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To recognize the chairman of the committee for a statement. Thank you senator burr and casey and members of the committee. Fornt to thank senator burr chairing the hearing today, senator casey for serving as Ranking Member and senator at senator murrays request. Leaders oneen real this subject. Sen. Burr the original author of the first passage of the pandemic and all hazards preparedness act. I will call the all hazards preparedness act. In 2006. The law helps protect us from the full range of Public Health threats from natural disasters to bioterror attacks. Burr and caseyrs led the bipartisan authorization of the pandemic and all hazards act. Any members contributed at the time. Some of whom are still on the committee including bennett and isaacson, warring, hatch and others. Now the bill is to reauthorize for a second time. Todays hearing is the second we have had this year. Last week we heard from the administration on recommendations of advancing the reauthorization of the act including from the assistant secretary for preparedness and response, the food and drug administrator and the centers for Disease Control administration. In the middle of flu season, it is critical we reauthorize the act before many provisions expire in september. I hope we will do this in a bipartisan way and i expect this tradition with the law and the committee on this on almost all of our major bills. People are not as aware of the , iastation of the flu believe the figures are between 12000 and 50,000 americans die of flu every year. Dr. Collins has talked to us expediting of the universal flu vaccine which he sees soon. Tennessee has seen heartbreaking stories as the flu spread across the state and the country. Our state already in this season, a pregnant woman and three children have died of the flu. The act provides a Public Health preparedness framework that enables us to be prepared and able to respond to Public Health threats. By ensuring we have enough medicines to protect americans and to ensure our hospitals and state and local Health Departments are prepared to respond. Thanks to all our witnesses for coming here today, especially dr. Dries in her dr. Dreis ner. Sen. Burr we are holding a hearing entitled facing 21st century threats. Medical and Public Health profession fairness and response. Tomuld hear from dr. Nglesby. E i brent macgregor, Senior Vice President firm occurs commercial operations and cochair of the alliance for bio kruge,y and dr. Stephen head of Pediatric Medicine in chicago. Senator casey and i will have an Opening Statement and we will hear from the witnesses and then members will have up to five minutes for questions. I am pleased to chair the second hearing to inform our work on this. I would like to thank the chairman for us to bring senator casey and i to lead the discussion. We would hear from individuals were firsthand knowledge of the challenges we face combating Public Health threats and their ideas on how to move forward. ,ince the last reauthorization the framework has been tested by the emergence of pandemic flu, multiple natural disasters, and ebola breakout and a zika virus. The Lessons Learned in these events come from individuals like those sitting before us today in their efforts to protect and save lives. The last Hurricane Season resulted in three major storms devastating many communities raising new questions about our ability to manage and withstand of response. Ods the emergence of zika emphasized the need for improved Data Collection and surveillance to inform and protect as many mothers and babies as possible. Further, the ebola breakout in 2014 highlighted the need for a that brings the knowledge of the potential damage brought by these threats and a deep understanding of the efforts undertaken for research, development and procurement of medical countermeasures. I look forward to learning more about the opportunities and barriers each of you see to better leverage Innovative Technologies to solve these problems. Whether it is the challenge and developments of vaccines, the information crucial to a Public Health department in the midst of a crisis, the infrastructure a doctor needs to rapidly care for patients or improvements in the way policies complement one another. Your experiences reminds us we cannot let up on these efforts or lose sight of the urgency this mission demands. Get distracted by making changes to the laws that are outside of our focus of papa. Cting improving our programs to make the more effective in the future. I look forward to the insight each witness can provide and now i will turn to senator casey for any remarks he would like to make. Senator casey i would like to thank senator burr for his work on these issues. I would like to thank senator alexander chairman alexander and Ranking Member murray. Also i want to thank our witnesses for bringing their experiences to these issues and for joining us today. This is our second hearing on this topic. The focus of course is our nations preparedness to destinations preparedness to take on threats as we look reauthorize the act later this year. Now more than ever we must build our nations resiliency to help security threats, the threats that face our nation today are increasing in both frequency and intensity. It is critical to foster and advance innovation, drugs, devices. Ann we are considering emerging Infectious Disease or a bio weapon that has yet to be seen by man, or the response to a National Natural disaster, we do not and will not have a vaccine or countermeasure to protect us from these scenarios. In addition to supporting biomedical innovations, we must strengthen our hospitals and our Public Health professionals, our front line of defense against these Health Threats. We must ensure that we give our communities the necessary tools, they need to be ready when, not if, the next emergency strikes. By all accounts we have come a long way. I spoke at the last hearing about the success of the andital fairness program the Public Health Emergency Preparedness program. In the context of a Train Derailment in pennsylvania, one of many examples we could site. Grants or these programs also facilitate it helpsess activity, hospitals and Public Health systems with more regular occurrences. When subzero temperatures cause bursting pipes at st. Vincent ,ospital in erie, pennsylvania the hospital contacted the local Emergency Management agency and also the Regional Health care poalition created through hp funding who assisted in the response in that circumstance. The funding for these Preparedness Programs has withd from appropriations falling behind, authorized levels spiking only in response to ebola and zika. The impact of funding reductions means a decrease in the amount of time hospitals and megan medical staff have a have to plan and train for an emergency. The loss of thousands of Public Health jobs, the reduction in Emergency Managers and Public Health lab technicians. It is very dangerous to wait for a threat to emerge before passing emergency funding bills. We must be proactive, not reactive. How can we improve our Health Care System preparedness and our Public Health capacity and thereby improve our Situational Awareness in emergencies in an emergency . Can we work towards a per visit precision Public Health using better data and more efficiently guide responses to help emergencies to benefit our communities . I think we can. It was reported by publication nature when domestic transition of zika virus was confirmed in the United States, the entire country was not declared at risk. Surveillanceise defined two at risk areas of miamidade county. Neighborhoods measuring less than 2. 5 square miles. This allowed for targeting of resources to these regions. Building on that experience, we can expand surveillance through expensive valence, limited cause of disease and expand prevention. All last after last weeks hearing, we heard from assistant secretary catholic about the use of the empower program to identify and treat at risk individuals requiring electricity dependent assistant quitman. Identified a weakness. This only pulls in medicare data, not medicaid and not data. How do we ensure that we are acting on the data appropriately to protect these vulnerable individuals . The tragic death of 12 seniors at a nursing home during Hurricane Irma in september highlights this that more needs to be done to protect the most vulnerable citizens. Haveof our citizens additional characteristics that make them more vulnerable during a Public Health emergency. This includes our children, our ,arents, our Rural Communities individuals with limited english proficiency, individuals with disability and individuals with chronic illnesses and more. We must do better to help our communities prepare for potential Health Security trends. We must continue to invest in innovative biotechnologies and we must also improve our nonpharmaceutical preventions. Im looking forward to the hearing, for the witnesses testimony, and for how we can prepare hospitals and Health Systems to ensure equal consideration of all of our constituents. Thank you very much. We haver i am pleased four witnesses here today and i thank each of you for taking the time to beer. Introduce to be here. First i would like to introduce dr. Tom inglesby. He is internationally recognized for his work as a writer with numerous publications focusing and emerginge Infectious Disease as well the prevention of in response to biologic threats. Alexander to senator for an introduction. Senator alexander i would like john dreisner. A new didnt experience responding to state and local Health Emergencies including Infectious Diseases like zika and natural disasters such as wildfires the devastated eastern tennessee in 2016. Today, he will provide important insights into the preparedness and response capabilities of the state and local level where we can protect and save more lives. Sner is a physician with more than 25 years of service. Leadership inis tennessee and we welcome him to the committee. Younger, ae you were couple of tennessee basketball teams would probably recruit you tomorrow given their record this year. Next up like introduce mr. , brent macgregor, the Senior Vice President for for theal operations second Flu Vaccine Company in the world. The example of the success between public and private partnership to ensure we are better prepared for the crisis. Their facility in North Carolina is one of three advanced manufacturers in the country with the capability to rapidly respond in the event of a pandemic flu outbreak. Macgregor is the cochair of the alliance for bio security, it works to promote credible partnerships between the government, industry and other stakeholders to advance medical countermeasures. Kruge, the. Stephen head of pediatric emergency medicine at Childrens Hospital of chicago. He is also a professor of pediatrics at northwestern university. He serves as the chair of the american pediatric disaster bareness Advisory Council. Welcome. With that i will turn and you can lead with five minutes of testimony. Senator byrd, senator casey, members of the community, thank you for letting me speak about these issues. Im the director of the center for Health Security at Johns Hopkins Bloomberg School of health and professor of medicine at public and Public Health. Our mission is protect Peoples Health from disasters. Ill provide a brief overview of key areas that my colleagues and viable. Er the opinions expressed are are my own and dont necessarily reflect the views of Johns Hopkins university. The u. S. Faces a range of major Public Health risks, any of which could occur without much warning. They include natural disasters, Mass Shootings and bombings, chemical spills and potential use of chemical weapons. Radiation, Nuclear Threats and biological threats. Biological threats, whether accidental, or deliberate our particular concern and thus the big focus of my comments today. Biological threats can range from moderate size up to those capable opposing global catastrophic risk. What more can be done to prepare for these threats . We need to strengthen the Health Care System preparedness. That is the capacity to care for high numbers of sick or injured in emergencies. While there has been substantial for small disasters in the country, the nation is not ready to provide medical care for large catastrophes. Spyr program has helped fund these capabilities of the state and local level. A Significant Resource constraint limits what hpp can do. The trend should be reversed. New initiatives like establishing regional Disaster Resource hospitals could be a strong new additional component in improving medical preparedness. To strengthend the ability of our Public Health system to detect and response respond to threats. Since 2001 there have been serious to cdc and local levels to provide Early Warning provideutbreaks, diagnostics, investigate and contain outbreaks, communicate to the public, insure bio safety and security and more. There is been good forward movement, but not enough trained professionals to do the work. Public health relies on funding from cdc, Public Health emergency grants. That funding has been reduced by nearly 30 since 2002 even though Public Health crises have not declined. Believe a Public Health Emergency Contingency Fund should be established which would allow rapid Public Health response funding in emergencies. We need to move ahead in medical countermeasure development. There has been Good Progress with many priorities remaining. Including sustained funding and research development, manufacturing of countermeasures. Transition to new flu vaccine technologies, setting ambitious targets for Rapid Development of products. So that they are ready in the course of a given pandemic or epidemic. Fourth, the u. S. Needs to recognize threats that could inadvertently emerge from biological research. After the moratorium on potential panic, after Death Research was lifted after last month. Studying ways of making the most lethal viruses like bird flu respiratory transitional transmissible. This could lead to the accidental or deliberate release of a novel strain of the virus that could cause an epidemic or pandemic. I dont believe the benefits of this work are worth the risk, but if it goes ahead i advised there is high transparency in the program and serious dialogue among concerned governments. Fund the goalould of global Health Security agenda. The u. S. Helped launch with a billiondollar commitment to help countries prevent and respond to Infectious Disease threats. Since then, the cdc and usa have been working with 39 countries looking to stop increased increase resistance. At this point, u. S. Funding for ghsa is ending soon. If we pull away, others will soon. We should continue to support it. Its the most Effective Program we have to contain sources overseas. Improving our nations fairness and response capacity is a daunting endeavor. Im confident is an achievable goal. I appreciate the committees time and i welcome your questions. Morning. Thank you for this opportunity to appear before the committee and discussed the issue of significant importance to the defense of this country. Resilientagile and medical preparedness and response system. T is an honor to be here im a physician, commissioner of health in tennessee plus a local Health Director a decade before for a decade before that. The vaulted will be sharing are my own, but im confident they are shared by my Public Health colleagues from across the country who strive to repair and respond to threats of all kinds. Infectious disease outbreaks like measles, foodborne illness of are annual epidemic influenza can test our capacity. Also largescale National Events like ebola, zika or act of terrorism. Public health mobilizes during natural disasters like storms, hurricanes, tornadoes, floods, wildfires. And other extreme weather events and fortunately does a Public Health jurisdiction go more than a few years without experiencing. Mechanisms like the Emergency Management assistance compact, even unaffected or sections are called upon to assist neighbors. And Emergency Preparedness response and recovery is a responsibility, discipline and service we have to get right. Lives as well as physical and Economic Health depend on it. It is something we do every day. All disasters play out. It is also a matter of national security. The few moments just in moments we have i would like to share my perspective in the planning, in limitation and execution at all levels both in a military and civilian capacity. Let me set with a simple question. What is health and emergency medical preparedness and recovery mean . It is people. ,helters dont staff themselves a fire truck cannot put out a fire without firefighters and people like Public Health nurses cannot be hired and trained after the alarm sounds. They need to be there ready to go before the threat ever emerges to be effective in responding to it. Preparedness is about the people involved in the interconnected networks. Need three keywe things, trained people, some with local knowledge at all connected by relationships built on trust. Relationships at all levels, local, state and federal. Given occasion and Situational Awareness among leaders, people on the ground, and expert trying to do these things before an event begins to createave time this network after the event starts. In a way, the Public Health Emergency Preparedness Response Recovery network is like a safety net for a performer. It has to be in place before the show starts, angered, inspected and in good shape. Many people think equipment or are enough, but if your member and not nothing from a testimony, i would like you to remember this, people, not things are the net. People are the net. It is the people that run the response. The knowledge and trust over time are what strengthen the core, hold them together and keep them resilient. The more that unravel, the less capable it is for what we need to do it are most vulnerable times. Things like Durable Medical Equipment and Communication Infrastructure are central anchors for the net. Without it, they cannot be our compliments in preparedness response and recovery of the last 15 years illustrated in my remarks can be directly attributed to the pandemic and all hazards preparedness act. This was transformed relative to Public Health and health care preparedness, it has provided and cadence ofon accountability that it become part of the culture of Public Health and enable us to do our job in the best way possible. Reauthorization, resources must be lined up for the demand of the everexpanding threat department. Keeping our frontline and safety ability. Credible it needs are critical to this. This committee should be applauded for its work that gives states, localities in tribes the resources and tools needed to stay vigilant at this critical post and get the job done. These funds are not duplicative with emergency med management and Homeland Security, but, mentally and essential. Depending on the hazard, Public Health is your only responder. What we need as a nation to ensure a strong safety net is consistent reliable and sufficient funding to keep the people, their knowledge, the networks, their trust in tact. Thank you again for the opportunity to speak about this fundamental issue and caring about preserving our ability to respond to any hazardous threat for generations to come. Happy today questions. To take questions. Good morning centerburg, senator casey, members of the committee. My name is Brent Mcgregor and im the Senior Vice President of commercial obligate operations. I appreciate the opportunity to appear before you. I would like to focus my remarks on the importance of preparedness against pandemic influenza and the Critical Role played by the Biomedical Advanced Research and Development Authority and its industry partners. There are three issues alike to highlight from my written testimony. First, the pandemic influenza is one of the most urgent Public Health threats we face in the nation and must be a priority of biomedical enterprise. Third, that Congress Must provide sustained and todictable funding strengthen partnerships with the private sector and to ensure our nations preparedness. Regarding my first point, preparing against pandemic influenza, this is critical to our national and economic security. Are proud of the partnership we have with barda. Thanks to the leadership of senator burr, senator casey and members of this committee and the dedicated team at barda, our vaccine Production Facility in North Carolina is one of the examples of successful public partner public partner private Publicprivate Partnership in bio defense. Despite representing the p in pahpa, authorized funding has not been included in the legislation. Funding for critical activities such as stockpiling, advanced research and development has been episodic since 2009. Emergency supplemental funds provided during the 2005 and 2009 pandemics are now fully exhausted. Authorized byam congress would provide a clear signal to the private sector that the u. S. Is committed to preparing against pandemic threats in the future. The most recent fiveyear budget outline 630 million. We believe in annual authorization level of the least 535 million is needed to support hhss most critical activities. Regarding predictable mcm funding, over the last 12 years, this enterprise has improved our nations security and while bar da has improved of its industry partners, government must provide more certainty in the process. Procurement funding provided by the project special was her fund , the National Stockpile and b ardas Program Provides market certainty. Because there is no commercial market, companies can only rely on the commitment provided by hhs to make investments in research. Unfortunately over the last several years, the private sector has become more skeptical of the government commitment to bio defense. Funding has created uncertainty in the longterm sustainability of the programs. Publicprivate partnerships must be sustained over time to demonstrate a commitment by the federal government. There are dozens of companies both large and small that have committed to the mission and made significant investments in mcm development. Reauthorization in a renewed commitment will ensure these investments yield even more fda approved medical countermeasures. Securis supports the and by thetion biotechnology innovation organization. I would like to thank members of the committee and senator burr further commitment to the authorizing for reauthorizing pahpa in a timely manner. We believe we are excited about the future of our partnership with barda, we encourage the committee to reauthorize the program. This is a critical opportunity for congress to ensure barda has the research it Needs Resources it needs. I look forward to serving as a resource for this committee during the reauthorization process and im happy to answer any questions you may have. Thank you for that testimony. Good morning. Byrd, Ranking Member casey, distinguished members of the health committee. I am the head of the division of emergency medicine at robert h Childrens Hospital in chicago. I am the chair of the American Academy of pediatrics preparedness Advisory Council and bath of the 60s on behalf of the members, thank you for inviting me. Im privileged to serve on federal advisory committees and chaired the hhs National Bio Defense science board. My comments today are as a private citizen and member death i applaud the work of this committee for strengthening and improving our nations Public Health for medical preparedness with the pandemic reauthorization act. I will thank you for the firstever provisions for children in the last reauthorization. Those changes of help to make the needs of children a much higher priority in Emergency Planning and response. From heard last week leadership, each agency has a distinct role to play in ensuring our Health Care System is better prepared to meet the needs of all americans, including children, during and after natural disaster. The leaders of these federal agencies and countless reallyrking employees are the backbone of our nations 24 7 federal emergency readiness response capacity. Costrequency, severity and of disasters and emergencies are increasing meaning they will remain a significant threat to the health and safety of our community and nation. Maintaining and expanding the federal governments Strategic Focus on all hazard approaches is critical. This will require continuing engagement of all stakeholders including Public Health, medical and Mental Health services, academia, industry and state today of emergency and trauma services. Our nations it is evident that health care in systems that are regularly tested will be the most reliable and effective. Regular exercises and drills along with continuing education for care providers and First Responders are necessary in order to be ready for all populations when a disaster strikes. This is important if we hope to be ready to meet the unique needs of children. As aulation population we should strive for a healthier community. This will reduce the burden on the Health Care System during and after disasters. This means ensuring access to Affordable Health care and preventable services and reducing health care to spell it disparities. Financial drives in Todays Health Care environment are not aligned with the need for facilities to be prepared for Public Health emergencies. Costreduction measures have resulted in leaner stockpiles and is substantially smaller workforce. With the daily operations functioning closer to full capacity. This is promoted emergency and poort overcrowding Surge Capacity during seasonal epidemics and pandemics like the one we are going through now. The Surge Capacity gap particularly carries within pediatrics. Crisis funding does not adequately indicate primary care. They provide Vital Services before, during and after disasters. In the absence of mechanisms to provide assistance to impacted providers and disrupt practices, many have been forced to leave. It is not hard to see why so many communities have for that struggle to respond and why some may never fully recover after disaster. Communities rely heavily on resilience of the health care sector. For 25 of thet population and their unique vulnerabilities mean preparedness response activities at all levels must account for their needs. Children are different than adults. I would offer three additional thoughts. In terms of recommendations. Andt, reauthorize strengthen the hhs National Advisory committee on children and disasters with subject Matter Experts from the public and private sector. There provided code recommendations for health care prepared for children. Two, authorized the cdc preparedness unit which has proved to be an invaluable resource to the pediatrician community and other child serving institutions. This unit is a best practice example of an effect of public and private Sector Partnership that has brought tremendous value to preparedness. Finally, to reiterate comments already made, lets maintain the grant programs, those are distinct programs with strong pediatric Performance Measures and with increased funding. As disasters and universal risks can occur anywhere in the nation , it is essential all jurisdictions have a baseline level of preparedness needed by each of these programs. I want to thank the committee for the opportunity to testify and a look forward to your questions. As evidenced by the fact that im not sure in the past had a pediatrician on the floor for these related hearings, it shows we understand the need to get it right. I might say it is probably one of the most challenging areas because it is hard to incorporate pediatrics on the cutting it and the cuttingedge technologies that on one side are pushing and that that will always be a challenge to us, we need more subject Matter Experts to help us navigate through that. I will recognize members from 25 minutes starting with myself and move on a seniority basis. Securis has worked to make us better prepared, the facilities in Holly Springs, North Carolina is a promise and partnership between your company and the federal government. That if needed, we could flip a switch from the manufacturer of vaccines to seasonal flu to the manufacturing for pandemic flus. What are the Lessons Learned from this partnership and how can we improve the partnership . Thank you for the question. I think the lessons we have learned thus far, the partnership has been a good one since the very beginning. What has happened in recent years is the commitment that has n made and for which the and for which securis has delivered, the funding is not kept up with these ideas Going Forward. Even the funding for pandemic the originalart of pop up legislation, there is those emergency funds that are provided for flu, i think the big lesson we have learned since that time is that the funding has declined to a very low level , particularly since 2009. You start to question the commitments and what we put a commitment forward, a ,artnership forward with barda sometimes we feel the funding dedicated or earmarked for pandemic flu suggests there is not a serious interest taken to this particular section Going Forward. I think that is what weve learned. I think communication is another lesson be taken. For the most part, the communication between barda and our company and other companies that are in partnership with the butrnment has been good, there is always opportunity for improvement across the spectrum all the way to the snf. It is not bad, still room for improvement in harmonizing how it works across the spectrum. Lines weresdictional a little difficult at the beginning. Colleagues and this committee will remember in this committee will remember this years flu season and the severity of it, we dont know yet. As we get smarter at predicting what the threat is going to be, this is a great example of we are not smart enough to get a better than 32 right based on the current numbers and we have got to look at technology that allows us to address seasonal flu in a way that encompasses all of the above options that might happen. Ou mentioned barda it has done its work to better Public Health threats and it has been extremely successful in advancing innovative approaches to the development of medical countermeasures. What do you see as the greatest challenges to bringing things new and innovative to technologies through the medical countermeasure pipeline . Whatthink one example of you mentioned is new and innovative platforms and the plant at Holly Springs is an example. This is not the more conventional which we are which we think people are more aware. Da hasteraction with bar been strong. Not only allowing us to advance the cellbased technology was recently through the partnership through efforts to improve the yield. In acan not only benefit pandemic setting, but actually potentially benefit in a seasonal setting. In benefit would not only be vaccines coming sooner to market, but the other promise we hope, technology that is invested by the government is that it offers the potential for providing a better match in the event of a mismatch. Let me turn to you, innovations and in technology have drastically improved our bio surveillance and Situational Awareness capabilities to monitor and detect and identify the Public Health threat in as timely a fashion as possible. The federal government lags behind in its ability to leverage these technologies. How can we improve the federal programs to create more cohesive and realtime surveillance capability for Public Health risks . As a side to that, do you believe that we use enough open Source Information outside of the mechanisms we have set up domestically and internationally . Questions a very good and people have been working on that for a long time. There are many Surveillance Systems in the country that are into that goal. They are not together under one roof. It has been a goal the federal government to try and consolidate and bring the system together. One of the things that we could do better is to get more information out of the Health Care System to Public Health during emergencies. We have a lot of advances in Electronic Health records, but for the most part, Public Health agencies dont have any resources or analytics to see whats going on in Health Care Records around the country. So if we could do more to bridge that divide between Public Health and medicine, that is where a lot of the information will come in outbreaks. From doctors and her nurses seeing unusual things. Diagnostics,atory getting that information together. I think closing that divide and also bringing together unusual sources of information like whats going on in the animal systems. Foodsable to trace back when big food outbreaks arise is a difficult challenge right now. We are much better than we were a number of years ago. Confident that mechanisms are in place for that transmission of information. All we need is one breakdown and it does make one wonder in the overall scheme of things why we top of the review of scripts written on a daily basis that gives us either confirmation of what we are hearing from the Public Health ofna or potentially a sign an outbreak of something we picked up in prescriptions that were administered the day before , the unusual thing is that gives us great clarity as far as geographical location of something all the way down to a nine digit zip and it seems like it is all of the above. Jason senator casey senator byrd talked about the morehis year, we are told cases7,000, 700 17,700 of the flu have been in pennsylvania alone. 32 people including one child have passed away because of them. While this is a particularly bad flu season, it does not come close to what we would see on a , infectiousscale disease emergency or of course in a pandemic flu scenario. Our Health Care Sectors are already near capacity with this flu season, so we are woefully unprepared to respond to a mass casualty biological event. So for both dr. Inglesby and dr. Dreisner, how can we prepare hospitals for a mass casualty biological event . I know that is a lot to bite off. Thank you for the question. I certainly welcome the comments as well. Said, fullyas been pp to his prior levels will be hugely helpful. I think dr. Krug make important point in terms of the financial incentives of the current system, just in time for supplies and for staffing, there is limited Surge Capacity and we are seeing that in tennessee right now. I had a call with our hospitals a couple weeks ago, some of the challenges, this is a flu season i think that is more severe than we typically see and a sen. Burr to doubt, we dont know what this will look like and compared to other seasons. One thing is true, we are reporting more. Many states are reporting child and deaths. We of already had tragic preventable deaths we have already had tragic preventable deaths. As people hear about those things, there is a perception of greater severity and with that, people visit place like dust place like emergency rooms. Need tore ill, you may call your Health Care Provider but you may not need to go to an emergency room. All of those types of things are in at of what we deal with flu season where there is heightened awareness. In terms of assuring we are of fundinghe amount available through the hpp grant has been inadequate for some time and i think as you pointed out, there is a need to bolster that. I dont think its its a great deal more, but certainly returning to earlier funding levels would be helpful. I agree with everything said. I would add going back to the beginning, the more that we can develop our flu vaccine technologies, universal flu vaccine being the ultimate goal. Less we will have six people in hospitals. We need a strong Health Care System Preparedness Program through hpp. There could be other facets of the program like having Regional Center that could show more responsibility in crises and take more care of nations. We have a Level One Trauma Center system that works well but nothing like that for Infectious Diseases. We have built biocontainment units in places around the country in response to ebola, most of those units can only take care of one or two or three patients at most. We want to raise the level of preparedness, we might think about creating some regional strength. At most hospitals you will need to take care of patients coming you will proficiency and personal protective equipment and relationships with the other hospitals and the Public Health agencies and the clinics where people are getting cared for in the community. Asis a network of care opposed to only relying on the major hospitals. We have to distribute that burden to the community when there are major epidemics. I might come back to it after we have other questions, but the ,evel one Trauma Center model how do you think we incentivize that in the context of what i think in your testimony you referred to as specialized Disaster Resource hospitals. Question, iyou that will come back later and his comments on it. The way you incentivize it is if have some kind of competition for it but you would have to provide resources because there is no give in the system. Hospitals are running small markets so they will not be able to build large entities or programs outside the usual programs unless the government says we want to do this and here is how. Thank you very much. Thank you chairman berg. Urr. Dr. Inglesby you wrote about the agenda. That was established in 2014, where is that now . It is in multiple agencies of government, particularly cdc and usaid. Who is the quarterback for it . I think you would say usaid and directors. Who are integrally involved. When the Ebola Outbreak took a rockyou referred to areas around United States that containment areas. From a modest standpoint we were at nih meet the threat and a couple of places. Backirst doctors who came which is where broke out. How much of that, that was enough of that was enough of the time, but how much should be built in preparation for and anticipated the need of having that again . Maybe not for ebola but some other Infectious Disease. I think if you speak to the leaders in that program, they would say it would be difficult for them to take care of more than one or two patients in the current units. I think we need to get better cost information about how much those units cost. It would be difficult to scale or 100, but i think we could build more capacity in the systems, share the Lessons Learned and see if we can spread that responsibility out a bit further. Right now it is a small number of units. , death most cases capital money and training. You talked about the Contingency Fund or recommending have some sort of contingency planning, do you recognize how much that ought to be . If you base Contingency Funding on what we have spent in other Infectious Disease emergencies, we typically is spent at least 500 million in response to things like h1n1, ebola, zika. A fund somewhere in that range, Public Health agencies and others outside have called for 2 billion Contingency Funds closer to what fema uses for Disaster Relief funding. Thatthat would be would provide a lot of acceleration in Public Health response and emergencies. Because biological threats are more recognize, barriers are something the community has to dissipate in together. Absolutely. For that and so is usaid, could that be where the International Agenda ought to be coalesced . I think the way the global Health Security agenda has worked is that it brings different parts of government, including finance sides of government, security sides. In the u. S. It is bigger, there is participation by security and finance and economics. Mr. Mcgregor, does the plant at North Carolina manufacture the flu vaccine . Yes. Do we still have enough given for an epidemic going on . We have been constantly enhancing the capability in that plant. ,rom a seasonal perspective looking at the seasonal perspective, we more than tripled our capacity into the market this year. That plant is also responsible in delivering one third of the requirement in the event of a pandemic. And responding within a sixmonth period. What is the shelf life of that back save . Vaccine . The antigen is five years. Antigen that is in our stockpile that is older than from a cell perspective. That is the state of affairs as far as ourselves a vaccine is concerned our cellbased vaccine is concerned. Theres the potential of being a better match in the event of a mismatched strain. Publicprivatel partnership, that is the promise that our company is trying to deliver on on behalf of the government. Fixed all of you for your testimony. Thanks to all of you for your testimony. Thank you, senator burr and senator casey for your leadership on this issue. Good morning and thank you for being here. I wanted to start with a question for you. All know, puerto rico was recently devastated by Hurricane Maria and the island is still trying to rebuild from the disaster. The effects of that disaster are obviously widespread. Hospitals in New Hampshire and around the country are dealing with among other effects medical product and equipment shortages because the storm devastated some of the manufacturers on the island. What does this shortage say about our overall preparedness in the case of a future event or other types of emergencies where medical supplies cannot be easily replenished . What can we do here in congress with this issue . Hassan, yes, i agree with you completely that the puerto rico hurricane and other storms have revealed how vulnerable are supply systems are. One possibility to consider to consider whether there are some critical supplies , such as sailing bags orine bags, whether not they should be included in the National Pharmaceutical stockpile. That is not have a stockpile is configured or resourced now so it would need to be Additional Resources for additional admission, but the stockpile has Great Success in acquiring medicines and being able to deliver them to localities. Ift would be one possibility there was additional purpose and funding for the stockpile. May i interject . Holly springs is another great example and the other two facilities that when faced with a pandemic, we actually became visionary and we thought, what can we do to meet what we dont know . We went into a partnership with three Different Companies where we funded three quarters of the plant, but with a condition written into it that at any point, we could turn it in to what is in the nations best interest. All three owners knew that and participated in it. It may be a model that we look ,t as we identify other things but we have shown a degree of vision in the past. Sen. Hassan i think thats very helpful and i think the example of what happened in puerto rico after maria really helps us focus on one of the next things we should be doing. I wanted to ask all of you and i think i start the question with you. I love what you said about preparedness and response being about people and time. Obviously both demand resources. New hampshire uses its hospital preparedness funding to support a single statewide Health Care Coalition that works to bring together have a and Emergency Management professionals to ensure the Health Care System preparedness is there across the spectrum of care from hospitals to home care to longterm care and beyond. New hampshire, like other states, relies on this funding to make sure its prepared for all kinds of emergencies, mass casualty incidents to hurricanes. Unfortunately like many other states, New Hampshire has seen a decrease in hospital preparedness funding in years. We dont know when the next emergency will happen or what it will precisely entail so we need to make sure the coalition in New Hampshire and is not only collaborating regularly but training regularly. Its hard to do that when funding is dramatically reduced. I will start with you. From all of you, do you agree that we need to increase investments in the hospital Preparedness Program and that it should continue to fund those efforts in all states . Thank you for your question, senator. I would say absolutely yes. ,f you think about who response in my written testimony, you talk about professionals who do this every day. We have people who are highly trained and they are called upon. Theres an actual emergency like the one you describe, but they typically have different duties on a daytoday basis. One of our emergency coordinate is in tennessee actually directs our board of emergency medical services. When we have an emergency, shes in the state operation center. We have this third tier thats everybody else and the people that you are talking about. They are the Public Health nurses. They are the clinicians in the hospital. They are people called upon whenever there is a need to serve. In training and exercising and actually responding, creating the relationships and the knowhow, what do i do, where do i go, who do i talk to those are the critical things. Those are relationships built on trust that the funding really helps solidify. Unfortunately when you reduce that funding, that is one of the first things that goes. You try to preserve the physicians and some of the things he invested in. The more fungible assets are the very things you need more of. I think you spoke to this very elderly. Eloquently. Sen. Hassan i will ask the other three panelists anything you would disagree with or add to what was just said about the funding. Just the point that it is about people. The earlier question about how we get the hospitals better prepared they have to train. If you dont have trained people coming to response will not be effective. That has been shown in many other industries, including health care. With a focus evolving from hospitals to Health Care Coalitions, which i think is an appropriate move, its not just the hospitals that need to be trained. Its the entire community that needs to be trained. As an emergency physician, can i just do a brief pivot . After oxygen, the elixir for how we treat patients is saline. Whether youve been an explosion or bus crash, if you dont have saline, you lose lives. There could be nothing more fundamental to our Emergency Response after oxygen than sailing. E. Salin sen. Hassan i know im over and i will just submit for dr. Krug a question about Behavioral Health needs, especially for children and disasters and the trauma that disasters impose on our kids concerns me lately. Thank you for focusing on the populations of special needs. Im the mother of a special needs young man and i thank you for raising that in your testimony. Sen. Burr senator smith. Muchsmith thank you very to the other members of this committee for your work on this and focus on Emergency Preparedness and also to our test the fires here today. Here today. S minnesota was hit by an avian flu outbreak that ended up costing somewhere in the neighborhood of a billion dollars. It was the largest and most expensive animal disease response in the history of this country. It hit poultry growers incredibly hard. I was really relating to what you were talking about, about how this safety net that we have is about people and not stuff. As we responded to this catastrophe, we needed stuff, but we also really needed the people and the relationships that made our response work and function incredibly quickly, which was such an important part of it. Im quite interested in this idea of a one Health Approach and how we can build that kind of approach into our thinking about Emergency Preparedness. I know that senator young from indiana has raised this question just last week. Youve probably been talking about it for much longer, but raised this question of whether we need an initial additional approaches or resources to do this. Maybe i would like to turn to dr. Inglesby. Can you talk about what tweaks we would need to be legislation the legislation to address this question of what we ought to be doing better there . Dr. Inglesby first of all, i completely agree with the values and principles of one health and think you are absolutely right that there are strong connections between animal and human health. Principlesthat those you will find those principles and federal agencies. People believe theres a lot of acceptance and believe in one health. It is not houston a particular program. Housed in a particular program. Byo think theres a National Defense strategy now being written or completed by the white house. Its purpose is to bring together Animal Health, plant health, and human health for bio defense. Thats the first time the strategy has been written that way. There was a lot of coming together and agencies over the last year in the agencies over the last year on this. We do not have strong animal surveillance. We talk about shortages in workforce. The human health, Public Health workforce is strapped in the Animal Health Public Health workforce is even more scrapped. Strapped. Im not sure that would be within the scope or not, but we dont have a lot of information coming from our animal systems. It doesnt cross over into human health very easily. Trying to create the bridges between the systems would be a good step. Sen. Smith thank you very much. Dr. Dreyzehner thank you for the great question. If i can make this point, as Public Health professionals, we think about the primary prevention of flu as stopping it in the first place. I think we have to look at ourselves and we have to think about, how do you primarily prevent the flu from ever occurring in the human population or another disease, ebola, occurring in the human population while doing things around the animal sources are critical . You have Avian Influenza and stamping that out in poultry. We also have to make sure we circled the workers and their families because thats primary prevention of a potential novel influenza strain in the human population. One health is an essential perspective. From my perspective and i would of from the Association Health professionals perspective, id be interested in happy to work with you on kind of crafting how to specifically as dr. Inglesby mentioned, bringing ag professionals, Public Health professionals, the health world together to do a better job of keeping animal diseases in animal populations and not transferring to human beings. One other point somebody came to commerce years ago and said, we need some money to teach people how to properly prepare bushmeat in africa because we know they are going to eat it and how to properly gather fruit that may have been defecated on by bats. That wouldve been a hard sell. When you think of the money we spent on the Ebola Outbreak that emanated from those practices and lack of education around that risk, it wouldve been a relatively small investment. Sen. Smith thank you very much and i look very much forward to working with this committee and senator young on this issue of one health. I know im out of time, but i might also submit later to dr. Krug. Im very interested in this question of how we respond to what is another epidemic seriously affecting children, which is the Opioid Epidemic, especially in indian country. That will be for a later time. I would very much appreciate your thoughts on that. Sen. Burr senator roberts. Roberts thank you, mr. Chairman. I want to thank you for this committee and both the Ranking Member and distinguished chairman for focusing on this issue. Last month over in the agriculture committee, we held a hearing on safeguarding american of the culture agriculture in the globalized world. Dr. Inglesby really hit the head with your comments. One of our witnesses was general , from kansas state university, home of the national and agricultural defense facility. In his testimony, general myers notes that because there were two Homeland Security president ial directives in 2004, one for people and one for animals. There seems not to be a strong focus on the executive level on crops and livestock. He suggested reasons why this is surprising and i will enter his full testimony to the record at this point if that is all right, mr. Chairman. His reasonings are essentially every country that ever developed an offensive bio Weapons Program, including the u. S. , crated weapons targeting agriculture as well as people. I would just like to insert at this time that we have a lot of interest in this by former senators sam nunn and the old threats andandemic also by tom ridge and Joe Lieberman with regards to agriterrorism. And itf was in charge was called the emerging threats subcommittee. Its north and west of moscow. Thereby seeing one of the secret cities that we are not allowed in now, but we were then because they needed the money. We were focusing on security, but in touring the area, i was really stunned with regards to vast warehouses of pathogens that they were making ready with regards to attacking a countrys food supply. We ran an exercise at that particular time. It was called crimson sky. It was a misnomer because you dont want to burn carcasses or anything like that. It was put in mouth disease. By the time texas put a stop order from shipping cattle to oklahoma or oklahoma to texas so they dont ship cattle in to kansas and nebraska and north dakota and south dakota, we had an epidemic on her hands. We had to terminate thousands if not millions of cattle. Ofver exports stopped all our exports stopped. There was a run on Grocery Stores all throughout the country. People finally discovered their food did not come from Grocery Stores. It took us years to get back to a situation where we could literally feed not only this country but a very troubled and hungry world. That was quite an experience for me. First as iveid indicated that every country that ever developed up by Weapons Program also targeted agriculture. Every pandemic is a disease that can spread from animals to people. Threats thatterror the Homeland Security has issued a material threat determination, are zunet for smallpox oonotic. They could really devastate public threats as well. Until its operational in the next four to five years, i regret that its taking that long. There is no u. S. Laboratory for Livestock Research to be conducted on ebola. Swine being the host animal for both. I would like to work with you and all of our colleagues on this reauthorization to be sure that we are preparing for these threats. I25 seconds i have 20 inglesby ifask dr. Engels you would like to respond. Leading the countermeasure enterprise, this is supposed to be where all the coordinating agencies, the department of defense, v. A. , Homeland Security, along with all the , tot responders involved update our strategy and to implement our plan annually. From your perspective, are we doing the job . Dr. Inglesby i think we have a lot more work to do in the realm of agriculture, food, and crop safety. I completely agree with what you said about the importance of animal vaccines could the shortage of animal vaccines to protect herds against threats to the planet. I agree with what you said to the threat to agriculture. Both animals and plants have been relatively neglected the last few years. How to organize that and the government i dont have a strong sense of how that should be organized. Its complicated in that usda is responsible for the promotion of food and the business of food. It perhaps could be difficult to have that protection of food in the exam site same exact place. Ive seen signs of life in those programs that ive not seen in the last 10 years. Sen. Roberts secretary perdue and the office would run that. The construction of that is Homeland Security and they are responsible for any attack on the United States. Its difficult to focus on this. Some years back on this committee for which might distinguish friend is the chairman, we were able to determine what keeps you up at night. In the top 10 was an attack on our food supply. That is not the case today. Director,th our cia mike pompeo, who happens to be from kansas. We are trying to reassess that threat and i think its a very real one. I thank you all for your service and im over time. Sen. Burr you did not disappoint me. I knew there was going to be a question somewhere in that dissertation. Senator baldwin. This discussion today is important and timely and brought into focus the sobering fact that if experienced one Health Emergency every year in the five years that ive since serving on this committee, from ebola to zika to the hurricanes this year. I was serving previously in the house of representatives during the 2009 h1n1 pandemic and also in 2004 when we saw a dangerous shortage of influenza vaccines to our insufficient Domestic Production capabilities. We are also in the middle of a particularly severe and deadly seasonal flu year. So i wanted to focus specifically on our readiness for a pandemic flu outbreak. With a lack of sustained and predictable funding for the pandemic vaccine stockpile. Im committed to working with my colleagues to advance a specific authorization for pandemic flu activities. Mr. Macgregor, in your testimony, i was troubled that are pandemic flu stockpile does not match the current strains of influenza and is full of expired vaccine components due to underfunding. It is especially concerning as bird fluhe h7n9 circulating in china that continues to evolve in ways that has the potential to trigger a global pandemic. Are we adequately prepared for an outbreak of pandemic flu that could strike in the near term . How would a pandemic in the middle of this severe seasonal flu season complicate our Vaccine Readiness . Thank you for the question, senator. At the start of your statement, yet admittedly gave part of what would be my answer. I think your question and your comment about the stockpile as it exists today is a result of the underfunding that has occurred particularly since 2009. With the funds that were 2005,ed up to 2009 from the buildingor up of a stockpile of various pandemic strains. It was allowing us to test and to understand how to manufacture. This was a Good Partnership with barta and was fundamental to our preparation at that time. Since then, the funding has really dropped off as you commented. That is really whats behind the point that i was making. Theres product that sits in the stockpile today that was manufactured quite some time ago. In some cases, seven or eight years ago. Our ability and the ability of the government to replenish the stockpile whether it be with antigen or whats also in the stockpile has been diminished by the lack of sustainable funding to support its efforts. In answer to your question, because of that, i dont believe we sit in a great state of readiness today. You mentioned the h7n9 and we barta, but weth need sustainable funding Going Forward to enhance our readiness. Sen. Baldwin this question is for you mr. Mcgregor and dr. Inglesby. My home state of wisconsin has long been a leader in medical innovations that help grow our economy. Not only are we home to a world renowned flu scientist working to develop a universal vaccine, but we are also the hub for Biomedical Companies producing new technologies. A company in madison, wisconsin is producing a new regenerative Skin Technology to treat severe burns through a contract with ba rta to develop tissue as a medical counter measure. Instead of painful skin graphs, they are designing tissue designed to mimic skin. Discuss why its important to maintain our federal investment in medical countermeasure research and development to foster innovation that keep pace with the evolving and increasing chemical and biological threats . What a we start with you, dr. Inglesby . Why dont we start with you, dr. Inglesby . Dr. Inglesby for problems like the one you described for patients with burns and with pandemic influenza and other kinds of outbreaks, there is not necessarily a commercial market for those products. Companies face a very difficult challenge planning a lot of uncertainty. If the government can provide more clarity both in the early phases and the research and the developer face, particularly , companiestion phase can decide to make investments in this space as opposed to other commercially valuable opportunities they might pursue otherwise. I think it will continue to be a very Important Role for the government to play for products that we want that are otherwise not produced by the commercial markets. Thatwould certainly echo comment. That needs tosm exist to have Innovative Companies like the one you mentioned and the alliance for bio security to be able to continue innovating in the space. There needs to be sustainable funding in the space. Make is comment i would just to add that its interesting to hear from a number of colleagues in the space that when you look at Institutional Investors and the like, where there used to be more of an attraction for them, when the funding was more certain, that attraction has gone away at little to no value on theon mcm work current context because of the lack of sustainable funding. Sen. Burr sen. Cassidy. I enjoyed your testimony, all of you. I enjoyed it so much because you agree with me. One of you spoke about the need to have professionals, health care professionals, be able to go across lines and have liability protection. I was a practicing physician when katrina hit. The fema would not allow people to set some of these broken bones because he was out of state and they were concerned about liability. I think we need a good samaritan. If you are from out of state and youre in Good Standing with your state, you get blanket protection. I think we need that on a federal level as opposed to the patchwork. I have proposed a bill that would do so. Secondly, i think dr. Krug , you spoke toby the need to have a Public Health emergency fund. Senator shot and i have introduced something with that. It doesnt need a special appropriations, but when the emergency hits, dollars are appropriated and it cannot be encumbered or put in escrow by another effort. Those dollars are there. Still have accountability where you have to come back to congress and get approval. Gao will make sure they do it. We also take care of contracting because the previous cdc directors said you had to get 10 sign offs on travel vouchers for people to get over to africa and that slowed the response. He had to contract with ngos to contract to get transportation for people and goods. We are trying to circumvent that and we put something together in regards to the. At. Let me hit on stuff thats perhaps more provocative. You speak about the need to maintain this international network. Three erratically theoretically the world health is doing that. Im not sure we ha are getting a bang for our buck with will help. World health. If we are funding internationally world health and the cdc is doing it separately, that does not seem in a time of scarce resources a wise use of resources. Thoughts . Dr. Inglesby the World Health Organization has some of the best experts in the world on diseases around the world and they are the normative agency for setting policy and guidance around the world. A strongnot operational agency. They dont have resources for going to train the world or build labs around the world. They have some money for that, but there budget is their budget is constrained as well. Sen. Cassidy if they have the money, would they be capable of doing it . Dr. Inglesby not right now. Sen. Cassidy we are having to supplant International Organization with the centers of Disease Control. It almost seems like were compensating for something which should have the responsible the already. Dr. Inglesby the cdc and 65 other countries are all contributing in some way, some with a lot of money and somewhat their experts, but the global Health Security agenda was a way of getting a Large Consortium of countries to go out and hope. And help. Sen. Cassidy it seems like world health should be doing that. You mentioned about having regional areas of expertise. Let me go back to my formative experience with hurricane katrina. When the fecal material hit the fan, it was just overwhelmed anything. When i went to haiti as a private citizen after the earthquake there, i was struck that the israelis came in and they just plopped down the hospital and unfolded it in every capability they need was there in a field hospital. Since a Public Health emergency could happen in baton rouge, shreveport, or topeka, or you name it, how does every region have that kind of expertise as opposed to a Public Health hospital that may set up at your. , which is a Government Health facility . It seems like a better way to respond because you truly have expertise that is deployable in a moment. Any thoughts about that . Dr. Inglesby we should be able to rely on the local institutions. The v. A. Is a great source of strength in some cities. Teams, some of the teams that responded to katrina sen. Cassidy let me go back to ebola, which was specialized. You have to take off your booties in the correct fashion or else you were exposed. Dr. Inglesby the u. S. Was not prepared to send doctors and nurses to ebola. They did not take care of patients. Sen. Cassidy would it be better to have that sort of expertise that truly could go to a community and we are going to be the Expeditionary Force . The health care Expeditionary Force that is going to be able to manage this and we dont have to have a lot of an Service People are hitting the door right now. We will give you inservice, but , soill provide direct care whether its baton rouge or topeka or new york, we know we have expertise deployed. Dr. Inglesby with Something Like that on a smaller scale called dmat teams. Sen. Cassidy they are more generic. Dr. Inglesby we do not have Infectious Disease oriented like the one youre talking about. It would be good for us to be able to build those teams. Sen. Cassidy i yield back. Sen. Burr i would like the record to show that North Carolina tried to deliver to louisiana after katrina and affordable hospital. It was the governor who would not sign the Liability Agreement that put that hospital in mississippi. So we have this incredible Surge Capacity im learning about. Its just that we have hurdles in the way that stop it dead in abstract if it ever starts the motion dead in its tracks if it never stops the motion of collectively addressing the problem. Sen. Cassidy we in louisiana continue to be indebted to other dmats around the nation. I cannot tell you the gratitude that we feel. Sen. Burr senator kaine. Kaine want to ask each of you to address a workforce questions. The observation is this. When we reached a deal yesterday so the government would open, there really two components to the deal. One is a guarantee of a debate and vote on permanent protection for dreamers, but the second half of it was we have got to get out of continuing resolution mania and get back to real budgeting against the fund again to fund these priorities and others. One of the questions we are grappling with is the question of budgetary caps because of votes of earlier congresses that would impose such caps. When the caps were imposed, they were imposed equally on defense and nondefense. And theour testimony testimony of the Panel Last Week is about national security. This is national security. I just came from a closed hearing about Americas Nuclear posture in the Armed Services committee, but you are national security, too. What your proposals floating around is that we would increase caps on the defense accounts but not on the nondefense accounts. So your are nondefense national security, but you are not defense. The lynchburg, virginia economy is based pretty heavily on companies that build Nuclear Reactors that go into carriers and subs. Those are under the control of the department of energy not dod. Point that im making is that as we grapple with these caps, it would be foolish to not raise caps. If we are not raising caps appropriately to fund Emergency Response or we are not raising caps appropriately to fund the dod programs to build the programs, we are not taking care of our national security. Thats my observation. The quote in your testimony written and verbal is about people. One of the things i love about this committee is that it is health, education, labor. Summits within our health jurisdiction, but envy education jurisdiction in the education jurisdiction, we are approaching rewriting the Higher Education act with programs like loan forgiveness. This is on the education side. You all approach your jobs from different backgrounds and expertise, but share any concerns you have about the current Public Health workforce in this country as you look forward because we might be able to do something about that. We might be able to do some things about that as we grapple with the Higher Education act rewrite. If you want to start, dr. Krug . Dr. Krug thank you for the great question. As has already been said, this is a lot about people. We do need more stuff, but we do need more people. The budget environment today constraints the number of people that you can employ, which is why theres this justintime thing going on in health care, which is why we dont have a lot of capacity. In the end, there are not enough nurses to staff all the hospitals or all the clinics. Some of those limitations are greater in certain communities than others. I will defer to my Public Health colleague, but i believe there is a Public Health issue is what. As well. What we need to do through incentives is direct more of our future young people toward these important careers because these are careers where in addition to taking home a paycheck, you are making a difference. You are serving the community. You are serving the public. You may not be a special government employee, but youre still making a difference. I think if we can redirect the flow, we will be better prepared to deal with a calamity. Sen. Kaine others who would like to address it . Mr. Macgregor i will go down the line quickly. My main response to this would be some of the strain that comes on Public Health is referenced by my colleagues up here is the need to respond to an emergency. I feel a big part of the reauthorization discussion the notion of sustainable funding really has as its core the avoidance to respond to an emergency that puts an undue strain on the Public Health system. Drifted from your question about workforce, but i wanted to make that particular point because it gets to the sustainability question. Sen. Kaine thank you. Dr. Dreyzehner thank you, senator. A very important question as mr. Mcgregor said in his comments about medical countermeasures and the uncertainty around having a market for those. Dr. Krug mentioned folks who are engaged in this area are highly committed, compassionate people, but they need certainty in the profession being there tomorrow. That has not been the case for the last 15 years. Theres been a lot of questions marks raised about will the area that i devoted my life to, and really called upon after 9 11 and anthrax when we developed are more modern and responsive higher capacity Public Health and preparedness infrastructure, but those are festivals have evolved around that. Many of them are now becoming senior. Many are retiring and making decision as to whether they want to enter the field. Will there be a profession for me if i decide to enter the field or to stay in it . All those things are really important. Sustaining and maintaining funding is a very important. Not pulling at the last minute to redirect it to some other priority is really important. You referenced that briefly. I absolutely think your points are really important. I think the threat to the Public Health workforce is that they will decide to go do Something Else and possibly they will retrain and childcare where there is a little more and to health care where theres a little more stability. To have other options, but they have other options, but they like these jobs. They are important jobs in areas where they exist, both rural and f urban environments and urban environments. You need to recognize the passion of these professionals and the relationships they built in the lives and property they have saved in the last 15 years since this regime were reauthorized. Sen. Kaine might i ask dr. Inglesby to respond briefly . Dr. Inglesby the Public Health Emergency Preparedness program that supports so much of the Public Health workforce has come down pretty substantially since the start. Thousands of jobs have been eliminated and Public Health since we began this effort back after 9 11. I think theres great excitement in the field. Young people want to work on these issues in medicine, and ar nursing, and Public Health. There are some loan forgiveness programs that need to be attended to to draw people in to the field. People will come to these jobs if there is a field there. A lot of this money comes from the federal government and supports jobs directly. Continuing these programs would help ensure that we have a workforce. Sen. Kaine thank you for that. Sen. Burr senator young. For aoung thank you series of hearings on a very important topic, Public Health threats. I would like to turn to the topic of insurance for pandemics. I will be asking a question of each of you related to this topic, but by way of background, and our last hearing, we heard from admiral red from the centers of Disease Control prevention. I he said the strategy to prevent diseases that spread from animals to people such as ebola and Avian Influenza is a reactive strategy. Are there any strategies that might take this from a reactive stance to use a modern term proactive one . I found that last year the world Bank Launched the first pandemic bond to quickly finance Public Health emergencies. You may be familiar with this. Financing emergencies like pandemic influenza strains,omething called coronaviruses viruses like ebola, and others. According to the world bank, their pandemic emergency Financing Facility would provide over 500 million in coverage of pandemics in the next five years. My question to you is do you think congress should experiment in the creation of similar financing structures like the pandemic emergency Financing Facility or some other type of insurance mechanism to protect against pandemics . Regardless of your thoughts on that, if there are other proactive strategies, do you think we should turn to first . If you could volunteer that, i would appreciate it. We will start with dr. Inglesby please. Dr. Inglesby ive not studied enough whether that would be some value to do in the United States. Ive not heard that before so i can get back to you with thoughts on that. One alternative that is less complicated that we talked about aready would be to establish Contingency Fund that would only be used in the event of emergencies declared by other congress with the secretary of health. Gowould have a fund ready to kind of like an insurance policy. It would be a Fund Available for rapid response. Sen. Young ive done work like mechanismsinancing from health care to social am of, so i respectfully the opinion that this would not be all that complicated. It would be a way to capitalize a fund like those invoked earlier. Thank you very much, doctor. Dr. Krug im not sure i know what insurance means anymore. Back to the prior levels is insurance to make sure the people that need to be there when the balloon goes up are there and able to do what they do. I think the Contingency Funds could be a very important piece of ensuring that the unknown unknowns are insured against. Dr. Dreyzehner and they will certainly occur. Ho what dr. Ec inglesby said. Our best insurance is making sure we have adequate people and relationships and networks and experts available at a moments notice to respond. Sen. Young thank you. Mr. Macgregor . Mr. Macgregor s mechanisms such as these if mechanisms such ofthese in the event protecting a pandemic wants it has hit, i might be inclined toward financing mechanisms that might allow us to be more prepared in advance and not having to deal with the tragic aftermath. What the just maybe world bank is proposing is something that could be more of a global kind of effort that cannot only benefit the u. S. But benefit other countries as well. By benefiting other countries, it actually contributes to the preparedness we can have here. Sen. Young thank you. Dr. Krug its good to be last. I agree with all the comments made by my colleagues. I would offer to hopefully help full perspectives. I would offer to hopefully helpful perspectives. If we can mitigate the problem and avoid the disease, that would solve a lot of problems. That gets back to a proactive vaccinations and help globally and other local level looking at those vectors and prevent early on those diseases before they spread. In the end, its pretty clear to me and i know you guys get this that theres not enough money to go around to make this all work. We have all told you we need to improve funding for the core because of the process if you want to do it for less, thats what youre going to get. Your going to get less and that is what we are seeing you are going to get less and that is what we are seeing today. Is long overdue for a discussion with the public about the threats that we face, the reality of our resources, and how we can collectively make a difference. I think most americans share some common values and i think andcollective survival making america stronger is something that most people would want to do. In the end, theres not enough resources when the cavalry arrives, whether its the state, local, or federal government to meet the needs of everybody in a town or city or whatnot. If citizens were better prepared and we began a discussion about the values and the culture with personal readiness and with a strong helping the week, helping your neighbor, make a show thats ok, then we would not have to sort of rescue everybody. Maybe we would be rescuing fewer and in doing so because there will be citizens who cant do that for a variety of important reasons. If we get back to the culture that i think i grew up with in grade school where that seemed to be a value, i think that would help us both with this and probably with some other issues as well. Sen. Young i thank you all. I threw a Novel Concept that you. If you have initial funds, i would be appreciative. Mr. Chairman, i would note that that point on community is something that has been invoked consistently whether were talking about the Opioid Epidemic or social but that all with social pathologies a need to address the public issues we are dealing with. Not an easy want to tackle, but an important reminder. Sen. Burr senator warren. N when a Public Health emergency hits, its all about what is happening by a minute by minute or hourbyhour basis. How the t get response to disaster actually works when it was on the line. All the drills and the dry runs and training. I understand these are the investments we have to make in our nations preparedness and response to the abilities if we are going to capabilities if we are going to be ready when an emergency strikes. Im going to talk about one specific investment today and that is investing in the therapies or medical Counter Measures that save lives when disaster strikes. Vaccines for ebola or influence of products influenza products, next generation b biotics, congress created a program called bio shield. I want to just dig in a little bit about this program. The idea was to accelerate development of medical countermeasures by investing in biomedical research. Dr. Inglesby, you are an expert on bio security. When a Company Develops a new drug or device, they get a lot of funding from private investors. Why did medical countermeasures need Public Investment from a program like project bio shield . Dr. Inglesby the reason why Companies Need that kind of support from the government is because the products that we are trying to make for pandemics like anthrax or the bowl of you referred to, they dont have a commercial market. Sen. Ng we hope warren we hope. Dr. Inglesby its going to be and stockpiles and we need sustained investment in those companies to get them to do those work. Project bio wen shield got 5. 6 billion. Congress decided in advance that it would spend that amount of money. They do not come back every year during that tenure 10 year period to decide to put the money in as promised. That changed in 2013 when the initial 10 year commitment ran out. Project by a shield had to get a yearly set aside on basis like everyone else on appropriations process. You worked in the bio security field at a company that makes flu vaccines. The authorization levels for project bio shield, thats what Congress Says we could spend on it, have state exactly the same since 2013. Is that right . Mr. Macgregor since 2013, the authorization sen. Warren authorization stays the same, but appropriations levels did Congress Actually get that money out the door to you . Mr. Macgregor know. No. For by a shield, the bio shield,n was the authorization was 4. 8 billion so that was a shortfall. Sen. Warren a pretty significant shortfall. What does that mean for Companies Like yours that are trying to make decisions about searching and developing these kind of countermeasures . Mr. Macgregor you call into question what the commitment is. For a lot of companies, its very difficult in the space to do longterm planning and to forecast in a way you would typically forecast in a commercial space. And make it very difficult to plan. I think what has happened with this uncertainty and i know ive mentioned it before, but during the initial 10 year per iod, there was a lot of private investment because there was a value that was seen there. Ive heard that pool of investment has really dried up. There isto at little to any value that the market puts in the space. Sen. Warren this really worries me. You are telling me its a market that only works if the federal government makes the investment and that the yearly appropriations process is not working in this field. I think that is what im hearing from the two of you. It just seems to me that keeping our nation safe from these kinds of threats that the most important Investment One of the most important investments we can make, you can make up cannot make up ground overnight on this, but you cannot do it once the threat is on your doorstep. We have to be in this on the long haul. As the Committee Works to reauthorize, i hope we can discuss the importance of providing robust, Stable Funding to researchers who are working to help us avert the next Public Health emergency. Thank you, mr. Chairman. Sen. Burr thank you, senator warren. Let me just say the colleagues. I think senator casey and i have been in the trenches for a long time and have written more letters to appropriators. The definitive change was one president ial budgets did not ask when president ial budgets did not ask for the full bio shield money. A pivotal point. It was that lack of request. Unfortunately up here as senator casey and i have found, even our letters to the appropriators would not get them to fill a hole bigger than what the President Shall budget request was and we have seen the steady decline. I think i can say on behalf of the chairman that this committee has always said that we ought to appropriate at the authorization. Evels you probably hit on the key thing that was the toughest thing to recognize and that is where is the role of the federal governments responsibility at creating the incentive for people to create something that there is not a commercial market for . And i will say though hiding in the back of the room is one of the authors who now works as she has been feverishly writing notes so everything you said is. Oing to find its way back when this was originally designed, trying to find somebody to be the spokesperson for disaster, we had to create a new position called emergency secretary of Emergency Preparedness because nobody wanted to raise their hand and be in charge. This is something this committee has got to be absolutely vigilant on from a standpoint of what the needs are because i would say mr. Macgregor is a great example. If this dries up, who wants to be in the vaccine space . The same reason we have a shortage of antibiotics today. Who wants to be in the antibiotics based . Space . Its millions and millions of dollars of development. Its not only addressing this. Its technologically trying to come into the 21st century and our reimbursement as you look at genebased platforms that may cure genetic defections and children in children on one side and diseases we have not been able to cure tomorrow today that we can cure tomorrow. How do you reimburse for that . You cannot do it based on how much you put into it. You have got to look at it from a standpoint of how much we are saving over the life of living with that disease. This is foreign to government. This is something we have to tackle in a bipartisan way to get it done. Senator casey and i have just a couple more questions. I will stick around as long as we need to. Dr. Krug, identifying emergent islic Health Threats important to treat and mitigate its effects. One of these tools is the diagnostic test. In the midst of combating ebola and zika, determining individuals in need of treatment help to inform providers and those on the front lines of the outbreak. How do rapid point of care diagnostics work to better inform for these public emergencies . Dr. Krug they help immeasurably. Imagine for a moment that you are in a scenario with multiple sick victims. Colleagues pointed out, your Ebola Treatment Center can take care of at most three patients. Which of these three patients will you admit to the ebola treatment unit . With the Older Technology we have with diagnostic testing that took over 24 hours back when we dealt with the bowl as a treatment center, we had no other choice but to treat those patients to make sure they are not had the disease. It came during a time of the year when we work not operating at peak hospital operating capacity. If that was today, i dont know what to do with this problem because i would not know who to treat. By treating some of you actually have the disease in need any the treatment, it could prevent someone who needs the same treatment area and icu bed and that icu care team meeting their needs. In the hospital setting and in the field, these diagnostics are terribly important. In the field, these resources are even more limited so the fundamental decisions made in that setting are also vital. Sen. Burr tom, i want to turn to you since dr. Krug mentioned ebola. Is the statement correct . We learned enough with the ebola crisis to understand our limitations, but we have done nothing to increase our capacity if it were to happen tomorrow. I think that a high level, that is probably true. There are some lessons that are built into the system, but we have not changed resources that are available for the mission. We learned enough to know that we have a no or very little Surge Capacity for an Infectious Disease of that magnitude. That is true. Let me come back to you from a pediatric standpoint there have been a number of news reports i do not know the accuracy of them that suggest tamiflung adults taking have had hallucinations. Makehallenging does that to try to expand these new treatments to the pediatrics population . Thank you. You have hit the nail squarely on the head and it is not just tamiflu the bigger issue is vaccination. With the exception of a glass of water, there are going to be side effects with anything that you prescribe or give to a patient. Whether you something or not is driven by evidence of positive effects versus side effects. Media,in part to social everything that occurs that did not occur the way it should have and reports of adults who were having hallucinations with make their way to places so that the average family that i care for that has a smart phone, they already know about this and when i try to advise them at their child should have something and it is three driven by cdc, they say to me, but doctor, this medication will cause my child to have four heads. , i am nots like, well even sure the is true and the likelihood of that occurring from the disease is much more head youan the four are worried about. The point is that does make it more difficult. The partnership that we have been able and that is not just the American Academy of pediatrics, their other specialties in terms of partnering the cdc and getting out guidance to families on a reliable website and perhaps counter information that makes it clear that if your child has an underlying medical problem and they are in their first day of illness with the flu, tamiflu is probably a good idea. The challenging thing is to fulfill your wishes which is to increase Pediatric Indications youit you have to have have to have kids that are willing to have child join clinical trials. We have done unusual things by emergency release order a but i think you would agree with me that is physically different than what a dose or drug might have been approved for, you do not know the reaction you are going to get. My hope is that we map out a way. We want to make sure that the Pediatric Indication is a normal process and the future. It should be a part of the process. There are ethical concerns. The concerns you have to address are sent to eventually a substantially greater than adults. Discussionresting that we since we do not know if it is going to work, should xe try and test the anthra vaccine in children before an occurs, and in to end, we deferred and came the conclusion that it was probably not ethical. How do you do that . It is toughry where to convince people to develop things where there is no market and the market is even smaller to kids it is a steeper hill to climb. Sen. Burr i want to turn to you really quick. I think it is safe to say that countermeasures are difficult things to develop. Human ethic studies are not feasible in some countermeasures. 2015 set the way forward with the animal role. What are the challenges and six at in successfully bringing forward a successful medical measure without relying on animal rule . You are reliant on the data ruleenerate from that being something you extrapolate to something a being of use to humans. It is beneficial in the sense that allows us to bring medical countermeasures forward. In that regard, it is good. It is a rule that the industry has to adapt to Going Forward. Senator casey. Mr. Chairman, thank you. I want to continue on the topic of children. G, in the last observation, we were able to put together a new National Advisory committee. I appreciate your work and testimony today. The only question i have for you ofwhat our areas preparedness planning go where you see the greatest need for more intention to the needs of children . I know you have answered different parts of this but maybe my wrapup would be there. Dr. Krug in all facets and we have made tremendous progress which has contributed to that direction. From a health care perspective, and that is a narrow perspective because the whole process is bigger than health care the Healthcare Industries primarily put together to take care of. Omebody like me somebody not a child is somebody with underlying medical problems towards the end of and the point is that with the exception of the facilities and their smaller number that specializes in kids, the rest of the system does not. There is nothing wrong with it that is how it works on a daytoday basis. , everyommunity institution, every clinic that is where the care may need to be provided. That includes kids. Current operations, if you have a sick child, you put him in the ambulance and you send them to the tall Childrens Hospital. That is not going to work the tall to Womens Hospital has been disabled by the event or the nature of the disaster does not permit transportation or everything is fine, but they are already full. The challenge that we have and the good thing is that everybody likes kids, we have got to get everybody better prepared to take care of kids. One of the most important ways to get there is through training. It would make us better in caring for all populations. Sen. Casey thank you very much. Thank you to our witnesses. In 24 years, i have done a lot of hearings. Ive found it almost impossible to have an agency witness at the table who testified and the private panel come up second and give a Agency Person to stay in the room to listen to the private sector. Time ivee a first looked and we have not had a government witness, but we have had agency folks who have attended to hear what the members in the private sector say about the reauthorization of a program. That is unusual. I hope it is a trend that is going to become the norm and not the exception. I say that as a message to go back. Your testimony is not only valuable to us, it is valuable to the agencies that are affected by the issues that you are here to talk about. I want you to know, they got her did not just by the agency itself. I think all four of you for your willingness to be here for the insight that you provided. This hearing is adjourned. The Senate Health Committee Hearing and last weeks it is on our website. Ent mark warren tweeting yesterday, President Trump signing the shortterm the portraitunder of mckinley at the signing of peace treaty signing with spain on 1898. Heres more about that from washington journal. On the list of this winner and losers

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