Transcripts For CSPAN Public 20240706

Panel, don oconnell, the assistant secretary for preparedness and response. Rochelle walensky the director of the center for Disease Control and dr. Robert califf the commissioner of the food and drug administration. On our second panel we will hear from a doctor and Robert Wiseman and martin mccarrick. We have two very important panels. Let me begin by thanking all of the folks that run the first panel. All of us know that the last three years have been unprecedented in our lifetimes. We dealt with the worst Public Health crisis in 100 years. I want to think all of you under those difficult circumstances for the work you did for the American People. Today, our job is to take a look at at where we are today in terms of where we are preparing, god forbid, for another pandemic. And, the need to reauthorize the pandemic preparedness act later this year. I want to take the opportunity to acknowledge the previous leadership on the bill from senator murray, chair of the committee, and senator burke, the Ranking Member. As well as the poppa working group that i have helped convene with Ranking Member cassidy to include senator casey and senator romney. Those senator 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 in terms of the possibility of future pandemics. Everybody here knows that tragically in the United States we lost over one Million People from covid. Putting that in perspective we lost more people from covid the last several years then we did in world war ii. While cases, deaths, and hospitalizations are declining, covid is still today the leading cause of death in our country with some 250 americans on average dying everyday. The World Health Organization reports that 7 Million People died from covid globally. There are experts that think that is an underestimate of the number of people that have died globally. I think, to be honest, as americans, we understand every public official tried their best during covid. God knows how hard people work and what stress they were under. But the truth is, we were very unprepared for what hit us three years ago. It took longer for us to effectively respond to the emergency then it should have. All of us real will remember that months after the pandemic corrupted we saw pictures of doctors and nurses in overwhelmed hospitals lacking the personal protective equipment to keep themselves healthy. We all remember those images and seeing doctors and nurses using plastic trash bags because they did not have the personal protective equipment they needed. We know that many hundreds of medical personnel died during their duty trying to save their fellow americans. During that time we did not have the tests we needed to figure out who had covid and who did not. We did not have the infrastructure to deal with the pandemic. All of us remember overwhelmed hospitals from all over the country. We did not have the vaccines or treatments that American People and people throughout the world desperately needed. We had to shut down our schools and our businesses and much of the economy for too long causing billions of americans not only lose their jobs, but their health care in the middle of a pandemic. Here is the scary news we have to face. It may be the most important reason for holding the hearing. Scientists are telling us that there is a reasonable chance that, god forbid that a pandemic as deadly as covid19 could occur in 10 years. Most of us hope that will not occur but our job is to make sure we are prepared if it does occur. That is what this hearing in legislation is about. Scientists have told us there are now seven viral families which could cause the next pandemic. Because, they contain viruses that spread to the respiratory system that could easily spread from persontoperson. Our job is to make sure we are protecting the American People. We spend huge amounts of money on the military because we say we need to protect the American People. If we want to protect the American People we need to deal with this issue as well as it means we have to have a capable workforce in place, not just nurses and doctors, but Public Health officials with disease in a few minutes who can tell us where to set up a vaccination clinic for example. If there is an outbreak on the west coast can we learn about it immediately so the rest of the country is alerted, etc. Tragically during the pandemic, it impacted not only this hearing but future hearings. During the pandemic nearly one out of every five healthcare workers quit their jobs. Or are contemplating doing so as the experience as a result of the normas stress and burnout they have experienced. We need accurate Public Health data to know who is getting sick. We need tests, treatments and vaccines that we can get to everybody that needs them and we need to make sure medical personnel have the supplies, the masks, the grounds, the gloves they need. We need Clear Communication with the public. That is something that has been difficult to do. We need to improve our communication capabilities. We especially need to make sure we protect the most Vulnerable People in our society, seniors in nursing homes, individuals with disabilities, children, and infants. That is where we are now. We have experienced a terrible pandemic. Our hope is we have learned something from that end we will be better prepared as we face and unsettling future. Sen. Cassidy before beginning, director walensky, we expressed sympathy for the family of the cdc employee killed yesterday. It is always a tragedy. Today we are discussing an important responsibility of the committee, the reauthorization of the bipartisan pandemic and all hazards preparedness act or pahpa. We need to keep in mind the wide array of threats the bill seeks to adjust address, not just diseases, but natural disasters, attacks, accidents that could put our country at risk. Papha was first enacted in 2006 largely to address the failures of the federal response following hurricane katrina. Anybody from louisiana saw firsthand the devastating impact on the community when governments are illequipped and ill prepared to manage a crisis. Papha sought to support states, local governments, and hospitals to be better prepared for future emergencies establishing the office of the assistant for the Emergency Preparedness and response, barta. A lot of awkward sounding akrons acronyms. And made improvement to the Strategic National stockpile so vaccines, treatments, and tests could be easily available during an emergency. In 2013 and 2019 congress acted to reauthorize the bill and this year senators romney and casey are continuing to work with the committee. We do not always agree but we set politics aside and came together reauthorizing papha. Its critical to protecting the health, safety, and security of us all. As we saw during the covid19 response they papha framework is far from perfect. Doctors and nurses were forced to use expired ppe. One picture i remember is like a huge quantity of masks being dumped right as the pandemic was starting because they were two weeks from being expired. It was not a first in first out manage inventory situation. In some ways the government hampered the private sector ability to quickly launch tests at the onset of the bendy make and the government clearly failed consistently and clearly to communicate with the public. Now, that is gone. We made mistakes. We learned tough lessons. Lets work to make it so next time it is not on we are figuring out but there are systems we can put into place. Lets update the playbook to make sure whatever we do is flexible enough to address threats beyond the pandemic. And emphasizing that we need to look towards threats of the future, not just prepare for the one that has already gone by. Being good stewards of limited taxpayer resources and better partners with estates in the private sector so we are already and willing to step in when the next Public Health threat comes our way. The committee will need to work in a bipartisan way to enact meaningful policies that make our country safer and better prepared to work towards consensus. I am committed to getting this build on. I thank you for being here. I look forward to your testimony. With that, mr. Chair, i yield. Chair sanders our first witness is ms dawn oconnell of the administration for strategic preparedness and response at the office of health and Human Services. Ms. Oconnell, thank you for being with us. Sec. Oconnell chair sanders, Ranking Member cassidy, members of the committee its an honor to testify before you about what we are seeking in the upcoming pahpa bill. I want to express condolences for the loss of our cdc colleagues. These extend our thoughts and prayers. We are living in an increasingly interconnected world where diseases and other threats can travel quickly, unnoticed for days. We are experiencing an increase in the frequency and intensity of natural disasters. As a result we are working on more high consequence no fail missions than ever before. We are proud to lead us so much work on behalf of the country and we want to be sure we need to continue to execute that work with the excellence, 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 act the same as we did at the start of the pandemic. I have taken several important steps of the last few months to transform our organization and incorporate Lessons Learned from the Covid Response. For example, now a Standalone Agency within hhs. This important change in our departmental status gives us the independence to build human resources, acquisitions, and finance infrastructure to better support our unique missions. I also just completed a structural reorganization that instill a institutionalized important new capabilities like our stockpile and domestic manufacturing work. These capabilities we built during covid and need to keep using moving forward. I also made the Strategic National stockpile and office that reports directly to me to increase visibility into and accountability of discrediting important part of the nations preparedness and response apparatus. With the changes i have taken the two most transformational steps available to me to build a better preparedness and response organization. Now i need your help to ensure i have appropriate authorities to execute our mission faster and stronger. With the authorities i am requesting at pahpa i am trying to solve three key problems. The first is how asper can procure more quickly the tools and supplies the country needs responding to a bio threat or disaster. Early in the Covid Response it was clear hhs could not procure the products our country needed at the speed in which our country needed them. As a result asper entered into a memorandum of understanding with the department of defense where they agreed to provide acquisition support on their behalf and the dod executed more than 90 billion in contracts for us over this three years of acute response. Our agreement with the dod comes to an end at the end of the school year and i am requesting similar for asper to fund prototypes and moves successful ones through the Research Pipeline without having to wreak compete contracts like we do now. We are seeking the ability to quickly procure experimental supplies and important finished products. Each of the new authorities will allow us to do for ourselves moving forward what we had to rely on dod to do for us during covid. The second problem i am trying to solve a south park pop aspr can invest in the domestic Industrial Base for key ppe and medical supplies to ensure we are never again in the position we found her self in in march 2020 that you both recognize doctors in nurses and nurses did not have access to the masks, gowns, and gloves they needed. Aspr has used the funds and Construction Authority given to us in covid supplementals to build new factories nationwide to produce the ppe and supplies we need in times of emergency and provide good paying jobs to many hardworking americans. Once the covid19 funds run out we lose Construction Authority and our ability to continue investing in some other projects. That is why i am requesting permanent Construction Authority for aspr. Its important we have funds and Construction Authority to sustain the work we have started and expand the work to other parts of the Public Health supply chain. The third problem i am trying to solve is how aspr can hire staff more quickly to form critical teams during large response efforts. In the early days of the covid19 response just as we relied on dod for acquisition support we relied on fema and the coast guard to bolster response staff. The ability to hire people quickly and compensate them appropriately are important tools missing from the aspr response toolbox and that is why i am requesting direct hiring and flexible pay authorities for aspr. Direct hiring will allow me to quickly scale response efforts so we have enough people when we need them. Patients ability will go along way towards sustaining staff through Dangerous Missions and ensuring we do not lose our seasoned First Responders and subject Matter Experts to the private sector that pay much more and often require much less of them. To solve each of these problems i have just laid out i requested important new authorities for aspr and i look forward to working with you to solve the important problems and many others as you draft the new pahpa bill. Thank you for fighting inviting me to testify today. I look forward to answering your questions. Chair sanders our next witness is dr. Rochelle walensky director of the cdc. Dr. Walensky chair sanders, Ranking Member cassidy, members of the committee, its an honor to be here. Before i begin i want to acknowledge our cdc family suffered a tremendous loss yesterday with the death of amy st. Pierre killed in the shooting in midtown atlanta. Amy was a valued member of our team at the division of Reproductive Health where she worked every day to save the lives of mothers and infants. Our hearts are with her, her family, her friends, and our colleagues as they remember her and grief this tragic loss. In addition to the work people like amy do every day to fight disease and support communities, i am here to talk about how the cdc works 24 7 to protect america and thank you for this important opportunity. The cdc has led Public Health responses since our founding in 1946 providing expertise, resources, and workforce support to states, tribes, local communities and territories the most pressing Public Health threats and at the u. S. And across the globe. No matter the outbreak, h1 in one come as eco, ebola, covid, polio. The cdc has been there offering worldclass assistance. Alarmingly, these Infectious Disease threats have been emerging at an increased pace and are increasingly complex. The diseases dont respect national or state borders and the increased outbreaks does not mean we should be asking not if we will face another Public Health threat, but when. For many life turned normal after years of covid. Pahpa helps agencies like the cdc and local state and Health Departments to remain response ready and protect americans from resolving or emerging health threats. We do this by actively supporting the core capabilities of Public Health including stateoftheart laboratories, a diverse Public Health workforce, culturally competent to reflect communities, worldclass data and analytics, Rapid Response outbreaks at their source and strong domestic and global preparedness. We are enhancing the capacities through and all Agency Review moving forward. We are committed to addressing the Lessons Learned from covid19, increasing accountability and improving how we deliver information to americans. The approaching end of the public of emergency again reminds us that policy changes and funding are essential to the readiness of future bio threats. The cdc will continue to closely monitor covid19 and provide information to which we have access. After three years of the pandemic in three months to prepare for the end of the php we have worked hard to sustain the data to understand what is happening with the virus in america. But the end of the php means the cdc will no longer be able to collect data and share information that Many Americans have come to expect. As the 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 the cdc will rely on data that we have demonstrated a reasonable surrogate. There are data we will no longer have available because they will no longer be submitted to us. Certain data for a National Picture of Health Disparities for race and ethnicity and along urban and rural lines. We will make you do. However, this should worry us all. Primarily because of what it says about the visibility we will have into 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 the committee are interested in advancing policy to close the gaps in our Public Health response to be better prepared for what comes next. For the cdc it means supporting the Public Health workforce by allowing us to recruit the best of the best. We must serve staff win that needed with simple changes to direct tire legislation and sufficient flexibility so bureaucracy does not stand in the way when an emerging threat arises. It maintains the infrastructure from covid19 to administer vaccines effectively and quickly. The fact teams vaccines for Adults Program proposal provides americans access to 14 routinely approved lifesaving vaccines and approves a response ready capabilities that we will move without continued investment. Lose without continued investment. It means modernizing data policy to protect access to better quality, standardized, timely data so individuals and families can make informed decisions about how that policymakers can better target resources to threats before they become Public Health emergencies. The United States should have the most advanced and capable agency in the world when it comes to the detection, tracking, and forecasting. It will take a more modernized, nimble, and and collaborative cdc and 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. Chair sanders thank. Our final witness is dr. Robert califf of the fda. Dr. Califf thank you for the opportunity to be here 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. Pahpa recognizes the key role of the fda in Public Health preparedness and Emergency Response and we have used the authority under pahpa to support our National Preparedness and response capabilities. However, there have been Lessons Learned about how these authorities can be modernized to ensure our actions could be even more effective. Providing Greater Transparency on the supply chains and ensuring operational readiness and Search Capacity when any fda inspector and review staff and improving Laboratory Testing regulation our priorities that will enhance National Security and Public Health preparedness. First, supply chains. There is a need for Greater Transparency in the supply chains of our medical products to improve resiliency and ensure continued access for critical medical products. For example, under the cares act, the fda received new authority to require medical Device Manufacturers to submit shortage notifications during a Public Health emergency. The fda used the information to help mitigate approximately 350 shortages. Unfortunately, these 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 phd including natural or human made disasters, geopolitical conflicts, production shutdowns and cybersecurity incidents. We know that these shortages impact our most vulnerable and underserved populations like children, rural populations and veterans in v. A. Hospitals. Additionally most drug shortages were historically due to manufacturing. In addition to disrupted supply. For which manufacturers of drugs and active pharmaceutical ingredients are required to notify the fda. The agency has relied on notifications to help prevent supply disruptions by working closely with and you fractures, expediting review and temporary regulatory flexibility. We have recently seen Unprecedented Demand for drugs that would benefit from similar notifications. The ability to require drug manufacturers and distributors to report demand to fda could help the agency better mitigate future shortages including for cortical overthecounter drugs like we saw in the fall. Additional improvements should require reporting api sources and the extent of manufacturer reliance on suppliers in the drug supply chain and ensuring the fda has an opportunity to inspect certain overthecounter drug facilities before such products are distributed. Preventing Food Shortages is critical to Public Health and we are grateful to congress for including a provision in the fy 2023 omnibus to require manufacturers of infant formulas and medical foods to notify the fda of dental shortages. It is sending the authority to additional categories of food to prevent future shortages in the food supply. Second, Search Capacity is critical in emergencies. The fda could achieve more effective and efficient oversight if it had authority to require internationally harmonized master files for drug manufacturing sites and improve authority for conducting regulatory assessments. Congress expended the fda authority for request records in lieu of inspection to devices and monitoring sites in the fy 23 omnibus prethe agency could better assure the safety of products even in times of crisis if the records request authority were expressly extended to all fda regulated products. In covid19 fda staff had to be pulled off other work to work relentlessly on pandemic issues. Leading to a significant backlog in certain areas. Through the creation of Specialized Programs to defend against emerging pathogens and other threats the agency would be wellpositioned to respond to emerging threats of concerned. The covid pandemic under skirt underscored the importance of diagnostic test access and accuracy and the need for a modernized Regulatory Framework to apply to all in Vitro Diagnostics that will be integral to ensuring the u. S. Is better prepared for the next threat and realizing the full potential of diagnostic innovation. When i look at the list of improvements a striking observation is the measurements will not only help the fda serve the public well in times of crisis, but 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. Chair sanders thank you very much. Let me start off with a question to ms. Oconnell and dr. Walensky. Nobody can predict what the next Public Health emergency will be. But since it is our job, and more specifically, your job, to put us in a position where we can react to people as effectively as we can so we dont lose over a Million People next time. My question is simple and maybe dr. Califf can jump in as well. Are we moving forward now . Can you tell us confidently we are moving forward as fast as we can creating the kinds of vaccines we may need in anticipation of the next pandemic . Do we have the kinds of treatments . I know you may not have them today. But are we moving to have the treatments we need if people become ill . Do we have the workforce infrastructure we need . Are you confident in telling us you can move rapidly when you learn we are facing a pandemic . And you can rally all the resources you need . Do we have the medical personnel to staff our hospitals if god for bid we find ourselves in the same position again. Sec. Oconnell this is one of my biggest worries, that we are losing time preparing for the next pandemic grade thats why the administration requested 88 billion last year to advance the american pandemic preparedness plan. We did not receive that funding. We have requested again in fy 24 25 billion of which 10 billion would go to aspr and barta to Research Prototype vaccines, therapeutics and diagnostics for the seven viral families most likely to cause the next pandemic. We were so lucky even though it doesnt feel like it. When it came to the coronavirus we had already done a lot of the early work on that because of sars and mers. Chair sanders are you saying we will have we have not done the kind of work you would like to see for what may be coming . Sec. Oconnell not for all viral families. Dr. Walensky we started with a frail Public Health infrastructure from decades of underinvestment. We have 80,000 Public Health works jobs in deficit now. Vermont hired 120 people during the covid pandemic. Through our workforce infrastructure grant, you are able to retain 12 of those 120. Just to give you a sense of how frail the workforce infrastructure is. Chair sanders are you concerned that doctors and nurses are leaving the profession for a lot of reasons including burnout and stress during covid . Dr. Walensky and Public Health workers, deeply. Chair sanders i dont mean to be empty rubbing you all the time. What ideas do you have as to how we can rebuild the critically important workforce . Dr. Walensky the workforce has already we are looking for in Public Health specifically are things like taxexempt loan repayment to entice people in. Chair sanders can you do better than taxexempt loan repayment . We have a massive workforce shortage. We need thousands of new workers. Dr. Walensky indeed we do. We have many physicians come out of medical schools with 200,000 of debt. Dr. Califf it does not seem like too modest. Dr. Walensky the work, the direct hire authorities for flexible pay. Danger pay for example. I have colleagues right now on the front lines of an outbreak not getting danger pay. These are the workforce things we need to do to entice people into health and Public Health. Those were the many things we are asking for as part of this. Chair sanders i am hearing you say that despite good intentions your agency is not as prepared as it should be, god forbid. Dr. Walensky i cant argue with that. Dr. Califf when it comes to technology we are unsurprised and ready to go with regards to drugs, devices, vaccines, tests. When there is a profit to be made, american industrys premier and goes forward producing amazing things. For Public Health we have a black a gap in translation that my colleagues are referring to. When there is not a profit at the end of that pipeline, we may not have the funding to stimulate the industry to produce these products. As a former practicing doctor until very recently i am concerned about the thing you all refer to and i want to stress the Public Health workforce, not just doctors and nurses. You lost an important person yesterday. It is emblematic of how hard the work is. We are way down in the workforce we need across the board to implement. Just talk to any friends trying to get an appointment in Mental Health these days. Sen. Cassidy dr. Walensky, if you dont mind, retrospectively, what do you feel like the impact of lockdowns were of Mental Health in this country . Dr. Walensky certainly, the impact of lockdowns resulted in lives saved from covid19 and challenges in connectivity. And, there are reports of some children doing better in school and at home. Sen. Cassidy the question is Mental Health. Dr. Walensky we saw increases in Mental Health challenges rising before the pandemic. Sen. Cassidy your sign lockdowns had no impact on Mental Health . Dr. Walensky i am not saying that. Im saying the impact. When you lose 1. 1 Million People in the country, there is tragedy and loss and loss of lives. There was loss of housing security, food security. All of these things impact Mental Health. Sen. Cassidy ms. Oconnell, recently we released a 300 page report on the origins of covid. Senator burr helped run that investigation. I want to give credit to the previous aspr and his efforts as well. It says there is a preponderance of evidence that shows the virus was released from a lab in wuhan, china. A significant amount of evidence suggests it was actually made in the laboratory in wuhan. As aspr what are you doing to research that issue . Is it important to know the origins of covid . Sec. Oconnell this is not in the purview of the work i have done to this point but i will take it back to the department. Sen. Cassidy do you think its import we know where the virus came from . Sec. Oconnell it would be useful to know for sure and the work is underway. Its not being done at aspr. Sen. Cassidy how would it be useful . Sec. Oconnell as we work to prepare for what is next, my job, its important to understand what i am up against. Whatever it is i am responsible for responding to it wherever it came from. Sen. Cassidy so if the virus was made in a laboratory it would be different than if it came from nature . Sec. Oconnell 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. Sen. Cassidy dr. Caleb, my next question is for you. The dia to deaden incredible job in the early days of the pandemic sequencing the virus then sharing it with any group they wanted to. Any corporation. At the end of the day two or three Companies End up with a vaccine that was workable. What did the other companies failed to do . 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 . Dr. Califf thats a great question. 90 of drugs dont make it to marcus because Mother Nature is much more sophisticated and complicated than our brains are as we devise new therapies. I think it was wise of the government to make a bet on nine or 10 vaccines and two or three made it. We often forget the ones that did not. I am not sure anything we could do would have changed that equation because its pretty much the equation we are seeing. That is why we have to do human Clinical Trials to develop a therapy. We think it will work. All of the 90 that do not make it, somebody thought it would work and somebody invested. I think senator romney, i guess you did not invest in these things. Sen. Romney i tried not to. Dr. Califf you have to take account of a high failure rate in this and i think the government is wise to do that. Sen. Romney there is some value to what the government developed, getting across the finish line. Not everyone was able to do that. I am not sure what the value is in being able to do that. But, you would agree there was more than just getting that across the finish line for the two or three Successful Companies . Dr. Califf the collaboration in the mrna platform developed over decades, the sharing of the viral sequence, just the ability to do the viral sequence, then, to use, methods to match vaccine did fax into virus was an incredible feat of science and collaboration that made a huge difference. We would have had may one vaccine out of 10 had there not been mrna technology. Sen. Romney some Companies Already had significant investment in mrna technology before covid was around, correct . Dr. Califf right. And that is why we are excited with new platforms with cell therapy, gene editing, and other areas. Sen. Romney thank you i yelled back. Sen. Murray its good to see all of you again. Dr. Walensky, my condolences to you and the cdc family for yesterday. Ms. Oconnell, i want to start with you. I am working to introduce my Public Health infrastructure saving lives asked to provide state and local Health Departments with the strong sustained funding they really need because we know how critical it is to have wellfunded strong Health Departments responding to any Public Health situation. I have heard from constituents in Washington State about how federal researches resources have helped during floods, wildfires, and covid. States and communities still often lack the funding and flexibility they need when they face a Public Health threat, especially when it comes to reaching and supporting people with circumstances that put them more at risk. We saw this during covid. What can congress do to help ensure we strategically support those most at risk in a Public Health emergency including people with disabilities, older people, children, and families . Sec. Oconnell senator murray, this is top of mind for us too. We just released a five year plan where we make clear that the country is not prepared until we are all prepared. All communities, though set greatest risk at greatest risk need to be accounted for. As part of the fy 24 budget there is an authority to start a Human Services Response Fund to quickly move money into various communities to be sure that we have boots on the ground able to respond to the various populations most at risk. I had a wonderful conversation tuesday with the head of our a. C. L. About how important this is. We have been in communication within the department about making sure that the Human Services side of our shoppers shop is also prepared and ready to respond to account for atrisk populations. As part of the last pop up, senator, you authorized three Advisory Committees. One for disasters and seniors. One for disasters and people with disabilities and one for disasters and children. We have been meeting regularly with the experts and really valued their input. We continue to keep this work front of mind. Sen. Murray good. With any emergency we need to be able to get supplies where it is needed most in a quick, equitable, and effective manner. My act signed into law last year includes directives to aspr to assist state and local Health Departments and assisting the Strategic National stockpile. Can you give us a quick update on how aspr is in permitting deprivation . Sec. Oconnell thank you. The Strategic National stockpile, making sure it is fully stocked and ready to go has been one of the big focuses of my tenure in this role. Its an important question for us and we appreciated the provisions in the prevents bill and we are working carefully against them. We just released our 60 day guidance for states and localities on how they might access the Strategic National stockpile. We continue to give Technical Assistance to states interested in maintaining their arm stockpile. What do they need and how do they need to switch it out . Then we are looking at all of the various innovations for how we might hold our stockpile with better managed inventory in other ways to switch in and out what we have. This is all front of mind for us. Thank you for those provisions. We will continue to keep you and your team updated. Sen. Murray one thing we really saw in covid was we needed accurate data. You cannot get ahead of an emergency and creative response if you dont have that. Create a response if you dont have that. Can you talk about ways your agency is working to improve Data Collection . Sec. Oconnell yes. Maybe i will break this into two parts. One, we are actively working on dana data modernization so data highways are operable and counties and local Health Departments can get data to swiftly on similar highways and we can offer it straight back to them so they can have their say what is happening not only in the county but counties around them. There is a huge return. Before the pandemic started we had 180 seven Health Facilities doing electronic case reporting. We are now at 25,000. Thats about when he percent of what we need across the country. So, massive strides are happening. Also in surveillance from our Emergency Department and Vital Statistics from death registries. All of this work is ongoing in our data highways. We could use your help in the structure of the data coming into us. We receive the data voluntarily and if the data do not come to us we dont have insight to deliver the data back. So that is among the things we are asking for in the reauthorization. Sen. Murray thank you. Thank you for being here today. Last october the gao asked for the assistant secretary of preparedness and response to develop a clear approach for buying medical measures for the national stockpile. Regardless of whether they received Development Funding from the barta authority. Assistant secretary oconnell, without a clear process for the stockpiled by countermeasures do you commit to the recommendation to document and approach to make sure there is equal consideration of medical countermeasures . Sec. Oconnell senator, thank you for that question. Absolutely we are working closely with gao to make sure we can take into account the recommendations they make and implement them, of quest, making sure the stockpile has what it needs is a stove goods a focus of mine. We have a group of experts that come together to give advice to myself and the secretary as to what should go in there across all of the various material threats dhs has issued. Thank you. Congress created an advanced Research Projects agency for health. Many of its efforts overlap with efforts taken by aspr. What steps can Congress Take to increase interagency coordination and remove some of the conflict of efforts . Sec. Oconnell we are really proud of the work barta does. Bartas work is developing countermeasures to make us more prepared against threats we see coming. Barta has a wider commitment to developing Innovative Products against any disease or threat, not necessarily the National Security threats we are responding to. But its important we have good collaboration between our fellow agencies. And we work very closely together and we continue to stay in touch. I see a clear line for barta and it is important barta stays in that lane to keep the country more prepared and ready to respond moving forward. Decentralized Clinical Trials, where trials take place on locations other than a Research Center, like a patient some, can make groundbreaking cure is more successful for patients that would not otherwise be able to participate, simple just because of where they live. Commissioner, what steps can Congress Take to reduce barriers for patients to put his fate in these trials to improve accessibility for those with rare diseases, the elderly, or those with mobility issues . Dr. Califf a fellow north carolinian, a very rural state. In didnt have your bio in front of me but i appreciate the accident. I was wondering if we lived nearby. It is really important. Dr. Califf it is really important. We just put out guidance on this. Decentralized trials are on the way. If you ask me, the most important thing you can do is to make sure the funding for expansion to all rural areas. I know the bill is passed and the funding is allocated. We need to make sure that the digital pipes are deployed out there. I have spent time at alphabets. There is no question we have technology that everybody in this country can use. So, doing this doesnt require a big Research Center unless you need special medical exams and thats the way to go. Chair sanders senator casey. Sen. Casey mr. Chair, i appreciate the work you are doing and drinking member cassidy on the reauthorization of the pandemic hazards preparedness act. I want to thank senator romney for working with us on this reauthorization. I want to start with director walensky. Supply chains and ppe. We learned a horrible lesson in the pandemic which the way i look at it, it was kind of a National Failure when we could not provide kind of ppe we needed. We dont ever want to have that transpire again. We had a buckling of that supply chain in the midst of the worst pandemic in 100 years. It adversely impacted First Responders and health care workers. Central workers, as you know. That was totally unacceptable. One factor that contributed was a heavier reliance on reported ppe. The dependence upon those foreign manufacturers and foreign suppliers is what drove them to creating a terrible risk that we all know that our families and communities paid a price for. How can we promote innovation when ppe designs are outdated and and sure ensure that these Innovative New technologies are always available to essential workers whether they are in health care or otherwise, especially during a pandemic. Pandemic . Sec. Oconnell thank you, senator dr. Walensky thank you, senator. I would love to have our team touch base with you. To ensure we have innovation and ppe. Our National Preparedness laboratory is working in sites like pittsburgh, looking at new technology for ppe used in health care and Public Health emergencies and other environmental hazards. That work is ongoing. We are working with academia in that and i would be happy to review what is happening there. Sec. Oconnell aspr invested 16 billion and 87 in 87 contracts for manufacturing of ppe and critical supplies. When we lose covid dollars we lose the ability to do the Construction Authority and invest in similar projects. We are seeing supply chain pinches across many different materials and products and its important we maintain the ability to keep the work going. Sen. Casey its a huge issue among many difficult issues. Commissioner, i want to ask you a question about device shortages, another challenge. Q we know that an intimate to make that was another significant we know that in the midst of the pandemic that was another significant strain. We saw a terrible shortage of medical devices. The fda took advantage of the authority it had during the Health Emergency and required manufacturers to notify the fda of potential or actual shortages. How many devices, if you have the number, how many device shortages has the fda been able to prevent using this authority . Dr. Califf approximately 350. Its a large number, and the authority will go away. We need it. We need notification both with drugs and devices. Not only when manufacturing is disrupted, but also, when there is a huge shortage in demand so we can help them make up for it. Sen. Casey . Mr. Chairman, i give back a minute. Chair sanders thank you, senator casey. Senator cassidy. Supper ready i respect you as individuals. And physicians that have demonstrated integrity my capacity, and commitment integrity, capacity, and commitment to the oath you have taken to the nation and your patience. Let me ask you, how many employees are you responsible for in your agency . Approximate . Dr. Walensky about 1000. Sec. Oconnell about 12000 and twice the number of contractors. Dr. Califf 19,000. I know some people feel these individuals must be corrupt or bad. They work for the government. They must have ulterior motives. My experience in dealing with those that i have dealt with is 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 people somehow creates false impressions about how effective our various 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 you do. Let me ask you if there are anything you think we need to 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 hear all the time, oh, the fda approved that because the people looking at it were investors in that country company. Is this an issue that exists in your various agencies . Dr. Califf since you mentioned the fda specifically. Saying fda officials and employees are prohibited from owning any stocks in any relevant entities they regulate. For us, that is 20 of the economy. So even like airlines, because they serve food, and food is a big part of our equation. I take great pride in appreciating what you said. What could be done to help the most to say a few things about federal employees. During the pandemic, there were doing regular work and pandemic work at the same time. Thank you. Dr. Walensky. Dr. Walensky i have an Agency Working 24 7 to take care of Public Health. They are not getting credit for it. What happens when there is a massive pandemic that affects 330 americans as they have rovers structured to start with. They were working 24 7. Their job is to protect the public from Public Health so you do not have to worry about it. Thank you. I was personally concerned and i know many others worry about the data that was available to the public our government about what happened with covid, who was getting it and what age groups were getting it. I was dismayed that i went to john hopkins to get the data, as opposed to coming to the cdc or nih. You indicated you are making strides to improve our systems. You also indicated that for many institutions, the data is only voluntarily provided. Are you suggesting we need to have mandatory reporting on a basis to where people cannot possibly be identified personally . Do we need to do something to have a better system of collecting data, providing this to the public and practitioners . Dr. Walensky right after the Public Health emergency, it took the cdc six months to negotiate data use agreement to negotiate data use agreement to receive hospitalization data. Website john hopkins was very efficient to do this while working with our lawyers. Very similar things happened. If we are supposed to and responsible for stopping disease outbreaks before they start, before they become emergencies, we have to have line of sight as to when the urgent issues and infectious threats are sparked. The only way we do that is by getting the report coming into the cdc so we can give back to communities. This rare thing that happened in their county is actually happening in the county next to them, so they know that. I would love to still the time for people that gave it up i will not do that. Mr. Oconnell, one thing about masks and dpe, is the machines that make those things. How do you make a decision about whether to keep productive capacity in place as opposed to just keeping basques in place . Are we making the right choice in this regard from your perspective . Oconnell that is exactly what we are working to do now which is insured stockpile is only part of the supply chain continue on. Which we have on hand in the stockpile is critical in the early hours or weeks of response while we ramp up what we have in the supply chain. The hospital employees that had two were bandanas instead of real masks should have been able to access them on the commercial market but were not able to. Stockpiles to back that up should have been there. If both are running well and we are investing in domestic manufacturing so our supply chain is stronger and yet, if both run well, we will not be the stockpile and can rely on the supply chain. But when that is pinched, we can rely on the supply chain. Stockpile. I want to thank our witnesses for all your work during a different difficult time. We are here talking about reauthorization of the pandemic in the all hazards preparedness act. I just want to state, not in the form of a question, but the juxtaposition of an act taken by the House Republicans last week, that would result in drastic cuts to our Public Health programs and our Research Initiatives and cuts that would undermine our nations competitiveness as well as oversee two, Public Health, and security, and leave us completely unprepared for the next Public Health emergency. I certainly stand with many of my colleagues whose who have voiced concern about that, in opposing the measure the House Republicans passed last week. Last congress, i worked closely with Ranking Member cassidy on the tracking pathogens act, which strengthens 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 must continue. The tracking pathogens act was signed into law, but unfortunately, there is no sustained funding. Dr. Walensky, can you describe why sustained funding for cdcs sequencing efforts, including through the advanced Molecular Detection Program is critical to preparing us for future Public Health emergencies . Dr. Walensky first, thank you for all of your bipartisan efforts and our ability to track pathogens and the coronavirus through our genomic sequence ease. We were doing tens of thousands of sequences a week so we could see. Continue to see where, and what pathogens, and subvariants are occurring. Now that we have this and can do this, it is the case that we have massive capacity to do this for other pathogens, antimicrobial resistance, and fungal pathogens. Have made great strides. Once we ramp this up, if we let it run dry, we will not be taking advantage of this capacity. I invite all of you to visit your state Public Health lab. If you go to your state Public Health 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 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 platforms can rapidly fitted to address previously unknown pandemic threats that is why i lead the disease x act that would dedicate resources to this particular goal. Ms. Oconnell, how can congress support bartel in better prioritizing the development of medical countermeasures against viral families that present the greatest pandemic potential . Thank you for that question. It is one of the premier pedicle organizations within the government but does not get a lot of credit. I am grateful for the opportunity to talk about them. They have begun to pivot to Platform Technology and we are seeing some advantages in the mrna vaccine where you can just click one part of the virus, switch it out and ramp up production. We will invest 100 Million Dollars to transition the technology into a pandemic flu vaccine. The work is underway but barta has also asked for an fy 24 60 million for threats agnostic countermeasures which go against used to be one bug, one drug. Now we are looking at what we can do for boastful drugs against multiple bugs. Half this in our budget and are continuing to look for countermeasures that we are currently developing. Thank you. Senator cassidy. I deferred to senator braun. I will start first with senator kayla dr. Califf. You have an upcoming hearing on cellular tissue and gene therapies from the Advisory Committee concerning a new muscular dystrophy drug and a new variety of it. Unlike most hearings, this one is being done virtually. It is prohibiting the use of cameras and choosing from the patients segment by lottery who can speak up in diseases like this and many others, where it is very progressive and maybe has a sharp prognosis window. Especially when there is something happening on the front that may be promising. Why would you go from the nominal format to this, deemphasizing the patient component of it . Centre, thank you for the question. Technology is obviously exciting. This is a technology meeting, not a hearing. It is following the same rules we have for all of our Advisory Committees. The goal is to have experts give advice about the Technology Companies as they did present their data. People have a chance for an input but there is a limited amount of time. That is why there is a lottery. It is not a deviation from standard procedure. How long has the standard procedure been in place . Dr. Califf years as best as i know. I was Advisory Committee chair 20 years ago and you are not limiting the participation of patients . Did you get the letter that i sent to you . Dr. Califf not that i am aware of. And yes i am aware of the letter. Some diseases have Clinical Trials that are working and drugs that are promising that probably should not have the same kind of dynamic as something that has less urgency. You view that should be may be looked at, keeping most of the Gold Standard that you always referred to . But since a of these windows do not surpass more than three to five years, should there be a different way of doing it . Dr. Califf we completely agree on that. In the user agreement that you all approved between us and the industry, are hiring about 150 people just in this area to focus on it because it is exploding right now with biological technology that holds great promise. That is great to hear because it is now bipartisan, bicameral, in promising pathways act with slitter dinner bram with senator gillibrand from new york. We will send this to your office and hopefully will get your endorsement on it. Dr. Califf we have had conversation several times in the past. Our lifting the federal Vaccine Mandate and the Public Health emergency on may 11. I will not forget easily all the angst that was out in the Small Business community when we had to put a Congressional Review Act out to make sure you are not going to force vaccines on employees down to employers of 100 employees. Dad had more fright when it was in the rear view that had more fright when it was in the rearview mirror. It was coming down and took the Supreme Court to thwart the bad idea. I would like to know if this was your recommendation, dr. Faucis . It was the Biden Administration that was going to do that and push forward this was a good idea before we had to intervene with a Congressional Review Act and get the Supreme Court to weigh in. Dr. Walensky here we are in 2023, when we had 96 to have had protection by one way or another. Either by prior infection or by vaccination. At the time, we were seeing our workforce and policeman conduits and Police Departments this was not long ago. This was only maybe months ago. When you and i had a conversation, we knew that it was going into the elderly and it was clear it was not going into the rest of the population. The trillions of dollars we spent, and effects the economy shut down, it was much slower to react to the Political Science and maybe not real science. I am just wondering, you and dr. Fauci, who were the ones that kept pushing on the issue of the Vaccine Mandate for private employers down to 100 employees . Dr. Walensky i can tell you there is a group of us that advises the president on president ial proclamations. I will also say that, to this day, we know our bivalent boosters still have two point seven times protection against death. If you have gotten the 5 four if you have gotten the bivalent boost versus if you have not. We continue to provide protection against people for all demographics. You said that dr. Fauci would probably never recommend showing the economy down or something similar to that, fyi. Thank you. Senator kaine. Thank you. I am a Public Health data. Unlike senator hickenlooper, who was a mayor, or if the chair who was a mayor, we have the experience of seeing silos and state Health Systems or federal Health Systems that do not share well with each other. And you have providers too. That created huge challenges for us early in covid. Just to run back the tape. At the beginning of covid, it was hard to even get racial information of those getting covid into dying from it. It took a wild to realize and some jerry rigging to realize it was affecting africanamericans and latinos more than others. But we did not know that right away. With a Better Health data system, we would have. Often minorities are low income and have had Less Health Care and Access Health care access, which has given them more comorbidities and make them susceptible to covid. They often worked jobs where they cannot just go virtual all so they were more susceptible. It took us a while to figure that out. But we did figure that out, and began vaccinating beginning in 20 put one with populations over 65, even though it was equally available to over 65 first come first serve, it was not effective because the communities that were most vulnerable are not the ones on their computer to find the nearest cvs to get vaccine. They did not have computer access or the free time to do it the way some people had. But because we figured that out, we were able to change vaccinated vaccination strategies you try to change for more equality and effectiveness. It is an indication that there is a million ways where a lack of a Public Health data systems closed on our response and ability to have effective interventions keeping people safe. I have worked with colleagues on this committee for a long time with the improvement data health act. Some amendments were included in earlier on the buses but there are other pieces still. In your opening testimony, i heard just the back end of it when i came in. Mentioned Public Health data and talked about how the better Public Health systems that interoperate can help the cbc do a better job and keep us safe. Dr. Walensky thank you for your interest and the state of virginia. Virginia has been one state that has piloted with the cdc and uscf. Cases of lab reporting and surveillance so we do have a better window. The case you thought brought up in covid is right. We were unable to see the ethnicity data. We have the same Public Health emergency declared two days after the peak number of cases. Again, we cannot see the race and ethnicity data and cannot see the places where vaccines were going into arms as were trying to make decisions about a scarce resource vaccine deployments with my colleagues. We cannot act swiftly, nimbly come more robustly if we cannot see what is happening from a data standpoint. If we wait for the Public Health emergency is to be declared an event, statebystate, dating authorizations and agreements that happen takes months. It took us six months to get hospitalization data on covid19. If we are to be nimble, even if we have remarkably robust interoperable data systems and there is nothing on the highways, will not be able to see what is going on. We want to have the data from the cdc so we can get back to the state and local health department. I hope as he finds a way to a big win in this area that we can include much more robust data that protects personal identifying information begins around professionals the tools they need. Dr. Califf, i heard from my constituents about shortages. We sent a letter to you and 15 colleagues asking what can the fda do to work with colleagues on factors that lead the shortages . As i close, i would like you to tell me that i hope you are prioritizing this because i am nervous about it. Dr. Califf the formula has gotten better. But we have gone to almost a lot of short time drug shortages. Almost 200, be preempted by working with manufacturers. But the number is going up. We are keeping actual shortages at the same level with our employers can only plug a certain number of holes in the system which has row problems. Particularly the generic drug pipeline. Have a lot of work to do. As i said in my opening statement, perhaps we get better data so we can get in front of this more. Look forward to working with you. Thank, mr. Chair. Senator cassidy. Let me echo what romney said. I think all the employers were working tirelessly through the pandemic and i appreciate that. Ms. Oconnell, congratulations on a good football season. That is really good. And, we have witnesses on the second panel that are going to suggest drug pricing policies they say would increase access to medical countermeasures. I raise that because i hear from experts that medicare medical Countermeasure Development is uniquely challenging. Many of these companies are small companies. Many of the companies that barton contracted with went bankrupt. Others got bought by Bigger Companies which are getting out of medical countermeasures. Is that a fairly accurate depiction of the state of play . Ms. Oconnell thank oconnell thank you for that question and the congratulations for the greenways. The type of company we work with is often small Biotech Companies because there is not a commercial market for countermeasures. We work with Smaller Companies who have to come in and are willing to be enervated of in a way. Just a second. It is my impression that a lot are living on Venture Capital and have not turned a profit before their first big product. Is that a fair characterization . Oconnell we often support the work they are doing in order for them to be successful. If you were to put restrictions on what countermeasure could be developed, perhaps without knowing all the variables, and this is a fair example that there is no secondary use for this particular issue. With that would that be encouraging of the private finances of these firms or discouraging . Oconnell we remain committed to making sure every governmentfunded. Countermeasures are available to everyone who needs them. But there is a risk if you were to add limitations in the contracting that we limit the amount of companies willing to come forward and do this work. You limit the number of companies and a number of companies is already limited. Oconnell there is a risk. Dr. Califf, good to see you. You are looking for. Let me just compliment you right off the bat. Another suggestion in regards to how to develop these products. It is to incentivize innovation with a large sum of money, that would be a patent and regulatory exclusivity. I dont know if you can comment on the finances of this, but do you think an x price would be an adequate substitute for one of these companies in louisville the patented regulatory exclusivity . Dr. Califf you know what a complicated question you just asked. I will say is the prices of drugs innovative drugs, are too high. The solution to that problem should not, in my view, bt do do away with patents. They serve a vital role in stimulating the concept you were just discussing. But where the bounties between those two and the role of progress is is a long discussion. It is not an either or. In general, protection plays a Critical Role in surviving innovation. Dr. Califf absolutely. We just talked to a company over that issue. It is important. If people are going to invest, it has to be intellectual property. Ms. Oconnell, there is a conversation about having reasonable pricing causes that would dictate the desk clauses that would dictate the price of something if it enters into the commercial market. In general, is there a commercial market for most things that barta is funding . Oconnell in general, there has not been. Of the 70 products we have license, very few of them are on the commercial market. I think data shows that from 1990 until 1995, they were commercial. After they removed them, here was because the production of the judge. They removed it and it took off. That may be assumption and not causation but do you think reasonable pricing costs will make a company more or less than to work with barta . Oconnell we have to take a look but there will be a risk in adding an additional contracting element to the work we are doing. I have more questions but no time. Thank you. The questions you raise are interesting and i look forward to ask you about them in the future. Senator markey. Earlier, dr. Walensky by the way, congratulations on the football team. [laughter] there is kind of a tale of two pandemics. With 200 15 people a day still dying. Can you talk about that . Who they are, and what the messages to them are and what the medical emergency . Oconnell the Public Health emergency is set to next week. We at the cdc are not changing the scene at which we are working to this resolving Public Health emergency. As we look at the kinds of people who continue to pass from covid19, they tend to be elderly and more vulnerable. They tend to be those not vaccinated or not up today on their vaccine. But more fragile people and people who are not uptodate. It is the case of the end of the Public Health emergency. You will have a window for the data among the things we happen talking about. He will lose percent positivity, will not get laboratory reporting work is reporting. With regard to what we are doing as we talk to these vulnerable communities, we have been doing a lot of work in the cdc to address our disabled communities, vulnerable communities, and over the communities. We have a teen opsware officer and disability officer. We have a meeting tomorrow to discuss with the Disability Community the impact of the Public Health emergency and what that means. We have been putting disability experts working with our partners within states to ensure they have resources and references within their local communities to understand the impact of covid19 and other respiratory threats. For that cohort, people over 65, people with preexisting conditions, immuno compromised, they still have to act as if the pandemic is going on. You can be in culture where everyone else is saying that we are back to normal. But to them, it is not back to normal in terms of what they need to do to protect themselves. Dr. Walensky last week, we provided an update to the bivalent boosting of recommendations of the community could actually get access to another dose. As part of the Public Health emergency ending, we would like to provide data on hospitalizations so people can see the hospitalization rates happening in their communities and make decisions to what is and when they want to take something. So they still act as though they are in the pandemic in terms of vaccinations and bivalent protections . I think that is a very important signal because it is a tale of two pandemics. 250 a day is 700 a week times 52 weeks a day. That is a lot people that will be affected. Dr. Oconnell, we see the effects in new orleans and other places with Climate Change just having devastating impacts on communities which then affects the Health Care System. It could be denying people access to opioid treatment, methadone treatment or whatever. When they when this bomb hits and the system collapses. Can you talk about what you do in order to make sure that system is strengthened, or needs strengthening across the country . We can really predictor almost guarantee that we are going to see intensifying storms in our country, all experts, all meteorologists are saying that. What do we need to do for our Public Health system to make sure it is warm and capable of responding . Dr. Oconnell we are seeing an increase in storms. Fema talks about a policy crises where they are seeing an increase in funding and fires. The intensity of storms happening. We are continuing to ramp up our response. That is one of the reasons why the authorities we asked for are so important. It would allow us to get were people on the ground and secure the tools we need in a faster way. We are looking across all those things in the new landscape we are living in to ensure we are strengthening what we have on the ground. Thank you all for the historically great work you did to have our country respond the way it did. We will try to get you additional resources. Recommendations are going to be sweet. Thank you, senator markey. Senator hickam. Dr. Califf, i am not sure you are looking that fit with respect. You look a little tired. You are doing the hardest jobs, you all are. Well make sure that it gets put back the right way with the proper resources which is going to be a big day for all of us. Dr. Califf, i wanted to start an effective regulatory partner into getting these platform technologies to the public in the context of a pandemic. The fda propose a Specialized Program to handle the emerging pathogen preparedness in your priorities for the fiscal year of 2024. Can you speak to your vision, specifically how the agency might be able to handle the regulatory considerations for these platform technologies . Dr. Califf sure. We are constantly looking. We had a good discussion today about platforms and how important they will be in the future, when you can mix, match, insert a new element and come up with a new era pi in a short period of time. That is the reality, but there are many others. You are asking for a team of people dedicated to this that can be looking to the future. It is included in some things they employ. We want to do more so we have these platforms ready to go. Then, you can depend on the platform and do not have to look at all the regulatory work would do if you are developing a drug from scratch. He also quickly i am 71. I got my bivalent vaccine a few days ago which is why i look a little tired. [laughter] i threatened to wear eight sawedoff tshirt as a demonstration with the bandaid but my staff told me that was not allowed in a senate hearing. Dr. Califf let me suggest you go and have a fourmonthold child at home. Then he will be really tired. Assistant secretary oconnell. Obviously, covid had economic costs and human costs. I do think important work will be done as we look back over the entire arc of this pandemic. Again, i remember vividly i was just a couple years out of being governor. I wash the decisions being made by governors all across the country and all of us in washington in real time with unbelievably limited information. The data was not there, the facts that was not there. It would be useful to go back and looked, given at each time what information we had, to be make the right decision . We should be a friend in saying there is no harm in that. The state is in time of crisis. It is impossible to get anything right. One thing we saw was the regional coordination and resilience which are our key to weathering future pandemics. Have the big City Hospital denver health, and the successful demonstration site for both the regional disaster of the response system and a national pathogen federal response program. Neither have gotten authorization. They are just test cases. Can you speak assistant secretary, as to the success of these and what the likelihood is in terms of getting more continuity there . Oconnell i think you are right. We built this system where we looked at coalitions locally and then expended them regionally, nationally. Covid was one of the first major responses be dealt with and needed a National Response immediately. To be able to have these strong places within the country to lean on has been an orton. Important. At this point, we only funded for. 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 is national. We have one from each region that can make sure we are coordinating across some thing like covid where the icus were overwhelmed in one hospital to know where to go within the region. The next one could take a bit and was critically important. National special packages you mentioned came out of the covid the abella response in 2014, when we realize not every hospital can handle an ebola patient. We sent of a system across the country of regional locations that were able to take those patients. We trained them. I am proud of the success they had. We have to exercise them recently with the ebola sudan outbreak in uganda and the other outbreak in equatorial guinea. We need to be sure we are ready to handle intrigue in case anyone comes back. We saw a lot of this. Also Regional Response and resilience that came from Community Health centers all around. This shows the strength of our Public Health care system. I will leave you. I am out of time. You will just have to think on it. But as we try to build the various platforms we build, from fairness preparedness is important. We also have to look at red tape and bureaucracy. Already, i am hearing people say , oh my gosh, apply for this or talk about that. It is so much paperwork and process. People are so worried about making a mistake. It is important to look at views, strengths, failures, misses, and hits or else we will never that we realize we will never get perfectly, but there is real value to possibly try to find ways we can limit the red tape. Especially in the fda. [laughter] there is work to be done. Thank you all for your public service. Thank you, senator hickenlooper. That is our last panelist. Now, we will hear from our next panel. Lets convene our second panel. We think our panelists for being here and sitting through the first panel. Before i introduce our panelists, let me just say a few words. I think that sometimes it is important to take a 30,000 foot look at the symptoms of the best systems under which we live. We do not do this often enough. We go crisis by crisis. In my view, we are living with a Health Care System which is broken and which is dysfunctional. We spend twice as much per capita on health care as any other country on earth. 13,000 every year which is unsustainable. Yet, despite that, 85 million americans are uninsured or underinsured. We are seeing in many parts of this country, unbelievably, above and beyond covid, and decline in our life expected. We have a half billion americans who, every year, experienced bankruptcy which is related to the medical that they have. We saw during the pandemic how unprepared we were for the Major Health Care crisis that hit us. There are a lot of reasons for the dysfunctionality of our Health Care System one is the outrageously high cost of Prescription Drugs in this country. What this means is one out of four patients who received a prescription from their doctor are unable to afford a prescription. How absurd and counterproductive is that . Too many folks that will get sick and maybe end up in the emergency room at higher cost to the system rated to the system. We have seen medicare costs are extraordinarily high because they pay very high prices for the Prescription Drugs that they dispense. Meaning our Deficit National Debt goes higher. At this together and we are losing 60 5000 people a year unnecessarily because they cannot work the medicine they need organ to a doctor on time. The questions we have to ask ourselves is where is our current Prescription Drug model working . I guess it is working for the pharmaceutical industry because they make tens and tens of billions of dollars a year. Their ceos make compensation packages of millions of dollars a year. And yet, millions of people cannot afford the outrageously high prices we pay. The questions we have to ask is how does it happen that we pay all the highest prices of any major country for Prescription Drug . I have been with americans going to canada where they got their medicine they needed at 1 10 the price they were paying in the United States. But i hope we will discuss is the dysfunctionality of the current model and how we advance to a another model. Do we all believes . It is terribly important comforting and Prescription Drugs to lives . Yes. We understand the best road in the world is meaningless if someone cannot afford it . Do we understand we have a huge deficit which is somewhat treated that somewhat attribute into the high cost of Prescription Health care is somewhat treated to the high cost of Prescription Health care. What do people do when they buy Prescription Drugs at the fraction of your people. There are a few things i hope you will be discussing. Senator. Thank, you, chair. My opening remark. [laughter] lets wing it. Thank you all. You each bring a unique perspective to this issue. We emerged from the pandemic with an understanding that however robust bartow was in the past, it was not adequately reposed. The always say generals by the last war by think our general plan for the next. Since you are the general hoping a plan for the next four, there are some things you will be considering guard traditionally far fewer but nonetheless, i look forward to your input. You all have been very impressive resume. Thank you for giving your time to be here. Thank you senator cassidy. Our president reshma roatan drawn, and asus limit our friend, and it is in ensuring state these technologies. Dr. , thank you very much for being with us. Chairman sanders, member cassidy, and the other Ranking Members. At mesa assistant professor of medicine at your school medicine. With a policy program called neyo collaboration for integrity and transparency. I am also a primary trans commission. I am honored to supply before you today. I remarks reflects my own views not reflect my own views or my employers or whoever i work with. Soon the click of the emergency will come to an end. This reauthorization brings an opportunity to reflect on this period and you live the life we learn from Public Investment that led to Successful Development of vaccines and therapeutics. To inform this legislation, congress will answer the next question. How can we assure the net american because apple measures in direct responses Public Health emergencies in the future. The feedback into the covid nine pandemic, the federal government effectively reviews effectively removed vaccines in risks by granting direct Public Investment as long as severance access and resources across agencies. In return, the American Public who underwrote these have received little if they will have equitable sustainable access and the political emergency period ends. Manufacturers have announced plans to continue building, a mooring this even at lower pendant prices, they have been able to maintain profit. Without interruption. My will locations help, as well as those at higher risk who bear the burden of untethered pricing. Current policies offer some measure of protection to ensure americans. They will too likely confront these indirectly in the form of higher premiums. The federal government is securing vaccines and therapeutics and will bear the expected increase costs. Texture spending, always have medical countermeasures, that there will be less money and Resources Available for other critical and Public Health interventions. Moreover, based on trends we have studied in public and private procurement of another vaccine of influenza, these initial covid19 vaccine prices following the covid19 Public Health period would be the reason for price hikes in the future. First, congress should empower the federal government to exercise necessary leverage without funds for the elements of countermeasures and negotiations for contracts. The government negate the impact of substantial price increases to renegotiate a lower price as they did during the covid19 pandemic. To further prevent these prices from continuously rising year after year as a habit of vaccines, the government should call for feeling price to be upheld. Similarly to what they have been able to negotiate in a few contracts, the government could insure many manufacturers give them the best price compared to other in the country. The federal government must not sacrifice access in compliance of safeguards with the thinnest contract are the guys of flexibility and speed. Using a contract mechanism like other Transactions Authority inhibits the ability of the federal government to remove unfair axis barriers, to tackle things like affordable pricing. Instead, allocation of funds should be tied to provisions to support the medicare visual is effective. During the ongoing covid Health Emergency, it may be helpful for 30 products to remain. But the federal government must condition taxpayer money to intend that they work as intended in to answer other country questions. Understanding how different treatments and vaccines, compared to one another, where across cooperation could better determine how many doses pure cure of each product and at what price. Covid19 demonstrated how effective government can be and spread the rapid medical measures. The success of these should not only be measured by what the medical products do when they reach the market. This excess is redefined. As an government acting as a steward of pecks peer funds and answering equitable assets are effective. Thank you very much. Our next witness is mr. Reisman who is president of public citizen. He is an expert on Public Policy and insuring equitable access to drugs. Thank you very much chairman sanders and more for being here today. It is fair to say operation warp speed was a Great Success in speeding the validation of the barda investment model. To an extent. It was a great failure and we need to learn the lesson more. It was a failure in that although the u. S. Government was responsible for funding the Covid Vaccine from before covid even emerged, through the isolation of the key spike protein, through Clinical Trials and up through the development and production of the back the vaccine. Barda impose effectively no restraint restraint on how moderna and other partners would operate. The result was that while moderna executive became billionaires, taxpayers were price gouged. Hundreds of thousands or millions of people lost their lives because we had a global shortage of a vaccine that could have been avoided if we have shared technology. Now moderna announced it plans to quadruple cut prices, further limiting access, further gouging consumers, further gathering the taxpayer. If everyone agrees, we need to learn lessons from the pandemic period and do better going forward. We need poppa, barda, and need to do better. First, more transparency in the contracting process. Taxpayers should know who theyre providing games too, who are they making acquisitions from, and on what terms . Vaccine makers are making coinvestment in products. Tax clickers taxpayers should know how much is being done on the private side along with the public side. Second, reasonable pricing for products that we, the taxpayers, pay for it. If we pay for it, we may not be able to pay with unreasonable prices. The start should be that the u. S. Did not pay more from like more than any other country and, as they should do. You should tailor a reasonable price to the amount of private sectors for investment and risk taken. For the government pays for the development of a drug all the way through. The price should be lower than when they took on that and had to make a lot of earlystage investments. We need to guarantee international access. We know this means everyone around the world knows the products we are talking about. Drug manufacturer vaccine makers may not have capacities and often does not have interest in solving the global properties. We should have a requirement for announcing to the world the Health Agencies of crucial information and share into the algae and knowing how to make sure other manufacturers can produce products everyone needs. Last, we should consider, as well as the traditional model for support search and development, prime models. Such as those who have supported in the past legislation. We know in the case of barda, the monopoly model supported information and does not work. If that is why they are making the investment because the private sector model in these cases, as commissioner califf said earlier does not work. It is at least insufficient. We have to think creatively about how we can get better. Prices can be recalibrated to provide special incentives. As our resources into this space, while also ensuring affordability and access on the back end. We could also do other things to promote inflammation to promote innovation like giving everywhere the people do not a product that contributions along the way. These are some lessons that have come out of the pandemic and that we must incorporate going forward. Senator cassidy, did you want to introduce yours . We are joined by dr. Marty mccarley, a researcher for the Johns Hopkins school of medicine and from John Hopkins Carey business school. Dr. Makar broke his research on health care and other issues ranging from health care to covid19 and previously worked for the World Health Organization where he helped his surgery checklist which help reduce surgery related death around the world. He completed his medical training at georgetown in Johns Hopkins and is the coauthor of over 250 period papers. That i get that right . Pretty impressive. Thank you for joining us. Thank you. Center standards and member cassidy and senator markey. It is a privilege to present. I speak on behalf of myself, not john hopkins or the National Academy of medicine. Congress should avoid the false narrative that insufficient federal findings were to blame for our pathetic Covid Response. Take, for example, one Johns Hopkins to dent rated a covid tracker the world used. It was not created by the 21,000 employees of the cdc. When hhs met with the cdc, they said it would create that take months to create such a tracker. Then the cdc need 25,000 employees or 50,000 employees . We just had the assistant secretary of preparedness and response say she needs more hiring power. How about firing power for incompetence . Or both. 21,000 employees cannot come up with a covid tracker . We are tragically the nih has 42 billion. Barda, which is a part of the poppa act has another billion dollars. They could not do the most basic Clinical Research we needed done to answer the basic questions to enter the controversies in the conspiracy theories. To finally get at the questions americans were asking, which is how does it spread . From touching surfaces . Do i need to import 20 gallons of alcohol on my groceries . Dr. Fauci was telling teachers in july to where gloves and goggles. Or was that spread airborne . That could have been answered in 24 hours. One week of Clinical Research to answer where sea peak of viral shedding, how long do you need to quarantine for, do masks work . We could have ansell this with definitive basic research early. They did not. I think it is fair to ask how did they do in preparing us for the pandemic . We spent over 20 billion over the last 20 years. What has that done for us . How many lives were saved during the covid pandemic because of investors by poppa pahpa or barda. They have done good work. Regardless of one political affiliation, they need to acknowledge that we doctors were flying blind. We had opinion ruling the day on what we should do. He could have been governed by evidence, policy driven by good placing basic Clinical Research. We did not have that so we had a void of Clinical Research. Over half a year, one year, two years. Filled the void were political opinions. The controversies couldve ended early. We have the money. As a result, the covid pandemic became the most politicized pandemic in u. S. History. Much of it was avoidable. I Research Team at Johns Hopkins did a study of where the nih spent their money in 2020. They spent 2. 3 times more research on aging than they did with covid. I am all for aging research especially as i get older, but not during a global candidate when 3000 americans are dying day. Much of this research was misguided and our study published in the bmj that i included in the packet showed it to the nih after they decided to fund a research study, five bus to get the money to the researchers. That does not work during a Health Emergency. The mia got an of the reauthorization of barda is. The public has a right to ask what has barda and poppa done for them in preparing for covid . How many lives were saved because of the investment . What is the single best investment barda made with roughly 20 million before the pandemic . That saved lives. It is fair to ask those questions. How many beds are available today . We track the Number Available . We are going to have more catastrophe. Not just viral pandemics but mass shootings, floods, and other natural disasters. We spend a lot of money at barda , making hospitals a lot of money. Contractors making a lot of money. The question is, where was the basic Clinical Research . We have to invite his hunting internationally, sitting teams to get exotic viruses and bringing them into populated areas. I look forward to your questions . Let me start with an issue that has bothered me for a long time. If i have a product that can save his life, and i say, bill, you can have it but it will cost you 100,000. And you say, i do not have that and i say, sorry, bill, my Business Model is that price. Sorry you are going to die. You were talking about maybe millions of people around the world, for people dying because they did not have the vaccines. We have it and i think the vaccine, as i understand it, it costs a couple dollars to reduce produce. What is the morality and i want all three of you to respond to it of us having a product that costs a few dollars to produce, but not making it available to people around the world who are dying and in our own country as well but poor people around the world . Dr. Ramachandran what you are describing, the hypothetical is the reality i see every time i have a clinic where patients come to me and say that cannot afford what i am prescribing them and the fact that this can happen to a fun delete federally funded vaccine is frightening. It should be unconscionable and should not be allowed for that to happen. No one should be poor because they are safe and no one should be sick because they are poor. Sen. Sanders if i have a product that can save your lies the cost that costs me a few dollars to produce, when we look at it globally, what is worth understory underscoring is that there is no market in low and middle Income Countries for big pharma. They are not holding out to see if someone can pay more. They just wont say so there at cell there at all. In those markets, we just have to figure out ways to get the technology to someone who is there and when it comes to lifesaving Technology Like a vaccine. If they dont want to make it to sell there, find, fine, but required them to shut the technology to other manufacturers and give them to the knowhow so they can make it on their own. Sen. Sanders should people die because they cannot afford a vaccine that affords a couple the cost a couple dollars . Mr. Weissman thank you for your work sen. Sanders we are going to have them next week and they will be sitting where you are sitting along with the three major insulin manufacturers in the world. I was that . How is that . Mr. Weissman great. The fda commissioner was asked about shortages and what he is doing and he said we need enter data. How about these mass monopoly powers . We have three suppliers that supply 80 of u. S. Hospitals and they enter into these contracts. The manufacturer gives eight flimsy supply chain for Something Like insulin sen. Sanders all of your points you are raising our good points. I will get back to you. Tell me about the moral issue. Is that our moral Business Model we should sustain . Dr. Makary it is an unacceptable barrier but the best way to lower drug prices in america is stopped taking drugs we dont need and cut the waste of the system. Thank you for being here. Dr. Makary, what do you really think that man . The theoretical given is an absurd theoretical because moderna has pledged they will make it available. I speak with some authority between Medicaid Expansion state, drug should be available for those i can give you a heretical. Theoretical. What if we sell and this incentivize the and this incentivize think we have to have a note of reality as we give theoreticals. Had a productive conversation before the last hearing. One concern i had, either way by the way, the federal agencies that we refer, generally conceded that they did not do well. They are making major efforts to reform so lets acknowledge that. One of the production conversations we should have is how you have production sharing that would not be saddled or quarantined by a federal agency but with sufficient protection of privacy that there will be accessed by under other researchers that may have a different idea then the than the fcc. Cdc. The cdc may maintain it but good researcher at Johns Hopkins who wants to test the thesis can do so with appropriate safeguards. What are your thoughts . Public Health Officials downplayed in silenced this sense many levels. Why has won the vaccine never been approved to be u. S. , being given to one billion people . What is it with the cozy relationship between regulators go back to the information sharing. Is there a way we can have more, a Group Outsourcing and Group Sourcing the data to allow us to have better public houses Health Decisions . We didnt get it. Probably it doesnt support the narrative. Science should not be censored i have limited time. Mr. Weissman, you heard one concern that if you go to that that would be a d isincentive companies to make large scale investments. Your thoughts . Here is that dr. Is mistaken. You are talking about countermeasures countermeasures where the government is the sole purchaser. It is not about charging the most for private individuals. All that gives the all that does it gives the company the u. S. Funded more Bargaining Power when we purchase from them. I think the original premise was that if youre trying to get companies to commit significant resources to develop something, is it better to give them an eventual them intellectual property we have to jumpstarted so the premise of this discussion, it is is it better to get them one prize or is it better to give them intellectual Property Protection and give them a traditional electoralm etc. Traditional intellectual, etc. . Mr. Weissman i would reverse what you said. One model is the winner take all. The one who gets the patent, that is the winner and we dont know the value because you dont know what the market will be. You have more certainty with the price because you know the value of it but you can calibrate the price prize even if they are not the winner so you may give an award to someone who drove the Research Forward but did not get the final thing. That is nice that is a nice approach to it. I can of vision the lawsuits over it is my share. That is a minefield that has been treaded. Thank you for your good work. Let me finish by saying this. I have a graph showing that there is a regional pricing loss in the cooperative research and Development Agreement which stopped in 1995 and prior to that point, you have this kind of level of commercialization of research. After that, removal, it took off. It is it suggests that the conclusion of this is the primary stimulus for the increase in the cooperative research and Development Agreement after 1995 was the removal of reasonable icing clauses pricing clauses. Would you disagree with that . Dr. Ramachandran during covid19, we did see the use of regional pricing clauses, which companies, including major manufacturers accepted. Pfizer was one of them with paxlovid. Within that contract, there was a favorite nation because, clauses that pfizer accepted. We are seeing this outside of the medical countermeasures space. One university announced regional pricing provisions for their products so even for products where there is a large commercial market, these protections could be included especially like an agency like nih that has leverage the companys one have want to have . Sen. Sanders let me follow up on senator cassies point cassidys point. You called my question an absurd hypothetical. I suggested people die and get sick when people cannot afford medicine. You think that is absurd . 100,000. Cancer drugs are 100,000 right now. So we have two doctors an expert, is it an absurd hypothesis to suggest that people are dying or suffering are going bankrupt im having their lives disrupted because they cannot afford the prices of Prescription Drugs . Dr. Ramachandran it is not a hypothetical at all. It is the reality of so Many Americans. Sen. Sanders you see it in your practice . Dr. Ramachandran all the time. Mr. Weissman viewpoints a few points. In the global context, it is commonplace. Sen. Sanders how many people do we think died because they did not have access to the vaccine . Mr. Weissman there are estimates between hundreds of thousands and millions. Most of us who got vaccinated did not get the Higher Quality vaccines. In the u. S. , as you said, 25 or 30 of americans rationed their Prescription Drugs because of price. Now all of them not all of them are dying but some are. The launch price of new drugs are 182,000. 100,000 is not far out sen. Sanders i think many cancer drugs out there are over 100,000. Is that correct. Mr. Weissman yes. The question you asked about to senator kennedy cassidy, in 1995, the point that nih stopped using the regional pricing provisions, they added a new category so the original category was standard those stayed roughly consistent after the removal of the regional pricing clause. They added a new category of material. The numbers that show the seeming just position reflected change in seeming juxtaposition regarding change dr. Makary it happens. The American Cancer Society said that 48 of Cancer Patients say they avoided or delayed future care for fear of the bill. With the promise of the Affordable Care act lowering costs not pending after, we have created new deductibles. Sen. Sanders i dont think senator cassidy, my hypothesis was absurd. We could talk about vaccines, like lack of availability worldwide and that is different than pahpa. Theoretically Medicare Part b providers coverage for most of the cancer drugs. Sen. Sanders occasionally . Judith sen. Cassidy im not if the Affordable Care act was successful sen. Sanders i am not here to defend the Affordable Care act. We are having an intellectual exercise. I think we will have to catch planes. I want to thank you for the work you are doing and thank you for being with us and heres my your credit think my bureaucratic thing. For any senators who wish to ask additional questions for the record, we have a this is day on may 18 at 5 p. M. I have as for consent for these records the midi the committee stands adjourned. Thank you very much. Sen. Sanders thank you very much. Appreciate it. Oh, i did not know that. [captions Copyright National cable satellite corp. 2022] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] the Senate Budget Committee Looked at the House Republican approved mark zandi and others testified. Watch that tonight at eight eastern on cspan, also on cspan now or online at cspan now work cspan. Org. The 118 congress has some of the interviews will bring you we will bring you tonight include and i went congressman. That begins at 8 p. M. Eastern on cspan two and you can watch all the freshman interviews online at cspan. Org and dont forget to download our free video app cspan now. Watch video on demand anytime online at cspan. Org and try our point of interest feature