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Time and i want to make sure that we have just think our panelists and prepare for our next panel which is terrific and pleasing run join me in thanking the panel. [applause] [applause] [background sounds]. Will come up we will move on to her second panel. Im very excited is actually i want to say that i have a good friend doctor Janet Woodcock sue is the Principal Deputy commissioner has been at the fda for a number of years and is helped reorganize and restructure offices and centers. And is probably one of the best executives i know in the public and private sectors. She has always been willing to do the hard work that others are unwilling to do make the hard decisions. And then continuing have a brain trust doctor mark mccalla, who ran to federal agencies including serving as fda commissioner and so, im an a internal printed so this is fun for me because we are going to spend time talking about how to fit agencies and organizations during the pandemic it, biomedical innovations and convex work pretty well we got vaccines we had therapeutics and took some time i have been in record time and all of this probably sitting here today probably because those things actually happened eventually got them out into the community and the Public Health infrastructure unfortunately, operated largely in a silo. Fragmented the kind of locality events. As we think about the agencies are three primary agencies inac the cdc and the fda and the nih. They all function very differently during the pandemic and so my hope was to spend time talking about how the fda successes and it was not perfect but it did a pretty darn good job. What we can learn from that thinkingng about how to fix the cdc and the nih Going Forward and making road right more robust Public Health infrastructure. And doctor Janet Woodcock, a few thoughts from you. Well, i dont want to criticize my fellow agencies but i would say, we do not have a systemic approach to medical chronic testing in response. Its very very fragmented and all of the showed like with the pendant make a right. The cdc struggled i think a great deal because of the distributed nature of the Public Health system. In another country, that had more nationalized Public Health system in Healthcare System as well. Were able to respond more like systematically because they were unified some kind of central approach coming unified approach. So i think that we suffer from this you know which we celebrate our federated nature but we also for victims of it to some extent because yes, from fda standpoint think the Public Health data about the vaccinations and its effectiveness we relied on scandinavia in israel. Dated everybodys beating up on us and why are you putting that into but they had all the information and i do the biologic centers who had set up etsurveillance programs and for the health records. The vaccine, was vaccinated was not in the medical records. Because it was done through different system. In the states with their own privacy laws in their own approaches, we could not get those data. So we could not link adverse events or outcomes like what did you get covid19 or not, we could not link that to whether you are vaccinated or not so we were unable to draw conclusions about vaccine efficacy and safety from the real world data in the United States and the cdc had a relatively when you say small, many thousands of people, so they had academic link program they were using for that but then its a small data that we had some really bad problems with the false signals which is what you get with small data and incomplete data and so forthle r the vaccines, adverse events and there really really safe should be right and so you need hundreds and thousands of exposures to look for adverse events or you should see only have a few hundred people that you dont have a viable vaccine right so what i think that that was repeated in the same for mr, to me if i am talking too much. Okay, so the same for say the Clinical Development programs was a therapeutic operation warp speed and so we find a getting a lot of stuff that was fairly successful but there was not a Clinical Trial network in the United States that we could utilize. E the industry does in the United States most of the development Clinical Development work and frankly, pandemic planning that u. S. Had done, presumed there would be influenza. It will be treatments already in diagnostics already everything. As of the Clinical Development and the evaluation was something completely neglected in the sense of thinking about how large of an effort that would be in at of the day, is industrial effort, the Clinical Trials and so forth, in the United States that actually gave the leading data that we were able they did the vaccine trial. Operation warp speed they did the therapeutic trials and got but not totally got these treatments available Vaccines Available whereas the uk is able to put together a recover Child International Health System in large pragmatic trial that showeder a very cheap agent and steroid are useful linda late stages disease, ards type of problem and mark you probably remember in medicine even in medicine medicine for 40 years about this whether or not steroids us shouldn be used in rbs penalties for this type for covid19, the related respiratory failure the steroids proved to be lifesaving and now the cornerstone ofov the therapy and so we were only able to do that she widely available could be used in any country in many different relations were able to show that because they had a network a Clinical Network rapidly assemble Clinical Network and also one more thing before i stop and im sorry but i talked to martin one of the prs w and uk and with his permission i point landrys law and his law is the number of Patients Enrolled in any site is inversely proportional to the number of professors. And i would say that the nih networks are all Academic Health center and i said all right where is the industry preferred sites are usually not because theyre focused on patient so forth. And actually were the words that delivered industry sites and i will stop there. Of a question something we all have thought a lot about, what makes an agency successful. And agencies are organizations just likefu businesses, one of things we talked about performance metrics and accountability and clear budget, how do you think the fda is distinct from the cdc and the nih in that regard. I janice point, very clear nationally focus mission we dont have state and local you know review boards, we have one National System and i am concerned about some of the recent court cases that have come to challenge some of that but we have one National System that is able to put a lot of expertise into answering questions about safety of the drugs and you just heard janice say if we move into having that far from perfect but better market look funny Data Available and learning a lot more from realworld evidence and overall, for fda try to clear the metrics and so a lot of the budgets and biologic centers related to enable to get the clear guidance. In all of that came in very handy in the covid19 response in do you want to like backup little bit in talking about the metrics where i think there really are needed as you know, this well we were both involved in a covid19 Planning Group effort which was insupportable could potential to be a Bipartisan Commission we look at what working with did it and people were just going some issues now but that is why any kind of deep thoughtful bipartisan effort after 911 we done for other Major National crises. This whole effort was fully god and we do not get that commission but there was an effort by centerburgr, and marie last congress and so get that over the wind. Some of the other legislation to prevent act, this one did not quite come together so is very important to have meetings and discussions like this to think about what worked and what did not work and probably get past some of the high level talking points of people have been one of the things we got in this effort was the reality is a little bit different to what ise different people are 700 summarizing one of the things that most critical here is that we do not have as soon a unified National Strategy for you bring o different components of the federal government together so that they can do each of the things that they need to do as part of an effort for National Response in a crisis like this and support the responsibly our federal government and federal country every part of the country has somewhat different governments and institutions and capabilities that could be a good thing were so diverse. That means that youak need fedel support to make it easier for these things that can and should be done at the local level to be done effectively in fda, working with industries, was able to do thises especially for warp speed and a signature the pandemic getting vaccines works go and massproduced and available for the other component more problematic than you mentioned the goal for cdc and also roles mask proof or a critical Public Health agency with all of these flexibilities towi deliver care and support. The cdc tried as well to get back to some of the failures in all of these areas but we have the best treatment vaccines we had by late 2020, largest availability of good diagnostic tests including the ones people use it all, we did real problems and translating that into impacting part of that was a cdc is been vying for the talk more about that as well and part of it think goes beyond that but because any Infectious Disease Going Forward requires a different kind of response we had in the 20th century, no longer good enough to go door to door and finally got local spreading infection and try to understand this and grow it in the lab or whatever and from now on, these infections can potentially spread globally super quickly but we havent t technology to manage in any threat should be something we should be able to sequence since no monthly in a matter of days. We should be able to produce large scale and test basic Technology Make those available not only in Public Health labs but health Court Advocate organizations that do most of the testing around the country and we seenti this happen with response out and we should have treatments offtheshelf to know what kind of virus or infectious agent this is we can try to abide testing framework then was talking about quickly. We have Synthetic Biology that enables us to make them monico antibodies and other wetechnologies treatments in a matter of weeks to months so that they can work and factorem them a scale have axes also but we also need along without, a capacity to engage the public so they understand what was going on what we do or dont know every step of the way starting to detect the infections and hopefully understanding it and taking good steps quickly to contain thread and respond to that requires just the cdc, but also the assistant secretary for preparedness and response and it requires the Healthcare System to act differently but we had her growing responses during the pandemic it, york of the parts of the country road to person repeatedly by successive waves we have struggled a bit more within to janice point, engaging people about whether they want to get vaccinated or not. Identifying people at high risk make sure they had test available and access to treatment in the community and communitybased privateht healthcare is much more and even some really bright spots organizations that cut out there and already doing like virtual and he knew the high risk patients were in the test had discussions with Treatment Community Health Workers to help teach them about a person country we just dont have that infrastructure in place. People could bringld in temporay you know Vaccines Centers football stadiums but that is not really an infrastructure that is geared to the fact that for any Infectious Disease we gotta be able to identify quickly and identify where and how spreading containment through these other stuff it requires not just the. D accountability of the cdc but i think the accountability in healthcare as well and think about where we are moving in a Healthcare System and more housing can we identify health risks before they progress and and apply it into virtually every problem today. It is notot only medical respons that we need but that is an important part of it is so there is a lot to learn here we have not really put together yet that are why do not think that is a part of this set of issues but i really appreciate us coming out here to talk about it talk about some of the problems and opportunities and hopefully for the rest of her time we cant. In some senses not necessarily even surprise that the cdc struggle because we didnt actually necessarily set it upt for success right becaue we test the agency with a it printed addressing Public Health everything. And then we are surprised when this once and century pandemic and the focus on that variety of other components of Public Health and that readiness andnd response function atrophy. Monkeys you have a limited overall you know then relatively flat over some decades to help h the budgetary challenges in the Great Recession of 2008, and having the ability to cover recover by the time covid19 came around and this is unlike fda which is a National Pressure forgetting safe and effective treatment of people right now, and using it for the health and cdc, genocide is very much a federal agency and so most of its limited budget goes to will kind of a passthrough cdc oversight for the state and local Public Health offices, ffthere over 3300 seen local Public Health offices across the country, and with limited grant funding, and that funding through the way they appropriate through a bunch of different silos. In the Emergency Response and about other good Public Health goals, to your point, smoking sensation and Maternal Health, and filling in gaps in our Healthcare System and around Infectious Diseases and hiv patient biggest fire our Healthcare Providers. And its understandable that it is hard for them to put all of that together. I think there is about forward in a new cdc director and incoming cdc director talk about this partnerships here and maybe more partnerships with fda has certainly more partnerships the state and local levels withit yu North Carolina and some of our effectively responses were getting onto the Rural Communities and he was there entrusted well, like the egg Extension Services in good point of contact for the farmers and frontline Healthcare Providers within need support to do this is something that you know whato the cdc couldel help them canto it alone in healthcare and social service could be involved as well. In the cdc and staffing and culture built around that could help. Is very Broad Mission and if you look at the cdc what they have on the website and for the Public Health is called Public Health three. Zero recognizing that Public Health is certainly not just about hygiene making sure the water is clean and thes foods are safe and so forth an important collaborations with the fda there and i do but also about all of these opportunities with technology in medical technology and all of the opportunities and have behavioral choices and constraints of people face and influence of the Public Health outcomes, and so broad and i think about budgets and about 13000 per person, in healthcare in the United States and about 3500 or 4000 on social services and all those things and about 300 per capita think 15 maybe in between the cdc funding and other federal state and local Public Health funding, and you know this is gotta be a partnership. Absolutely although i would say the question would be what is the return on the investment of the population an investment in the disease in the cdc is the right leverage to do that and should another agency be taking on some of this maybe had more local or state level rather than a federal level, that would allow the cdc sort of to blossom in the Pandemic Response and Infectious Diseases response and perhaps have a different workforce. Will the maybe starting to go in that direction and i think that this is another area where is a i really productive to have discussion about how can you do t the better because Healthy People and 20 or 30 so these are all goals out there. [laughter] and so like will whos exactly supposed to be doing what to get there. Will often, every year we make new goals every ten years this population keeps getting worse and so were not doing something right okay and so. Knowledge about behavioral nonmedical example skin from Public Health and i have a better drugs than ever before and could contribute to all of this and cdc does not have the budget to be held accountable to get to those goals by themselves and were starting to see in many of the Healthcare Organizations, the priorities and we heard about the Service Payments and paying for accountability andou for Better Health outcomes so more payments andar Healthcare Providers safer diabetes. Did you swing your population effectively. Hemoglobin levels indicating good diabetic control through a whole combination of neckism ins . Mechanisms . New diabetes treatments. Food is medicine prescriptions, help with engaging people in help with engaging people and using personal help apps to get healthier. That is something that cmf can help with. I agree with your point about faith and local levels. Seeing a lot of really indicater work happening across the space. Indiana, North Carolina, massachusetts trying to have this around people and have some tracking accountability at a local level for the equivalent of these. This is way bigger than something that the cdc can work on speedy mac i absolutely agree the federal level or better at the state level or even at the local level. Who was most effective to undertake this and coordinated . Along these lines, i had ati question for you. I was thinking about Clinical Trials, how the biomedical inflation complex. We are all thankful for that. The nih is a powerhouse for basic science. In what do you think, or do you think that there are lessons for what shoot on 10 what we should focus on speed mac i have long been an opponent sponsoring Clinical Trials. They ought to think about the infrastructure, funding and infrastructure rather than funding what i call this. This small very not good trial. They have traditionally funded as part of our one agreements and so forth. W what we lack in the United States because we have left Clinical Development to industry , that is fine doing it effectively and so forth. When a crisis arises like this or for Public Health issues, industry will not necessarily pursue, right, because they have a different object if. Inwe really lack an infrastructe k to do that. We have the opportunity. We can harness realworld evidence. We can do large scale experiments. Some of the things you raised, mark, they cry for cluster randomization. We have had this for 30 years. They have not made progress. We need evidence driven or data driven intervention. Even social intervention rather than best intention intervention that we keep doing they are not working. I dont think that they are set up for that. I dont know the answer for it. There isp a big gap in the pubc sector ofnd research. That is a huge gap on the clinical. I want to ask you about diagnostics. A covid diagnostic really took off at confiscating a billion dollars for the program and they put in a program, they developed standards, reference standards and, you know and so forth. Exactly. An algorithm and they help with. Manufacturers are sending us covid test and they tested them in 30 people. They were supposed to be used by millions. They did not work. If we offered a standard evaluation protocol that the thirdparty could do, we could run those through very quickly and got them on the market. The data would have been generated. A known testament is something used in the Telecom Industry all the time. That is what i mean. This is not rocket science. They were all out there. Little diagnostic companies. This and that. They did not have the clinical and people could not get a hold of the variance, you know, and so forth, if we put these standards in place, you could run a lot of different diagnostic tests through their very rapidly, give the evidence the fda would be standardized. We would not have to question it, we would not have to inspect. That is what happened when all these tests became available because it could be easily, clinically evaluated. Directly to consumer accounts. Rapid response time. It can be really, reallynt valuable for containing an outbreak. You and i are big proponents. Realworld evidence in moving trials out. Into a broader, you know, Larger Community setting. H da should have a map of communicable trial apparatus. They should have that. Part of clinical care. So, what do you think that the nh offer could target to help prevent that . I think if da can do further assessment for healthcare, too. The current commissioners as well to try to make progress. The hardest thing about doing trials in a realworld setting is you actually have to deliver realworld care. The solution, lets just expand our funding for traditional trials by bringing in, you know, protocolol reviewers and local oversight trial conditions and data collectors and all of that just does not lend itself to the delivery of care and routine practice. Healthcare organizations are pretty stressed these days financially. The good news is that we have a lot better electronic data than we used to do. A lot of the data that matters for payment is pretty darn accurate. We have Healthcare Systems that are no longer working at the oneoff clinician level. Not talking about a traditional small crummy trial that would have come from one academic at this one institution, pairing with a few of his or her ufriends, where you really would worry about is that particular clinician really implementing objective standards and right though right kind of process and are they collecting data accurately . Systems that have systematic implementation of electronic record systems, clinical protocols supported by emr, whole teams of people working togetherol. Holding those individual clinicians accountable for how exactly is the trial going in the same way that we did in the old style, it just is not right and getting to ways of kind of certifying Health Systems as having good patient protections, consent, oversight, good objective data collection, that they are already using for their own care and their own payments in many t cases based on that data. That is the future. I do not think, janet, the nih funding for these platform kinds of practical randomized Clinical Trials or frankly a lot of the fda oversight regulations have yet, you know, matched up with the potential there. This morning before i came down here talking to the people in the uk, a group they were on the revision of the good clinical practice guidelines, the pragmatic trial list which is really what we are talking about here have staged a little bit of a revolution against that at which is appropriate. Trials should f be for purpose. There are not regulatory trials that we should decide what decisions you will make out of that information and you should design the trial to yield that data and information in a reliable way. I think that we will be revising,w including revising o was responsible and how can you distribute it. Sending out some guidance and information on that. Wewe have to recognize that the world is changing, the way things are done is changing. That would have, you know, the question, brians question is what would have enabled the u. S. To put together more rapidly, okay, Clinical Trial say out of warp speed. I have a tremendous amount of problems getting that done at enough scale. Right. They were small networks, but, you know, we did not have the kind of scope. Because, uk, the recovered trial managed to be incorporated agencies eventually and test them. They did a lot of repurposed agents. That could be a good use for the nih research efforts. Helping come up with realworld evidence measures. How do you clean e hr data, for example. You would need a group that is focused on clinical evaluation and methodology. Okay. We have some. I am talking about an institute, and institute, right. Where the department of clinical evaluation around the country . This is a sideline for most people. It is not supported by robust grant. I think even for nih the traditional role could be, if they sort of open their eyes about this, at least to support, not just the basic science, but the clinical evaluation and the science of clinical evaluation, that may be nih through role outputting the actual evaluation itself. That may be ahe bridge too far. I think thats a really good point. I think i could rapidly decrease cost and increase access all in one specific policy change. It may improve the quality overall in the United States of theub investigations. Roi published on the fact that most of the trials that were set up in the United States back the hundred by the Academic Centers were inadequate. They were not inadequately powered. They could not answer the questions. Tens of thousands enrolled in trials that were not able to answer questions they were asking. So, you know, raising the levels of expertise around clinical exploration, i had to bring in people fromst industry and they were the people who knew actually how to do this and get this done. So, you know, we just do not have that sett of expertise in the government except maybe laugh mac here and there. You really need a kind of machine to really get this done. This would be a significant change. Om Something Like that. I think the other pieces are lining up. I work with a group called advancing Clinical Trials which includes a number of these Health Systems which to jans point just do not feel like the premarket Clinical Trials are answering all the questions. What are the longterm effects of these treatments . What do i do about drug interactions . Is this the right dosage. If i have a side effect, what is the best way to manage it . Those are possible questions to answer in a Clinical Trial. They are exactly the kind of questions you could answer if you have much larger scale platforms and arere focusing on lethe key Data Elements to collect. We already have a good understanding of major side effects, mechanisms of action, things like that. And, these organizations, you know, these are the kinds of questions that we want answered. Around cardiovascular disease, drugs, diabetes, drugs that may be very helpful for prediabetes, obesityve, not known yet the consequences for the longterm use at higher dosages, newer treatment for neurodegenerative diseases, alzheimers. Iet have not quite seen the nih, you know, big change to get there. Th one other possibility may be the new funding for a program for advanced transformative projects. Maybe a jumpstart here around a few platforms could lead to the desired goals of the program. Faster better evidence and transportation. They just, there is a study published and this sounds like we not done this electric compulsive therapy versus ketamine for severe depression, all right, and, you know, thattl is a little edgy. Those are the questions Healthcare Systems and insurers need to answer. What should we pay for . They have this chronic disease and they have been on this regimen, they are not responding or whatever you need, what should we go to . Right now, well, my mentor taught me this. Extent your small crummy observational studies . [laughter] yeah. And art instead of a science. That is right. Evidence driven. That is much of healthcare right now. And yet it is amenable to hypothesis driven evidence generation ifit we would only organize it a little bit. That means, like mark said, those that would be participatingrs, they have to se the value of this information to them. Yeah. I think that we will open it up to questions. My microphone is coming to you. There you go. Thank you. As a data person, we have more data flying around in this country that we are not using well. I guess i am thinking of leapfrog. About 20 years ago revolutionized getting hostile datain. Abcd scorecard. Pretty simple to understand. Yes, there is data behind that they are gathering to determine abc or d. What did that lead to . It led to value based contracts because, guess what. Insurance companies do not want to send to they will have to pay for, nor do the employers to a t hospital. So why we cannot take that lesson and more fit. I will give you one example of an Insurance Company who decided to pay for getting people to walk companion dogs for people at end of life because that companion dog delivers more value to that person than any other thing. We have an example of what is going on in the private side. We are not morphing to the public side. It is about time that we grow up a country and learn from what is going on in the stance of care going on from North Carolina, utah, massachusetts and et cetera. Thank you. Great point. [laughter] it just highlights how important it is to shift out of the traditional way we paved in Healthcare Hospitals andth institutions andac recognize tht all of these factors influence health peer to make that work, though,em like leapfrog really emphasizes, measure what really matters and create a way of aligning payments with that. A lot of it is happening with the private sector, as you said. Medicare programs, publicly funded, privately delivered with some accountability and there are some things we can do to improve that program. Very much in alliance with the stuff weve been talking about. I would say the challenges and measurement. Have a network, we dont haveil the ability with scale in the real world and we spent billions of dollars on translational research, publicly funded, but dont have these sorts of questions in mind. But we do know the measures. Patient experience, caregiver experience, caregiver tools that can help them they are not as widely accepted and they are not as widely used, but that is where policy can make a difference. Regulatory stuff like janet was describing, these measures digitally collected, remotely, could be used for Clinical Trial, practical trials, may be put emphasis on paying for what people really care about. Prthat could help in these approaches, to. I have some friends who are actually involved in some of these programs implementing is micromanagement. So, you want to value the outcome, not micromanage the people. Because then they have to fill in the providers a lot of forms. I did this and then pretty soon they are spending an hour on all of this stuff that they can dream up that would be helpful for the patient. So, the design of the Program Needs to be evaluated. I think Medicare Advantage is that to some extent. There is moree we could do. Evidence base. Does this actually change your behavior . Right. Having that infrastructure to answer that question quickly. Thats right. Because we dont have that. We dont have that. Right. Talking about vaccinations and football fields. I would take that a step further and say its time to have the football field be the vaccination site. We should have the plan in place and the machinery ready to set that up quickly. I think a lot of lessons we are pulling from is we need to be pragmatic and we need to be flexible and ready to go. A lot of our infrastructure is not that way. Infrastructure that is sitting there unused and has billions of dollars spent on it every year is not necessarily what we need. We need the ability to rapidly scale and deploy. I think you need creativity in advance. When wehe had, we got them developed, we paid for them, we had them in hand that we could not deliver them. I was in charge of that for quite a while until i aged a revolution about it. We could not deliver them. Who do people turn to . The ambulance services, the emts were fabulous at this. They knew their communities. We had to send it to them, okay. I think the Expansion Services for rural areas, they could pair up with the emergency emt services and they could deliver, who do the people actually interact with . Who do they work with, who do they trust . Who was there and how would we arrange to send them stuff so we reach all of our population. The football fields work if you live near a football stadium, but then you need the personnel to give it and so forth. I really think in times of peace we should not just think about the Public Health system and all the people in here, we have to think of who is capable. You are also talking about a decentralized system coupled with central organizations. Having ems is not having someone in atlanta, you know, boston, chicago, telling them what to do. They get the supplies they needed maybe theres some federal coordination, but that is often a local or state effort because we cannot underestimate their importance. Great. That is where we need to think about that in advance. It took us a while. We tend to mobilize those people. Dialysis centers. They are good with ivs and stuff like that. The home help people were able to help with delivering the monoclonals and so forth. We had to dream all of this up in the middle of a crisis and then reach out to these people. Some of these Community Organizers in different communities were fabulous at organizing vaccination and delivery off therapeutics to their people. But they were not the people that came to mind instantly. Some good examples of everything except for the good news, the challenges, how you make that scalable and how you make itn easier to replicate and the same financially. Most of the funding for that, some of it will come from Public Health as i have talked before. There is just not a whole lot of resources there. A lot more around social Service Programs for many states, indiana does a great job of integrating eligibility programs, precision programs and their social programs can help a lot with these issues and linking it to Healthcare Providers who are trying to address social needs for individuals. And on the healthcare side, lots of Healthcare Providers around the country are playing key rolls in local and state public responses. The best responses around the country were invariably a combination between state and local government and Business Leaders and especially healthcare leaders including ambulance providers and so forth. But, we are not systematically giving them the data that they need. We have fragmented Public Health data, healthcare data that could support all of this with further steps likely than talking about in cmf and our big healthcare paymentt program. I hope that that is an area for progress. There are some states and localities doing it well. This is all connected back to your point about what are the goals we are trying to work on together. Co where can we get to more real accountability. Are we truly ready . Have we done a stress test for the next Regional State response to a Public Health emergency with the right kind of federal support . Are we doing the right thing to address other localc Public Health threats like opioid use disorder, Maternal Health inequities and things like that. I think going to that, actually, localities funding to very narrow [laughter] so they end up with 1520 different funding streams or tiny bits of money with broad goals and no flexibility to organize them. Thats not the right way to do it. Not at all. I want to give you an opportunity to talk a bit about various Regulatory Approval processes, the acronym eua became familiar to all of us during the pandemic. I wanted to hear a bit about the role of different pathways to approval especially duringg a pandemic. How they are functioning, how they could be doing better. I think its important to talk about this. People can get confused about why things get approved, why things can be revoked, why it can take time to get full approval and so on. What is the role with all of this . . I think the emergency foster eyes asian pathway is a very good one and function very well for the country. It enabled the fda to get out things. What it basically does is it is no longer investigational. You dont have all the informed consent. It is deemed as good enough in considering the emergency that it could be made available, authorize for availability without, you know, being investigational anymore. Without all of the Different Things that along with that, on the other hand, it does not require, thats, i do think, is what confuses the population. Four example, for the vaccines, probably some of the largest ever done. We had a huge amount of data on ngsafety and effectiveness in te spirit we were not cutting numbers there. All sorts of things required. We could do all of those things and have the flexibilities with the eua. I think the major problem with it is to confuse the public and thinking it was a lesser standard overall and they are getting substandard stuff where we taken shortcuts. Of course, this was combined thwith the social narrative that was out there that was very confusing to the medical community. Like this wasth some kind of plt on the public. So, i think we probably need to pay more attention should Something Like this happen again to how we position this and what the narrative is around why we are doing this. We tried, but nobody is really good at communicating extremely well these more complex concepts enduring an emergency. But the actual mechanism functions extremely well. The fda put out dozens of ua products. Then, okay, revoked, it would be revoked because more data came out or there was a better alternative that became available. That is hard to explain to the public. That happens c all the time in medicine. A cancer drug and then we get a better one. Nobody is using the old one anymore because something more effective or safe or came along so, explaining that Natural Evolution that is accelerated during crisis, it is difficult for the public. Another issue we have not solved yet is effective communication. Especially in an emergency when the Knowledge Level improves and changes quickly, but lots of unknown and conveying that in a way that is accurate and practical is another area i think where more of these partnerships could be helpful. Cdc can be a good source of analytic information, especially if they are able to get good data. If you look at National Polls across republicans, democrats, people getting their information from different frames, they do have commonalities around trusting their local healthcare provider, clinicians, trusting others in their community that could be ally, could partner. Talking about extensions and things like that before. That is a different strategy for not only describing what is approved but for helping people get the right practical information for them from a trusted source about what they need from them. I dont think weve solved that problem yet either. We had a huge Partner Network , consumer organizations. All kinds of organizations. We had weekly phone calls with iathem and we gave them materias and we gave them talking points and we answered their questions and everything. It was still very difficult to get the sort of reliable and valid information out everyones hands. That may have been for other reasons, but i think there was a big effort to bring in local communities and recognition that those are the communities we reach out to. Those are the folks people listen to and trust. We are a country of countries. That is for sure. Thats right. [laughter] yeah. Well, i have one question i wanted to ask. Sort of burning about diagnostic testing. And, so, originally when we actually had the early stages of the pandemic, we did not have access to test. There were a variety of reasons why that happened. I guess my question for each of you is what do you think we should do to make sure that that does not happen in the future . As i said earlier, i think we ought to have a very rigorous plan and the plan is what mark said, we get the virus or whatever it is, the agent, we get it in, there is a collective, systematic effort to deliver Reference Panels, we get other possible interference, we get all of that and make a panel and then we invite people, industry academic labs, cdc whatever to contribute to that. You need a gold standard. We can do these, you can do the blots and you can do the pcr and everything on this Reference Panel and you can characterize it. I cannot even emphasize enough what an Important Development to all that is you will have to do testing of robustness and proficiency testing and so forth like that to make sure that the test is in peoples hands. Having these Resources Available to various parties so that they can do Rapid Development and generate the evidence needed, but we have to have a plan to do that rather than just put the plan together. To add to that, i think there ist a lot of agreement on, thee are a lot of issues on how do we respond to Public Health emergency. Where i think there is agreement is the technology is there to make available very quickly, there will be other test to build on it or more rapid findings and things that people can do on their own at home, but through our existing Laboratory Network including not just the Public Health labs which we relied on at the beginning of covid and not just through cdc, but through all of the labs that didnt want to help, trevor bedfords lab in seattle trying to do early diagnosis, we got the capacity to do this, number one, we all would agree on can we get this test out to healthcare Partner Organizations all across the country, enable us to do hopefully a quick assessment of just how much this new agent is spreading and if you work with the Healthcare Organizations, all of these labs are connected via nationally consistent standards and way that could feed back that data, at least at an aggregate level to local responders and local Public Health agencies, Healthcare Organizations they work with as well as the cdc and whoever is in charge of National Planning for the emergencyed response. We have not worked that out yet. That seems like some common ground. Couple that with janets reference testing for any new test thatt comes along. Make it available. That would be a really different response than we are able to pull off the mac absolutely. Mark is talking about this threat at the very beginning. We need really good laboratories to be working together to do that surveillance. They have to agree on standards. We have a lot of people fighting each other about this, that and the other thing. As that moves forward, out of that effort comes a Reference Panel. You have to objectively decide you will construct that. Healthcare Public Health effort together. That is right. You have to get those samples from healthcare so you can create that. And theny the diagnostic companies, they are the ones i can do this at scale. Lets get over it. Okay. They can do this, the easy test, the point test or the strip test, they can do all of this stuff, but they need the tools, the substrates given to them. They need a flexible platform upon which the multiple partiess can compete to develop the standards and on top of that to rollout they need to have the logistics to get the tests out and then also get the data in a standardized form. They need to be standards around Public Health and health data so that it is more affordable. On top of that, you need to thserve starbucks for the number of coffee sold at each of their Stores Across the world to be able to, at the local, state or federal level, get the data identified and secured. That sounds a little complicated, but we do some things like this now. We do have electronic reporting for like today. Covid cases from hospitals and emergency rooms. We did have states and localities adopting electronic standards for sharing lab report that. Positive and negative and identified and protected. We have not done it nationally yet. It seems like a great combination of what we can support nationally. And in forming and supporting very well done local responses. They are far more effective. Well, thank you. Thank you all for joining us. We will end on that note. Hopefully, i think that we have a series of ideas and policy principles for our bipartisan way forward. Hopefully the next time we run into a pandemic, maybe 34 years from now. May be sooner. [laughter] we will be in a better place. [laughter] thank you. [applause] next week on the cspan networks the house and Senate Return for their last week of legislative business ahead of the august schedule three recess. The houses expected to work on federal spending bills to fd the government to 2024 as current funding is s to expire septembe30 the senate will continue working on the defense programs and policy bill also known as the National Defense authorization act. A final vote expected by the end of the week. On wednesday, Homeland Security secretary will appear before the House Judiciary Committee to answer questions on the agencys handling of the u. S. Border and immigration enforcement. Also, the House Oversight and Accountability Committee will hold a hearing on unidentified aerial phenomena also known as uap. Witnesses will give firsthand accounts as the federal Government Transparency on the issue and their potential threat to national security. Later, Federal Reserve chair Jerome Powell will hold a News Conference following the federal open Market Committee meeting. Watch next week live on the cspan networks or on cspan now our free mobile video out. Also head over to cspan. Org for scheduling information or stream video live or ondemand any time. Cspan, your unfiltered view of government. Double moco. Cspan is your unfiltered view of government. Funded by these Television Companies are more including comcast. Are you thinking this is just a Community Center . 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