Have learned during the crisis to better prepare for pandemic or other biological events of this scale in the future. Folks of todays hearing is the Strategic National stockpile. First established with a 51,000 appropriation in 1958, the sns was codified in 2002 and obtained its current name with an expanded mission in 2003. Over the years, management responsibility for the sns has changed between different agencies within hhs and dhs. In developing a plan for this committees oversight for the federal governments response to the coronavirus, the role of the Strategic National stockpile was an obvious area of interest, as is the vulnerability of our supply chain and theyre very interrelated. I assume that staff would be able to quickly obtain the list of items that should be held together with required and actual inventory levels of each item. Once again, i learned it is dangerous to assume. We quickly found out that those lists do not exist or certainly are not made available to congress or the public. As we will hear in testimony, its not from a lack of dedicated individuals working within the agencies or the Strategic National stockpile. Instead, it seems to be a more pervasive problem of a lack of clarity and understanding of exactly what the snss role is and what it should be. As indicated above, to the extent theres been a congressional or executive branch articulated Mission Statement, it has evolved over time and outside the managing Department Agency has not been generally understood. Were paying the price for this lack of articulation and clarity during the current pandemic. The frustration expressed by state, local, tribal, and territorial governments and their elected representatives is largely caused by the reality, the demand for so many of the needed products and supplies has dramatically exceeded supply. The form of available inventory and production capacity. As a manufacturer in the private sector, whenever i was faced with a problem, i always asked what opportunity presented itself in finding a solution. The same dynamic can apply here. As the men and women who are working tirelessly to address the current demand develop models, that information needs to be captured and put immediately to use, updating and redesigning the structure and management of the Strategic National stockpile. I would like to thank our Witnesses Today for their testimony, their past efforts, any future help they can provide to help our nations response to future pandemics. With that, ill turn it over to senator peters. Thank you, mr. Chairman. Thank you to our witnesses for being here today. Over the past several months, the United States has faced an almost unprecedented challenge, fighting a deadly virus that has infected millions and has taken the lives of more than 120,000 americans. A pandemic can overwhelm even the most prepared communities. And that is why we have the Strategic National stockpile. The nations Largest Store of lifesaving pharmaceuticals and medical supplies. To insure the federal government has the resources to help states protect the health and the safety of americans during a Public Health emergency. The scale of the coronavirus pandemic depleted our National Stockpile in just a matter of weeks. Leaving state and local governments scrambling to acquire the masks, the gloves, and other supplies that were so desperately needed in order to keep people safe. Many communities facing the highest rates of infection struggle to obtain the supplies they needed, including my home state of michigan. Instead of providing a coordinated National Approach to effectively using the Strategic National stockpile and other tools to acquire and distribute supplies nationwide, the president told states that they were on their own. That move forced states to compete against each other and the federal government for life saving medical supplies that were already in shortage all across the world. Since the crisis began, congress has passed several supplemental emergency Appropriations Bills to rebuild the stockpile. And while this funding will help provide some stability, theres no question that our nation would have been better positioned to tackle the pandemic if congress and both the current and prior administrations had invested more in the stockpile before this crisis struck. It is abundantly clear that the federal government was not fully prepared to address a crisis on the scale of the coronavirus pandemic. And the result is the tragic loss of 120,000 of our fellow americans and millions of families who have suffered the consequences. Insuring the preparedness of the Strategic National stockpile is an issue of National Security and should be treated as such. We cannot allow a disaster of this magnitude to catch our government off guard again. We must provide steady funding to all our Pandemic Response efforts and insure that the Strategic National stockpile is well maintained and prepared to address a broad range of possible threats. We must improve the communication between states and the federal Government Regarding available resources and strengthen the federal governments role in managing supplies during this and future crises. Finally, we must also take steps to address our overreliance on foreign manufacturers of critical drugs and medical supplies. This is a serious National Security vulnerability, and the pandemic has only further heightened highlighted just how significant this risk is to the health and safety of the american people. So todays discussion will help us identify and prioritize critical decisions and investments to insure we can continue to combat coronavirus as well as emergencies in the future. I look forward to hearing from all of our witnesses and look forward to working alongside each and every one of you to deal with this very daunting challenge. Thank you, mr. Chairman. Thank you, senator peters. It is the tradition of this committee to swear in witnesses. You dont need to stand, but if you raise your right hand. Do you solemnly swear the testimony you will give before this committee will be the truth, the whole truth, and nothing but the truth, so help you god . Thank you. Our first witness is dr. Julie gerbiding, the former director of the centers for Disease Control and prevention and former administrator of the agency for toxic substances and disease registry. The doctor is now the executive Vice President for Strategic Communications, Global Public policy, and Population Health and the chief patient officer at merck. She also cochairs the center for Strategic International studies commission on strengthening Americas Health security. Doctor. Distinguished members of the committee, im really honored to have a chance to talk with you today about the strateging National Stockpile because i know what an incredibly important asset it is and how disappointed some people have been in certain aspects of its deployment and performance this year. Im going to testify in front of you from four perspectives. First and foremost is my background as an Infectious Disease doctor who is a hospital epidemiologi epidemiologist, responsible for Occupational Safety of Health Workers in the early aids era and an expert in personal protective equipment and how to really keep Health Workers safe. As you mentioned, i also cochair with former senator kelly ayotte, and thank you for accepting that into the record. I also am the chief patient officer in evp at merck where we engaged from a manufacturer perspective with various interactions with the u. S. Government in our efforts to bring an ebola vaccine through the licenser process in the drc and west africa, and also other products that are germane to our Overall Health security. And finally, i will say that i was the cdc director during not the very beginning of the stockpile, but in its infancy, and i watched it evolve over time. I visited several of the sites where the stockpile is hidden in plain sight and participated in observing some of the exercises of deployment and so forth, so i have a pretty deep knowledge of whats in there and how it has evolved over time and what we may need to be doing going forward. I do believe this is a Strategic National asset. Were somewhat unique in the world in having such an asset at our disposal, and obviously, its an enormous investment and one we need to make the best of. Its incredibly innovative, and i would say overall, through its entire history, its been reasonably well managed, from a budgetary and fiscal responsibility perspective, and it has been innovative in its approaches to preparing for many challenges. But in spite of that overarching point of view, i recognize that there are important areas where the stockpile needs clarification and improvement. And ill just mention a few. I think the most important thing is the clarification and consistency of the strategic intent of the stockpile. It has gone from being something that was oriented toward bioterrorism, then to all hazards, cbrn preparation, then influenza pandemic. There have been debates and inconsistencies in whether or not it was conceived of something that would be deployed locally, not preparing for a National Crisis of a panamerican scale, if you will, to where we are now today, where we needed it to be able to meet the needs of our Health System across the entire country. Its also not clear whether its an asset that should operate as a standalone entity and be prepared to provide for all the needs or whether or not its there to augment what states and Health Care Settings are already doing and have hardened into their own planning. So that inconsistency has led to somewhat of a pingpong approach to what should be in it and how to make decisions about procurement. I think theres another opportunity for improvement in terms of the Accountable Leadership of the stockpile. As you know, it has moved back and forth from the cdc to dhs to cdc to hhs, and fema has been involved in the logistics of the current deployment, so it has not been consistent and Accountable Leadership for really making sure that number one, there is clarity of strategic intent, but number two, that the stockpile consistently delivers in support of that intent and that theres accountability and measurement of the success. I think a third area for improvement is the budget process. Its impossible for congress or anyone else to be able to budget to the stockpile if there isnt clarity about what its supposed to accomplish at what scale. What has happened all too often is that the tail wags the dog. So we may have ideas about what the stockpile should be capable of supporting, but the budget is the thing that determines what actually gets procured. The current budget going into this event was not adequate to provide for the kind of ppe that we needed for a panamerican Infectious Disease pandemic. In part, that is because there was not consistency in exactly what the requirements were for the stockpile and whether it was supplemental to the states or whether it was intended to be able to supply the full force. I think lastly, theres a real opportunity to improve the engagement with the private sector. As you have said, our supply chains are very problematic, and the people who know the most about that and have the most to contribute are people in the private sector who i believe would be only too willing to engage to think through how can we improve resilience, agility, and Surge Capacity in support of this Strategic National defense. The last point i would make is one that has not come up through the csis process, but as the Commission Moves forward, we would be very willing to take it on. That is that the stockpile is not a warehouse full of stuff. The stockpile is a capability, and it needs to be thought of not just in terms of what do we buy but how do we learn how to deploy and utilize those resources that the state, local, territorial, and tribal level, in collaboration with the Health System and the Public Health end users. That means a strong exercise curriculum, continued deployment, and utilization capability enhancement, and a cycle of planning and improvement that is inclusive of the frontline personnel. Ill stop there, and again, thank you for the opportunity to testify. Looking forward to the comments of my esteemed colleagues. Thank you. Thank you, doctor. Our next witness is dr. Daniel gersteen. Hes a policy researcher at the rand corporation. Prior to his work with rand, he served as the acting undersecretary and deputy undersecretary of the department of Homeland Securitys science and technology directorate. Before his time with dhs, he served in the u. S. Army both in active duty and as a principle director for countering weapons of mass destruction in the office of the secretary of defense. Doctor. Good morning, chairman johnson, Ranking Member peters, and distinguished members of the committee. I thank you for the opportunity to appear today, and discuss the future of the pandemic preparedness response and the Strategic National stockpile. While i will focus a majority of my remarks on looking forward, i do want to briefly assess the u. S. Response to date. In short, covid19 has exposed serious weaknesses in our National Preparedness and response systems. The United States relies on a just in time medical Delivery System that lacks resilience in times of crisis. We are also witnessing an inability to scale at the National Level to meet the demands of a Public Health emergency. Overall, the federal response has been slow and inconsistent, confusing at times, and has deservedly become a target of criticism. We have seen shortfalls in areas from the basic science to our Emergency Management government and doctrine, Strategic Communications with the american people. One particular concern is the Strategic National stockpile. Several key sns issues have been evident, including Unrealistic Expectations for the sns, historical underfunding of the stockpile, lack of timely decisions regarding energizing supply chains, and the federal governments altering of the mission of the sns during this National Emergency. Looking to the future, a Bipartisan Commission should be established to review the nations performance during this pandemic, basic assumptions regarding Emergency Management and Disaster Preparedness and response, including the role of government at all levels, should be on the table. One outcome should be an agreement that Public Health must be elevated to and receive prioritization and funding as a National Security issue. Just as the department of defense and intelligence community. Specifically, i offer five recommendations for improving our nations preparedness and response capabilities. First, reexamine the sns concept. Congress should ask for a complete accounting of the sns performance during this pandemic. The mission of sns should also be reconsidered. A new Mission Statement codified in law and not subject to the whims of any administration should be developed to signal the capacities and limits of the stockpile. The federal government owes this to the state and local authorities. It agreed stockpile concept must be stress tested and optimized through training and exercises to insure it meets the preparedness and response goals that have been set. Second, develop a National Strategic supply chain approach. Rather than consider the sns as a discreet element, it needs to be thought of as part of a broader National Supply chain that combines stockpiling and direct contracting with manufacturers, more production lines for some key commodities, procuring of large quantities at the National Level to take advantage of economies of scale, and shortening supply chains. The goal should be to determine the most effective and efficient methods for insuring critical needs will be met for envisioned areas. This would include mapping out critical equipment and supplies to allow for the determination of their availability over time. Third, increase Public Health funding. Years of underfunding of state, local, tribal, territorial, Public Health programs should be reversed. These shortages affect preparedness response for a wide variety of naturally occurring Public Health events, accidents, and natural disasters and deliberate attacks. During the covid response, the shortfalls have negatively affected staff support, the government leaders at all levels, via surveillance activities, contact tracing, stockpile shortages at the beginning of the pandemic, and broader supply chain issues. Public health shortages have also adversely effected the cdc and nih. Fourth, develop the Vaccine Distribution system now. An important part of the supply chain for this current pandemic will entail the distribution of the vaccine when it becomes available. While a vaccine may be ready by early 2021, much remains to be done to insure timely distribution. Planning should be ongoing now for administering a vaccine here in the United States and globally. Only after a large portion of the worlds population is immunized will covid19 be controlled. Fifth, reestablish u. S. Leadership in global Public Health. U. S. Leadership is needed now more than ever. International collaboration will be vital for understanding the spread of the disease and developing medical measures. We should all seek to repair our relationship with the World Health Organization while working to make the organization more accountable. We need the w. H. O. To serve as a conduit for information and to coordinate with other nations as the covid19 disease spreads to other parts of the world and for future health crises. In conclusion, some have called the Novel Coronavirus a black swan event, an event that is unforeseen. I reject this characterization. We have had ample evidence of a potential for a Global Pandemic. However, competing priorities, inadequate funding, and a lack of National Focus led us to ignore this potentially existential threat until it was too late. Unfortunately, well see more pandemic events in the future, given human activities that disresult environmental habitats, promote the mixing of species and allow humans and pathogens to crisscross the world. Efforts should be made now to ready ourselves for such a future event. Thank you for inviting me to speak today, and i look forward to your questions. Thank you, doctor. Our next witness is ms. Andrew phelps, the director of oregons office of Emergency Management. Previously, he managed the new Mexico Department of Homeland Security and the local preparedness program. He also serves adthe Planning Section chief. He appears before our committee today on behalf of the national Emergency Management association. Mr. Phelps. Thank you, chairman johnson, Ranking Member peters, and distinguished members of the committee for inviting me here today. Im proud to present testimony representing the National Emergency association. On behalf of my colleagues, we thank you for holding this. The 122,000 covid19 related deaths in the United States preventing loss of life our heartfelt condolences go out to those who are recovering from or grieving the loss of a loved one during this pandemic. Hundreds if not thousands of lives. Comparatively speaking, oregon has fared well. We utilized our entire Emergency Management system to support the work of our Public Health partners. We continue to adapt our structure to compensate for insufficient federal resources, for instance, there was initial confusion as to whether the c. A. R. E. S. Act funding would enhance or replace programs typically available in federal Disaster Preparedness. We expect action from the federal government. When it became apparent the allocation we began preparing on our own. To date, oregon has received only 15 surgical masks and 5 of the gowns we were expecting. While a major disaster declaration was appreciated, oregon requested 75 months ago. At least 44 other states are also this lack of commitment added to already uncertain financial landscape in this National Crisis. We also await confirmation and guidance regarding the use of crf powers and Critical Response process. This lack of guidance leaves states in limbo, nervous about improper spending, and slows our recovery efforts. Our experience in oregon is shared by many of my colleagues across the country. It has led to six initial recommendations for improving the capacity. We need to understand this. As keepers of the sns, the federal government state and local emergency plans rely on sns support. States need to know what they can or cannot expect from sns. Rather than only making a large stockpile we support the critical needs and standing with manufacturers. Throughout the response, the reliance on critical supplies for National Security and put states in an unfamiliar role. Some states the average delivery time for gowns in one state was 46 days. Sometimes faulty supplies, masks, counterfeit respirators or a fraction of what we need. We must empower states with resources. Relieve some demand on the sns. At a minimum some states receive some equipment, more equipment. Other recommendations will be in my written testimony. As a nation, overall, the failure in the system does not rest solely on the sns. Theres a lack of investment in the Emergency Management system at all levels have left us ill prepared. The supply chain needs transparency. We have seen a lack of expectation management. The managing of complex, statewide and these issues allowed for more sustainable and flexible responses for the states to utilize the sns to respond to any disaster with efficiency, confidence, and most importantly thank you for the opportunity to speak to you today. I look forward to questions. Thank you, mr. Phelps. I was able to hear you, but your audio is not coming in real strong. Your video looks good, so maybe you want to see if you have a different microphone when you start answering some questions. Our next witness is pl greg borel. Mr. Borel is the former director of the Strategic National stockpile, a position he held for 12 years. He served as director of planning for fema. He is the president and principle consultant for hampton grace llc. Im honored to continue to support the mission of this Critical Organization by testifying today. I had the privilege of serving as director for almost 13 years. I am a fellow of the National Academy of Public Administration and as chairman johnson noted, president of hamilton grace llc. For more than 20 years, sns has protected National Health security as the nations repository of medical countermeasures, both drugs and devices. Sns is a highly specialized and capability organization, but its utility for certain responses such as those for a nationwide pandemic event, are constrained primarily by a lack of funding. When sns was established as the National Pharmaceutical stockpile, the design was to develop inventory to respond to chemical, biological, radiological and nuclear or or cbrn threats. Over time, sns highly specialized medical logistics capabilities became apparent across government. As a result, sns expanded to an all hazards mission. But instead of mission creep, it experienced mission gallop. Such a leap in expectations couldnt occur without an increase in funding. Our appropriations have not kept pace with the growing burden to expand inventory and manage all hazards. It requires a threatbased review to find the desired content of the sns. The review is conducted under the auspices of the Public Health emergency of us a auspices of disease spreads and our specialized medical and scientific areas. Recommending content held in the sns. The top Level Committee is actually led by the hhs assistant secretary for response and includes the director of cdc, director niaid and other highly senior officials across government. This group makes the final decisions for the sns contents based on recommendations of the other experts. But because appropriations are limited, its necessary to balance a riskbased need across threats to purchase the best mix of products. When we try to buy down that risk. It is also notable the statute requires sns prioritized products simply unavailable in the commercial markets. Many things procured by the sns are purchased and held nowhere else. These, for example, include the only fda licensed antitoxin saved lives and reduced illness during the 2015 outbreak in ohio. Simply put, without sns pthese products wouldnt be allowed to manufacture. Any lack of national Public Health preparedness does not solely or predominantly rest with sns or any other entity but result insufficiency in Public Health at all levels of government. Compounding these problems, manufacturing and the nation must rely on a lean supply chain optimized and less than optimal for crisis response. Early 2000s congress authorized supplemental funds to prepare for influenza. Much product developed used to respond to the 2001 h1n1 pandemic flu and additional funds never authorized to replace that material. State, local, tribal and territorial another key piece of the preparedness puzzle and they have a vital role to play. These levels of government are responsible for planning and response in unique jurisdictions so federal assets can be called upon and used correctly when other options have run out. Prior to the 2009 h1n1, many states had their own stocks ultimately disposed of later. Public funding must be funded. Public health consistently and robustly funded. A long history of heavily investing in Public Health when its clear theres a problem. Further we move from significant adverse events, public memory fades and funds often decrease along with that. Our way forward must include more consistent mandatory funding for Public Health and include a greater emphasis on Public Private partnerships. The nation is better prepared with government and private sector working together for preparedness. I welcome the opportunity to work with fellow panelists, the congress and all other stakeholders to improve the sns in our Public Health preparedness. Thank you for the opportunity anding participating today. No doubt that were going to have to provide more funding for the teaching National Stockpile but the first step and incredibly important first step is it needs a Mission Statement designed and codified and articulated clearly. The om one we find is on hhs website. Ill read current Mission Statement for the sns. Stra teefk National Stockpiles role, supplement state and local supplies during Public Health emergencies. Many states have stockpiled, had product stockpiled as well. Not sure thats really true. Supplies, medicines and devices for lifesaving care contained in the stockpile can be used as a shortterm stop gap buff whir the immediate supply of adequate amounts of these materials may not be immediately available. I think we just described what the problems been. Strategic National Stockpile implies we have massive amount of well thought out supplies and weve got this, you know weve got adequately stocked to handle pandemic. Theres nothing in the Mission Statement that even talks about the level of supplies needed for a massive pandemic like were going through right now. So if thats the role we expect the Strategic National stockpile to play we need to articulate that. We need to codify that. So from my standpoint first step as congress we have to codify and articulate the Mission Statement that we intend. We need to assign the proper roles between local, state and the federal government. Then the next step is going to be to you know, lay up that list. Start with mr. Burel. Was there a different Mission Statement when you were head of National Stockpile . Has it been modified, reduced . Senator johnson, thank you for the question. I think that you describe the situation we find ourselves in extremely well. Originally we were working towards building stocks, as the doctor noted, to respond to biological terrorism, chemical, radiological, nuclear events. What weve seen over the years and more and more emphasis placed in the Strategic National stockpile to be prepared for all hazards. Unfortunately, funding has not followed to be prepared for every hazard. Particularly a nationwide pandemic. What weve been able to do is concentrate on that primary nation we felt from the beginning, and that is establishing stocks of cbrn material that dont exist anywhere else and developed cabinets to be ab cabinet capabilities to respond and responded i think successfully to the h1n1 pandemic and coming back to issue, what is the emphasis the congress chooses to give the sns and how can it be funded to meet the many requirements its called upon. At what level . I mean, to be the sole supplier . To stockpile or manufacturing capability to provide every n95 mask . No responsibility for the state and local governments to stockpile . Again, theres such a lack of clarity of what that mission station is. We are going to stockpile these kinds of supplies. Okay. At what level . In my briefing i saw with elobo weve stockpiled 50 50 ebola kits. Now, 50. Fortunately we didnt need all of those 50 but might have needed thousands or tens of thousands. In the case of this pandemic, we literally need hundreds of millions if not billions of some of these supplies. So ill ask the dr. Do you agree, the first step define the mission what this is . We can talk about what inventory is, but unless we really know what its mission is, what its role is and what state and local government roles are, were still completely blind and will come up short. I cant hear you, doctor. Are you thank you. That is exactly what i hoped to try to emphasize in my written testimony and oral comments. If we dont have a consistent and clear strategic intent, that the whole of government agrees with and when i say whole of government i mean state and local, territorial and tribal. Not just federal. Were just bouncing around from the last crisis to the next crisis, and not really consistently building that level of preparedness. Thats why one of the main recommendations from the csis report is that we establish permanent leadership of our Health Security at level of National Security council who has accountability for articulating among other things strategic intent of the stockpile to support the level of Health Security our nation intends to achieve. We have a in number of different situations, cyber, bio defense now here, seems like the recommendations of these commissions have been consistently somebody has to be in charge. Then i dont disagree with that. I dont necessarily think its going to be that person which should lay out this Mission Statement. I believe this falls to Congress Working with the administration, possibly working with that individual to codify what this, this statement is so that Everybody Knows what the role is, what the level of the role is. Go ahead. I agree with you, senator. I believe that the National Strategy for Health Security is a responsibility of the National Security council, but congress is the bill payer, and obviously, in order to build the stockpile we need, Congress Needs to direct the strategic intent in support of the National Security agenagenda. Never the less, a great help to have that clarity and consistency from congress. Mr. Gerstein. Appreciate your testimony. You laid things out quite nicely. Once we established that Mission Statement, you know, were going to have to then identify the items, have to figure out certainly what the inventory levels and manufacturing capability needs to be, but i think you hit it in your testimony. This shouldnt, i dont think this should be filling a bunch of distinction warehouses but looking at the entire supply chain 23figuring exactly how it flows through that. At what level do we have excessing products and how do you keepmoving. Would you ay agree. Hit it on the head. We are focused on this particular program and set of facilities, but i think it goes broader. Its actually understanding where supplies come from and making Strategic Decisions about how to satisfy the requirements we anticipate. There is not enough money, unless we completely redid lots of different programs, in order to outfit for every envisioned scenar scenario. What we can do, understand where supplies and equipment, reagents and such will come from and be able to map those in and determine, what are those choke points that we need to resource or have manufacturing here in the United States . What are those that we can outsource . We need to understand the timelines in which we can satisfy those. So id like to see it as part of a broader discussion. The sns definition is absolutely essential starting out. But then we also need to, on all sides of that, talk about things like stockpiling and direct contracting and production lines and procuring large quantities. We need to have agreement with the states and the locals in terms of, what are they going to do and what are the federal responsibilities . Its very important so that the expectations on all sides by all stakeholders including industry, who is an absolutely essential stake holder, needs to be able to come to the table and talk about how they would assist in this process. Im out of time. Let me make my final point. I think we absolutely have to change the name of Strategic Management stockpile. Its misleading, i think. One of the components of what we need to do here. Well have to stockpile some things. This is more a coordinating role. Similar to fema, we rely on local governments to do what they can do first. When they cant handle it states step in. Cant handle it National Government steps in. Certainly things only federal government can do but a far more coordinating role. For colleagues as we look at potentially legislative fixes for this i first suggest we need that Mission Statement and a new name. Otherwise well continue to mislead people and have them believe that literally theres all of this ppe sitting there and in stockpile. Why dont we have our fair share . Why cant you supply us everything we need . Again, frustration, and its legitimate frustration, but because we simply dont have the supplies to meet the enormous demand in this type of situation. With that i turn it over to senator peters. Thank you, mr. Chairman and thank you to each of our witnesses for your very comprehensive opening statements. Appreciate your testimony here today. I want to spend a little time focusing on supply chain, which has come up repeatedly in testimony as well as in some of the answers to the questions from the chairman. So my first question is to mr. Burel. Certainly this pandemic exposed our countrys reliance on Foreign Countries to provide critical medical supplies to us, and particularly china, which manufactures critical drugs and medical supplies. In fact, last year i released a report from this committee identifying vulnerabilities and called for action to address what is fundamentally in my mind a National Security threat given our reliance on these foreign entities. My question to you, as former director of the sns for 13 years, whats your opinion on a reliance on foreign suppliers for critical drugs and medical supplies . And what steps specifically would you believe we should be taking in order to address this threat . Senator, i am as concerned as anyone else about our overreliance on foreignproduced products and significant issue we face in this particular event but in all events as well. Something disrupting that supply chain outside the United States and we cant do anything about it domestically, we have a significantly worse issue than we would otherwise. Some of the things i think we can do is encourage manufacturing to come back into the United States. I think we also have a responsibility to expand those Public Private partnerships so that we can understand what its going to take to get the private sector to come back and do more manufacturing, and how they can create more robust capabilities themselves, whether it be more manufacturing, additional security stocks to fill finished products. Additional security stocks, for example, in the drug world of active pharmaceutical ingredients. I believe we must encourage continued relations with the private sector and a strong comprehensive cooperative way so we can together find the best way forward, not just for these events but for all Health Care Needs in the United States. We see drug shortages routinely and many are impacted by the situation you described. Thank you. Dr. Gerstein, same questiberdin. Addressing this National Security threat . I do. I mean, i think that we have to make known what the requirements are going to be. That the federal government in coordination with the state and local and tribal, territorial governments sees as what will be required for a pandemic. Or for any sort of event that we intent to have the sns or whatever follows it. You know, whatever we intend to have is the set of scenarios. I guess, you know, it all comes down to, really, mapping this out very methodically and sundaysing the types of scenarios we intend to be prepared for and building resilience and flexibility into the system. This virus has been very different than, say, what we faced in the h1n1 in 2009. Or during ebola. You know, if history is any indication, we need to design it with a great deal of flexibility. So i would say that we should rely on u. S. Innovation. We should get with stakeholder communities, including the private sector, and we need to figure out what their capacities are. Some cases we do need to have warm lines available that can be turned on very rapidly. We know if its going to be a Global Pandemic were going to face the exact same set of circumstances with a globe competition which is unhelpful, and but its a, its a matter of, you know, whats going to go on for other nations to try to get supplies that they might need. So we need to be prepared and build in resilience. And its make no mistake, though, senator. It will cost money to prepare for this, but we have done this in other areas where we have pry prioritization and should do it for u. S. Public health as well very good. The point about how we have to have more information, i think, is significant. My understanding is that asper does not have the information to inform planning for the Strategic National stockpile or protect Critical Infrastructure such as essential manufacturing plants we may have here in this country. For example, asper should know the location where those manufactures plants are for some of the active ingredients. The apis and other critical drugs. Actually ive introduced legislation called the part act address this by actually requiring the fda to share certain manufacturing data with asper and the d. O. D. To help serve the drug supply. Maybe your comments on what would, what Additional Information required by this act, how would that help us prepare for future pandemics, natural disasters as well, National Security threats. Mr. Burel, ask you to comment as well. Youve focused on the lack of information what they have. What are your thoughts, doctor. You hit it right on the head, senator. We need to understand in the same way that other corporations who are riding supply chain support, i wont name them, but i think we all know who many of them are. They know who theyre suppliers are. They know what happens and where, you know what their lead times are and what happens if their supply chain is disrupted. So they have developed a Business Model that makes sure that they dont ever run out of those items with the supply chain. And we need to do the same thing. We need information. One of the problems that occur, interestingly, when you had the transition from cdc to asper and then during this immediate pandemic to fema providing some sort of support, an interesting outcome was that it wasnt clear that fema knew where all the stockages were. So they didnt have the initial understanding of what was remaining in the stockpile. You know, fema is good with management and logistics but they do it for, you know, the source of supplies they typically rely on for natural disasters and such. And you know, this is a very specialized set of requirements that is inherent in the sns and so not having that information is a little bit like trying to make allocations with blinders on. Thank you. Im out of time now. Mr. Burel well get back for your viewpoints as well. Thank you for your testimony. Thank you, mr. Chairman. Senator portman . Thank you, mr. Chairman. First, i want to thank you all for having the hearing and for our witnesses and this is a critical issue not just with regard to the pandemic but going forward. We need to change our approach. I agree with the chairman. There needs to be a mission clearly defined. I also agree and struck by mr. Gerberdings comments about the lack of consistent Accountable Leadership and ive experienced some of that dealing with the issues of ppp, but when you go from cdc to asper to dhs to fema, to dla, there is a lack of consistent leadership, and certain accountability. I know there is inner Agency Groups as an example, mr. Burel talked about that teal with the contents of the Strategic National stockpile. The problem is there doesnt seem to be consistent and accountable and Performance Measures not in place to be able to keep people accountable. So missions a good idea. But leadership to me is critical. I wondered, dr. Gerberding, since you raised that issue, if you could comment on what that leadership ought to be and perhaps mr. Burel, you could comment on that as well. Dr. Gerberding, are you there . Yes. Im on . Can you unmute me, please . Can you hear me now . We can hear you. Okay. Tell us what your solution is in terms of leadership . Wish it was that easy, sir. As i tried to express, people think of the stockpile as the warehouse of stuff we buy and store. But it really is a capability. There are different aspects of capability and they may not all need to be under the same roof. For example, asper probably is the right place to do the contracting and procurement for novel countermeasures that need that nih, barta, procurement and management of those contracts and processes, but the stockpile utilization and planning is a very operationally dlriven effort. To me, thats why you have operating agencies like the cdc, whos intimately connected with the users of the stockpile and in a great position to be able to understand what are we aiming for . Where are the gaps . How do we plan, exercise, plan and make sure it meets local requirements . In my world i think the accountability for of operation of development and exercise management of the stockpile is best suited for an operating agency like the cdc, but the aspect of the contracting and procurement of these new and novel countermeasures and the other things that may be on the innovation forefront is the kind of thing asper and barta are designed to do well. It isnt a onesizefitsall solution, but you can hold the accountability to the leaders responsible for their specific Performance Measures and requirements. Thats not what really happened. Im going to ask you to to think about that a little bit, because you said leaders, plural. If no ones in charge, then its very difficult to hold one entity accountable. So i would challenge you on that, and i think cdc, if you say thats the operational entity, it certainly didnt work this time. Im sorry. So i would challenge you to just give us some more clearer guidance as to how you get exactly what you identify . Absolutely rights you neat consistent, Accountable Leadership. Senator, can i just quickly come back to that. Why we need the National Strategy, and i do agree. One person needs to have the accountability. My own view is that person should be the director of the cdc, because thats been my experience and my framework for that. I dont have specific responsibilities and i think its that sort of having an accountable leader, plan horizontally and make sure you execute vertically with the appropriate measures of success. Okay. Thats helpful. I will say im also intrigueed by what ive heard today about our lack of understanding of the needs for a pandemic like this but also the reality that, of which, with regard to cbrn. Everything else out there the stockpile was supposed to be to are initially including a nuclear attack, lets say. Cdc may not be the right entity for that. The center for Disease Control. Not for a biological or nuclear attack, which would be more of a war footing. I think we need to do thinking about that and figure out what is the right leadership model to go along with the appropriate strategy. With regard to this issue of ppe and the stockpile. My great frustration we dont seem to be doing obvious things to reshore our ppe. And i would ask the question, i guess, of the entire panel here and see who would like to answer it, but do you agree, one, we need a reliable source of ppe in the stockpile. And, therefore, do you agree with me we ought to be reshoring ppe. Not all of it. Depending on, again, what we find is the real mission of the Strategic National stockpile but some of it, enough of it to be reliable. Something like a pandemic, you cant rely on Global Sources you might otherwise because they need the ppe also. Certainly weve learned that in the last few months. I have a real frustration with the executive branch not providing longTerm Contracts. Because for domestic reshoring youve got to have the market signal youll have a customer and that customers going to be the u. S. Government towards the stockpile at the National Level. It may be the states, it may be even some private sector entities that are given responsibility here, but we dont have that now. Dla is issues contracts for 90 days right now. So my question is, do you agree we need to give industry this clear signal to build up our capacity and do you think that it is necessary to have a reliable Surge Capacity . Senator youre on the video. What do you think . Ill start just by saying that we have to understand from the standpoint of ppe we are supply constrained. Doesnt matter in the stockpile or the Health Care System or the state. We have a supply constraint there. First and foremost thing to concentrate on, remediating. Yes, i agree the more we can build out our National Capacity in that regard the more secure we will be in the context of a Global Pandemic. Your other point about longterm contracting i couldnt agree with more as the company just got an ebola vaccine licensed and are under contract to fulfill is certain number of doses for a stockpile. What happens when that ends . Weve built a factory to make this vaccine and will be sitting with idle capacity because there really is no future there. You wont have investment. I hope you and the other panelists as well, my time is up. Let me just say today im sending a letter to dla along with three other republicans and three democrats asking for them to change their policy with regard to the 90day versus a longterm contract so u. S. Companies can make that investment with certainty, able to bring ppe back to our shores. Thank you, mr. Chairman. Is senator carper ready . Mr. Chairman, by the way, could i ask unanimous consent to have that letter made part of the letter . Absolutely. Without objection. Senator carper, are you available . I am here. Okay. Go ahead. Thanks to the witnesses. I dont know who lined up the witnesses, but reminds me of new york yankees back in the 1930s. Like a first row. What talent. Nice. In reading through the testimony, rereading during this hearing, in looking at, mr. Gerstein what you said about recommendations. You made five recommendations. Im going to repeat them and ask that the other three witnesses have them agree with you on any of these five recommendations. All right . Thats the question, going to be muy question. First recommendation that you make is to reexamine the Strategic National stockpile concept. Can we just say for those of you who agree with that, raise your hand. If you agree with that recommendation, reexamine the sns concept raise your hand. Okay. Some of you are raising two hands. Thats okay. Secondly, develop a Strategic National supply chain approach to developing that, Strategic National supply chain approach. Do any of you a glee with thaag, also raise your hand. All right. Okay, mr. Gerstein not agreeing with your own recommendation okay. Thats okay. All right. The fourth one is to develop relaxing Distribution Systems relative to two hands on those. Good. And finally, to reestablish u. S. Leadership in global Public Health and do you agree with that . Yes. Well, good. All right. Well, a lot of support there from your colleagues. Always good to hear, senator. I wish i did that well amongst my colleagues. Good to see that you enjoy that position. I have a couple other questions, and this next question is for all of our witnesses. Just take a moment to discuss importance of oversight . Thats what we do on this committee. Pay us big bucks for and also point to the jos high todo li list. Provides this committee every two years specifically with routine information on Government Programs help us do better jobs in conducting oversict. Actually high risk. The National Strategic stockpile managed and overseen by several different agencies over the years. It appears that effective management would require agencies partnering with each other and with congress to ensure that the stockpile has the resources and management needed to respond to a National Emergency. Question. For all witnesses. What additional action can congress and the administration consider taking to ensure of effective oversight in stockpile is contacted on a regular basis . Anybody want to take a shot at that . Go with dr. Gerberding. Thank you. I dont have a short answer today, but as i do cochair the cias commission, i with former senator ayotte oversee a panel of incredible experts and some bipartisan members of congress in both senate and the house side. Senators young and murray and Congress Representatives esshoe, cole, barra and i forgot my fourth member. I apologize. The point is we are wellpositioned to be able to perhaps provide advice on that issue, and would you interested in doing that. Your own colleagues. Okay. Thank you. Same question what initial action should congress and the administration consider to ensure effective oversight and stockpile contacted on a regular basis . Mr. Burel, would you like to take that . Several Different Things that can be done. I have a fellow in the National Academy of Public Administration and napa has done a good job in the past making recommendations to congress about how to manage Government Programs, how to think about Government Programs. Napa might be an excellent source to try to get involved in thinking on these things. I think one of the things i would suggest is the good thing about the oversight would make people more aware what of sns does and needs and how to move forward. So i think to help, suggest a comprehensive oversight structure beyond what exists today, i, as dr. Gerberding suggested would like to come back to you with additional thoughts on that. And ask our other two witnesses to answer that question for the record. A different question related that id like to ask. Mr. Gerstein and mr. Organization such as tasked with regularly reviewing the stockpile and reporting on its ability to respond to the National Emergency what senator, this is dan gerstein. It i understood, you broke up a little there but i think asking about, should an organization such as jo do periodic reviews, and in answer to that i would say having been subjected to many reviews during my fairly lengthy service in government i would say absolutely. The reviews will be important. Especially given that we are talking now about redefining what the sns is, thinking about turning it into an element within National Supply chain for Public Health equipment and supplies, and all of that, it is really something that is going to require somebody to take a look at it. On the issue that you also, that was also brought up had to do with, i use the military term. Command and control. I think its going to be very important to understand and the gao is well suited to look at this, and to determine, know, if were moving in the right direction with respect to whos going to be in charge . Whos going to have oversight and authorities to be able to manage this process . Thank you. Same question. Organization such as jo tasked with regular reviewing this . Very briefly, please. Yes, absolutely. Help with identifying performance metrics, evaluating efficacy of existing performance metrics and help with expect and management. We at the state and local level have a better idea what you can expect and a plan mr. Chairman, then to i think i dont have many good ideas but might be a good idea and something we can do every couple of years. I sure there would okay. Good luck, everybody. Okay. Appreciate that, senator carper. So everybodys aware, next senator scott and rosen, langford, holly, romney and hasan. Senator scott . Sure. First of all thank you, mr. Chairman forgings this. I agree, comes with exactly what our mission is and if you have the right mission and have the right funding you probably get a good result. I appreciate as governor of florida we went through quite a few hurricanes and didnt just sit and wait for the federal government to the show up. We created our own stockpiles, food and water, tarps, things like that. To make sure we were prepared, because we didnt, cant expect somebody else is going to always be able to take care of you. I think we have a lot of people across the country trying to figure out how to put ourselves in better position for the next pandemic. While also trying to figure out how to make sure we have all the right protective gear just with this pandemic. I know as i talked with some of my friends in the health care community, still struggling with getting the right protective gear and part of it is controlled by fema, which might make a lot of sense. But weve got to change how we do this. All of us learned we cant trust china. Communist china. We know now theyre our adversary and im very concerned we do anything in the future that continues to rely on communist china for any part of our protective gear, or pharmaceuticals or anything because we know theyre not a reliable partner. We have to figure out how to produce american goods. Also have American Companies ready to ramp up the time we have the next pandemic. I prospose a bill, american mad protection for Health Care Workers and First Responders act. Basically what it requires is, whether its through stockpile or through Companies Getting ready in america. We build up america capacity to take care of our First Responders and deal with the next pandemic, and i just want to get yalls feedback how important it is to reduce our, our our reliance on communist china and hour important to make sure whether through stockpile or through having americanmade companies ramp up we have americanmade products ready for the next pandemic . Senator scott, appreciate your question. I think its vitally important to our preparedness overall that we ensure as many of the products we need for essential health care be made in the United States so that we can control the supply chain for the better. So that we understand how to protect it better. Weve done some work with the Health Care Industry Distributors Association to map locations of manufacturers, but we cant reach back to active pharmaceutical ingredient manufacturers for example or components of devices because theyre outside the United States. I think we need to have as much capability in the u. S. To do that as we possibly can. Weve got to work with the private sector to understand what its going to take to really bring that back to the u. S. What they need. Whether its the longer Term Contracts mentioned before, which i also support. Or anything else we need to do to help encourage them to do that work with the federal government and for the public. I know they want to do that. And i would say to your comment about fema doing buying. I think fema can be a great partner for the sns and anyone else, but as said previously, some of these are very unique items. To try to buy the right things that are licensed and appropriate for use, i think hhs and sns are best qualified to help direct that. Particularly to direct how we work with bringing manufacturing of those critical items back to the United States. Thank you, sir. Thanks. Mr. Gerstein and ms. Gerberding what do you think of inability to rely on china in the future and importance making sure americanmade products . Senator, ill start off. I mean, i certainly agree that we need to take a look at the supply chain and understand those critical elements, if you will, that are on the Critical Path to be able to have the capability that we need for a future pandemic. But i would try to inject just a bit of, a dose of reality on a couple things. The way our supply chains have stood up with respect to things like active pharmaceutical ingredients, some of the ppe. These have been made through economic decisions that essentially have been turned over to industry, that is, you know, those that are providing the health care. So if those kinds of commitments are to be made, its going to be more than just, know, putting out a pronouncement. It also has to do with looking at subsidizing the medical delivery industry to be able to incentivize them to want to be a provider, to bring the manufacturing back. We should also recognize there are probably some elements that we are not all that keen to bring back, if it can be done more cheaply, and theyre not on the critical pass. We need to figure out that Critical Path, those issues. The other thing i would say is we do need to think about the International Role in global Public Health. Or in our national Public Health, said another way. So while there are frustrations with some of the ways in which china has gone about, know, with transparency and such, we definitely need to continue to rely on a global system, and that was why i recommended in the fifth recommendation about trying to repair our relationships on the global Public Health stage. Ms. Agagerberding . From the cis perspective i think we are trying to frame our Health Security in the same mental model used for other elements of our National Security. In that sense we might want to have the same outlook on how we manage our Critical Pathway supply chain we would if we were thinking about how we outfit our department of defense and in our foot soldiers. In that domain we would not want to be interdependent on an interNational Supply chain, i dont think we should do that when it comes to protecting the health of americans. Yeah. I think thats a good way of thinking about it. Right. Its no different. Buying supplies for our military than trying to keep our, our public safe. Its the same issue and we should think about it the exact same way. Ms. Phelps, did you want to add anything . I think that reliance on foreign supply chains causes a couple of problems at the state and local level. We saw fema do something pretty innovative, and brought to states in the process on where ppe is going and many cases to the point fema to hospitals that caused problems for us and the problem is very frustrating for us based on n 95 mask to purchase and no longer suitable in Quality Control is a problem as big issue if not bigger than relying on thank you. Thank you, mr. Chairman. Thank you, senator scott. Senator rosen . Here i am. Thank you, mr. Chairman, and Ranking Member, for bringing this important hearing here today. I want to thank all of our witnesses for their life time of hard work in this area. Preparing and planning for emergencies, pandemic, disasters. Hard work. Its good work, and we appreciate you there. Of course, were talking about the supply chain, the federal response. According to Johns Hopkins, the United States is now over 121,000 deaths from covid19. Recent Data Analysis shows 70 to 99 of the deaths from the virus could have been prevented. However, there is still time to make a difference based on how we proceed. As dr. Fauci recently said were still in the first wave. So with this in mind we must continue to respond to this pandemic with urgency. Our response must be timely, targeted and thoughtful. Different parts of the country are experiencing the pandemic at different rates with varied timing. We can and we must protect lives and livelihoods, and we have to do better than weve done before. It does require a strong National Strategy and a process for delivering key supplies to all of our communities, and we should be constantly correcting our actions to be sure that we improve our response. So i know we need to improve transparency and in the supply chain, of course, all recommend that. I believe you should have used greater use of the defense production act in our national response, but to mr. Burel and mr. Phelps, talk about rural areas. Seen fewer cases of covid19 compared to urban areas but have felt a real impact of this pandemic. Huge scarcity of supplies. Access to c. A. R. E. A challenge especially more remote areas of nevada. What specific recommendations do you have in how we might improve responses for our rural areas, critical testing supplies, ppe what changes might you recommend . I guess mr. Burel, can you go first, then mr. Phelps. Thank you, senator. We have long recognized that there is a vast difference among the states and the localities and available toll to respond. Personal assets, material aspects to respond both from Emergency Management perspective or from a health care need. I think that we need to continue to create better relationships, stronger ties, with state and local government. So that we understand better what some of those unique needs of those rural localities, for example, are. Just as we might consider a dense urban populated area and how to respond to that differently, we need to think about the same thing for a rural area. I think for the states to be able to establish stockpiles that are independent of the federal government, as many of them had some years ago, to try to help supply those rural areas directly as we bring in more product. They have a better understanding. We recognize the states and the locals have a better understanding of what they need for support than the federal government does, and if we position them to be better able to support themselves, i think that the response would be stronger in the rural areas. Thank you. I actually am going to senator hasan has another another call. A chance to be on. So im going to yield the balance of my time back to senator hasan, if everyone doesnt mind. Thank you. Thank you so much. Thank you, senator rosen, so much, for your graciousness and the chair for accommodating it and my schedule and to all panelists, thank you so much for your work in this area. I wanted to ask a question first to dr. Gerstein. Obviously we have to improve the distribution of strategic stockpiles during a pandemic. My state of New Hampshire like so many others struggled to get the basics and when they did get supplies from the National Stockpile many items were unusable or expired. Its not enough to say we have a stockpile. Our stockpile has to be sufficient and it has to be up to date. What best practices do you recommend that the assistant secretary for preparedness and response implement to ensure that the Strategic National stockpile supplies are adequate and also rotated and distributed before they expire . Well, thanks for that question. I mean, obviously, you know, the rotation of stocks is a big deal. Its a very expensive process. The federal government is spending about 570 million a year to maintain the stockpile, which includes the rotation and it includes moving things through and restocking where necessary. You know, i would also say that improving the stockpile is also going to come down to things like dr. Gerberding talked about. That last mile. Its an training the state and local. You know, its not that theyre they just had a different focus at the state and local, tribal territorial level. One of the things federal government can do assist with training on some of these very complex medical countermeasures. Things like nerve agent antnecd toxin nueurorx. Need pushed down into the state, local, tribal territorial. One of the calls we have is, once we get the stockpile, the way we want it, we needs to exercise and stress test it hard to make sure that its doing what we think and that all partners, all stakeholders, can truly be confident it has been developed. Thats where i would be interested in seeing. And one other question to mr. Burel. Strategic National Stockpile consists of variety items some shelf stable. Some needing refrigeration and most requires regular rotation before expiring as we just discussed. Does the sns maintain a National Database of every item in the stockpile including condition, date of purchase and Expiration Date . Senator, we main thain ta information in a National Database we rely on for the kind of product rotation we do. Also we invest in assuring ke were extend life spans where it is chemically and scientifically proven we can do that with particular drugs as long as possible to protect the nations investment. The other thing that would help us is if we have the ability to lets use the term sell off stock as it nears its Expiration Date and realize the income from selling off that stock so that we could invest it in new stock. Right now we dont have that option. Well, thank you for that answer. Kind of begs the question why the administration failed to provide a clear picture of disbursement over the past three months. Im take that up with them. Thank you for your service and thank you, mr. Chair. Senator lankford . And then holly and romney. Mr. Chairman pick up on what senator hasan as talking about, explanation. An issue needs resolved long term. You mentioned before about the authority to sell off. Two philosophies here. You talked about frequently. This is not a big warehouse. Storing things at this point, its not that kind of structure. Selling off things is one way to do this. Managing the stockpile in another location that is with the producers, that they actually manage it at that spot and then do regular rotation to be able to move out is another way to do it. Are you trying to determine whats the right way to be able to do this . Have it, own it, then be able to ship it out once close to explanation to sell it with loss, be replenished or maintain locations and a normal turn there . Senator, we already engage in what you describe. Call it intermanaged inventory. The problem is much of the material we hold, we hold in so great a quantity that the market cannot absorb the rotation of that material on a regular basis. We have to hold those large quantities to protect the u. S. As we discussed pandemic, seems need even larger quantities of something. There is a lot of logic in using bigger managed inventory where it makes economic sense and done a lot of work when i was there to do Economic Analysis where that vendor managed inventory works well and saves the government money, versus the government owning it itself and then trying to dispose of it in some other way. So youre saying you need legislation for those resources that we own that we could sell before expiration . We need legislation that would allow us to sell off product before it expires, but also to realize the income and have it not go back to the general fund. So that we can use that to buy replacement for that product or to buy the next generation of product in that line, or to buy whatever else the stockpile needs that day. All right. So i think reasonable request and i think something our committee should be able to work on as a result of this hearing. Do you have text youre proposing or just an idea you propose jrchs thank you. I proposed text previously and will send it to you under separate cove. Thank you. Appreciate that very much. How do we avoid the pendulum swing inevitable that Strategic National stockpile is not just about a virus pandemic . Naturally occurring. Obviously a lot of other issue, k Chemical Attacks and other things we focus in. The natural pendulum swing, werent ready for this. Do whatever we can and take out of eye off the ball that other areas. What are we doing to be strategic in all areas not just overcompensate for one. Again, thats an excellent question. Concerned about that and always concerned not having enough money to cover the entire waterfront of known threats including pandemics. I would suggest that we consider making the Strategic National stockpile or the successor organization, whatever we think we need to do here, mandatorily funded at a minimum level to be able to manage and rotate current requirements at the time that that mandatory appropriation is set. I think we can continue to grow the stockpile beyond that. I think there are a number of things that can contribute to that whether additional supplemental appropriations as new requirements are identified that cannot be covered in a mandatory appropriation, whether it may be, for example, setting up a capability for the stockpile to receive donations from philanthropic organizations to reinvest the Sales Authority i spoke to before and so on. We certainly, we talked before about supply chain. Thats significant issue for all of us. Ive seen some for military, for instance. Where its not just the manufacturer, the part, the plane, the whatever it may be. The product. Its the products that go into that products, obviously again supply chain and asked the question, who actually manufactures the manufacturers and manufacturers and start working your way back to identify it. I hope a process is in place already like that, and that yall are working through not just whos the contractor . Whos the subcontractor and subcontractors to the sub. Talked about precursor chemicals for pharmaceuticals. Most obvious here. Dependent on communist china for precursor chemicals. And it may not be the product, but the Rare Earth Mineral that goes into that product is 60 to 90 from communist china. All of those areas, how indepth are you going actually pursuing the supply chain . Senator, we struggled this over years trying to make inroads in this area. In just the last several years, in fact. Much of that supply chain beyond the, that precedes that finished product is extremely opaque to the federal government and the Strategic National stockpile in particular. We understand that many private firms want to closely hold the information about their ultimate supply chain all the way back to the earliest item in that, that constituent product, but weve got to understand better what that comes from, because only then would we be able to say to you, we are particularly concerned about this product, because the only act the pharmaceutical ingredient availableability comes from china or some other location and were concerned that we may not be able to get it. We would need your help to allow this Strategic National stockpile to reach into fda for date a they hold and ask for Additional Data around things like what is the api source of all of these critical products . With the authority to insist that we get that data. I know that that is concerning to private sector. So do you believe you and your organization should house and track that . Or someone else to actually manage that supply chain and delivers it to you . Sir, a thii think sns could if but expanded to do that work. Well placed under assistant secretary for preparednesses and respond work across that organization with barta, knows about the products theyre buying maybe in more depth they commercial products and with Critical Infrastructure group that exists, combining that some way with the sns to figure how best to understand that supply chain all the baway back to the precursor product, i hope we could do that and work on authorities to break down barriers getting access to that get the information. I appreciate how youve talked about local entities have to be prepared. We found for the ppe that hospitals and clinics and such had only days supplies there. They also werent prepared for this. And there was a wide assumption that it would wed be able to get ppe when they needed it. That proved not to be true. Grateful for what youre doing and helping the local to be better prepared for next time, as well. Thank you. Senator . Thank you, mr. Chairman, and thanks to all of the witnesses for being here. Can i start with you i want to ask if i could a couple of questions about stockpile levels and replenishment after the h1n1 and you wrote about factors that required replenishment following outbreak. Ive seen that it drew down 100 masks including n95 respirators from the stockpile. Is that right . Do i have those figures right . I no longer have access to the exact data, but i believe that your numbers are approximately correct. Its my understanding that a federally sponsored h1n1 task force recommended replenishing those masks and supply. Is that your understanding . Yes, sir. Do you have any idea why the Task Force Recommendations were not acted upon . Its a matter of appropriation to make those purchase. All were made with supplemental Funding Authority that we were provided to prepare for pandemic. That funding after we used those products was not reauthorized. We never received funding to do that again. We closely guarded what we had available in the event it needed to be used again. We need more funds to be able to address the cbrn threats as well as emerging Infectious Disease threats. Let me ask Mother Nature about the funding. In 2012 i believe it was, the hhs secretary at the time, kathleen sebelius, was asked to explain the rationale for why the administration, points administration, was proposing cutting 48 million out of the stockpile funding, this was at a house hearing, and she responded that resources ought to be focused on replacing expiring countermeasures such as anthrax treatments which i think we probably all agree are very vital. Im wondering if you think enough attention was being paid to restocking ppe at that time . Did you ever get the sense that when it came to the stockpile that in the balance of things ppe was really being prioritized . Sir, what we try to do is prioritize the best that we can do across threat levels based on available funds. We look to the fmc that i mentioned earlier to help us make those priorities. A reality is many of the drugs we need for those events would never be produced and would stop being available if we didnt invest in those. Unfortunately, when we do that, that leaves limited Funds Available for many of these expected to be commercially available items like ppe. So to your question, i think that we have to prioritize both in some way. But the problem is the funds dont support being able to do that. So if we give up buying cdrn drugs, theyll not be made. We also see we need more of the commercially available product. In your view, what should have been done differently following the h1n1 pemek pandem restock the ppe . I believe that she should have had available funding so we could buy what we use and replace that, maybe thats something to think about legislatively such that every time product is deployed from the sns there being automatic funding for replenishing that. I also think that we never achieved the full amount of product to be prepared for a complex pandemic such as we face with covid. To build the stock to the place it should have been for pandemic influenza even. So there were additional funds needed then. Very good. Thank you for that. As we look back, theres a lot we can learn from this recent experience. But as we look back at about choices that were made in the past, we arrived at the presents crisis clearly at a deficit. And i think weve got to take steps to make sure that that does not happen again, particularly with something as basic as ppe, which was not adequately provided for in the stockpile. Thats a big problem. Doctor, let me switch to you if i could. Id like to discuss more the dual role that sns plays in our crisis response. I know the chairman and several of my colleagues have raised issues about the stockpiles mission, and youve been discussing that. Lets talk about it more. You write in your testimony that we need an effective balance in the stockpiles dual mission and said it covers Public Health threats and biological, chemical, radiological, nuclear threats. Can you elaborates Mother Nature on what you think that effective balance is and given the resource constraints that we were talk discussing . Thank you, senators. I use the expression the tail wagging the dog, and i just think when you listen to gregs testimony, hes basically saying the same thing. We have a finite budget, and so we build a stockpile to utilize the budget, but we dont necessarily build a stockpile to address the threats that implicit or explicit are on the table and part of the planning scenario. So you know, the history of the stockpile has flexed between one point of view and another. But i think always in the background, the intent was to be assured that the stockpile was able to handle the all hazards or cbrn threats. And thats been, as greg said, an area where if we didnt invest federal dollars in those countermeasures, we would not have those countermeasures. Were not done yet. Ideally, in my point of view, the thinking about those bioterrorism excuse me, terrorism threats, the allhazard threats, is we need to be thinking not whats the countermeasure for this but really what can we do to take this threat off the table. And that happen mentality is not afforded by the current budget approach that we have to the Strategic National stockpile. But we have revealed how vulnerable we are to those kind of threats. I dont think the Terror Threat is any less today than it was in 2001 when we were dealing with anthrax. In your experience, when you think about the roles that sns plays, Public Health, bioterrorism, has one of those typically been given priority over the other in your observation . Well, independent of the Strategic National stockpile alone, i think broadly speaking we fight the last war. So we have an anthrax attack, so we make sure that wont happen again. And then we have a sars, so we go to sars. And were constantly responding appropriately to what we needed to learn from the last problem we had. But we dont consistently forge ahead in the prospective sense to assure that were broadening our preparedness, not just adjusting to what we missed last time. What do you think of the idea of creating a separate stockpile just for the procuring and deployment of ppe and a disease outbreak . I dont think that would really help things because what ppe and disease outbreak materials are necessary would largely depend on the nature of the specifics of the biological threat. Its really hard to draw a dividing line. And the capabilities and the planning and exercising for that are going to apply to a much broader set of issues. I think by segmenting that out you would create a redundancy, and to some extent theres an overlap between the ppe you need for covid and the ppe you need for an anthrax attack. So its hard to separate them. Given the fact that ppe was not prioritized after the last major pandemic and we entered this crisis at a very significant deficit of which it took us quite some time to recover from and given your testimony and mr. Burrells about the lack of the the lack of available funds to do everything that you would like to do, wouldnt creating a separate authorization and funding stream be something thats useful . Its always worth looking into. I do want to emphasize, however, that the ppe bottleneck is a supply constraint. And in order to improve the availability of those materials, we really have to create the capacity in the market for us to tolerate an inventory. And right now, those products are commoditized, and theyre purchased really just in time in most Health Care Settings. They dont keep a large inventory because they count on the availability of the turnover. When suddenly theres a surge in demand, there is no pipeline of product to flow into it. So the stockpile really has to create the bubble in the system. That wont be efficient, as greg has pointed out, because those materials will be at risk for expiry. If were trying to build a stockpile for efficiency, weve already lost the battle. I see my time has expired. Well follow up with additional questions for you in written form. Thank you very much, mr. Chairman. Senator . Thank you, mr. Chairman johnson, and thank you to Ranking Member peters for this important decision. Thank you to our witnesses for joining us to discuss the Strategic National stockpile and its role as part of the coronavirus response. As you all are aware, arizona is a growing hot spot. The number of confirmed cases, positive test rates, and hospitalizations have increased dramatically since the end of the stayathome orders in the middle of may. We have lacked personal protective equipment which has stunted our Testing Capacity since the pandemic first started. And of course, significantly contributed to our states current dangerous situation. Arizona still ranks in the bottom quartile of states according to data for Johns Hopkins university. That leads me to my first question for dr. Burrell and mr. Phelps. When we realized that state and local supplies of personal protective equipment and allocations from the stockpile would be grossly inadequate for arizonas coronavirus response, i moved to help our local manufacturers switch their production lines to making ppe. I was inspired by the dozens of local businesses and manufacturers in arizona that shifted or retooled their production and Manufacturing Capabilities and began producing face shields, masks, gowns, Hand Sanitizer, and other needed ppe. These are Companies Like amsafe in phoenix, wl gore in flagstaff, tyr tactical in peoria, click tech in scottsdale. Our breweries and distill reece began producing Hand Sanitizer and donating them to food banks, First Responders, and local businesses. Arizona State University and entrepreneurs like the van hoof dental studio in tempe, have used 3d printers to produce the nasal swabs and face shields needed to stand up Community Test sites. My question is how do we make it easier for the stockpile as well as state, local, and federal governments to partner with these types of domestic suppliers who step up during a crisis but dont normally produce these items in the regular course of business . Thank you for your question. I was the recipient of several questions from Small Business that wanted to try to help. And many of those wanted to try do it in more of a philanthropic way than anything else. They knew that they had capabilities to make something else, and they wanted to be able to donate those for use where they were best needed. So one of the things that we need to do is we need continue the ongoing outreach from the Strategic National stockpile to private sector partners. Maybe we need to think about how to widen that audience from that Health Care Marketplace that we normally talk to, that weve talked to frequently to other businesses. Another thing that would be helpful is i have been able to watch over the years the Cdc Foundation support the cdc in its mission. So to provide for the Strategic National stockpile, to have an outlet, a capability to work with the foundation dedicated to the Strategic National stockpile, to help look for those philanthropic new capabilities and so on and bring those in to bear through the stockpile or directly to states and locals when they need hem i think would be useful, as well. Senator, from my perspective in oregon, we were overwhelmed by the positive way of the outpouring of support from our private sector partners. We saw as you saw in arizona a lot of distill reece producing Hand Sanitizer. We saw our athletic Manufacturing Companies producing face masks. A lot of this equipment wasnt meant necessarily for medical use but for individual citizens to use as face coverings, some of those individual protective measures. I think we can empower and make a little bit easier for these private sector partners to integrate with the system. We stood up a website early on that allowed manufacturers to indicate what they could offer, and we would do outreach to those manufacturers to plug them into our system and incorporate them. Ultimately in a state like oregon, four million people, it was a drop in the bucket, frankly. We really rely on the mask producers to provide medicalgrade equipment to protect our First Responders. I will say that the private sector and the resources they brought to bear certainly had an impact on limiting the spread, the Community Spread here in the state of oregon. The other issue with a lot of these requests to assist, it forced a lot of time tracking down whether or not there was a viable resource. Everyone seemed to have a cousin who knew someone that could produce or procure masks. We wanted make sure we were getting the resources that would ultimate help our medical frontline folks. Thank you. Im going to move on my next question for dr. Burrell. The initial allocation from the straage to could National Stockpile was based on population size. There were additional supplies of personal protective equipment and ventilators going to states with the highest level of need. That hurt us in arizona because our lack of testing made our case load appear artificially low at the beginning of the coronavirus. What recommendations do you have on how the stockpile and other federal resources can establish a better allocation process that is more fair and equitable and takes into account testing inconsistencyies which, of course, are likely to be present in any pandemictype situation . Thank you. Im just start. I think there is a situational dependence here because obviously in this case the pandemic didnt rally out simultaneously around the United States and was initially at least concentrated in certain places that had higher needs and whose Health Systems were very overwhelmed. But i do think thats an opportunity where advanced planning and exercising could be extremely informative. I looked at arizona. I know something about the population of demographics in your state. And you and i have talked about that. So you know, wouldnt surprise me at all that there would be a fairly high need natufor person protective equipment in arizona. That is something in the process of planning ahead for this kind of situation that need could have been better recognized and would have been a factor that could have been better considered in the allocation process. I agree with the doctor. Its situationally dependent. One of the things that we had at the Strategic National stock pile when i initially became director was a strong tie to Public Health Emergency Preparedness at the state level. And to a certain extent even at the local level. Unfortunately, the decision was made that that resided would better reside in another part of cdcs organization. At that time, the sns lost its direct tie to the states and to the localities. I think that we need to reestablish those. At the time that we did that work, we used a tool called the Technical Assistance review to really understand what the demographics were, what they would really need, and how we could better do allocation in the event of this type of of a concern. Thank you. Mr. Chairman, i see my time has expired. Thank you. Thank you, senator. And again, i want to thank all of our witnesses. I think this has been, first of all, an incredibly important hearing, but also very informative one. I cant thank you enough. I really want to work with a number of you moving forward on this incredibly complex issue. We need to emphasize how complex this problem truly is which is why i emphasized from the very beginning we need to articulate exactly what the National Stockpile needs to accomplish. You know, what those capabilities are, what the responsibilities are between local, state, and the federal government. So it starts there, and then you start once we have that established, then you start really dealing with the complexities. Again, i thank you all for the participation, look forwards to working with you in the future on this, as well as my colleagues not only in this committee but also within the senate. The record will remain open for 15 days until july 9th at 5 00 p. M. For statements and questions for the record. This hearing is adjourned. Today at 1 15 p. M. Eastern, President Trump will be in cleveland, ohio, giving remarks on the economy. You can watch live coverage of the event on cspan3. Weaknights this month week nights this months were featuring American History tv programs as a preview of whats available every weekend on cspan3. Tonight at 8 00 eastern, a look at the end of world war ii. August 6th marks the 75th anniversary of the u. S. Bombing of hiroshima, japan. That was followed by a second atomic bomb dropped on nagasaki three days later. Watch a special edition of American History tv and washington journals coproduction of the hiroshima anniversary. Well look at the strategic situation in the Pacific Theater leading up to the bombings. President Harry Trumans decision to use the new weapon, and the legacy of these atomic attacks. Enjoy American History tv this week and every weekend on cspan3. Our next guest served in the Obama Administration as acting labor secretary, hes currently visiting professor for Public Affairs at cornell university. Here with us to talk about the unemployment and the job situation during the pandemic is seth harris. Good morning. And we have you here just a
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