Transcripts For CSPAN2 Public 20240706 : vimarsana.com

Emergencies. Did you see director warned about the implications of the Current Public Health emergency depending on 11th but sent Health Committee also hears from commissioner about Lessons Learned from the covid19 pandemic. This is just over two hours 10 minutes. Rusmac hey, thank you. The Senate Committee on Health Education and pagers will come to order. This afternoon we are going to hear from two panels. We are going to hear from our first panel the assistant secretary for preparedness and response. The shot will instigate the director centers for Disease Control and doctor robert the commissioner for food and drug administration. Our second panel we will be hearingat from them will hear fm Robert Wiseman and martin carey we have two very, very important panels. Let me begin by thanking all of the folks who were on the first panel. All of us know the last three years have been unprecedented in our lifetimes where we with the worst Public Health crisis 100 years at the thank all of you under this very difficult circumstances for the work youve done for the americannd people. Today, what our job is, is to take a hard look at where we are today in terms of preparing, god forbid, or another pandemic and the need to reauthorize pandemic all hazard preparedness act. Later this year. I want to take this opportunity to acknowledge the previous leadership on this bill from senator murray. That Ranking Member as well as he working group five help convene with Ranking Member cassidy to include senator casey and sandra romney. All those senators have set aside for their staff to meet with mine every week because we all understand how terribly important issues are that we are facing the possibility of futurd pandemics. As everyone knows tragically the United States we lost over 1 Million People from covid. But he that joe prospectively lost market from colored in the past several years and we did in world war ii. Both cases, deaths and hospitalizations are all declining, covid is still today the leading cause of death and our country with some 250 american on average dying every day. The world healthth organization reports 7 Million People have died from covid globally there are experts who think that is that underestimates the number of people that have died globally. I think to be honest as americans we can understand every public official trieded their best god knows how far they worked in the stress they worked under theun truth is we were very, very unprepared for what hit us three years ago. It took a lot longer for us to effectively respond to that emergency then it should have. All of us will remember. All of us will remember months after the pandemic erupted we also pictures of doctors and nurses and overwhelmed hospitals lacking the personal protective equipment to keep themselves healthy. We all remember those images. Remember seeing doctors and nurses literally using plastic trash bagsas because they did nt have the personal protective equipment they needed. We also know many, many hundreds of medical personnel died doing their duty trying to save their fellow americans. By that time we did not have the test needed to find out who had covid and who did not. We did not have the infrastructure we needed to deal with the pandemic. All of us are of the overwhelmed hospitals in intensive care units from one end of the country to the other. We did not have the vaccines or the treatments the American People and people throughout the world desperately needed. We all recall we hadde to shut down our schools, our businesses and much of the economy for far too long causing millions of americans not only too loser jos but their healthcare as well so in the middle of a pandemic of millions of people lost their healthcare. Here is a scary usually got to face up to what we really do. Hmay get the important part of the hearing. What scientists are telling us there is a reasonable chance that god forbid a pandemic as deadly as kogan would occur in 10 years. All this hoper that will not occur but our job is to be prepared for it does occur that is with this hearing is about thats what this legislation is about. Scientists have told us there are now seven viral families that could cause the next pandemic because they contain viruses that spread to the respiratory system and can easily spread from persontoperson. Our job is to make sure we are protecting we spend huge amounts of money on the military which theyve got to protect the American People. If we want to protect the American People we have got to deal this issue as well. That means he must have a capable workforce in place. Not just nurses and doctors but Public Health officials. Our disease detectives hear more about this in a few minutes, who can tell us where to set up a clinic for s example. There to outbreak t developing n the west coast can we learn about it and immediately so the rest of the country is alerted et cetera. Tragically, during the pandemic this is incredible for approximately this year end future hearings. Duringng the pandemic nearly one out of every five healthcare workers quit their jobs. And are contemplating doing so as a result of the enormous stress and burnout they have experienced. Cewe do have accurate Public Health attitude is getting sick need to not have test vaccines and treatmentss available we have to be able to get those out to everybody who needs them. Way to make sure medical personnel has the supplies the mass, the gloves they need. We show Clear Communication to the public. Some think that is spent really very difficult to do but we need to improve our communication capability. We need especially to make sure we protect the most Vulnerable People in our society seniors in Nursing Homes and individual disabilities our children and our infants. So thats where we are right now we have experienced a turtle pandemic. Opus we have learned nothing from that. I will be better prepared as we face an unsettling future. That or cassidy . First before beginning director will sequel express sympathy for the family the cdc employee killed yesterday. Its always a tragedy. But we feel that in particular. Today we are discussing important responsibility to the committee the reauthorization of the bipartisan pandemic at all hazard preparednessar act. Not my will focus on the word pandemic which is almost a big part of the discussion board we need to keep in mind the wide array of threats this bill seeks to address. Not just diseases but natural disasters attacks of the things that could put our country at risk. I felt a nudge of the origins of the bell inn was not a congress of the time. As an act of 2006 largely to address the failures of the federal response following hurricane katrina. And anybody from louisiana saw firsthand the devastating impact on the community when governments are illequipped and illprepared to manage a crisis. Sos support states, local sgovernments and hospitals facility better prepared for future emergencies established office of assistant secretary for preparedness and response the Biomedical Advanced Research and development authority. A lot of long thing to come up with awkward sounding acronyms. Also made improvements to the Strategic National stockpile to vaccines treatments and tests could be easily available during an emergency. Both 2013 and 19 congress acted bipartisan way to reauthorize the bill district surrounding casey are spearheading the work with the committee. Now we do notat always agree. But we set politics aside and come together reauthorizing. We know poppa is critical to protect the health, safety, security of u all. As a soldering kogan 19 response the framework is far from perfect. Poor management and maintenance of the Strategic National stockpile meant doctors and nurses were forced to use expired ppe. One picture i remember was huge quantity of masks being dumped right as the pandemic was started because there to ask me expiredng. Certainly was not a first in first out manage the inventory type situation. I think we can say in some ways government hampered these private sectors above the quickly lawaw launched test at e onset of the pandemic government clearlyov failed who work consistently and clearly failed to communicate with the public. Now that is gone. Lets get better but we made mistakes, we learned some tough lessons so lets Work Together so nexium was on the fire figuring it out with their systems and put in place. Update the playbook make sure whatever we do is flexible enough to address family pandemic and emphasizing maintenance look toward the threats of a future and not prepare for that which is already gone by. Being good stewards of limited taxpayer resources the better part of a stately private sector so we are all ready and willing to step out in the next Public Health threat comes our way. To accomplish a sick immediately to work on bipartisan way to neck meaningful policies to make our country safer and better prepared to work towards a consensus. Im committed to in this bill done. Thank you for being here i look forward to hearing your testimony. And with that mr. Chair i yield. Thank you, senator cassidy. Now were going to hear from our witnesses the first witness ms. Don oconnell assistant secretary for preparedness response and the administration for strategic preparedness and response at the department of health and Human Services. This oconnell thanks for being with us. Fixture sanders Ranking Member cassidy, distinguished members of the committee edison ought her to testify before you today about ongoing work of the additional authorities we are seeking in the upcoming bill. But first some he joined the center and expressing my condolences for the loss of our cdc colleague. We are very sorry please extend our thoughts and prayers. We are living increasingly interconnected world where diseases and other threats can travel quickly unnoticed for days. We are also experiencing increasing the frequency and intensity of natural disasters as a result working on more high consequence note failed missions and evernc before. We are proud to lead so much work on behalf of the country and want to be sure we have the authorities we need to continue to execute that work with the excellent sufficiency and expertise the American People deserve. As we validate cute face of coveting response it would be management malpractice for us to look the same and act the same as we did at the start of the pandemic. Ive taken several important steps in the last few months to transform ourm organization and to incorporate Lessons Learned from the covid 19 response. For example is now a Standalone Agency withinle hhs. This important change in our departmental status gives me the independence to build out human resources, acquisitions and finance infrastructure. So better supports our unique missions. Ive also just completed a structural reorganization that institutionalize important new capabilities like our stockpile supplychain domestic manufacturing work these capabilities that we built during covid and need to keep using moving forward. Also made Strategic National stockpile in office that reports directly to me too increase visibility into and accountability of this critically important part of the nations preparedness and response apparatus. With these changes i have taken the two most transformational steps available to me to build a better preparedness and response organization. And now i need your help to ensure i have the appropriate authorities to execute our mission faster and stronger. With the authorities im requesting i am trying to sell three key problems. The first problem im trying to tsolve is how asper can procure more quickly the tools and supplies the country needs when responding to a bio threat or disaster. Early in coveting response it became clear hhs could not procure products or countries needed at the speed in which our country needed them. As a result entered into a memorandum of understanding with the department of defense in wiwhich they agreed to provide acquisition support on ourwh behalf. Using their unique authority dod executed more than 90 billion in contracts for us over the three years of the acute response. I cream with the id comes to an end at the end of this fiscal year which is why i am requesting similar authorities for asper these include the ability to fund promising prototypes and move the successful ones throughr the advanced Research Pipeline without having to re compete the contract like we do now. We are also seeking the ability to quickly procure experimental supplies and important finished products. Think it is no authorities for ourselves moving forward we had to rely on dod to do for us during covid berm the second problem trying to solve how a contingent investment expansion Industrial Base for key pp medical supplies to make sure we are never again in the position we found ourselves in march 2, 0201 to both recognize or doctorsu and nurses dont have access to, glands, gloves idi needed. Westbridge is the funds in Construction Authority given to usun in the covid supplementalso build the factories nationwide to produce the ppe and supplies we need in times of emergency these investments also provide good paying jobs to many hardworking americans. Was the covid 19 funds are not with this Construction Authority and our ability to continue investing in similar projects. That is why im requesting permanent Construction Authority. The party of funds in Construction Authority to sustain the work we have started to expand this work to other parts of the Public Health supply chain. The third problem im trying to solve is how they can hire staff more quickly to search critical teams during large response efforts foror the early days of covid 19 response, just as we relied on dod for acquisition support we also relied on fema and the coast guard to bolster our response staff. The ability to hire people quickly and compensate them appropriately for that long hours and sometimes hazardous work are important tools missing from response toolbox. Which is why im requesting direct hiring and flexible pay authorities. Direct hiring authorityti willin allow me too quickly scale up our response effort so we have enough people when we need them. Pay flexibility will go a long way toward sustaining our staff these Dangerous Missions and ensuring we do not lose this season First Responders subject Matter Experts to the private sector pay much more and often require much less of them. To solve each of these problems i was laid out everquest important authorities for asper. At four to working with you to solve these important problems and many others as you draft the new poppa bill. Thank youhp again for inviting e too testify today look forward to answer questions. Thank you very much. Our next witness doctor Rochelle Wolinsky director of the centers for Disease Control and prevention. Chair sanders, at regular cassidy and distinguished numbers of the committee. Its honor to be here with you todayhe. Before i begin i like to take a moment too acknowledge our cdc families suffer the tremendous loss yesterday withdc the deathf amy who was killed in a shooting in midtown, atlanta part amy is a valued member of our team at the division of reproductive house where she worked every day to save lives of mothers and infants. Our hearts are with her, her family, friends and our colleagues as they remember her and grieve this tragic loss. In addition to the work people like amy do every day to fight disease and support communities im here to talk about how cdc works 24 7 to protect america and you want to thank you for this important opportunity. Cdc hasha led Public Health responses since our founding in 1946 providing expertise, resources and workforce support to states, tribes, local committees andta territories on the most pressing Public Health threats in the United States and across the globe. No matter the outbreak, h1n1, zika, bola, covid 18 polio impacts, cdc has been there offering worldclass assistance. Alarmed ladies Infectious Disease threats have been emerging at an increased pace of increasingly complex. These diseases do not respect national or state borders and the increased frequency of outbreaks means we should not be asking if we will face another serious Public Health threat, butou when. For many life has turned to normal after three years of covid 19. Public Health Agencies like cdc and your state and local Health Department mission is to continue to remain response ready to protect americans for threat. Ging health we do this by actively supporting the core capabilities of Public Health including stateoftheart laboratories, and diverse Public Health workforce, culturally competent to reflect communities, worldclass data and analytics for Current Public Health<\/a> emergency depending on 11th but sent Health Committee<\/a> also hears from commissioner about Lessons Learned<\/a> from the covid19 pandemic. This is just over two hours 10 minutes. Rusmac hey, thank you. The Senate Committee<\/a> on Health Education<\/a> and pagers will come to order. This afternoon we are going to hear from two panels. We are going to hear from our first panel the assistant secretary for preparedness and response. The shot will instigate the director centers for Disease Control<\/a> and doctor robert the commissioner for food and drug administration. Our second panel we will be hearingat from them will hear fm Robert Wiseman<\/a> and martin carey we have two very, very important panels. Let me begin by thanking all of the folks who were on the first panel. All of us know the last three years have been unprecedented in our lifetimes where we with the worst Public Health<\/a> crisis 100 years at the thank all of you under this very difficult circumstances for the work youve done for the americannd people. Today, what our job is, is to take a hard look at where we are today in terms of preparing, god forbid, or another pandemic and the need to reauthorize pandemic all hazard preparedness act. Later this year. I want to take this opportunity to acknowledge the previous leadership on this bill from senator murray. That Ranking Member<\/a> as well as he working group five help convene with Ranking Member<\/a> cassidy to include senator casey and sandra romney. All those senators have set aside for their staff to meet with mine every week because we all understand how terribly important issues are that we are facing the possibility of futurd pandemics. As everyone knows tragically the United States<\/a> we lost over 1 Million People<\/a> from covid. But he that joe prospectively lost market from colored in the past several years and we did in world war ii. Both cases, deaths and hospitalizations are all declining, covid is still today the leading cause of death and our country with some 250 american on average dying every day. The world healthth organization reports 7 Million People<\/a> have died from covid globally there are experts who think that is that underestimates the number of people that have died globally. I think to be honest as americans we can understand every public official trieded their best god knows how far they worked in the stress they worked under theun truth is we were very, very unprepared for what hit us three years ago. It took a lot longer for us to effectively respond to that emergency then it should have. All of us will remember. All of us will remember months after the pandemic erupted we also pictures of doctors and nurses and overwhelmed hospitals lacking the personal protective equipment to keep themselves healthy. We all remember those images. Remember seeing doctors and nurses literally using plastic trash bagsas because they did nt have the personal protective equipment they needed. We also know many, many hundreds of medical personnel died doing their duty trying to save their fellow americans. By that time we did not have the test needed to find out who had covid and who did not. We did not have the infrastructure we needed to deal with the pandemic. All of us are of the overwhelmed hospitals in intensive care units from one end of the country to the other. We did not have the vaccines or the treatments the American People<\/a> and people throughout the world desperately needed. We all recall we hadde to shut down our schools, our businesses and much of the economy for far too long causing millions of americans not only too loser jos but their healthcare as well so in the middle of a pandemic of millions of people lost their healthcare. Here is a scary usually got to face up to what we really do. Hmay get the important part of the hearing. What scientists are telling us there is a reasonable chance that god forbid a pandemic as deadly as kogan would occur in 10 years. All this hoper that will not occur but our job is to be prepared for it does occur that is with this hearing is about thats what this legislation is about. Scientists have told us there are now seven viral families that could cause the next pandemic because they contain viruses that spread to the respiratory system and can easily spread from persontoperson. Our job is to make sure we are protecting we spend huge amounts of money on the military which theyve got to protect the American People<\/a>. If we want to protect the American People<\/a> we have got to deal this issue as well. That means he must have a capable workforce in place. Not just nurses and doctors but Public Health<\/a> officials. Our disease detectives hear more about this in a few minutes, who can tell us where to set up a clinic for s example. There to outbreak t developing n the west coast can we learn about it and immediately so the rest of the country is alerted et cetera. Tragically, during the pandemic this is incredible for approximately this year end future hearings. Duringng the pandemic nearly one out of every five healthcare workers quit their jobs. And are contemplating doing so as a result of the enormous stress and burnout they have experienced. Cewe do have accurate Public Health<\/a> attitude is getting sick need to not have test vaccines and treatmentss available we have to be able to get those out to everybody who needs them. Way to make sure medical personnel has the supplies the mass, the gloves they need. We show Clear Communication<\/a> to the public. Some think that is spent really very difficult to do but we need to improve our communication capability. We need especially to make sure we protect the most Vulnerable People<\/a> in our society seniors in Nursing Homes<\/a> and individual disabilities our children and our infants. So thats where we are right now we have experienced a turtle pandemic. Opus we have learned nothing from that. I will be better prepared as we face an unsettling future. That or cassidy . First before beginning director will sequel express sympathy for the family the cdc employee killed yesterday. Its always a tragedy. But we feel that in particular. Today we are discussing important responsibility to the committee the reauthorization of the bipartisan pandemic at all hazard preparednessar act. Not my will focus on the word pandemic which is almost a big part of the discussion board we need to keep in mind the wide array of threats this bill seeks to address. Not just diseases but natural disasters attacks of the things that could put our country at risk. I felt a nudge of the origins of the bell inn was not a congress of the time. As an act of 2006 largely to address the failures of the federal response following hurricane katrina. And anybody from louisiana saw firsthand the devastating impact on the community when governments are illequipped and illprepared to manage a crisis. Sos support states, local sgovernments and hospitals facility better prepared for future emergencies established office of assistant secretary for preparedness and response the Biomedical Advanced Research<\/a> and development authority. A lot of long thing to come up with awkward sounding acronyms. Also made improvements to the Strategic National<\/a> stockpile to vaccines treatments and tests could be easily available during an emergency. Both 2013 and 19 congress acted bipartisan way to reauthorize the bill district surrounding casey are spearheading the work with the committee. Now we do notat always agree. But we set politics aside and come together reauthorizing. We know poppa is critical to protect the health, safety, security of u all. As a soldering kogan 19 response the framework is far from perfect. Poor management and maintenance of the Strategic National<\/a> stockpile meant doctors and nurses were forced to use expired ppe. One picture i remember was huge quantity of masks being dumped right as the pandemic was started because there to ask me expiredng. Certainly was not a first in first out manage the inventory type situation. I think we can say in some ways government hampered these private sectors above the quickly lawaw launched test at e onset of the pandemic government clearlyov failed who work consistently and clearly failed to communicate with the public. Now that is gone. Lets get better but we made mistakes, we learned some tough lessons so lets Work Together<\/a> so nexium was on the fire figuring it out with their systems and put in place. Update the playbook make sure whatever we do is flexible enough to address family pandemic and emphasizing maintenance look toward the threats of a future and not prepare for that which is already gone by. Being good stewards of limited taxpayer resources the better part of a stately private sector so we are all ready and willing to step out in the next Public Health<\/a> threat comes our way. To accomplish a sick immediately to work on bipartisan way to neck meaningful policies to make our country safer and better prepared to work towards a consensus. Im committed to in this bill done. Thank you for being here i look forward to hearing your testimony. And with that mr. Chair i yield. Thank you, senator cassidy. Now were going to hear from our witnesses the first witness ms. Don oconnell assistant secretary for preparedness response and the administration for strategic preparedness and response at the department of health and Human Services<\/a>. This oconnell thanks for being with us. Fixture sanders Ranking Member<\/a> cassidy, distinguished members of the committee edison ought her to testify before you today about ongoing work of the additional authorities we are seeking in the upcoming bill. But first some he joined the center and expressing my condolences for the loss of our cdc colleague. We are very sorry please extend our thoughts and prayers. We are living increasingly interconnected world where diseases and other threats can travel quickly unnoticed for days. We are also experiencing increasing the frequency and intensity of natural disasters as a result working on more high consequence note failed missions and evernc before. We are proud to lead so much work on behalf of the country and want to be sure we have the authorities we need to continue to execute that work with the excellent sufficiency and expertise the American People<\/a> deserve. As we validate cute face of coveting response it would be management malpractice for us to look the same and act the same as we did at the start of the pandemic. Ive taken several important steps in the last few months to transform ourm organization and to incorporate Lessons Learned<\/a> from the covid 19 response. For example is now a Standalone Agency<\/a> withinle hhs. This important change in our departmental status gives me the independence to build out human resources, acquisitions and finance infrastructure. So better supports our unique missions. Ive also just completed a structural reorganization that institutionalize important new capabilities like our stockpile supplychain domestic manufacturing work these capabilities that we built during covid and need to keep using moving forward. Also made Strategic National<\/a> stockpile in office that reports directly to me too increase visibility into and accountability of this critically important part of the nations preparedness and response apparatus. With these changes i have taken the two most transformational steps available to me to build a better preparedness and response organization. And now i need your help to ensure i have the appropriate authorities to execute our mission faster and stronger. With the authorities im requesting i am trying to sell three key problems. The first problem im trying to tsolve is how asper can procure more quickly the tools and supplies the country needs when responding to a bio threat or disaster. Early in coveting response it became clear hhs could not procure products or countries needed at the speed in which our country needed them. As a result entered into a memorandum of understanding with the department of defense in wiwhich they agreed to provide acquisition support on ourwh behalf. Using their unique authority dod executed more than 90 billion in contracts for us over the three years of the acute response. I cream with the id comes to an end at the end of this fiscal year which is why i am requesting similar authorities for asper these include the ability to fund promising prototypes and move the successful ones throughr the advanced Research Pipeline<\/a> without having to re compete the contract like we do now. We are also seeking the ability to quickly procure experimental supplies and important finished products. Think it is no authorities for ourselves moving forward we had to rely on dod to do for us during covid berm the second problem trying to solve how a contingent investment expansion Industrial Base<\/a> for key pp medical supplies to make sure we are never again in the position we found ourselves in march 2, 0201 to both recognize or doctorsu and nurses dont have access to, glands, gloves idi needed. Westbridge is the funds in Construction Authority<\/a> given to usun in the covid supplementalso build the factories nationwide to produce the ppe and supplies we need in times of emergency these investments also provide good paying jobs to many hardworking americans. Was the covid 19 funds are not with this Construction Authority<\/a> and our ability to continue investing in similar projects. That is why im requesting permanent Construction Authority<\/a>. The party of funds in Construction Authority<\/a> to sustain the work we have started to expand this work to other parts of the Public Health<\/a> supply chain. The third problem im trying to solve is how they can hire staff more quickly to search critical teams during large response efforts foror the early days of covid 19 response, just as we relied on dod for acquisition support we also relied on fema and the coast guard to bolster our response staff. The ability to hire people quickly and compensate them appropriately for that long hours and sometimes hazardous work are important tools missing from response toolbox. Which is why im requesting direct hiring and flexible pay authorities. Direct hiring authorityti willin allow me too quickly scale up our response effort so we have enough people when we need them. Pay flexibility will go a long way toward sustaining our staff these Dangerous Missions<\/a> and ensuring we do not lose this season First Responders<\/a> subject Matter Experts<\/a> to the private sector pay much more and often require much less of them. To solve each of these problems i was laid out everquest important authorities for asper. At four to working with you to solve these important problems and many others as you draft the new poppa bill. Thank youhp again for inviting e too testify today look forward to answer questions. Thank you very much. Our next witness doctor Rochelle Wolinsky<\/a> director of the centers for Disease Control<\/a> and prevention. Chair sanders, at regular cassidy and distinguished numbers of the committee. Its honor to be here with you todayhe. Before i begin i like to take a moment too acknowledge our cdc families suffer the tremendous loss yesterday withdc the deathf amy who was killed in a shooting in midtown, atlanta part amy is a valued member of our team at the division of reproductive house where she worked every day to save lives of mothers and infants. Our hearts are with her, her family, friends and our colleagues as they remember her and grieve this tragic loss. In addition to the work people like amy do every day to fight disease and support communities im here to talk about how cdc works 24 7 to protect america and you want to thank you for this important opportunity. Cdc hasha led Public Health<\/a> responses since our founding in 1946 providing expertise, resources and workforce support to states, tribes, local committees andta territories on the most pressing Public Health<\/a> threats in the United States<\/a> and across the globe. No matter the outbreak, h1n1, zika, bola, covid 18 polio impacts, cdc has been there offering worldclass assistance. Alarmed ladies Infectious Disease<\/a> threats have been emerging at an increased pace of increasingly complex. These diseases do not respect national or state borders and the increased frequency of outbreaks means we should not be asking if we will face another serious Public Health<\/a> threat, butou when. For many life has turned to normal after three years of covid 19. Public Health Agencies<\/a> like cdc and your state and local Health Department<\/a> mission is to continue to remain response ready to protect americans for threat. Ging health we do this by actively supporting the core capabilities of Public Health<\/a> including stateoftheart laboratories, and diverse Public Health<\/a> workforce, culturally competent to reflect communities, worldclass data and analytics for Rapid Response<\/a> to outbreaks at their source and strong domestic and global preparedness for it we are these capacities throughout all agency review, cdc moving forward we are committed to addressing the Lessons Learned<\/a> from covid 19, increasing accountability and improving how we deliver information to america. The approaching end of the Public Health<\/a> emergency once again reminds us that policy changes in funding are essential to the readinesspo of future bio threat straight cdc will continue to closely monitor covid19 and provide the information to which we have access. After three years of the pandemic in three months to prepare for the end we have worked hard to sustain the data to understand what is happening with the virus in america. But the end mean cdc will no longer be able to collect data and share information Many Americans<\/a> have come to expect. As cdc often does we will adapt to limitations and utilize triedandtrue systems to monitor other respiratory diseases. To keep our eye on covid19. In some cases cdc will rely on data we have demonstrated are a reasonable surrogate but there are day that we will no longer havee available because they wl no longer be submitted to us. For example certain data for National Picture<\/a> of Health Disparities<\/a> both for race and ethnicity long urban and rural lines but we will make do. However this should worry us all. Primarily because what it says about the visibility we will have it to the nextwi outbreak. We will be back to square one having to build and negotiate surveillance capacity while we fight a pathogen. I dont members of this committee are interested in advancing policy to close the gap in her Public Health<\/a> response to be better prepared for what comes next. Fort cdc this means supporting Public Health<\/a> workforce by allowing us to recruit the best ofof the best there improvements in student loan reimbursement authority. We must also be able to serve staff when needed to simple changes to direct hire legislation sufficient budget flexibility so bureaucracy does not stand in the way when an emerging threat arises. This also means maintain the infrastructure of our nation stood up during covid19 to administer vaccines effectively and quickly. He vaccines for Adults Program<\/a> proposal not only provides americans access to 14 approved and routinely recommended lifesaving vaccines but also supports a response ready capability that we will lose without continued investment. Finally, modernizing data policy to support access to better quality standardized and timely data so individuals and families can make informed decisions about their health and policymakers can better targett resources to threats before they become Public Health<\/a> em emergencies. The United States<\/a> should have the most advanced and capable agency inou the world when it comes to detection, tracking and forecasting. It will take a more modernized nimble and a collaborative cdc d it will also take partnership with congress to fully turn cdc into a response ready agency. I am committed to working with you to better protect Americans International<\/a> security. Thank you enough torture questions. Thank you very much. Our final witness commissioner of the u. S. Food and drug administration. Good morning chair sanders Ranking Member<\/a> cassie members of the committee. Thanks for the opportunity to be here today to discuss the importance of preparedness and how fda can work with congress to ensure the countries ready for the next Public Health<\/a> threat. Recognized key role of fda and Public Health<\/a> Emergency Preparedness<\/a> andnd response. We have effectively is the authority provided under poppa to support nationsse preparednes and response capabilities. Howeverr there been Lessons Learned<\/a> about how these authorities could be modernized to ensure our actions could be even more effective providing Greater Transparency<\/a> in thete supply chain and ensuring operational readiness and Search Capacity<\/a> within the fda inspectorate and review staff, and improving Laboratory Testing<\/a> regulations priorities that will enhance National Security<\/a> and improve Public Health<\/a> preparedness. First supply chains. Theres a need for Greater Transparency<\/a> into the supply chain of her medical products. To both improve resiliency and ensure continued access for critical medical problems. For example under the cares act fda received new authority to require medical Device Manufacturers<\/a> to submit shortage notifications during a Public Health<\/a> emergency. Fda uses information to help mitigate approximately 350 shortages. Unfortunately these notifications will no longerrfoe required following the end of the current covid19 Public Health<\/a> emergency. However we know medical device shortages occur in many situations that are unrelated to pags including natural or human made disasters, recalls public geopolitical conflicts, production shutdowns and cybersecurity incidents. We also have the shortages most often impact our most vulnerable and underserved populations like children, rural populations and our veterans and va hospitals. Additionally shorts were strictly due to manufacturing issues that disrupted supply. For which manufacturers of drug radiance are required to notify the fda. The agency has relied on these notifications help prevent supply disruptions working closely with manufacturers expedited review and exercising temporary regulatory flexibility. However we have recently seen Unprecedented Demand<\/a> for drugs patient. The ability to require drug manufacturers and distributors to report surges in demand to fda could help the agency to prevent or mitigate shortages including critical overthecounter drugs like we saw in the fall. Additional improvement should include reporting api sources uncertain suppliers in in the drug supply chain and ensuring fda had overthecounter drug facilities. Before such products arer distributed. Before this is critical to Public Health<\/a> are grateful to congress for including a provision in fy 23 on the both require manufacturers of infant formulas and medical foods to notify fda potential shortages. They sent us authority to additional categories of food prevent future shortages in the food supply. Second ensuring operational readiness is one emergencies. For apple fda could achieve more effective and efficient oversight if it had authority to require internationally harmonized masterfile drug manufacturing, siphon or use for conducting regulatory assessments. Congress expanded fdas Authority Authority<\/a> to request records in advance and will be devices in bioresearch monitoring sites in fy 23 on the best. However the agent tohe get bettr for the safety of products needed times of crisis if this records request Authority Works<\/a> freshly extended to all fda regulate her products. Additionally during covid19 we found fda staff had to be pulled off other or have been working relentlessly on pandemic issues as have our college for the past three years leading to a significant backlog in certain areas into fatigue great for the creation of specialized programs for defense against emerging pathogens and other threats the agency would be wellpositioned to respond emerging and identified threats of concern. Third by the covid19 pandemic underscore the importance of both diagnostic texts access critical need for a modernized Regulatory Framework<\/a> that applies to all in vitroeeiz diagnostic is to be inch of u. S. Is earned for the next threatened to to realize the full potential diagnostic innovation. This list of improvements a striking observation is these measurements will help the public wellin times of crisis, they would also enable us to help prevent catastrophic outcomes and conduct date work more efficiently and affect thank you enough for your questionsue. Let me start off with a question wilensky. But the Public Health<\/a> emergency will be. It is our job and more specifically your job with us in a position effectively as we can we do not lose over a Million People<\/a> next time around. My questions of three simple questions. After caleb can jump in as well on this one. That way that we are moving forward as fast as we can with a creamy kinds of vaccines in anticipation of the next pandemic . We have the kinds ofds fruit you may not have them today better moving aggressively forward to have the treatments that we need people become ill . We have the workforce infrastructure that we need . But in talent as you can move over rapidly we a pandemic in effect facing a pandemic . And rally all the resources that you need. You have been medical personnel to m staff are hospitals of god forbid we find ourselveses in ts off of that place . Thank you for this question for this is one of my biggest worries is we are losing time in preparing for the next pandemic. It is question requested 88 billion last year for fancy american pandemic Preparedness Plan<\/a> we did not receive that funding. Again fy 24 budget 20 billion of which tenant o ago you asked for that research into the prototype therapeutics and diagnostic for the seven viral families most likely to cause luck it doesnt feel like it but the one place we were lucky when it came to the coronavirus is we had already done a lot of the early work on that because of sars and mers. Leniency is the same headset progress are you telling us we have not been the kind of work you like to see done in preparation for what may be coming . Correct not in all the viral t families. Thank you for that question. With a very frail Public Health<\/a> infrastructure from years, decades of underinvestment. Some have at as a Public Health<\/a> work dropped in deficit right now affect your own state of vermont hired one or 20 people during covid19 pandemic and through our workforce infrastructure able to root infrastructure greg are able to retain 12 of those 120. So it just gives you a sense of how frail the workforce infrastructure in addition to Vaccine Court<\/a> let me interrupt you. Aree you concerned this and nurses are leaving the professiong for a lot of reasons but including a burnout and experience of covid and questar parks and Public Health<\/a> workers yes deeply. I will excite that need to be interrupting him time, what ideas you have as to how we can rebuild that critically important workforce . Correct so much of itfo workfore authority we are looking for Public Health<\/a>ce specifically things like taxexempt loan repayment to entice people to getly in. Flex point do a little bit better than y taxexempt loan repayment we have a massive workforce shortage. The up thousands of new workers records indeed we do many of these physicians come out of medical school with 20000 with a debt. It seems like a very too. Odest direct hire authorities, flexible pay, danger pay for example. In politics right now on the frontlines of an outbreak theyre not getting dangerer pa. These are the workforce things we need to do to entice people to come and help of Public Health<\/a>. Those are many other things were asking for. Im hearing you say despite good intentions your agency is not as prepared as it should be of god forbid yes. What i would center it comes to technology we are unsurpassed and ready to go with regard to drugs, devices, vaccines, tests when it was a prophet be made american issues premier bos fortin and produces Amazing Things<\/a> before Public Health<\/a> we have at gap in translation which is in the quality or are referring to. When theres not a profit at the end of the pipeline we need to have the funding to stimulant industry to produce these products were going to need for the future bird as a former practicing doctor until very recent and very concerned about the things you all refer generally to stress Public Health<\/a> workforce not just the docs and nurses you lost a very important person yesterday. It is emblematic of a hard this work is. We are way down in the workforce that we need across the lord to implement raid talk to any of your friends trying to get an appointment in a clinic practically in Mental Health<\/a> these days. Survey center cassidy. Next ill defer to doctor berg. Ranking member and chairman. Doctor if you dont mind retrospectively what you feel the impact of lockdowns were on Mental Health<\/a> in this country . X certainly of lockdowns result in the lives saved from covid19. And also challenges in connectivity and there are reports of some children doing better in school at home. Ng but also some children my question is Mental Health<\/a>. Arctic lack of connectivity and challenges in Mental Health<\/a>. We saw increases in Mental Health<\/a> challenges before the pandemic. They are rising before the pandemic practice in the lockdowns had no impact on Mental Health<\/a> . X nonce are not saying that forn the impact when you lose 1. 1 Million People<\/a> in this country there is a tragedy, theres loss, this loss of lives there is loss of housing security, foods agree all these things impact. And give ms. Oconnell recently we release a three page report on the origins of covid Center Burner<\/a> help around that investigation but want to give credit to the previous asper doctor kadlece and his great efforts as well that reports of theres a preponderance of evidenceis that shows this virus was released from a lab in wuhan and a significant amount of evidence would suggest is actually made in that laboratory in wuhan. What are you doing to research that same issue . Do you feel its important we know the origins of covid . This is not been the purview of the work i have done at this point. But ill be happy to take this back to the department and other colleagues. Because you feltck important we know where the virus came from . It would be useful to know for sure. And i know that work is underway. Not been done in asper. How would it be useful . As we work to prepare for whatever comes next which is my job. Be important to understand when coming upep against. Let me be clear whatever it is i am responsible for responding to it wherever it came from. If the viruses made a laboratory your response might be different if it came from nature . Would help us prevent it from happening get up into the source regardless of that my responsibility to the country is to helpga them respond to whater comes next. Its okay. Max questions for you. The nih an incredible job of the early days of the covid t pandec sequencing d the virus and sharg that with any group they wanted to anyny corporation. At the end of the day two or three Companies End<\/a> up with a vaccine that was workable. Was there anything we could have done to help promoted other companies to be more successful from wind and the inability to maybe three vaccines . Its really great question which we had six hours to discussion. 90 of drugs that enter phase i do not make it to market because Mother Nature<\/a> is much more sophisticated and complicated that our brains areth as we deve vinew therapy. I think it was wise of the government to make about nine or 10 vaccines in two or three made it. We often forget about the ones that didnt. I am not sure anything we could do would change that equation. That is pretty much the equation we are seeing. So we have to human Clinical Trials<\/a>. We develop a therapy with things going to work 90 dont make it so i thought it was going to work and somebody vested. I think senator romney guess you didnt invest in theseno things. [laughter] as i tried not too. But cap take account of a high failure rate in this which the governments wise to do very Quick Service<\/a> and value it took with the government developed to get to the finish line. Not everyone is able to do that im not sure the valueam is in doing that but you would agree there is more than just selecting that across the t finh line for those two orff three Successful Companies<\/a> . The collaboration the platform the been developed over decades from the ability to the viral sequence she used methods to match vaccine to virus. That was an amazing feat of science and collaboration and made a huge difference. We wouldve had maybe one vaccine out of 10. Some of the companies had significant investment in the mrna technology before covid was even around, right . That is correct that so excited about new platforms coming along with regard to cell therapy and gene editing in other areas. Think i yield back. Thank you very much mr. Chairman for holding this hearing. Thank you, good to see lb again. Dr. Walensky my condolences to you and all the cdc family as well for yesterday. To help provide state and local Health Department<\/a> and the funding they really needed. Have a wellfunded strong Health Department<\/a>s responding to any Public Health<\/a> situation. Ic i have heard from my constituents in Washington State<\/a> have helped during floods and wildfires and of course covid. States and communities still often lack the funding and the flexibility they need when they face a Public Health<\/a> threat. Especially when it comes to reaching and supporting people with circumstances up with the more at risk for and resell the string covid. What can congress should help ensure we strategically support those most at risk in a Public Health<\/a> emergency . Including people disabilities, children and families . Senate marie thank you so much for that question for this is top of mind for us too. We just relieved a strategic plan, a five year plan in which you make very clear with injuries not paired prepared until we are all prepared those at greatest risk need to be accounted for in all the planning we do and the response that wee do. As for the fy 24 budget theres authority to start a Human Services<\/a> Response Fund<\/a> which would quickly move money into variousic communities to be sure we have boots on the ground able to respond to the various populations most at risk for it a wonderful conversation on tuesday with the head of her acl about how important this is where in communications within the department about making sure the Human Services<\/a> side of our shop is also prepared and ready to respond to account for these at risk populations in senator you will recall as part of the last popup you authorized three advisoryry committees. One for disasters and seniors one for disasters and people disabilities and one for disasters and children. We have been meeting regularly with those experts in a really value their t input. We continue to keep this work front of mine. Good. I should know if any emergency we need to be able to get supplies where they are needed mostge. In a quick effective and equitable manner. Proven pandemic act signed into law unless your close directives to assist state and local Health Department<\/a>s in accessing the Strategic National<\/a> stockpile. Can you give us a quick update on how asper is implement that provision . Thank you the Strategic National<\/a> stockpile maga Church Square<\/a> its fully stockede, and ready to go ised when the big focus is my tenure in this t ro. This is an important question for us we appreciate theue provisions that we are working very carefully againstth them. We just released her 60 day guidance which is guidance for states and localities and how they might access the Strategic National<\/a> stockpile. We continue to give Technical Assistance<\/a> to those that are interested in maintain their own stockpile. What do they need to have and how did they need to switch it out . And then we are look at all the various innovations for how we might hold our stockpile with vendor managed inventory andnd other ways to switch in and switch out what we have. This isal all front of mind fors free thank you for those provisions will continue to keep you and your teame updated. Very good i appreciate that. Dr. Walensky one of things we really saw encoded was that we needed accurate data for you cannot get ahead of an emergency and create a response to it if you do not have that. Its i wanted to ask you today, can you talk about ways your agency is working to improve Data Collection<\/a> . Yes maybelle break this into two parts ones were actively working on today that modernization efforts that is her data highways are interoperable the countys local health apartment can get data swiftly to us in similar highways we can offer it straight back to them so they can see in on whats happening in their county but counties aroundac them. It was a huge return. Before the pandemic started we had 187 Health Facilities<\/a> doing electronic case reporting. When out 25000 bread that is about 20 of what we need across the country. So up massive strides happening but also in the surveillance or Emergency Department<\/a> of Vital Statistics<\/a> from right death registries this work is ongoing highways. Tade or we could really use your help is the structure coming into us but receive this data voluntarily. The data do not come to us we do not have line of sight and cannot deliver data back thats among the things we are asking for in this reauthorization, you. Think you mr. Chairman. Thank you chairman and thank you to the witnesses are being here today. Last october the gao said the assistant secretary for preparedness and response needs to develop a clear approach for buying a medical countermeasures for national stockpile. Regardless of whether they receive Development Funding<\/a> from the secretary, without a clear process in place for the stockpile to buy countermeasures, will you commit to implementing recommendation to document an approach to make sure therehe is equal consideration of medicalof countermeasures . Enter thank you so much that question. Absolutely. There were quite close with gao to make sure we can take into account the recommendations they make and implement them. Of course make sure the stockpile has what it needs is a focus of my we have an Inter Agency Group<\/a> of experts that come together to give advice to myself and the secretary and what should go in there across all of the various material threats dhs is issued. Thank you for that. Your congress created advanced Research Projects<\/a> agency for health. As it is currently outlined many of its authorities overlap with efforts undertaken by the assistant secretary for preparedness and response. What steps can Congress Take<\/a> to increase interagency coordination enter most of the duplicate of efforts between and your agency . Center thanks given that question. We are really proud of the workt barta does for its limited to developing countermeasures to make us more prepared against the threats that we see coming. As i understand in a wider remit to develop Innovative Products<\/a> against any disease or threats. Not necessarily the National Security<\/a> threats we are responding too. But it is important have good collaboration between our agency. We work very closely together and continue to stay in touch but i see a clear lane for barta its important to stay in that lane in order to keep this country more prepared and ready to respond moving forward. Thank you. Neat centralized Clinical Trials<\/a> were trials take place in locations other than at a center like a patients home make groundbreaking cures more accessible would not be able to participate because of where they live. We saw how important flexibilities were during the pandemic. So commissioner, what steps can Congress Take<\/a> to reduce the barriers for participate in the trials to improve accessibility for Rare Diseases<\/a> or they have mobility issues . Thank thank you center being a fellow north carolinian is that some studies but also very real estate. Separation of the accent i wondered if we neared live o nearby. This is really important put out a guidance on this these essentialist trials are on the rights dependent on Digital Technology<\/a> review asked me the most important thing you can do is to make sure the funding for internet expansion to all the rural areas. I know pass the findings allocated the pipes are deployed out there think the masses are coming along great. I spent time at alphabet. There is no question we have technology that everyone in this country can use for almost everyone has a self on the method of doing this not requiring the big Research Center<\/a> unless is a specialized area you need. Special medical exams it is the way to go. Looks very good, thank you all again chair i yield back. We owe you a minute next site laugh at. I will take a very quick senator casey progress mr. Chairman thanks very much appreciate the work you are doing and Ranking Member<\/a> cassidy on the reauthorization of the pandemic. The hazards prepared his neck asked when the thanks and a romney for working with us on tthis reauthorization. This starts with director on supply chains and ppe. We learned a horrible lesson in the pandemic which come the way is look at it kind of a nationl failure we could not provide the ppe we natively do not want to ever have that transpire again. We had a buckling of that supply chain in the midst of the worst pandemic w in 100 years that adversely impacted First Responders<\/a> and healthcare workers, essential workers as you know that was totally unacceptable. One factor that contributed was a heavy reliance on imported ppe. And they dependence upon those foreign manufacturers in foreign suppliers is what drove that. It created a terrible risk we all know our families and communities paid a price for. How can we promote innovation went ppe designs are outdated and then ensure Innovative New<\/a> technologies are always available to essential workers whether they are in healthcare or otherwise especially during the pandemic . Thank you, senator. I would be happy to have our team touch base with you all the research happening to ensure we have innovation and ppe. One is the personal protective Technology Laboratory<\/a> that is workingra inside like pittsburg. I looked at new technology for ppe is in healthcare and Public Health<\/a> emergencies and other environmental hazards. That work is ongoing were working with academia be happy to review your staff on the work hhappen there. Thank you dr. Walensky. Senator casey just to say the organization has invested 16,000,000,000. 87 different contracts for domestic manufacturing ppe and other critical supplies. We lose the cove adults would lose the ability to Construction Authority<\/a> and continue to invest in a similar but are we see supply pinches and materials and products to keep the work going. Mission are going to ask you a question about device shortages which is a nether challenge. We know in the midst of the pandemic that was another significant strain. In particular we saw a terrible shortage of medical devices. And had during the Health Emergency<\/a> required manufacturers to notify fda of potential actual shortages. How many devices, if you have this number, how many device shortages will h prevent using this authority . The price with 350. It is a large number. We need notification not only when manufacturing is disrupted but also when theres a huge surge in demand. The make up for it. Thanks very much for mr. Chairman get thank you, senator casey. Center cassidy. Thank you. I could do a number of times. I dont know ms. Oconnell as well but i respect you as individuals. And physicians have demonstrated integrity and capacity andsi commitment to the oath you have taken the nation but ill do your patients. Let me ask each of you how many employees you have the are. Responsible for in your agency approximately . About 1000. About 12000 twice the number of contractors. Okay thank you precooked 19000. There are some people who feel individuals must be corrupt or it must be bad for their work for the government they must have ulterior motives. My experience in dealing with those ive dealt with this they are good people. They are brothers sisters, moms, dads. They are trying to the best job they possibly can pretty j sometimes worry a projection other people are evil somehow creates false impressions about how effective our various agencies are. And hope you and others recognize the great majority of us and certainly in this body respected and are the work you do. We ask and theres anything you think we need to do to improve the integrity and the credibility that is held by the public for your respectivee agencies. For instance prohibitions on owning stocks and pharmaceutical companies right here all the time fdada approved that because of people looking at were investors in that company. To those issues you are concerned about desist existing or agencies . As you mentioned fda specifically are prohibited from owning any stocks in any of the relevant entities that they regulate. Even airlines they serve food food is a big part of the equation. I take great pride in appreciate what youha said. What can be done to help the most to say a few nice things about federal employees they work hard. We can verify they work during the pandemic. The echo the cries of your comments and say im Agency Working<\/a> 24 7 to take care health and public helpers were not getting creditca for. Pe what happens on a massive pandemic that affects their 30 americans there working 24 7. Their job is subject Public Health<\/a>. A few nice things i would say goes a really long way. I was personally concerned many others were about thekn Data Available<\/a> to the public more government about what was happening. What age groups are getting as little dismayed i went to jon hopkins you also indicated for many institution the data that comes is only voluntarily provided. Are you suggesting we need to have some mandatory reporting on a basis or people cannot be identified personally . Do we need to do something you have a better system of collecting data as well as a practitioners . Right after the Public Health<\/a> emergency cdc six months in order to to order hospitalization data which is jon hopkins was a very efficient way to just while we were working with our lawyers to do agreements. Supposed to responsible for disease outbreaks before they start there before they become emergencies we have to have line of sight with the urgent issues as infectious threats are. The only way we do that is getting a recording coming into cdc so we can again give it back to the communities this very thing that happened in their county is happening the county next to us. Thank you prick i love distilled type of people gave it up i will doo that. Its just you asked a question asked and ppe its another to stop by the machines that make those things. Are we making the right choice inin that regard from your perspective . Presenter thanks so much that xaquestion. Joint one part of the supply chain continuum. What we have on hand the stockpile is critical in the hours and weeks of the response to my rampp up what we. We were bandannas instead of real masks should have been out to access those in the commercial market for were not able too. Stockpile search back that up should have been there to backstop for that. If both are running well were investing in a domestic 90 factions of the supplies is more resilient about the running well will not in the stockpile rely on the supply chain. Not yet spent will have the stockpile. Thank you. But thank you, mr. Chairman. I want to thank our witnesses for all of your work to have very, very hard time. Want to state that in the form of a question but the position of an act taken by the House Republicans<\/a> last week that would result in drastic cuts to our Public Health<\/a> program and cuts out undermined the competitiveness as well as ourco safety bear Public Health<\/a> in our security. Leave us p completely unprepared for the next Public Health<\/a> emergency. I certainly stand with many of my colleagues who voiced concern about that in opposing measure of the House Republicans<\/a> passed last week. In the last congress are closer with Ranking Member<\/a> cassidy on the tracking pathogens act. It enhances our ability to prepare for future pandemics. To strengthen ideas for new viral threats. Through genomicug sequencing. Thanks to genomic sequencing identify, survey and understand emerging variantsey of covid19n other diseases but artwork really must continue. The tracking pathogens act was signed into law as part of the fiscal year 23 omnibus. But unfortunately there is no sustained funding for this work. So doctor canky you describe why sustained funding for cdc sequencingin efforts including e advanceddv Detection Program<\/a> is critical to preparing us for future Public Health<\/a> emergencies . Personal thank you, senator baldwin for all your effort the bipartisan efforts in our ability to track pathogens and to check the coronavirus through genomic sequencing. We dont tens of thousands of sequences a week. We continue to have biweekly what pathogens and sub variants are occurring. It is also the case we know now that we have this and that we can do this of mass and capacity to be able to this other viral pathogens for bacterial and fungal. In the capacity here to make greate, strides. However once we have ramped this up, if we let it run dry it will not be taking advantage of all of that capacity. I invite all ot your state Public Health<\/a> lab. If you go to your state Public Health<\/a> lab i have been to a lot of them he will see a really frail laboratory infrastructure. Do you have a genomic epidemiologist to do this work, or a sequence on site to do this work in your lab . Parts of the Construction Authority<\/a> is to develop the capacity in your own estate lab so we can not only have the resources to do the genomic sequencing, but then have the places of homegrown people able to do it. Thank you. Barta has recently began to explore capabilities for emerging threats. I believe that as we work to prepare for the future, we must focus on the development of medical countermeasures for viral families with the greatest pandemic potential. Flexible potential. Platforms can pivot to address previously unknown pandemic threats. Thats why ive loaded the disease acted that would dedicate resources to this goal. How can congress support to better prioritize the medevelopment of medical countermeasures against the families that present the greatest pandemic potential . Thank you for that question. One of the premier organizations in the federal government but its an unsung hero in a lot of ways that doesnt get a lot of credit so im grateful for the opportunity to talk about them. Theyve begun to pivot to the platform and we see some of the advantages where you can click a switch itiece in out in very quickly ramp back up production so we are exploring that. What would it mean to transition that technology into a pandemic fluc vaccine so that is underwy but also asked for 60 million for threat agnostic countermeasures. We are looking at what we can do for multiple drugs and that is underway we have it in the budget anddr we continue to look for different applications of the current measures we are developing. Will senator johnson and i sent you a letter earlier this week for an upcoming hearing on cellular tissue and gene therapies that your Advisory Committee<\/a> concerning new muscular dystrophy drug trading a variety of it. Unlike most hearings, this one is being done virtually prohibiting the use of cameras and choosing from the patient segment by lottery who can speak up and diseases like this and many others where its very progress abandoned has a sharp prognosis window especially when theres something happening on the front that may be promising. Why would you go from the normal format to this deemphasizing the patient component of it . Thanks for the question. The technology istr exciting and this is an Advisory Committee<\/a>, not a hearing so its really following the same rules that we have all of the Advisory Committee<\/a>s the goal is to have experts to give advice about the assessment of the technology is ogthe Company Presents<\/a> its data and the patients have agents for their input but there is a limited amount of time so its deviationfrom the standards. How long has the standard procedure been in place . Years as best i know. And youre not reducing the amount of patient participation . Did you get the letter that we sent to you . Im aware. Ive been at the forefront of the promising pathways act. They probably shouldnt have the same dynamic do you view that should be looked at keeping the Gold Standard<\/a> that you referred togo but since the windows dont surpass should there be a different way of doing it . In use of the agreement that he wall approved between us and the industry we are hiring about 150 people, additional people to focus on it because its exploding right now with biological technology that holds great promise. Its now bicameral, promising with senator joe legrand of new york that would address this and codify it we will send it to your office and hopefully get your endorsement. We have had a conversation several times in the past of course we are lifting the federal Vaccine Mandate<\/a> the Public Health<\/a> emergency on may 11th. I will not forget the angst that was in the Small Business<\/a> community we had to put a Congressional Review Act<\/a> out to make sure you are not going to force vaccines on employees down to employers with 100 employees. That friday when it was in the Rearview Mirror<\/a> and it was coming down and took the Supreme Court<\/a> to thwart that bad idea. I would like to knoww if that ws your recommendation, doctor faucis,kn it was the Biden Administration<\/a> who did it. Who was going to push forward that that was a good idea before we had to come in and intervene in the act and get the Supreme Court<\/a> to weigh in. Here we are now in 2023 with 96 of people who have protection by one and one way or another withth a section or by vaccination. At the same time we o were seeig the workforce and Police Departments<\/a> First Responders<\/a>. This wasnt that long ago this was just last year you had maybe 96 but when you and i had a conversation we knew that arriving to the elderly and it was clear that it wasnt going much more deeply into the rest of the population and the trillions of dollars that we spent and the fact the economy was shut down for that long i think was slower to react to the science and maybe not the Political Science<\/a> and im just wonderingal if you and doctor fauci and who were the ones who kept pushing forward on that one issue of the mandate or employees, private employers now the hundred employees. I can tell you theres a group of us that advises the president on these president ial exclamations. I would also say to this day we know that the booster still has 2. 7 timesll protection against death. If youve gotten it then if you havent so we still know that they continue to provide protection for people across all age demographics. By the way doctor fauci in the last interviews that he would probably never recommend shutting the economy down again for something similar to that, fyi. Senator kane. Thanks to the witnesses. Im a Public Health<\/a> data geek because like senator hagan labor i was a mayor and like the chair who wasli a mayor we have the experience of seeing the silos at the local Health Systems<\/a> and state Health Systems<\/a> in federal Health Systems<\/a> and then you have all the providers and that created huge challenges to run back it was hard even to get a racialal information about those getting covid and dying of it and it took us a while to realize and it took a lot to realize okay this was affecting africanamerican and latino more than others but we didnt know that right away. Theyve had Less Health Care<\/a> hee access which has given them more Health Comorbidities<\/a> that makes them less susceptible to serious cases of covid and the minorities were working and provisions like Home Health Care<\/a> aides were Grocery Store<\/a> clerks where they couldnt just go virtual old was not and so they had more exposure but it took us a while to figure that out. Then we did figure it out and when we started to vaccinate beginning with the populations over age 65 we figured out pretty quickly even though it was equally available that it wasnt really equitable or ineffective because those that were the mosts vulnerable were not the ones sitting on their computer. They didnt have computer access or the free time to do it but because we had figured out that out we were able to change the strategies to get to equity and effectiveness but its an indication of a million miles it slows down the response and ability to have effective interventions keeping people safe. Ive worked with colleagues on this committee for a long time on the improving data and Public Health<\/a> act and some of the pieces have been included in earlier appropriation on the buses but there are other pieces i still think we need to include. In your testimony you mentioned the Public Health<\/a> data. Talk about how they can help the cdc do a better job to keep us safe. Thank you in your interest in this. The state of virginia is one that has piloted with a combination of case reporting, lab reporting and surveillance so that we do have a better window. The case you brought up is exactly right we were unable to see the race and ethnicity data. We had the same challenge and a Public Health<\/a> emergency that was declared three days after as it turns out the peak number of caseste and again we couldnt se the race and ethnicity data or the places the vaccines were going into arms as we were trying to make decisions about the deployment with my colleague here. We cant act swiftly, robustly if we can to see what is happening from a data standpoint. If we wait for the Public Health<\/a> emergencies to be declared and then statebystate daily use authorization and agreements to happen it takes months. It took six months to get hospitalization data. If we are to be nimble even if we have remarkably robust data systems thatrk there was nothing driving on the highway us we wouldnt be able to see what was going on and truly we want to have the data to give back to the state and local departments. As we find a way to include i think the data that obviously protects peoples personally identifying information but gives the Healthcare Professionals<\/a> the tools they need. Ive heard a lot from my constituents about drug shortages and we sent you a letter recently about 15 colleagues asking what can the fda due to work with identify factors that lead to shortages and i would like for you to just tell me i hope that you are prioritizing this. As the formulas gotten better ive gone now to fulltime drugs and shortages because we have hundreds, over 200 in the last year and weve preempted by working with of the manufacturers but the number is going up and we are keeping the actualbe shortages at the same level but the employees can only plug a certain number of holes in the system which has got real problems particularly the generic drug pipeline so weve got a lot of work to do and weve asked as i said in my Opening Statement<\/a> perhaps we have better data so we can get out in front of this more. Theres more to ite. Than that d i look forward to working with you on that. Senator cassidy. Thank you again. Let me echo i do think all of your employees are working tirelessly through the pandemic. Congratulations on a great football season. And mr. Connell, we have witnesses on the second panel that are going to suggest drug pricing and policies that they say would increase access to medicall countermeasures. Now i raised that because i hear from experts that medical Countermeasure Development<\/a> is uniquely challenging that many of the companies are Small Companies<\/a> that many ofl the companies that bar of the the contractthat went bankrupt s got bought by Bigger Companies<\/a> and Bigger Companies<\/a> are getting out of the medical countermeasures. Is that a fairly accurate depiction . Senator cassidy thank you for the question into the good wishes for thenn greenway of. We are very proud it doesnt happen a lot, but to your question the type of company that we have to work with are often small Biotech Companies<\/a> because there isnt a commercial market for thell countermeasures so we do have to work with the Smaller Companies<\/a> that have to come in, are willing to be innovative in a certain way. Its my impression a lot of the companies are living on Venture Capital<\/a> and havent turned a profit before their first big product. Is that a fair characterization . We often support the work thatra they are doing in order r them to be successful. If you were to put restrictions about what medical countermeasure developed could beer priced for perhaps without knowing all the variables and that theres really no secondary use as far as this particular issue would that be encouraging of the financing . We remain committed to making sure any government funded countermeasures are available to everyone in america that needs them so we are committed but there is a risk if we were to act in limitations that we limit the number willing to come forward and do this work. You limit the number of companies and the number of companies is already limited. Theres l a risk. You are looking for it let me complement you right off the bat. Another suggestion with regards to how to develop some of these products is to incentivize innovation with a large sum of money but that would be in lieu of patent and regulatory exclusivity. I dont know if you canant comt on the finances of this but do you think it would be an adequate substitute for one of the companies in lieu of the patent and regulatory exclusivity . Well, you know what a complicated question you just asked and what i will say is the prices of innovator drugs i believe are too high but the solution of the problem shouldnt inin my view be to do away with patents. They serve a vital roll in stimulating the kind of thing you were just discussing but the balance between the two is a longer discussion. I dont think that its an either or discussion. But it plays a critical roll in incentivizing innovation. Absolutely. We just got sued today again by a company over that issue, so its very important and people are going to invest in the companies that has to be intellectual. Im going to ask a question somewhat related to the last. There is a conversation about reasonable pricing clauses that would dictate the price of something should it enter into the commercial market. Now in general is there a commercial market for most of the things funded . In general, there hasnt been. If the products that we have led licensed a few of them are available in the commercial market. The data shows the reasonable pricing clauses from 1990 to 1995 and after they removed them, heres the kind of production of drugs and then they removed it. That is may be an association, not a causation but do you think a reasonable clause would make the company more or less willing to work on medical countermeasures . There would be a risk in adding an additional contracting element to the work that we are doing. I have more questions but no time. I look forward to discussing the questions in the future. Senator markey. Thank you very much. Earlier i think doctor wilensky said, and by the way congratulations on the great year the Football Team<\/a> had. This kind of tale of two pandemics with 250 people a day still dying, can you talk about covert, who they are and what the message is to them as the medical emergency in general . As the Public Health<\/a> emergency is set to End Next Week<\/a> i want to reiterate at the cdc we are not changing the steam that we are working through this resolving Public Health<\/a>me emergency. As we look at the kind of people that continue to help, they tend to be elderly and more vulnerable and those that are not vaccinated or uptodate on their vaccines. The more fragile people who are not uptodate. It is the case of the Public Health<\/a> emergency we will have less window to the data and that is among the things we talked about we will lose a percentage and we wont get laboratory reporting or case reporting. With regards to what we are doing as we talk to these communities weve been doing a lot of work to address our disabled communities, our elderly communities and among those things with every response now we have a cheap Health Equity<\/a> opals oriented disability officer. Weve been working with our colleagues and have a meeting tomorrow to discuss the impact at the end of the Public Health<\/a> emergency and whatat that means. Weve been putting disability experts with working within states so they have resources and references within the community is to understand the impact. So for that cohort people over 65,5, people with preexisting conditions and compromise they still have to act as though the pandemic is stille going on. You can be in a culture where everyone else is saying we are back to normal but for them its not back to normal in terms of what they need to do to protect themselves is that the message . We provided an update so that community could get access to another dose and as a part of the emergency we would like to provide data on hospitalizations so people can see the rate happening and make decisions to whether or not they want to take extra measures. So they still act as though they are in a pandemic in terms of the vaccination protections. I think that is a very important to signal because it is a tale of two pandemics. 250 a day that is 700 a week times 52 weeks a year thats a lot for people that are going to be affected. We see the effects in new orleans and other places with Climate Change<\/a> just having devastating impacts on communities that then affects the Healthcare System<\/a> in those communities and could be delaying denying people access treatment when t this hits, when the system collapses. Can you talk about what you do to make sure that the system strengthens or needs strength ended because we can almost predict and to guarantee we will see intensifying storms in the country and all experts and all meteorologists, what do we need to do for the Public Health<\/a> system to make sure that its more capable of responding . We are seeing an increase in storms in fact we are seeing the increase in flooding and fires that the intensity of storms happening so we are continuing to ramp up the response elements and thats one of the reasons why the authorities weve asked florida are so important to get responders and people on the ground, be able to procure the tools we need so we are looking across all of those in the landscape we are living in to make sure we are strengthening what we need to have on the ground. Thank you all for the great work that you are doing to have the country respond the way it did and we will try to get the additionalet resources. Your recommendationsrc are going to be well received. Commissioner hagan looper. Mr. Chair its been a while certainly making sure that its put together the right way with the proper resources is going to be a big deal for all of us we take that very seriously. How can we do otherwise. I want to start an effective partner getting these to the public in the context of the pandemic the fdas proposed specialized programs to handle the emerging pathogen preparedness in the priority for fiscal year 2024 can you speak to your vision specifically how the agency might be able to handle the regulatoryy considerations for these platform technologies . Sure. We are constantly looking. We had a good discussion today about the platforms and how important they will be how you can mix and match and insert a new element and come up with a new therapy in a short period of time. Thats a reality we are asking for people that are dedicated to come up with. Some of the things are already imploding but we want to do more of us we have the platforms ready to go and then you can depend on the platforms you dont have to redo all the regulatory work that you would dolo if you were developing a dg from scratch. But we mentioned i got my vaccine a few days ago which is why i look a little tired. I threatened to wear a tshirt but my staff told me that wasnt allowed in a senate hearing. Let me suggest you go and have a four monthold child at homeom then you will be really tired. Assistant secretary. Economic costs, human costs and i do think important work will be done when we look back over the ark of the pandemic and again i can remember vividly i was a couple months out of being governor and i watched the decisions being made by governors all across the country and all of us in washington in real time with unbelievably limited i information because te data wasnt there. But it will be useful to go back and listen and look at each time when information we have did we make the right decisions and we should be upfront saying theres no harm i in that. One thing we did see is the regional coordination and resilience were the key to featuring the pandemics. In colorado it got the big City Hospitals<\/a> as the successful demonstration slide for the health and response system and Pathogens Program<\/a> but neither of these have gotten permit authorization they are just test cases so can you speak as to what the likelihood is in terms ofli getting more continuity. We then expand it out regionally and across nationally and thankfully covid was one of the first responses weve dealt with is that we needed the response immediately said to have these strong places to lean on has been important. You mentioned the regional disaster system. At this point we fully funded four of those, four regions have the benefit of put colorado as. One of the goals is to expand that so it is national and we have one of those in each region that can coordinate across you see m how important it is in somethings like covid when they were overwhelmed and one hospital with no idea where to go and the t next one that could take a bed was critically important. The National Special<\/a> pathogens that you mentioned those came out of the ebola routine when we realized not everyone could handle aev patient so we set upa system across the country of the regional locations that were able to take those patients and we trained them and continuing to work and im proud of success they pound. Weve had to exercise them recently with the outbreak in tanzania. Very important capabilities. We saw a lot of that also in the Regional Response<\/a> and resilience came from the licommunity Health Centers<\/a> and hospitals as well as research places. It shows the strength of the Public Health<\/a> care system as we tried to build the various platforms of the pandemic preparedness i think we will also be vigilant on the creep of red tape and. Theres so much paperwork and process that we created because so many people are worried about making a mistake and that is the most Important Senate<\/a> reviews for the successes and failures that wene realize we are never going to get perfectly but trying to find ways to limit the red tape. Anyway, thank you all for your public service. That is the last question are yand we think the panelists for being with us. Now we will hear from the next panelist. 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