Transcripts For CSPAN3 Public 20240704

[inaudible] okay, thank you. The Senate Committee on Health Education labor and pensions will come to order. This afternoon, we are going to hear from two panels. We are going to hear from, on our first panel, the assistant secretary for preparedness and response, rochelle walensky, and robert califf. Second panel, we are going to hear from doctor Reshma Ramachandran and dr. Martin makary and dr. Marshall. Let me begin by thanking all of the folks on the panels. All of us know that the last three years have been unprecedented in our lifetimes martin makary, we dealt with the worst Public Health crisis in 100 years, i want to thank all of you under those difficult circumstances. Today, what our job is, is to take a hard look at where we are today, in terms of preparing for another pandemic. And the need to reauthorize the pandemic and all hazards preparedness app act. And i want to take this opportunity to acknowledge the previous leadership, senator murray, who was chair of the committee and senator burr who was the Ranking Member, as well as the working group that ive helped convene with Ranking Member cassidy, to include senator casey and senator and all of those senators have set aside time for their staff to meet with mine, every week, because we all understand how terribly important the issues are that we are facing, concerning the possibilities of future pandemics. As everybody here knows, tragically, in the United States we lost over 1 Million People from covid. And putting that in perspective, we lost more people from covid in the last several years, then we did in world war ii. Cases, deaths, and hospitalizations are all declining, covid is still today the leading cause of death in our country, with some 250 americans on average dying every day. The World Health Organization reports that 7 Million People have died from covid globally. But there are experts think that underestimates the number of people who have died, globally. I think, to be honest, as americans, we can understand that every public official tried their best during covid, god knows how hard people worked and the stress they worked under. What the 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 claude that months after the pandemic erupted, we all saw pictures of doctors and nurses in overwhelmed hospitals, lacking the personal protective equipment to keep themselves healthy. We all remember those images. And doctors and nurses, people using plastic trash bags, because they didnt have the personal protective equipment they needed. And we also know that many hundreds of medical personnel died doing their duty trying to save their fellow americans. During that time we did not have the tests needed to find out who had covid and who did not. It would not have the infrastructure we needed to deal with the pandemic. All of us remember 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 that we had to shut down our schools, our businesses, and much of the economy for far too long, causing millions of americans not only to lose their jobs, but their health care as well. So in the middle of a pandemic, millions of people actually lost their health care. Here is a scary piece of news, we have to face up to, it really do. Maybe the most important part of holding this hearing. What scientists are telling us is that there is a reasonable chance that, god forbid, a pandemic as deadly as covid wooded here in ten years. All of us hope that that will not occur, but our job is to make sure that we are prepared if it does occur. Thats what this hearing is about, thats what this legislation is about. Scientists have told us that 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 person to person. Our job is to make sure that we are protecting we spend huge amounts of money on the military. We say hey, we have to protect the American People. If you want to protect the American People, you have to deal with this issue as well. And it means that we must have a capable workforce in place, not just nurses and doctors, but also Public Health officials, disease detectives. Well hear more about this in a few minutes. People who can tell us where to set up a vaccination clinic, for example. If there is an outbreak developing on the west coast, can we learn about it immediately, and so the rest of the countrys alerted . Et cetera. Tragically, during the pandemic, nearly one and this is incredible. It impacts not only this hearing, the future hearings. During the pandemic, nearly one out of every five Health Care Workers quit their jobs. And contemplated doing so as a result of enormous stress and burnout they experienced. Further, we need to have accurate Public Health data, to know who is getting sick. We need it did not only have tests, vaccines, and treatments available, we have to be able to get those out everybody who needs them. We need to make sure that medical personnel have the supplies, the masks, the gloves, the gowns they need. We need to have Clear Communication to the public. Something that has been really difficult to do, but we need to improve our communications capability. We need especially, to make sure we protect the most Vulnerable People in our society. The seniors in nursing homes, those with disabilities, our children, and our infants. So, thats where we are right now. We have experienced a terrible pandemic, our hope is that we have learned something from that. And that will be better prepared as we face an unsettled future. Senator cassidy . Thank you senator sanders. Before beginning, director rochelle walensky, i think we all experienced sympathy for the families of the cdc employees killed yesterday. Always a tragedy, but we feel in particular. Today we are discussing an important responsibility of the committee, the reauthorization of the bipartisan pandemic and all hazards prepared this act. Many will focus on the word pandemic, which is obviously a big part of the discussion, but we need to keep in mind the wide array of threat that this bill seeks to address. Not just diseases, natural disasters, attacks, accidents, other things or get our country at risk. I feel connection to the origins of this bill, although it was not in congress at the time. It was first enacted in 2006 to address the failures of following hurricane katrina. And anybody from louisiana firsthand, the devastating impact on the community. When governments are illiquid and ill prepared to manage a crisis. So we have to support everyone. The biomedical but you come up with awkward sounding acronyms. Also made improvements today for they stop treatment, easily available during emergency. In both 2013 and 19, congress acted in a bipartisan way to reauthorize the bill. And this year senators romney and casey are spearheading this. We dont always agree, but we set politics aside and come together on really authorizing papa. We know it is key to protecting all of us. The papa framework is far from perfect, poor management and maintenance of the stockpile meant that doctors and nurses were meant to use force to use ppe for firefighters. One picture a member was a huge quantity of masks being dumped, right as the pandemic was starting, because they were two weeks from being expired. It certainly wasnt a first in, first out, manage the inventory situation. I think we can say in some ways, the government hampered the private sectors ability to launch tests at the beginning. And they consistently failed to communicate the public. Lets get better. We made mistakes, we learned some tough lessons. So lets Work Together to make it so that next time it isnt on the fly that we are figuring it out, rather, there are systems we can put into place. Update the playbook, make sure whatever we do is flexible enough to address the threats beyond just pandemic. And emphasizing, we need to look toward the threats in the future, not to prepare for that one was already gone by. Limited taxpayer resources, and better partnered with states in the private sector, so we are already, and willing, to step in for the next Public Health threat. To accomplish this, the meaningful policies, to i thank you for being here, i look forward to hearing your testimony. And with that, mister chair, i yield. Thank you senator cassidy. Now we are going to hear from our witnesses, first witness is miss dawn oconnell, assistant secretary for response in the administration from the tragic in the heart of health and Human Services. Miss oconnell, thanks very much for being with us . Chair sanders, Ranking Member cassidy, distinguished members of the committee, it is an honor to testify before you today about and the additional authorities we are seeking in the upcoming bill. But, first let me join the senator for my we are very sorry, we are living in an increasingly interconnected world, where diseases and other tribes can travel quickly unnoticed for days. We are also experiencing increase in interconnectivity we are working on more high consequence, no failed visions than ever 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, efficiency, and expertise the American People deserve. As we move out of the acute phase of the covid19 response, it would be management malpractice for us to look the same and at the same as we get at the start of the pandemic. Ive taken several important steps in the last few months to transform our organization and to incorporate Lessons Learned from the covid19 response. For example, asper is now a Standalone Agency within hhs. This important change in our departmental status gives me the independents to build out our human resources, acquisitions, and finance infrastructure. So it better supports our unique mission. I also just completed a structural reorganization that institutionalized important new capabilities, like our stockpile, supply chain, and domestic manufacturing work. The capabilities that we built during covid, and needs to keep using moving forward, like i also made the Strategic National stockpile in office, that reports directly to me, to increase visibility into, and accountability of, this critically important part of the nations preparedness and response apparatus. With these changes, ive 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 all of three key problems. The first problem im trying to solve is how we can procure, more quickly, the tools and supplies a country needs when responding to a bio threat or disaster. Early in the covid19 response, it became clear that hhs could not procure the products our country needed, at the speed at which our country needed them. As a result, we entered into a memorandum of understanding with the d. O. D. , in which they provided acquisitions for on our behalf, using their unique authorities, executing more than 90 billion dollars of contracts for us over the three years of the acute response. Our agreement with d. O. D. Comes to an end at the end of this fiscal year. Which is why im requesting similar authorities for asper. These include funding promising prototypes, and moving the successful ones through the research by a plan without having to recompete the contracts, like we do now. We are also seeking the ability to quickly procure experimental supplies, an important finished products. Each of these new authorities will allow us to do for ourselves, moving forward, we have to rely on the d. O. D. To do for us during covid. The second problem im trying to solve is how aspr can continue to invest in the expansion of the domestic base for keep the email surprise, to ensure we are never again the position we got ourselves out in march 2020. When our doctors and nurses did not have access to the masks, gowns, and gloves they needed. As far Construction Authority to build new 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, but what if the covid 19 funds run out . We lose our Construction Authority, and our ability to continue investing in similar projects. That is why i am requesting Permanent Authority for aspr. Its important we have funds and Construction Authority to sustain the work we have started. And to expand this work to other parts of these public supply chain. The third problem i am trying to figure out is how we can hire staff more quickly during large response efforts. In the early days of the cruel covid19 response, just as we were live for acquisitions war, we also relied on fema and the coast guard to bolster our response staff. The ability to hire people quickly and competent them appropriately for their long hours and sometimes hazardous work, our important tools missing from asprs response tool box. Which is why i am requesting direct tyrant authority, which will allow me to quickly scale up our response efforts, so we have enough people when we need them. And pay flexibility will go along it saves our staff and assure is that we do not lose these seasoned First Responders and subject Matter Experts to the private sector, who pay much more, and often require much less of them. To solve each of these problems, i have just laid out, i have requested important new authorities, i want to solve these important problems with, you and many others, as you draft a new bill. Thank you again for inviting its justified today. I look forward to answering your questions. Thank you very much. Our next witness is doctor rochelle walensky, director of the centers for disease control. Dr. Walensky . Chair sanders, Ranking Member cassidy, and distinguished members of the committee. Its an honor to be here. Before i begin, i would like to take a moment to mention that our cdc family suffered a horrible loss yesterday. Amy was a valued member of the team at the division of reproductive health, or 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 grief this tragedy. In addition to the work that people like him you do every day im here to talk about how the cdc works 24 7 to protect america. And i want to thank you for this important opportunity. Cdc has led Public Health response since our founding in 1946. Providing expertise and resources and workforce support to states, local, and tribal communities on local territories. No matter the outbreak, h1n1, zika, ebola, covid19, polio, and pox, cdc has been there offering worldclass assistance. Alarmingly, bees Infectious Disease spreads have been emerging at an increased pace, and are increasingly complex. The increased frequency of outbreaks means we should not be asking if will face another serious Public Health threat, but when. For many, life has turned to normal after three years of covid19. Agencies like cdc and is to continue to remain response ready, to protect americans from any was delving or emerging health threat. And we do this by actively supporting the four capabilities of Public Health. Including stateoftheart laboratories, a diverse Public Health portfolio that is culturally competent worldclass, data and analytics, Rapid Response to outbreaks at their source, and strong, domestic, and global preparedness. We are enhancing these through an allagency review. The cdc moving forward. We are committed to addressing the Lessons Learned from covid19, including accountability, and improving how we deliver information to americans. The end of the Public Health emergency once again reminds us that policy changes and funding are essential to the readiness of future we will continue to close modern covid19 and provide information to which we have access. After three years of the pandemic, and three months of preparing we have worked hard to sustain data to understand whats happening with the virus in america. But the end of the pag means the cdc will no longer be able to collect data and share information, Many Americans have come to expect. A cdc often does, we will adapt to limitations and utilize tried and true systems to monitor other respiratory diseases, to keep our eye on covid19. And some cases we will use surrogate data, but sounded will no longer be submitted to us. For example, certain data for National Pictures of Health Disparities for race and ethnicity, along with urban and rural lines. We will make do. However, the should worry us all. Primarily because what it says about the visibility we will have in the next outbreak. We will be back to square. One having to build and negotiate surveillance capacity while we fight a pathogen. I know members of this committee are interested in advancing policy to close the gap in our Public Health response, to be better prepared for what comes next. For the cdc, this means by allowing us to recruit the best of the best through improvements in student loan reimbursement authority. We must also be able to when needed, too simple changes to direct higher legislation and sufficient so bureaucracy doesnt stand in the way when an emerging threat arrives. This also means maintaining the infrastructure our nation stood up during covid19 to administer vaccines. The vaccine for Adults Program proposal not only provides americans access to 14 lifesaving vaccines, but also supports a response ready capability that we will lose without continued investment. Finally, this means modernizing david policy to support access to better quality standardized and timely data, so individuals and families can make informed decisions about their health, and policy makers can better target resources to address before they become Public Health emergencies. The United States should have the most advanced and capable agency in the world when it comes to tracking, and forecasting. It will take a more modernized, nimble, and collaborative cdc, and they 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, and our National Security. Thank you, and i look forward to your questions. Thank you very much. Our final witness is doctor robert califf, commissioner of the food and drug administration. Thanks for the opportunity to be here today, to discuss the importance of preparedness, and how the fda can work with congress to ensure the country is ready for the next Public Health threat. We recognize the key role of fda in Public Health Emergency Preparedness and response, we have essentially used the authority to support our nations we want to ensure our actions are even more effective. Providing Greater Transparency in the supply chains, and ensuring operational readiness and capacity within the fda and improving Laboratory Testing regulations, our priorities are to enhance National Security and improve Public Health preparedness. First, supply chains. Theres a need for Greater Transparency. Do both improve resiliency for critical medical products. For example, under the fda received new authority, to require manufacturers to submit during a Public Health emergency. The fda uses this information to help mitigate approximately 350 shortages. Unfortunately, it is notifications will no longer be required following the end of the current covid19 Public Health emergency. However, we know medical device shortages occur in many situations that are unrelated to p a. G. s including natural or humanmade disasters, recalls, geopolitical conflicts, production shutdowns and Cyber Security incidents. We also have the shortages most often impacting our most vulnerable and underserved populations, like children, raw populations, and our veterans and underserved populations in va hospitals. Additionally, shortages were historically due to manufacturing, issues that disrupted supply. For which manufacturers of judge are required to notify the fda. The agency has relied on these new vacations to help prevent supply disruption. But working closely with manufacturers, expediting reviews, and exercising temporary regulatory flexibility. Weve recently seen Unprecedented Demand for drugs. To report surges in demand to the fda, to prevent shortages, including for some critical over the counter drugs, like we saw in the fall. Additional improvements should include reporting sources and the extent manufacturer lions on turn suppliers in the drug supply chain. And ensuring fda an opportunity to inspect certain over the counter drug facilities, before such products are distributed. Preventing Food Shortages is often critical to Public Health, and we are grateful to congress for including in medical foods, to notify two additional categories of food, destroying a declared pag, and help and prevent future shortages in the supply. Second, ensuring operational readiness in Search Capacity is critical in emergency, for example, the fda could if it had authority, to require internationally harmonized master problems for drug manufacturing. And improved 30s for conducting remote regulatory assessments. Congress expanded fdas authority to request records and advance of or in lieu of an inspection. In the fy 23 omnibus. However, the agency could better assure the safety of products, even in times of crisis, if this records request authority were expressed and extended to all fda regulated products. Additionally, during covid19, we saw the fda had to be pulled off and ive been working relentlessly on pandemic issues, as have our colleagues, for the past three years, leading to a significant backlog in certain areas through the creation of special programs to defend against emerging pathogens and other threats, the agency would be well positioned to respond to emerging and identify threats of concern. Finally, the covid19 pandemic underscored the importance of [inaudible] Regulatory Framework that applies to all diagnostics. This will be necessary to ensuring preparedness for the next threat, and to realize the full potential of diagnosis. When i look at this list of improvements, the striking observation is that these measurements were not only helping the fda serve the public in times of crisis, but they would also enable us to help prevent catastrophic outcomes, and conduct our everyday work more efficiently, and effectively. Thank you and i look forward to your questions. Thank you very much. Let me start off with the question. Miss oconnell, and doctor walensky. Nobody can predict what the next Public Health emergency will be. Your job is to put us in a position where we can react as effectively as we can, so we dont live over 1 Million People next time around. My question is a Pretty Simple question, and maybe dr. Caliph can jump in this time as well. Are we moving forward right now, can you tell us, confidently, that we are moving forward as fast as we can with creating the kinds of vaccines we may need in anticipation of the next pandemic . Do we have the kinds of treatments that i know you may not have them today, but are we moving aggressively forward to have the treatments that we made for people become ill, and do we have the workforce infrastructure that we need . Are you confident in telling us that you can move rapidly when you learn that a pandemic is that we are facing a pandemic . And that you could rally all the resources that you need. Medical personnel, if god forbid, we find ourselves in the same position again . So miss oconnell, can you start off with that please. Chair sanders, thank you so much for this question. This is one of the biggest worries. Is that we are losing time in preparing for the next pandemic. Its the reason why the administration requested 88 billion dollars last year to advance the american pandemic preparedness plan. We did not receive that funding. We have requested again, in our fy 24 budget, 20 billion dollars of which time would go to asper and b. A. R. D. A. To begin that research into the prototype vaccine, therapeutics, and diagnostics for the seven families most likely to cause the next pandemic. We were so lucky. And it doesnt feel like it. But the one place we were lucky when it came to the coronavirus, we had already done a lot of the early work on that, because of sars and mers. We need to get the same are you telling us that we have not done the kind of work you would like to see us do in preparation for what may be coming . Correct. Not in all the viral families. Dr. Walensky . Thank you for that question. We started with a very frail Public Health infrastructure from years, decades in fact, under investment. Some of the estimated we have 80,000 Public Health work jobs in deficit right now. In fact, your own state of vermont hired 120 people during the covid19 pandemic, and through our workforce infrastructure, you are able to retain a workforce infrastructure grant you are able to return 12 of those 120. So just gives you a sense of how frail the workforce infrastructure is. In addition im going to interrupt you. Are you concerned that so many doctors and nurses but including the burnout and the stress they experienced during covid . And Public Health workers, yes. Deeply. I will also note i dont mean to be interrupting you, all the time. What ideas do you have as to how we can rebuild critically important workforces . So much of the Workforce Authority that we are looking for in Public Health specifically, things like exempt loan repayment, to entice people to come in. We know our laboratory can we do a little bit better than taxexempt loan repayment . We have a massive workforce shortage. We need thousands of workers. Indeed, we do. Many of these positions, for example, come out of medical school 200,000 in debt. Seems like a very modest and work in direct higher authorities, flexible pay, danger pay, for example. I have colleagues in Equatorial Guinea right now, on the front lines of the marburg break, and they are not getting danger pay. So these are the workforce things that we need to do in order to entice people to come into health and Public Health. Those are many of the things that we are asking for, as part of what im hearing you say is, despite good intentions, your agency is not as prepared as it should be. I would agree with that. Okay. Doctor califf . When it comes to technology, we are unsurpassed and ready to go. With regards to drugs, devices, vaccines, tests. But when theres a profit to be made, american industrys premier, and goes for, it and is producing amazing things. But the Public Health, we have a gap in translation. Which is what my colleagues here are referring to. When there is not a profit in that pipeline, we need to have the funding, in order to stimulate the industry to produce these products. We are going to need them for the future. And as a former practicing doctor, very recently, im very concerned about the thing that you all referred to, i want to stress the Public Health workforce, not just the doctors and nurses. We lost very important people yesterday. This is not, its emblematic of how hard this work is. We are way down in the workforce that we need across the board. Just talk to any of your friends trying to get unemployment in a clinic, particularly, in Mental Health these days. Okay. Senator cassidy . I will defer to dr. Marshall. Thank you, Ranking Member, and chairman. Dr. Walensky, if you dont mind, retrospectively, what do you feel the impact of lockdowns were on Mental Health in this country . Certainly, the impacts of lockdowns resulted in lives saved from covid19. And also challenges in connectivity and there are reports of some children doing better in school at home, but also some children my question is Mental Health. Right. And the lack of connectivity and challenges of Mental Health. We saw increases in Mental Health challenges before the pandemic, they were rising before the pandemic, and certainly defend dimmock so youre saying the lockdowns had no impact . No, im sorry, im not saying that. The impacts, when you lose 1. 1 Million People in this country, theres tragedy, theres loss, there was loss of lives, there was lots of house insecurity, food insecurity, all of these things are impacting Mental Health. Thank you, miss oconnell, recently we released a three and a page report on the origins of covid. Senator byrd where that investigation, one previous in his great efforts as well. Theres evidence that shows that this virus was released from a lab in wuhan, and evidence that would suggest it was actually made in that laboratory in wuhan. What are you doing to research that same issue . Do you feel its important that we know the origins of covid . So, this is this has not been in the purview of the work that ive done up to this point. But id be happy to take us back to the department and other colleagues that are taking a look to feel a case important that we know where this virus came from . I think would be useful to know, for sure. And i know that work is underway. Its not being done in asper. How would it be useful . We worked to prepare for whatever comes next, it would be important to understand what im coming up against. But let me be clear, whatever it is, im responsible for responding to it wherever it came from. So if the virus was made in the lab, your response might be different than if it came from nature . I think it would help us prevent it from happening again, if we knew the source, regardless of, that my responsibility to the country is to help them respond to whatever comes next. Okay. Robert califf, doctor califf, my questions for you now. Did a great job in the early days of the pandemic sharing that with any group that they wanted to, and a corporation. At the end of the day, to our three companies and up with the vaccine that was workable. What did the other Companies Due to fail . Was there anything we could have done to help promote other companies to be more successful . Why did we end up with two, maybe three vaccines . Thats a really great question, i wish we had like six hours to discuss it. Because as you all know, 90 of because Mother Nature is much more sophisticated and complicated than our brains are, as we devise new therapies. I think it was wise with the government made a bet on nine or ten vaccines, we often forget the ones who didnt. Im not sure anything we could do to change that equation, because thats pretty much the equation that we are saying. Thats why we have to do human Clinical Trials, we developed a therapy, we think itll work, all of those, almost 90 dont make, it someone thought it was going to work, and somebody invested in it. I tried that too. You have to take account to a high failure rate, i think the government is very wise to do that but theres some value that took what the government developed, getting it across the finish line, not everyone was able to do that. Im not sure what the value is in being able to do that, but you would agree that there was more than just luck, getting that cross the finish line, to those two or three Successful Companies . The collaboration, and the mrna platform that have been developed over decades, and the sharing of the viral sequence just the ability to do the viral sequence match vaccine the virus, that was an amazing feat of science and collaboration that made a huge difference. We wouldve had maybe one vaccine out of ten, i think, as the Mri Technology significant investment in the mrna technology before covid was even around, right . Correct. Thats why were excited about new platforms that are coming along, with regards to sell therapy, and gene editing, and other areas. Thank you, i yield back. Senator murray . Thank you very much for holding this hearing, thank you, its good to see all of you, again and dr. Walensky, my condolences to you and all the cc family as well for yesterday. Miss oconnell, i want to start with you. I am working to reintroduce my Public Health infrastructure to save lives act, help provide state and local Health Departments when a strong sense of state funding that they need, because we know how critical it is to have well funded, strong, Health Departments, responding to any Public Health situation. I have heard from my constituents in Washington State about how federal resources have helped during floods, and wildfires, and of course covid. But states and communities often lack funding, and flexibility they need when they face Public Health threats. Especially when it comes to reaching and supporting people with circumstances that could put them more at risk. We saw this during covid. What can congress do to help ensure that we serve you to clear support those most at risk in a Public Health emergency, including people with disabilities, older people, children, and families . Senator murray, thank you so much for that question. This is top of mind for us. We just released in ad for outreach a five year plan, in which we make very clear that the country is not prepared until we are all prepared. All communities. Those at greatest risk need to be accounted for in all the planning that we do. And the response that we do. As part of the fy 24 budget, there is in authority to start a Human Services response fund, which would quickly move money into various communities to be sure that we have boots on the ground, able to respond to the various populations that are most at risk. I had a wonderful conversation on tuesday with the head of our acl but how important this is. So weve been in communications within the department about making sure that the Human Services side of our shop is also prepared and ready to respond to account for these at risk populations. And then senator, you recall, as part of the last popup, you authorized three Advisory Committees, one disasters and senior, as one for disasters and people with disabilities, and one for disasters and children. Weve been meeting regularly with those experts and have really valued their input. So we continue to keep this work front of mind. Good. As you know, with any emergency, we need to be able to get supplies where they are needed most in a quick and effective, and equitable manner. My which was signed into law last year, includes directives to assist state and local and accessing the Czech National can you just give us a quick update on how asper is implementing that provision . Thank you. The Strategic National stockpile, making sure that it is fully stocked and ready to go is been one of the big focuses of my tenure in this role. But this is an important question for, us we appreciated the provisions that were in the bill, and we are working very carefully against them. We just released our 60day guidelines, which is guidelines for states and localities on how they might access this tragic national we will continue to give one to they need to have, and how do they need to switch it out . We are looking at all the various innovations for how we might hold our stockpile with better manage inventory and other ways to switch in and switch out what we have. So this is all front of mind for us. Thank you for those provisions, we will continue to keep you guys updated. Very good, i appreciate that. Dr. Walensky, one of the things we really saw in covid was that we needed accurate data, you cant get ahead of an emergency and create a response if you dont have data. I, one day asked you, can you talk about ways that your agency is working to improve Data Collection . All right this into two parts. We are accurately working on our data modernization efforts, and that is our data highways interoperable with counties and local hall operations given data quickly to us on similar highways, we can offer back to them. So they can see not only what its happening in their county, but encounters around them. This has yielded huge returns. Before the pandemic, we had 187 Health Facilities that were doing electronic case reporting. We are now at 25,000. Thats about avoided cross the country. So massive things happening, i think also in surveillance from our Emergency Departments and battles to statistics from our deaf histories, this work is all ongoing, and our data highways, where we could really use your help is the structure of the data coming into. As we received that data voluntarily. If that it doesnt come to, us we dont have lines of sight, and we can deliver those dates back, so that is among the things that we are asking for in this reauthorization. Thank you. Very good, thank you. Thank you chairman. Thank you to the witnesses for being here today. Last october, the g. A. O. Said that asked barr needs to provide a clear approach for buying National Stockpile measures. Regardless of whether they receive Development Funding from b. A. R. D. A. , assistant secretary oconnell, without this in place, are you committed to implementing the recommendation to document in approach to make sure there is equal consideration of medical countermeasures . Senator, thank you so much for that question, absolutely. We are working closely with g. A. O. To make sure that we can take into account recommendations they make implement them. Of course making sure the stockpile has what its needing and if thats a focus of. Mind we have an Inter Agency Group of experts that come together to give advice to myself and the secretary, and on what should go in there across all the various material threats that dhs has issued. Thank you for that. Your congress created as it is currently outlined, many of its authorities overlap with efforts undertaken by the assistant secretary for preparedness and response or, you. What steps can Congress Take two and remove some of the overlap between these two agencies . We are really proud of the work that bardo does, and barbaras work is limited to developing countermeasures. Arpah has. As i understand it, a wider remit to develop Innovative Products against any disease, not necessarily the National Security threats that we are responding to. But it is important that we have good collaboration between our fellow agencies, and we work very closely together and continue to stay in touch. But i see a very clear lane for barda and its very important theyd stay in that lane in order to keep this country more prepared and ready to respond moving forward. Thank you. Decentralized Clinical Trials, where trials a close at locations other than at the Research Centers like patients homes, can make groundbreaking more kessel to patients who otherwise wouldnt able to participate, simply because, maybe, because of where they live. We saw how important this was during the pandemic. So, commissioner, what steps can Congress Take to reduce the barriers for participants in this trial, an ex increase accessibility for people with Rare Diseases or mobility issues. [inaudible] a very rural state. I dont have your bio in front of me, but i appreciate the accent, i was wondering if we lived nearby. [inaudible] most of my life. We just put out a guidance on this. To centralize trials on the, way depended on digital technology, if you ask me, the most important thing you can do is make sure the funding for internet expansion to all the rural areas, i know the bill has passed, the funding is okay, we have to make sure that those digital pipes are deployed out there. I think the masters are coming along great. I spend time with theres no question that we have technology that everyone in this country can use. Almost everyone has a cell phone. The method of doing this is not requiring big Research Centers. Unless its a specialized area that you need, special medical exams, thats the way to go. Very good, thank you all again. Chair, i yield back. We are you a minute next time. Ill take it. Thank you. Senator casey. Mister chairman, thank you very much, i appreciate the work you are doing. And Ranking Member cassidy. Working on the reauthorization of the pandemic hazards preparedness act. I also want to thank senator romney for working with us on this reauthorization. I want to start by with director doctor walensky, supply chains and ppe. We learned a horrible lesson in the pandemic, the way i look at it, kind of a national failure. We couldnt provide the kind of ppe that we needed. We dont ever want to have that transpire again. We had, we had a buckling about supply chain in the midst of the worst pandemic in 100 years. It adversely impacted First Responders and Health Care Workers. Essential workers, as you know, i think we all agree that was totally unacceptable. One factor that contributed was the heavy reliance upon imported ppe. And the dependence pan those foreign manufacturers and foreign suppliers is what drove that. It created a terrible risk that we all know, there are families in our communities pay the price for. How can we promote innovation, when ppe designs are outdated, and then ensure that these Innovative New technologies are always available to the central workers and in health care or otherwise . Especially during the pandemic. Thank you, senator. And id be happy to have our team touch base with you about the research happening at our institution now, ensuring that we have innovation in ppe. One is our national personal protective technology laboratory. Its working inside like the one in pittsburgh. It looks at new technology for ppe used in health care and used in Public Health emergencies and other environmental hazards. That work is ongoing, we are working with academia, i would be happy to brief you and your staff on the work thats happening there. I dont know if had anything to add to that. Thank you, doctor walensky. Senator casey, just to say, aspar has investigated invested millions of dollars for domestic manufacturing of ppe. But we lose the covid dollars, we lose our ability to do this construction, and to continue to invest in similar projects. As we are seeing supply chain pinches, as rob mentioned, across many different materials and products, its important we maintain this ability to keep this work going. Thank you. Itll be a huge issue among many. Commissioner caliph, i wanted to ask you a question about device shortages. Its another challenge. We know that in the midst of pandemic that was another significant strain. In particular, we saw a terrible shortage of medical devices. The fda took advantage of the authorities it have during the health emergency, require manufacturers to notify the fta of potential or actual shortages. How many devices have this number how many device shortages has the fda been able to prevent using this . Approximately 350. Its a large number. This authority is going to go away. We made it, we need it. For drugs and devices, not only when manufacturing is disrupted, but also when theres a huge shortage surge in demand. So we can help them make up for it. Thanks very much. Mister chairman, im giving back the minute. Think you, senator casey. Senator cassidy . Thank you, Ranking Member. Dr. Walensky, doctor califf, ive interacted with you a number of times. I dont know you all super well, but i respect u. S. Individuals and physicians who have demonstrated integrity and capacity and commitment to the if you have taken to the nation, but also to your patients. Let me ask each of you, how many employees do you have that you are responsible for in your agency . Just approximately. About 1000. About 12, 000, and about twice the number of contracts. Thank you. 19,000. Yeah. I know there are some people who feel that these individuals must be corrupt or must be bad, they work for the government, it must have ulterior motives. My experience in dealing with those that ive dealt with is that they are good people, they are brothers, sisters, moms, dads. And they are trying to do the best job they possibly can. I sometimes worry that a projection that other people are evil, somehow creates false impressions about how effective our agencies are. And i hope that you and others recognize that the great majority of us, and certainly in this body, respect and admire the work that you do. Let me ask you, are there any things you think we should do to improve the integrity, and the credibility that is held by the public, for your respective agencies . For instance, prohibitions on owning stocks in pharmaceutical companies, i mean, i hear all the time that the fda approved that because the people looking at it were investors in that company. Is this an issue that you are concerned about . Does it exist in your various agencies . Since you mentioned, the fda certainly. Fda facials our employees, they are prohibited from owning any stocks in any relevant entities that they regulate. And for us, thats almost 20 of the economy so even airlines, because they serve food, and food is a big part of our equation. I take great pride, and really i appreciate what you said. What could be done to help the most say a few nice things about federal employees. They work hard. We can verify they work extremely hard, particularly during the pandemic. They were doing all the regular work, plus the pandemic work at the same time. Thank you. I would just echo the gratitude for your comments. I have an Agency Working 24 7 to take care of health, and Public Health. Without getting credit for it. What happens when there is a massive pandemic that affects 330,000 americans, when they had frail infrastructure to begin with. Their job was to protect the public. So that you dont have to worry about it. So a few nice things i would say, go a really long way. Thank you. I was personally concerned, and i know many of us were, about the data that was available to the public from our government about what was happening with covid, who is getting, it what age groups were getting it. I was little dismayed that i went to Johns Hopkins, because the data, as opposed to coming to the cdc, or nih, or whatever. And you indicated that youre making strides to improve our systems for Data Collection, you also indicated that for many institutions, the data comes is only voluntarily provided. Are you suggesting that we need to have some kind of mandatory reporting, obviously, on a basis for people cant possibly beta fide personally, do we need to do something to have a better system of collecting data and providing it to the public, as well as to practitioners . Let me just note that during the Public Health emergency, right after it, the cdc took six months to be able to negotiate use agreements and receive hospitalization data. Which is why the web scraping of Johns Hopkins was very efficient while we were working with our lawyers to very similar things happened. If we are supposed to stop disease outbreaks before they start, before they become emergencies. Then we have to have a line of sight into when those urgent issues, those infectious threats, are stuck. And the only way we do that is by getting reporting coming into the cdc, so we can, again, give it back to the communities. I know its this rare thing happening in their county, its happening also in the county next to them. Thank, you i havent much time. Id love to steal the time from those who gave it up, but i wont do that. Miss oconnell, just to ask a question. One thing to stockpile, for instance, masks and ppe. Its another to stockpile machines that make those things. Do you make how do you make a decision about whether to keep productive capacity in places, as opposed just keeping masks in place . And are we making the right choice, in that regard, from your perspective . Senator romney, thank you so much for that question, thats exactly what we are working to do now. We want to make sure the stockpile is only one part of the supply chain continuum. What we have on hand in the stockpile is critical, those early hours or weeks of a response, while we ramp up what we have in the supply chain. But both should Work Together. The hospital employees that had to wear bandanas instead of real masks should have been able to access those on the commercial market, and were not able to. Stockpiles there to back that up should have been there. To be a backstop for that. But if both are running well, and we are investing in our domestic manufacturing, so that supply chain is stronger and more resilient, and both are running well . We would not need the stockpile, we can rely on the supply chain. But when that gets pinched, we will have the stockpile. Mister chairman, thank you. Thank you, senator baldwin. Thank you mister chairman. I want to thank our witnesses for all your work during a very difficult time, and we are here talking about the authorization of the pandemic and hazards preparedness act. But i just want to state, not in the form of a question, the juxtaposition of an act taken by the House Republicans last week. This act would would result in drastic cuts to our Public Health program and our research initiatives. It would undermine our nations competitiveness and safety, our Public Health, and our security. And leave us completely unprepared for next Public Health emergency. Most certainly stabbed with many of our colleagues who have voiced concerns opposing the measure the House Republicans passed last week. In that last congress i worked closely with Ranking Member cassidy on a tracking pathogens act. It enhances our ability to prepare for future pandemics by strengthening efforts to identify new viral threats through genomic sequencing. Thanks to genomic sequencing, the u. S. Has been able to identify, survey, and understand emerging variants of covid19, and other diseases. But our work really must continue. The tracking pathogens act was signed into law as part of the fiscal year, 2023, but unfortunately, there is no sustained funding for this work. So dr. Walensky, can you describe why sustained funding for the cdcs sequencing act, including to the advanced molecular to tech shun program, is critical to preparing us for future Public Health emergencies . First of all, thank you senator baldwin for all of your bipartisan efforts in our ability to track pathogens and the coronavirus through our sequencing. Tens of thousands of sequences a week. We continue to do it by weekly to see where and what pathogens and some variants are occurring . Its also the case that we can do this, we have massive capacity to do this for other viral pathogens, bacterial pathogens. And the capacity to make great strides. However, once we ramp this up, if we let it run dry, we will not be taking advantage of all that capacity. I will also note, i invite all of you to visit your state Public Health lab. If you go to your state Public Health lab, and ive been to a lot of, them you will see a very frail Public Health infrastructure. And a laboratory infrastructure. Do you know the genomic epidemiology that can actually do this work in your lab . Part of the Construction Authority that i think we are talking about is to develop the capacity in your own state lab so we can not only have the resources to do the genomic sequencing but have a place that homegrown people are able to do. It thank. You thank you. We have recently become to explore different types of platforms as you have said, to the flat form technology. We are seeing the advantages of that in the mrna vaccine, where you can clip one piece of the virus and switch it out and very quickly ramp back up production. We are exploring that, and if it gets to the pandemic flu, what would it mean . Weve invested 100 Million Dollars to invest what it would mean to pandemic flu vaccine. That work is underway. Theyve also asked for an fy 24, 60 million for threat agnostic countermeasures. Which are going against we used to be one bug one, drug now were looking at what we can do for multiple bugs and drugs. Work is underway, we have it in our budget, were continuing to look for different applications of the various countermeasures we are developing. Thank you. Thank you. Senator cassidy . I defer to senator brown. Thank you, i have to, questions one for dr. Caleb and one for dr. Dr. Walensky. I will start with you, dr. Califf. Senator johnson at i sent you a letter earlier this, week youve got an upcoming hearing on cellular tissue and jean their piece. To your Advisory Committee, concerning a new muscular dystrophy drug treating the do shins variety of it. Unlike most hearings, this one is being done virtually. It is prohibiting the use of cameras. It is choosing from the patient segment who can speak up, and diseases like this, and many others, which are very progressive and maybe have a sharp prognosis, especially when there is something happening on the front that may be promising. Why would you go from the normal format to this, de emphasizing the patient component of it . Well, sir, thanks for the question, the technology obviously is exciting. This is an Advisory Committee, not hearing. So to speak, it is really following all the same rules that we have for all of our Advisory Committees. The goal is to have experts to give advice about the assessment of the technology, as the Company Presents its data. Invitations have a chance at the hearing. Theres a limited amount of time, and so that is why theres a lottery. Its not a deviation from our standard procedure. We are using the standard procedure. And how long as the standard procedure been in place . Years. I was an Advisory Committee chair 20 years ago. And youre not reducing the amount of patient participation . Not that im aware of. Did you get the letter that we sent . You im aware that the letter came in, yes. Ive been at the forefront of promising pathways act. To me, on some of these diseases, that have Clinical Trials that are working, drugs are promising. Probably should not have the same kind of dynamic as something that has less urgency, where there are at least other treatments out there. Do you view the thought should be maybe look that . Keep most of the goal standards that you always refer to, but a lot of these windows dont surpassed more than 3 to 5 years. Should there be a different way of doing it . We completely agree on that. We the user agreement that you all approved between us and the industry, we are hiring 150 people just in this area. Just to focus on this. It is exposing right now. It holds great promise. Thats good to hear because it is now bipartisan, by camera, on a promising pathway, with senator gillibrand from new york, which would address this and codify it. I will send it to your office and hopefully we will get your endorsement on it. Thank you. Dr. Dr. Walensky, weve had a conversation several times in the past. Of course we are lifting the federal Vaccine Mandate, the Public Health emergency here on may 11th. I will not forget easily all that was out in the Small Business community, where we had to put a congressional view act out to make sure you are not going to force vaccines on employees down to employers up 100 employees. And add more fright when it was in the rearview mirror, and it was coming down and took the Supreme Court to come in and thwart that bad idea. I would like to know if that was your recommendation, dr. Fauci, was it Biden Administration . Who was going to push forward that that was a good idea . Before we had to come in and intervene with the good fashionable review act, to get the Supreme Court to weigh in . Maybe what else is here we are now, in 2023, we have 96 of people who have protection by one way or another, either infection, prior infection, or by vaccination. We at the time we were seeing our workforce and Police Departments First Responders who were this was not that long ago. This was just last year. Where you had maybe one 96 . When you and i had a conversation, we knew that it ravaged the elderly. And it was clear that it was not going much more deeply into the rest of the population. And the trillions of dollars that we spent, the fact that the economy was shut down for that long, i think that was much slower to react to the real science and maybe not the political science, and im just wondering if you and dr. Fauci, who were the ones that kept pushing forward on that one issue of the Vaccine Mandate for employees, private employers, down to 100 employees . I can tell you there is a group of us that advise the president on his president ial proclamations. I will also say that to this day we know that our boosters still have 2. 7 times the protection against death. If youve gotten that then if you havent. We know that the vaccines continue to provide protection for people across all age demographics. Thank you, by the way, dr. Fauci in his last interview said he would never recommend shutting the economy down again for something similar to that, fyi. Thank you. Senator cain. Thank you mister chairman, thanks to the witnesses. I am a Public Health data geek. Because like senator can luper, i was a mayor, i was a, senator like the, chair who was also a mayor. We have the experience of seeing the local Health Systems and state Health Systems and federal Health Systems that dont share that with each other. Then you have all the providers. To that created a huge challenge for us early in covid, and we just kind of ran back at the beginning of covid. It was hard even to get racial information about those who are getting covid and dying of it. It took us a while to realize, and a lot of jerry wrecking to realize okay, this was affecting African American and latinos more than others. But we didnt know that right away. With the federal health data system, we would have. Often minorities are lower income, and so they have had Less Health Care access. Which has given them more morbidity, which makes them more susceptible to serious cases of covid. Often racial minorities were working in professions like Home Health Care aides, or Grocery Store clerks, where they couldnt just go virtual all the sudden. They had more exposure to covid. It took us a while to figure that out. Then we did figure it, out and when we started vaccinating, in early 2021. Beginning with the populations over 65, we figured out pretty quickly that even though it was equally available over 65, first come first, survey was not really applicable and effective because the communities that needed it, that were the most vulnerable, that needed at the, most were not the one sitting on the computer can find the nearest cbs to get a vaccine. They did not have computer access. They didnt have the freedom to do it the way some people do. Because we figure that out, we were then able to change vaccination strategies to try to get equality, and equity, and effectiveness. It is an indication of the million ways where lack of a functioning Public Health system slows down our response, our ability to have effective interventions. Keeping people safe. Ive worked with colleagues on this committee for a long time on something we call the improving data and Public Health act. Some of the pieces of that have been included earlier appropriations, but there are other pieces that i still think we need to include. Dr. Dr. Walensky, in your opening testimony, i heard the back end of it when i walked. And you talked a little bit about Public Health data. You talked about how better public dealt data systems can help the cdc do a better job and help keep us all safe. Thank you senator, and thank you for your interest in this. The state of virginia has been one of the states that has polluted with cdc and the usps. A combination of case reporting, labrum, porting and surveillance to we do have a better window. The case that you brought up with covid is not exactly, right we were unable to see the race and ethnicity data. And by the, way it happens again with mpox, we had the same challenge. We had a Public Health emergency that was declared the peak number of cases and, again, we could not see the ethnicity data. We could not see the places where vaccines were going into arms. As we were trying to make decisions about scarce resource vaccine deployment with my colleague here from as we were making those decisions, we cant act swiftly, nimbly, robustly, if we cant see what is happening from a data standpoint. If we wait for the Public Health emergencies to be declared and then state by state, daily youths offers a, shunted to use agreements to, happen it takes months. It took us six months to get hospitalization data and covid19. These, things if we are to be nimble, even if we have remarkably robust interoperable data systems. If there is nothing driving on those highways, we will not be able to figure out whats going on. And truly, we want to have those data so that we can get them back the statement. I hope, as we find a way to have a big win in this area, we can include much more robust data. Obviously, a protects peoples personal identifying information. It gives our Health Care Professionals what they need. Dr. Dr. Califf, ive heard a lot from my constituents about brought drugstore dodges. We sent her letter recently, to 15, columns just asking hey, what can the do to work with stakeholders to identify factors that lead to shortages . I would like you to, id like, lows just tell me that youre prioritizing, this is that im not nervous about. It as the formula has gotten, better ive gone now almost to fulltime drug shortages because we have hundreds of shortages. Over 200 in the last year, we preempted working with the manufacturers. That number is going up. Were keeping the actual shortages at the same level, but our employers can only plot a certain number of holes in the system, that has real problems, particularly the generic drug, so ive got a lot of work to do. Weve asked, as i said, in my opening statement, it helps that we have better data as we can get out in front of this more. Theres a lot more to it than that and i look forward to working with. You thank you. Thank you mister chair. Senator cassidy . Thank you again, let me ask you what romney said. I think all of your employees for working tirelessly through the pandemic, and i really appreciate. That mr. Connolly, thank you. Congratulations on a football season. Thats really good. And mr. Connolly, we have witnesses on the second panel that are going to suggest drug pricing policies that they say would increase access to medical countermeasures . Now, i raise that because i hear that from experts, medical counter Expert Development is uniquely challenging, that many of these companies are small companies. That many of the companies that went bankrupt, and others got bogged by Bigger Companies, and then Bigger Companies or getting out of medical countermeasures. Is that fairly accurate depiction of the state of the place . Senator cassidy. Thank you for the good wishes for the green wave. We appreciate that. Were very proud of that the type of company that we have to work with are often small Biotech Companies because there is not a commercial market for countermeasures, typically. So you have to work with the Smaller Companies that have to come in and are willing to be innovative in a certain way. Can i stop you for sucking, its my impression that a lot of those companies are living on venture capital. And actually have not turned a profit before their first big product. Again, is that a fair characterization . We often support the work that they are doing in order for them to be able to successful. If you were to put restrictions upon what medical Counter Measure developed could be priced for, perhaps without knowing all the variables . And if there was an example, because i think its a fair example, that there is really no secondary use. Its for this particular issue, would there be encouraging of the financing . The private financing of these firms . If you will, discouraging . Let me first say we remain committed to making sure that any government funded i got limited times. Countermeasures are available to everyone in america to meet them. Theres a, risk if we were to add limitations in the contracting, we limit the number of companies that are willing to come forward and do the work. You limit the number of companies, the number of companies is already limited. Theres a risk. Yeah. Doctor dr. Califf, good to see, it youre looking fit. Let me just compliment you right off the bat. Another suggestion, with regards of how to develop some of these products, is to incentivize innovation with an x prize. A large sum of money. But that would be in a lieu of patent and regulatory exclusivity. I dont know if you can comment on the finances of this. But do you think an ex prize would be a adequate substitute for one of these companies in lieu of the patented regulatory exclusivity . Well, you know, its a complicated question you just asked. What i will say is, the prices of drugs, innovator drugs, i, believe are too high. But the solution to that problem should not, in my view, the to do away with patents. They serve vital role and stimulating the kind of thing you were just discussing. But the balance is between those two, and the prizes, that is a longer discussion. I dont think its an either or situation. But in general, the intellectual Property Protection plays a Critical Role in incentifying innovation. Absolutely. And we just got sued again by a company over that issue. Its very important. If people are going to invest in these companies, there has to be intellectual Property Protection. Miss oconnell, im gonna ask your question somewhat related to the last. There is a conversation about having what is called, quote, reasonable pricing, quote, clauses, that dictate the price of something, should enter into the commercial market. Now, in general, is there a commercial market for most of the things which sparta is funding . In general, there has not, been of the 70 products we have, very few are available on the commercial market. I have data that the nih has reasonable pricing clauses from 1990 to 1995, after the remove been, the amount of the production of, drugs they removed, it took off. That may be an association not a causation. But in your, sense do you think a reasonable pricing clause would make a company more or less willing to work with barda on medical countermeasures . We would have to take a look at that. There would be a risk and adding an additional contracting element to the work that were doing. I have more questions, but i have no time. Thank you all. The questions you raised are interesting and i look forward to discussing them in the future. Senator markey. Thank, you mr. , chairman very much. Earlier, doctor dr. Walensky, congratulations on the football team. Congratulations. The tale of two pandemics, 250 people a day still dying. So can we talk about that cohort, they, are and what the message is to them as the medical emergency in general ends . As the Public Health emergency is set to end next week, i want to reiterate that we at cdc are not changing the steam out which we are working through this emergency, resolving Public Health emergency. As we look at the kinds of people who continue to pass from covid19, they tend to be elderly, they tend to be more vulnerable. They tend to be those who are not vaccinated or up to date on their vaccines. As we look at those numbers, the more fragile people and people who are not up to date. It is the case of the Public Health emergency, we will have willis windows to the data. Its one of the things weve been talking about. We will lose our percent positivity. We wont get laboratory reporting, we wont get chase reporting. We will lose some of that. With regard to what we are doing, as we talk to these vulnerable communities, we are doing a lot of work in the cdc to direct address the vulnerable communities, the elderly communities. Another thing is that we have a chief health officer, a disability officer. Were working with our colleagues that acl. We have a meeting tomorrow to discuss the disability community. The impact the end of the Public Health emergency and what that means. We have been putting disability experts within so that they have resources and references within their local communities to understand the impact of covid19 and other respiratory for that cohort, people over 65, people with preexisting conditions, immunocompromised, they how to act as though the pandemic is still going on, in terms of protecting themselves. Because you can be in a culture where everyone is saying we are back to normal. But for them, it is not back to normal. In terms of what they need to do to protect themselves. Is that the message . Last, week, actually we provided an update to the recommendations, so that community can get access to another dose. And as part of the end of the Public Health emergency, among the things we would like to do is provide data on hospitalizations, local data on hospitalization so people can see the hospitalization rate happening in their community and make a decision as to whether or not they want to take active measures. Thank you, so they should still act as though there is still a pandemic in terms of the vaccinations, and the protections. Okay, i think thats an important signal. Because it is a tale of two pandemics. Those people still have theirs. 2 50 a day, that is 1700 a week times 52 weeks a year. That is a lot of people who are going to be affected. Dr. Oconnor, the planet is, six there are no Emergency Rooms for the planet. We see the effects in new orleans and other places with climate change. Just having devastated the community, which affects the Health Care System in those communities. And could be delaying and denying people access, for, example to opioid treatment. Methadone treatment. When this bomb hits, when the system collapses, can you talk about what you do in order to make sure that that system is strengthened, or needs strengthening across the country . Because we cant really predict almost guarantee that were going to see intensifying storms in our country and all experts, meteorologist, we climatologists are saying that. What can we do for the Public Health system to make sure that it is more capable. Senator markey, thank you so, much we are seeing an increase in storms. In fact, fema talks about a crisis of state where were seeing the increase in fires. Intensity of storms are happening. So we are continuing to ramp up our response elements. Thats one of the reasons the authorities we asked for in the bill are so important. They allow us to hire more respondents, people on, the ground be able to broker the tools we need in a faster way. We are looking across all of those things in the new landscape that we are living in, to make sure that we are strengthening what we need to have on the ground. Thank you, and thank you all for the historically great work, which you did. We want our country to respond the way it did. Thank you so, much will get you the Additional Resources you need. I think recommendations are gonna be well received. Thank. You thank you, senator markey, senator hickenlooper. Thank you, mister chair. Thank all of you, its been a while. Doctor tell, if im not sure youre looking that, fit you look a little tired. Obviously you are doing one of the hardest jobs, you all. Are we we want to make sure papa is put back together. We take that very seriously. How could we do otherwise . Doctor dr. Califf, i want to start regulatory partners, these platform technologies. To the public in the context of a pandemic. The fda has proposed specialized programs to handle the emerging pathogen. Preparedness is your priority for the fiscal year 2024. Can you speak to your vision specifically about how the agency might be able to handle the unique regulatory considerations for these platform technologies. We are constantly looking. Weve had a good discussion here today about platforms and how important they are going to be in the future, where you can mix and match, and insert a new element and come up with a new therapy in a very short period of time compared to what it used to be. That is a reality. We are asking for a team of people that are dedicated to looking to the future. It is included in some of the things already in play, but we want to do more of it so we have more to go. You can dip land on the flat form. You dont have to redo all the regulatory work that you would do if you are developing a drug from scratch. Let me also mention quickly relative several under questions. Im 71, i have my vaccine a few days ago which is why i look a little tired. Im just kidding i try to wear a soft tshirt as a demonstration project. I still have the bandaid, my staff told me i was not allowed in the senate hearing. Let me suggest to go and have a four month old child at home. The navy really tired. Dr. Oconnell, assistant secretary, oconnell, covid has had an immense cost. Weve gone over this this morning. Economic, caused human, cost i do think that important work will be done as we look back over the entire arc of this pandemic. And again, i remember vividly, this was a couple years after being the governor, i watched the decisions that were being made by governors across the country, by all of us in washington, in realtime with unbelievably limited information. In other, words the data was not there. The fact set was not there. It will be useful to go back and look, given each time what information we had, did we make the right decision . I think we should be upfront saying, there is no harm in that. Mistakes in a time of crisis, its impossible to get everything right. One thing we did see was regional coordination and resilience, they were a key to our future pandemic weve got the big city hospital, denver health, and a successful demonstration site for both the regional disaster Health Response system in the National Special pathogen system. These have gotten permanent authorization, theyre just test cases. Should we speak assistant secretary, to the success of these . Also what is the likelihood in terms of getting more continuity there . Senator, thank you for, that i think you are absolutely right. We built the system where we looked at the coalitions locally ethan expanded out regionally. Then across nationally. Frankly, covid was one of the first major responses we dealt with that we needed a National Response immediately. To be able to have these strong places within the country to lean, on its been a really really important. The regional Disaster Response Health Systems, at this point weve only funded four of. Those only four regions have the benefit of what colorado has. One of the goals i have is to be able to expand. That so it actually is national and we have one of those in each region that can actually make sure were coordinating across you see how important it is with covid when icus were overwhelmed in one hospital, nowhere to go within the region, the next one could take a bed, was critically important. The arit e. Asked pete tc, the National Special pathogens that we were talking, to not every hospital could handle in a bowl of patient. We set up this system across the country of regional locations that were able to take those patience, and we have trained them and continue to work with. Them im proud of the success they have had. In fact, unfortunately, weve had to exercise them recently with the ebola sudan outbreak, in uganda, and the tanzania and Equatorial Guinea. In case they came, back we have to make sure we will ready to handle it. Very important capabilities. A lot of, that the Regional Response and resilience came from the Health Centers as well as the hospitals, and the research places. It shows the strength of our Public Health care system. I will leave each of you, with my time, you will have to think about it. The various platforms, we are trying to build them, we build pandemic preparedness. We have to be vigilant on the creep of red tape and bureaucracy, and already im beginning to hear people saying well, oh my gosh, apply for, this talk about that, there is so much paperwork. There is so much process that we have created because people are so worried about making a mistake. Thats why think its important to have reviews, the strengths, the failures, the misses, the hits, we realize were never gonna get a perfectly. But there is real value in constantly trying to find ways we can limits the red tape, especially in the fta. I think theres endless work to be done. Thank you all for your public service. Thank you, senator hickenlooper, that is our last questionnaire. We thank the panelists very much for being with us today. Now we will hear from her next panel