to use advanced technique. Theres a total of 150 around the world including that can test food and water, environmental samples from animals so looking to the future its something that we need to continue to push out that would allow its something we can get more than the technologies thingslo like resistance to antibiotics or certain organis organisms. I think it was noted by the chairman. That is one reason i asked the question. We are glad to have you as a part of the committee. We have many different points of view but work well together so this is another subject that we intend to have bipartisan success. We are here to talk about the framework forer the response for all sorts of emergencies. I returned a few days ago from a trip to puerto rico. During my trip it was clear nearly four months after the storm, the crisis is a daily reality for tens of thousands and hundreds of thousands of people. You are at the top official in charge of preparedness and response. What is the biggest thing youve learned from the situation about how we need to strengthen out the preparedness and response capabilities x. I think theres a couple of levels to go, one is improving the healthcare structure. Another is a separate piece. Another is the terrible devastation that literally devastated the whole island and every life was touched. It was very difficult for the local Public Health and medical infrastructure there were some heroic stories of doctors, nurses, Bob Pretorius who responded and left their families and houses in disarray but i think that is one piece of this that needs to be addressed. The second is how quickly can we move in. We deployed teams to puerto rico to be available once the storm passed to basically respond quickly but even so with a level of devastation that was a huge piece of it not only the loss of communications and electricity butag also that limited some of the movement so one of the Lessons Learned is you want to go in before the storm if you can and we put peoples lives at risk from the Response Team including massachusetts has responded to all three storm and again from other states around the country that responded but also theres a piece of this we have to remove the dependencies and responses seeing how we can move quicker and faster a lot of it is dependent on being able to transport through air or barge responding to an island is a tough one. Re i appreciate this and im glad we are trained to think about what we need to do and to wacknowledge these efforts we need a better structure here but to apply these lessons we also need good data and know not just what we got right or wrong but when and what kind of difference it would make on the ground. One of the things that struck me during my trip last week is how sketchy the data are. I met with a federal and puerto rican officials have said no more issues with portable water, nono waterborne diseases. Athe water will be drinkable everywhere on the island. Not so much the. I met with the state Police Volunteers who told me they saw raw sewage in the water at the Public Health center and they said they still dont have drinkable or other patients and they said they serve 100,000 people in none of them have drinkable water. We heard the same contradictions when it came to statements about how many people lack power. So publicHealth Emergency czar really challenging the circumstances. But how do other agencies collect data in ways that is reliable so you can deploy the resources to hold yourself accountable to get the job done . Because of the loss of communications and cell phone towers and the like the ability to get information from authorities and clinics is practically nil. We went to the point to use runners from the National Guard to go to hospitals and clinics andit report but thats a major consideration that we are still learning and have tot address as a major shortfall because if you were to add it to the boy bands like this you could imagine the circumstances would be even more challenging and that is an area of concern. Im very concerned about th this. Senator cassidy and i sent a letter a with seven other membes of the Committee Asking for a hearing on the Recovery Efforts arof puerto rico and i hope we will be able to hold that hearing. It might not be in the front pages anymore, but it is a humanitarian crisis and we have a moral and constitutional responsibility to exercise their responsibilities here. Earlier responding to senator smith regarding a possible bill, we had the end he said that in the crisis there were ten different authorizations that had to be signed off on before he could get somebody to travel, kind of crazy and i kept on contrasting the process we were going through which was cumbersome and slow. They had to come to get the initial golfers and after congress recognized thats not the best way and then if it goes over that they come back and get another authorization. So we put together a bill that waways to contracting requiremes for that immediate period to deploy people into second, based upon the previous 14 years of emergencies we take the average of that expenditure and make the dollars available, still accountability to make sure they havent used it to go for a conference as opposed to fight ebola, but still the point being we would have the accountability built in. But we move into something different. I was struck speaking to people after this hit ended with respect if i could do things in retrospect i would be a millionaire on the stock markets but you could predict what is going to happen because supposedly brazil is flying folks from the South Pacific to work on their own olympic stadiums that had been broken out in the South Pacific where the workers were coming from. Now of course it is rich perspective but the thought occurs we can put in travel patterns in areas of receptivity and make at least at first blush a guess at where the next epidemic is going to be. Is this something practical . I agree with your overall statement. A way of looking at this is the path they followed was very similar where it existed in the pacific and caused big outbreaks in brazil in south america and another point that is the same is when we have the outbreaks in the caribbean, we knew the location. Its the same place we have seen outbreaks in the past. Can we use this predictably because if we can see they will be having this problem so lets encourage them to spray for mosquitoes. I think that its hard to do that. Its very resilient and there are questions. Im asking about the vector of resilience on the travel patterns where there is an outbreak and guess where there might be a spread of the outbreak. The challenges to have presented the outbreak in miamidade county. That takes it to the enemy so are we doing that . Do we have a worldwide map of hotspots overlaid with the travel patterns to guess, and i understand the cdc so im asking closer to the point. The quality of information is there. I dont think we have for example the information about influenza is better than the mosquito borne diseases out there. We know what viruses are circulating in china because of influenza and the risk for a global pandemic. I have seen maps which it shows here is this or that and the hotspot of a particular virus cannot not be overlaid with travel patterns . Some discussion talks about the numbers of diseases that cause infections in humans in certain parts of the world. But your question is how do we use that information . We do have travel maps where they travel to and from and various diseases occur at variable degrees of granularity. So how you use that to take a preemptive action is the question you are getting at. I yield back. I want to ask either of you about the cost of the vaccine delivery of a. What are our thoughts on perturbation to ensure we not only have the right amount of vaccine but the vaccine delivery devices . That is one of the problems that has to be addressed and if he is welcome to at this point. Even to have better delivery or better vaccines and one dose. 600 is two per person and there are new vaccine technologies that allow you to do it. All of those issues are being evaluated and pursued yet there are significant shortfalls as a matter of concern. Until the supply standpoint of making sure we are tapping into the existing commercial market and are able to leverage that system to stockpile without market can produce. Such a wonderful model working with the industry you develop the countermeasures. In connecticut this Protein Sciences which come out with an innovative way to develop a vaccine not traditional eggbased but they Dna Technology mechanism. They raised the issue of how you make sure having spent the money to develop the vaccines there is a market so they continue to develop the process and they are available. Whats the responsibility. It is in a marketable vaccine to ensure a bridge market exists. It goes into the Publicprivate Partnership and has been the case that we need to look a looe whole variety to not only get companies and to keep them in the marketing and viable going forward. If you dont get the opportunity to use it for some other commercial purpose. These are issues that are quite frankly one of the areas that deserve a little more consideration during the reauthorization i think you raise a very valid point if we talk about a countermeasure that doesnt necessarily have a dual use the only market is going to be in preparedness and stockpiling. Depending on what youre developing the cost of m. Be too high to justify. We tried to offset some of that but i will say that the value in the marketplace have diminished so the value to add incentive has gone down over time. This is something we should all contemplate. Appreciate the discussion here this morning. You recognized in response to the question and the challenge that puerto rico faced. They are not connected to the continental United States and we dont have a lot of roads. It speaks to how you respond to an outbreak and your ability to move in quickly and limited because of access limitations and we were reminded of this with all of the airspace. They can take out a major port that serves as access or airports. We had to b have to be our own e island when it comes to response, but you try to give stockpiles of vaccines or the likes. You can get stockpiles anywhere in the United States within 12 hours, did i hear that correctly . Should i be worried in a small remote not accessible by the road shut out by whether we cant even get a state trooper in the first three days. How do we ensure we can be responsive in these areas into the other part of the question is when it comes to the infrastructure of itself, we have the first sizable cruise ship going through the arctic and all kinds of emergency preparation drills and its not because we were most fearful of an oil spill from a ship that might hit the ice but an issue on a ship where you now have 500 passengers who need a level of healthcare. Whether it is an outbreak or some kind oweresome kind of a de natural or otherwise wants assurances can you give us from those rural states coming in i will turn to doctor m. And q. , admiral. The reality cant get anywhere to be delivered to the state authorities. The ticket to th the last termil mile where people need them and that is an issue of shares concern where the work has to be done and would have challenges. We have the telecommunications and access to laboratories and the investigations that would also be limited so this is probably fought off as a broad set of capabilities that are needed to assure the protection of populations. The. Its based on the Climate Assessment predictions and the impact of alaska as the state is seeing the impact of Climate Change you might not feel it here in the east coast but its warmer back home. They were able to tree as thosee nasty mosquitoes and they cant move these levels of outbreaks. Once again thank you for your welcome to the committee. I think senator casey may have highlighted into how they were talking about the roles. We have the ability to get them thinking like that. Whats being done for this kind of emergencies with the communities that are not having the daily healthcare that the immediate healthcare needs can be given to. One of the areas i touched in my testimony is the idea of creating a Natural Disaster Healthcare System taking advantage of the trauma system we have in our country. Its to not only cover states for mississippi and alabama as part of the country where you can actually share the resources and do better coordination mutually in those kind of situations and build the kind of relationships where you know about that availability. To ensure their survival there is a lot that can be done to. In some alabama has a few major cities in mobile and clearly there are some great facilities there as well as other parts of the state. One of the things weve done in this examine there are publication issues related to oral health and in health journal. I also was going to ask a question about citizens with disabilities. We provide two states in california as a part of the norm for those that would be at riskk to the Power Outages and what we probably special assistance if they needed to be evacuated and thats one piece of the problem quite frankly we dont have the data for medicaid for the individual states to. To include a section with a vulnerable population is the response plan. When we activate our Operation Center for the Emergency Response there is a functional desk on vulnerable populations to deal with this kind o those f issues that come up. Do you have any questions or concluding remarks he would like to make . We look forward to hearing from the nongovernmental stakeholders about how we can continue to strengthen their readiness for the future Public Health emergencies and keep the American Public safe and the emergency prepared this continuous and must devolve into these new and different types of threats. I remain committed to and sure the progress we have already made and prepare fo prepared foc Health Emergencies or i should say while continuing to work to anticipate the next thread. We have a strong bipartisan history of working together on this committee to improve the communitys ability to respond to all manners of Public Health threats and i look forward to continuing that tradition in the months ahead. Thank you for your work on this as well as the Ranking Member. Thank you, senator casey. This is one of the on many areaf reauthorization of the legislation to prepare the country for the unexpected disaster that might occur. A lot of progress has been made and i want to thank senator casey for the leadership over the years in this area. As he indicated, we will be having our second hearing on this topic next tuesday, january 23, working with senator murray, senator casey, senator burr and others. We hope to be able to write legislation revisiting this act and mark it up in the committee this spring and present it to the senate for bipartisan action. So i think the witnesses for coming today. The testimony has been helpful and attendance has been good. Record will remain open for ten days and within that time if they would like to set additional information. The committee will meet again tomorrow on a different topic of 10 a. M. For a hearing entitled reauthorizing a high year education act, Financial Aid simplification and transparency. Weve been working on taking a new look at the federal governments relationship to the colleges and universities. Theres 6,000 of them. Our major role is that we appropriate about 34 billion a year in grants for students to attend colleges and there are more than 100 billion new Student Loans each year in connection with all of that money theres a lot of opportunity and need for us to look at the innovation and simplification getting through the general red tape and other activities. There will be our major focus during this year and we hope also to have that Bipartisan Legislation in the senate floor sometime this spring. Thank you for being here today. The committee will stand adjourned. [inaudible conversations] [inaudible conversations] mr. Flake mr. President. The presiding officer the senator from arizona. Mr. Flake mr. President , near the beginning of the document that made us free, our declaration of independence, Thomas Jefferson wrote we hold these truths to be selfevident. So from the very beginning, our freedom has been predicated on truth. The founders were visionary in this regard, understanding well that good faith and shared facts between the governed and the government would be the very basis of this ongoing idea of