Sample . Some of those viruses came from the bbi resources, nih, and some of those viruses came from laboratories that received the initial seed from cdc. Thats helpful to know. In some conversations ive been a part of at nih, they indicated that the real key here was to get the dna sequence which china did eventually put up, i believe, at the end of december, early january. And that in terms of going after the vaccine, it was that sequencing that really mattered most Getting Started on Vaccine Development, and there are other scientists who are very distinguished that believe that the delay of getting the virus sample actually didnt set them back. Is that an accurate assessment or do you have a disagreement in that view . I know scientists disagree, so do we up here. But im kind of hearing that having the sequencing really mattered most and getting the virus important but did not set them back in proceeding to get the Vaccine Development underway. Sir, china posted the sequence on february 11, i believe. Its important to understand that when a sequence is available, some companies with some technologies can get started with that sequence information. Youre still vulnerable because you have another country in their laboratories that post on the internet or database their sequence. So there could still be challenges, especially from national security, about the integrity of that sequence. Before my time runs out well, its run out. I was going to ask, did they begin efforts at that time once they got the sequence . The nih began efforts on a synthetic nra vaccine candidate. However, without the viruses, you really cannot tell if the neutralizing antibodies listed by that or your diagnostics or your therapeutics can actually work. You can try to synthesize a virus with a sequence, but its never going to be representative of the actual virus. While were spending billions of dollars on drugs, vaccines and diagnostics, we want to have the most credible information possible. Thank you, madam chair. The gentleman yields back. A pleasure to recognize the gentleman from new york, mr. Engel, for his five minutes of questions. Thank you, mad pam chaam cha holding todays hearing. Doctor, if you were a betting man your microphone. Sorry. Thank you. Doctor, if you were a betting man, when would you bet that we would have a vaccine . Thats a very difficult question to answer. I know that there are companies in academic labs working very hard. Normally it takes up to ten years to make a vaccine. Weve done it faster in emergency situations, but when we had starting material in the freezer for ebola, but for a novel virus, this actually hasnt been done yet that quickly. A lot of optimism is swirling around a 12 to 18month time frame. If everything goes perfectly weaver never seen everything go perfectly. My concern is if we rush too quickly and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine, so its still going to take some time. I still think 12 to 18 months is an aggressive schedule, and i think its going to take longer than that to do so. 12 to 18 months from now or 12 to 18 months from when this all started the beginning of the year . It would be 12 to 18 months from when the particular manufacturers first received the material or information they needed to start developing that vaccine. Its critical to note when we say 12 to 18 months, that doesnt mean for an fdaapproved vaccine. That means to have sufficient data and information on the safety if not efficacy to be able to use on an emergency basis, and that is the consideration that we have in mind when we talk about an accelerated timeline. Thank you. I represent, in new york, bronx county and Westchester County which are at the epicenter of the u. S. Coronavirus outbreak, new rochelle, new york. While new yorkers have really rallied together in support of their neighbors, the administration has failed at every turn. The president has sidelined our best scientists, pushed basis conspiracy theories and more, recently suggested remedies like lysol for suffering americans. He urged the doctors to prescribe high clocydroxhydroxy despite proof that it works. Doctor, what are the dangers of chloroquine if prescribed incorrectly, and what happened when you raised the issue of chloroquine use in coronavirus patients with hhs leadership . Congressman, our concerns centered around the potential use of chloroquine in people who were infected with this coronavirus. There are data of effective use and safe use of chloroquine in malaria patients and other indications. We also knew there was a potential safety risk in chloroquine to cause irregular heart rhythms, and even in some cases, death. So our concern was with limited information and knowledge, especially of its use in covid19infected patients and the potential for those risks, then we should make sure that any studies with that drug were done in a carefully controlled Clinical Study and a close, watchable eye of the physician so they could respond to the patient if they did experience any of those adverse events. There wasnt sufficient data at that time to support use of this drug in patients with covid19 without close supervision. When you raised that issue of chloroquine use in coronavirus patients with hhs leadership, what happened to you . You were removed as a director of barda. Is that not true . I believe part of the removal process for me was initiated because of a pushback that i gave when they asked me to put in place an expanded access protocol that would make chloroquine more freely available to americans that were not under the close supervision of a physician and may not even be confirmed to be infected with the coronavirus. The scientists at barda and hhs worked hard to switch that with strict guardrails that a patient would be in a hospital under close supervision of a doctor who could otherwise not participate in a random study. My concerns were alleviated somewhat to be able to lock that in a stockpile of other physicians. However, i learned the department of health and Human Services were struggling to make that drug available outside of that to flood new york with this drug despite recommendations of the e. R. A. When i spoke with the government and shared my concerns with the public, that, i believe, was the straw that broke the camels back and escalated my removal. Thank you. The gentlemans time sis expired. A pleasure to introduce the congressman from kentucky. Thank you very much. Reading your complaint, i think the chairman said earlier, talked about the lack of urgency and implies the president s lack of urgency . I think most of my constituents want to know that things are getting done and where is the president on this . And youre having issues with the leadership at health and Human Services and youre giving them recommendations, so if theyre not accepting your recommendations, i would, i think, fairly surmise theyre not passing that on to the white house, so the president is probably unaware of what youre putting forth, because it says in your complaint, fortunately, white house trade adviser Peter Navarro shared dr. Brights sense of urgency. Talking about the urgency in the white house. So you have a meeting with him on saturday. You come back in on sunday where you prepare your recommendations in a memo for Mick Mulvaney, chief of staff, so essentially the president. You get around the leadership of hhs, meet essentially with the preside president , with Mick Mulvaney, and it says you have a meeting with navarro saturday. The memorandum for Mick Mulvaney on saturday, and on sunday it says the director met and directed dr. Kadlik of hhs on the recommendations. So it seems that i dont know how you could be more urgent in government than having a meeting on saturday and a memorandum on sunday and actions on monday once it got to the president s attention and the president s level. We appreciate the president moving forward on that. Im on the Ranking Member of o i, the investigations which you testified in front of before, and we appreciate that very much. Im going to look more into the process of putting this hearing together and some things. As we read through your complaint, the only reason we have it is because you made it public. In your complaint there are different kpikexhibits that youk about, and were having a hearing today, and there are actually 33 exhibits referenced in your complaint thats not public. I think we got a majority through the Washington Post or Something Like that, thats how we made documents available for this hearing, is my understanding. So the 33 exhibits that are not made public that are referenced in your complaint, would you make those available to the committee . Do you have those to make them available to the committee . I mean, if were using your complaint for this hearing, we need to have the documentation. May i address that . S. I dont have a problem with that. We will take that under advisement and get back to you. There may be privacy considerations in some of the documents, so we do need to look at these documents carefully. Also if you read through the email chains that were made available, some appear complete but some truly arent and theyre apparently not full email chains. So you will wonder if the context of the email would relate to the inferences taken from the emails. Would you make all the complete email chains available to us . I would like to address that as well. What is a problem is when dr. Bright was removed from his position, he was locked out of his email. He does not have access to his full email. So the email chains you have available we have. Thats correct. He does not have a full set of his email. I can address this, too. Thats exactly right. I was immediately locked out of the my email on april 20th of this year, and so i didnt have full records available to me on that. However, i believe i laid a Solid Foundation in my complaint, as detailed as i could be, for the offices of special counsel to be able to conduct an investigation and believe as part of their investigation theyll be able to access those emails and individuals to get the full story and get the full information so they can get to the bottom of this. It would have been helpful for us as well. Have you shared any of these exhibits with a majority thats not been shared with us on the Minority Side . Sir, i believe you have probably whats available in the public domain, and i believe the rest has been submitted to the office of smespecial counsel, ai havent made it available to anyone directly. To the gentleman, the minority and majority members all received the same packet of information. Which was made available to the public. That was available that was in the public domain. Are there any other documents in your possession or accessible to you that are not included as exhibits in the complaint but are, nonetheless, relevant to your allegations . If so, will you provide those to the committee . I believe i provided the information i have available to me at this point. If i had access to my email from hhs, there might be additional supporting information in that email. I do not know the status, if thats been deleted or wiped i just havent had access to it since april 20th. I appreciate your answers. Thank you very much. I yield back. The gentleman yields back. A pleasure to recognize the gentleman from north carolina, mr. Butterfield, for his five minutes of questions. Thank you, chairwoman, and to you, dr. Bright. Thank you, sir, for coming today, and thank you, most importantly, for your 25 years of public service. Dr. Bright, id like to ask you about your efforts to address supply shortages for administering covid19 tests. According to your count, as covid19 testing ramped up, you asked for an inventory of the Strategic National supply availability of testing supplies, including swabs, vial transport materials and extraction buffers. You learned that the national sto stockpile did not stock these items. After that you learned that the fdas source of swabs was a manufacturer in the region of italy which was the center of the covid19 outbreak in italy. It is my understanding that this information then prompted you to reach out to the d. O. D. Agency that had previously assisted your office with International Transportation of supplies related to ebola. My question is why . Why, sir, did your Office Contact d. O. D. At this point . Sir, it was quite a surprise to me that the urgent rampup of the testing did not include full consideration of all the critical supplies needed to support that rampup of testing, including those materials you mentioned, swabs, vial transport, buffers, et cetera. I was quite alarmed to learn from sitting behind the cdc director redfield that we were going to experience this shortage of swabs. I was even more surprised that our Strategic National stockpile did not plan to have any of those in supply. So my urgency to find a solution to that was supported by the fda director of the center for cdrh, devices and diagnostics at fda, and once i confirmed that there was a shortage, it was critical that we find a solution, and that was by partnering with our department of defense colleagues who worked with us for the ebola response. We actually worked with them to ship dosages of ebola vaccine from germany to the United States so it could be filled rapidly to respond to the outbreak in africa. So it was a natural occurrence or response for me and my colleagues in barda to come up with a solution for that critical supply chain. Let ask you this, was there an institution in italy that were asked to move forward with the request of d. O. D. . What we needed from the department of defense, we needed secretary azar to make a request of the secretary of defense. I and my colleague, dr. Gary disbro, raised this issue at our Senior Leadership meeting with dr. Kadlik who chairs that meeting at asper, and it wasnt a topic that he wanted to discuss on that day, and we were rebuffed by him saying he did not really want to talk about swabs right now. Both dr. Disbro and i raised that concern repeatedly in that call. Knowing it was critical and time sensitive and we had a critical shortage of these swabs, i placed a call to mr. Navarros office once again and asked if mr. Navarro could offer some assistance in contacting the secretary of defense to get clearance for d. O. D. To put those requests in place. That happened within minutes. After that from the secretary of defense, we were able to start those flights. We came back with 25,000 swabs. So literally within hours, he had coordinated with d. O. D. To supply the swabs . Yes. What is truly perplexing to me is why anyone would resist such an initiative. Thats a rhetorical question. I wont ask you to answer that. Finally, we still dont have enough testing supplies. I dont understand how and why that is possible. I understand that converting an auto plant to build ventilators might take a little time, but how could we be struggling to get adequate supplies of simple supplies like swabs . What does this say about the federal response to the coronavirus outbreak . It says to me, sir, that there is no master coordinated plan on how to respond to this outbreak. We dont have a dedicated agency sourcing those critical comb poents components in coming up with a strategy to have those supplies when we need them. We need to make sure we can respond to american lives. Thank you, dr. Bright. Youre a great american. I yield back. A pleasure to recognize the gentleman from virginia, mr. Griffith, for his five minutes of questions. Thank you, madam chairman. Appreciate it. It seems like mr. Navarro has done a pretty good job in listening to the questions. I do wish we had more of the information available, and its one of the reasons why its not your fault but why i wish we had done this through regular channels. But i would ask this, on some of the questions that were just asked about supplies being available, i kind of got the impression from prior testimony that project bioshield which you urged to put money to and we put 700 million in 18 and 735 in 19 was supposed to take care of some of that. Am i misunderstanding project bioshield . Project bioshield was used to invest in drugs and investigation of vaccines. It didnt help on this at all . It didnt help on this at all, sir. That being said, and i would hope we had everything available to us, and i understand that may not be your fault, but it does create issues. But everything is going crazy, people have all kinds of things going on, and this hydroxychloroquine comes up, and there are email exchanges in exhibit 54 of your documents that indicate Christopher Houchens writes and says, you know, we should probably look at this, im paraphrasing, but the line i took out of it was, especially when we have few options. A frustration ive had for many years with our community trying to respond to all different kinds of diseases, we want to have all the sciences there which makes sense if you have an alternative. When you have few or no options, it seems to me you would go after those things that are available, and if hydroxychloroquine was one at one point, then remdesivir. Have they done the blind studies related to covid on remdesivir . Has that already happened . Then ive got an article from the Richmond Times dispatch april 15th where a doctor used high doses of vitamin c and a drug called actermra. All of these are floating out there. Doctors are using all kinds of things because we dont have other options, so im wondering, what was the great hesitancy to at least let doctors try even if it was anecdotally having some effect . Wouldnt you have to have that available to be able to do the test . And if youve got few or no options, why wouldnt you want to go down that pathway . We want to make sure that the drugs that we consider are safe and effective. The highest priority is safety. So many of these studies that we had or anecdotal reports we had did not include safety vetting of those drugs. There are some known side effects of some of those drugs. Many of the drugs were repurposed so they werent built to novo, so we knew about some of those safety concerns. We didnt have any evidence of how those safety concerns would appear in people with this virus. This virus takes a lot out of your body. It actually infects multiple organs in your body and causes official organ shutdown in some cases before death. It literally turns your lungs into a brick. Its scary stuff, and you said with hydroxychloroquine, one of the problems is you might have an irregular heartbeat. If youre worried about not having a heartbeat at all, youre not worried about irregular if you dont have a heartbeat at all. Am i right about that . People were dying out there and here was the first one that showed some promise. Why wouldnt he accept an offer from a manufacturer to giff uvea lot of it out there for widespread use . It didnt work in that case, so he tried something else. I think thats what were really going to have to do in an emergency situation, am i correct . We need to do it carefully, sir. We have to make sure we have that information available, those potential drugs available. We are thinking outside the box cant we be so careful that we accidental kill people . We need to show that we can put up a Clinical Study in less than a week. Its important to use available clinical data, and if we know there are potential risks, we need to make sure were cognizant of those risks and make sure the drugs are used in a very safe and controlled manner. I appreciate that, and let me just say this. Its our job to ask some tough questions sometimes, but just like you found friendly ears at the white house, you might have found some friendly ears on our side of the aisle here as well. I would note that in 2018 you were talking about vaccines and you were talking about offshore production, and i said, let me know what i can do to help get more production onshore, but i never heard from you. Im happy to help. I want onshore production. Im with you on a lot of these issues. I dont know whats going on behind the scenes. Weve got to investigate that. Today, unfortunately, was not the day to do that investigation. We dont have enough information, a lot of stuff isnt here for us. But dont hesitate in the future, if you see something, let us know on both sides of the aisle whats going on. I appreciate it and i yield back. Thank you. The gentleman yields back. Its a pleasure to recognize the gentlewoman from california, ms. Matsui, for her five minutes of questions. Thank you very much, madam chair, and thank you, dr. Bright, for appearing before us today and thank you for your public service. Dr. Bright, you discussed a series of opportunities that left our country. Many americans are eager to return to normalcy, as we can all understand, but to even begin safely reopening, we need widespread Testing Capacity and organized Contact Tracing work force and a Health Care System that can handle further surge. Ultimately a vaccine or cure is required. I would like to ask you a series of questions about your warnings to the administration while at barda. I believe you can succeinctly answer that it takes time for our country to recover from the coronavirus pandemic. In 2020, you began to acquire sequencing for virus samples. Has the administrations action shortened or lengthened our timing for reopening . There was delay in getting those samples, that means there will be a delay in getting the countermeasures. The countermeasures are critical for reopening our country. Throughout the month of january, you made hhs aware of the urgent need to increase funding to combat the virus. Hhss leadership said it believed bardas funding was sufficient. Has this shortened or lengt lengthsened our timeline to reopen . That has extended our ability to respond to this pan dedemipa. On january 19th, you pushed dr. Kadlik to push this across the country. Dr. Kadlik initially told you this was not time sensitive. Did that delay lengthen or shorten the time for reopening. That lengthened reopening. We needed those policy discussions to take place as soon as possible. You pushed to ramp up production of n95 masks, ventilators and syringes. Has that lengthened or shortened our time to reopen . No time in reopening our country will bring those people back to us. Thank you, dr. Bright. No influence can say when we can safely reopen, but im hearing if hhs had heeded your warnings early, we could have limited the toll this pandemic has taken on our country. Its become clear from the whistleblowers report that the Trump Administration prioritized political concerns above the drug hydroxychloroquine. Despite the effectiveness in the treatment of covid19, the president supplied the drug to americans because it was seen as an immediate win. Dr. Bright, do you see other instances where the government relied on politics rather than science to make decisions . What risk might that have put on Public Health . We have a lot of adjustments we make on drugs through barda and the department. There were some attempts to bypass that rigorous vetting process that caused me great concern and actually increased the tension between me and dr. Kadlik. Without that scientific vetting, it does increase the risk of a drug being evaluated or supported that could have safety concerns. And we really needed to have the best scientists in our country weigh in on whether or not that drug should be evaluated and how it should be evaluated to address those safety concerns. Certainly. The Trump Administration waited until april to invoke the defense production act to increase production of lifesaving medical supplies like masks months after doctors began experiencing shortages and three months after your initial january warnings. Should hhs have invoked the defense act earlier to increase production of critical medical supplies, like masks and swabs . Im not an expert on masks and swabs, whether we should have had those earlier. I believe we should have ramped up the production of that medical equipment as quickly as possible. It should have been a high priority. Thank you very much, dr. Bright. Ive run out of time and thank you very much for appearing before us today. Gentlewoman yields back. A pleasure to recognize the gentleman from florida, mr. Bill rockus, for his testimony. Im focusing on the hydroxychloroquine. When was the potential use of chloroquine and hydroxychloroquine as treatment for the covid19 first brought to your attention, sir . I believe it was probably midmarch, between march 10th and march 17th, somewhere in that time frame. And not prior to that . Not that i recall. The first i heard of the drug itself is a call i received from dr. Woodcock at the fda asking if i had heard of the drug. I hadnt heard of the drug and i hadnt heard of it in use of covid19 patients. She said it might be something to look at and she provided a draft manuscript and thats the first i learned of the drug itself. So you werent aware of any news articles and Research Papers in january discussing benefits of the drug . I heard anecdotal stories and reports, sir. You had . I cant recall if i did specifically for chloroquine, but i tried to track the media and the scientific journal as well. However, i rely on the guidance of the science within hhs, and the first i had heard of that was from my colleague, dr. Woodcock, at the fda. Then in a summary report from our scientists at fda, hhs and barda that determined the evidence for its benefit was weak and the evidence for its safety concerns was stronger. And they did not believe at that point it was something that should be supported. Again, what was your reaction permanently . Did you think it was something worth pursuing initially when you heard it from dr. Woodcock . Initially i said, i do believe i trust dr. Woodcock and her scientific judgment immensely, and if she said it was something we should look at and something we should consider testing in a randomized clinical control study, i would be supportive of the team reviewing that protocol and that information to see if it should be used. Sir, ive heard from experts in the area, and im certainly not an expert, that the drug were talking about in this case, hydroxychloroquine, if its used, first of all, timely, because i know and understand there is a window there as far as the patient, the efficacy of the drug. Have you heard this, that if its administered properly, there is a small window there for the patients as far as risk is concerned . Can you elaborate a little bit on that, if youve heard that . Again, this is not from a layperson, this is from our expert. We have seen and heard of anecdotal data from different positions that they believe theyve seen benefit or patient improvement from use of this drug in either combination with an antibiotic azithromycin or a combination of zinc or other things, but there was never a system from a randomized control study that it would show significant risk. You need to look at the benefit in early stage treatment or late stage treatment. Most of the data coming out from those clinical studies to date havent shown an overwhelming evidence that it has benefit in those patients. It doesnt mean it might not still have some benefit in individuals or a case or two in different studies or that physicians believe they see a benefit in their patients. But in the context of a randomized controlled study, we havent seen an overwhelming level of benefit. Have you reviewed the studies in other countries such as france and possibly japan . I just want to know, because my constituents ask these questions. Do you take those studies into consideration when you make these decisions . Absolutely. We look to see if they were done with the right controls in pl e place. Was it statistically relevant . Was it done with a few people or a lot of people . The studies we saw early were only done with a few patients, so it was unclear even with the description of some of those studies that were not in peer review journals whether all the patients were treated the same, whether they had full participation throughout the Clinical Study itself. And looking at the statistical power of many of those studies, they were very small. So it was very difficult to understand the impact, the benefit. We also saw a study that the v. A. Hospital conducted with hydroxychloroquine that showed that people who were treated with hydroxychloroquine had a higher rate of death than those not treated with hydroxychloroquine. That study, too, has weaknesses. No study is perfect. You take all those studies into account when you decide how to further use that drug. Its my understanding that not my constituent but a u. S. Citizen, a veteran, was cured again, this is just from what ive heard from the drug. That was a late stage case, but ive also heard of early stage cases as well. I wanted to get that on record. Thank you, madam chair. Its a pleasure to recognize the gentlewoman from florida. Thank you. Doctor, thank you for saving lives. I want to ask you about the n95 respirators. These respirators are essential personal protective equipment. Theyre not the cloth mask or surgical mask that Everyday Americans are encouraged to wear by the cdc. Dr. Bright, are n95 respirators necessary to protect the lives of nurses, doctors, emts and those on the front lines . Yes, they are essential personal protective equipment to protect those front line care workers from getting infected. This is not a hypothetical concern. Just last week the l. A. Times reported a tragic story about a heroic nurse, celia marcos, who died when she lacked an n95 respirator who rushed in to help a covid patient who stopped breathing. According to another report, over 700 staff at one Health Care System tested positive for covid19, and the cdc reported a month ago that 900 Health Care Workers had tested positive and a dozen had died. One tampa hospital said n95s are still very difficult to procure. She said there is a dire need for n95s. One of my Community Health centers said we continue to struggle to get n95s. There are so many folks trying to sell knockoffs. Then a large tampa Bay Area Health system says the supply chain remains inconsistent and irregular and the bay area remains concerned as we head into the fall for n95 masks. The demand will continue to increase due to the flu season and the continued presence of covid19. Dr. Bright, you understood that america was face a shortage of respirators in january, is that right . We understood the u. S. Would have a shortage of respirators for the Pandemic Response in 2007. Weve known it every year since 2007. It was examinrecognized that we need 25 billion n95 respirators in our stockpile to help our Health Care Workers in a Pandemic Response. And you sounded the alarm repeatedly but were ignored by the Senior Leadership at the department of health and Human Services. Please explain what steps you took and the response you received. We knew going into this pandemic that critical medical equipment would be in short supply. I began getting alerts from industry colleagues in mid and late january telling me that from an outside view, from an industry view, that the supply chain was diminishing rapidly, telling me that other countries that we relied on to supply many of these masks were blocking export and stopping transfer of those masks to the United States. I learned that china was trying to buy the equipment from the United States producers to have it shipped to china so they could make more. Each of these alerts, and there are dozens of these alerts, i pushed those forward to our leadership in asper to dr. Kadlik and his Senior Leadership team. I pushed those warnings to our Critical Infrastructure team. I pushed those warnings to our strategic stockpile team who has the responsibility to procure those supplies for our stockpile. In each of those, i was met with indifference, saying they were either too busy, they didnt have a plan, they didnt know who was responsible for procuring those. In some cases they had a sick child and would get back to it later in the week. A number of excuses. But never any action. It was weeks after my pushing that finally a survey was sent out to manufacturers or producers of those masks, a fivepage survey, asking producers or companies if they actually made those masks. In your whistleblower filing, you discuss a february 7th meeting of the Department Leadership group in which you urge the department to focus on securing n95 masks. Can you describe what happened at that meeting . They informed me that they did not believe there was a critical urgency to procure masks. They conducted some surveys, talked to a few hospitals and companies, and they did not yet see a critical shortage. I indicated that we know there will be a critical shortage of these supplies, we need to do something to ramp up production. They indicated if we notice there is a shortage that we will simply change the cdc guidelines to better inform people who should not be wearing those masks so that would save those masks for our Health Care Workers. My response was, i cannot believe you can sit and say that with a straight face. It was absurd. In fact, it took three months from your initial warnings until midapril for the federal government to invoke its authority under the defense production act to require the production of millions of more n95 masks. And even then, the administration required the production of only 39 million masks, which is far fewer than you and other experts said that we would need. What was the consequence of this threemonth delay and inadequate response . Were lives endangered . Lives were endangered and i believe lives were lost. Not only that, we were forced to procure the supplies from other countries without the right quality standards, so even our doctors and nurses in the hospitals today are wearing n95 marked masks from other countries that are not providing the protection that a United States n95 mask would provide. They are not as protected. Theyre assuming theyre protected, but theyre not. The gentle womwomans time h expired. I recognize dr. Buchon for his testimony. Thank you, dr. Bright, for testifying. Im a cardiac and vascular surgeon and have been in practice for 30 years. I want to comment on how the medical Community Responds to this type of thing. Doctors across the country will use drugs off label in a circumstance where they dont have or they dont see a viable alternative to that. And i think this is one of those circumstances. Im hearing from doctors across the country, and look, im with you. You have to have double blind studies, you have to have proof under normal circumstances, but in this situation, i think a little bit of understanding and leeway from the federal government is in order. We do want to ensure the safety. This is a drug that has been proven safe for many, many years in the appropriate doses. It does prolong the qt interval, as youve outlined, which can lead to cardiac a rit marrythmi used properly. When doctors were told to stop using it, they had to back off because physicians wanted to use it. If things are working even anecdotally, theyre not going to wait for the government bureaucracy to approve it. I just want to get this on the record. I just want to say this is why doctors are using this drug. Whether its right or not, data will show. If two years from now we have the studies and we say, hey, that stuff really would have worked and the government stopped that from being used, if i was a family of a person that was stopped from getting hydroxychloroquine, i would be pretty mad. I want to talk about the supply chain issues as it relates to ppe, the personal protective equipment. I think there is enough blame to go around in the federal government about what happened there. After h1n1 where stockpiles were depleted, we didnt replenish them. We have people on both sides of the aisle talking about this and i think there is some blame to go around. But, you know, i dont want to be accusatory but i do want to go over some of the facts about b arks rr bardas situation with masks. A Company Called halyard announced a mass production line. According to financial records in 2018, hhs signed of on a 3. 3 million, with an m, payment to halyard to build a machine that could churn out millions of protective masks at high rates of speed during a pandemic. However, in september of 2018, cdc reported that the machine was never built. And despite bardas billion, with a b, dollar budget, barda reported there was not money for the project. Why was the project scrapped and did you sign off on that decision . That project with halyard was to build a novel new machine to make a face protection mask faster, as you described accurately. The Technical Team must have reviewed that proposal on further investment in that machine. I believe the investment to date was made to design the machine, build the blueprint of the machine, and im not sure if it was to build an actual prototype of that machine. At that time, in 2018, were you the head of barda . I was the director of barda. Did you sign off on that . Money was allocated primarily from hhs to barda to do this. I wouldnt expect that to be scrapped without the director of barda signing off on that, right . Did you sign off on that to scrap the project . Not to necessarily scrap the project. We rely on necessary information from our vetting office, so that particular project never made it to me. If it wasnt approved, it didnt make it through the proper vetting process in barda. The decision to end or begin that project was not brought to me. I find that surprising, but ill take your word for it. Nicole lurie, who hired you, told the Washington Post that the halyard contract was part of an explicit strategy to ensure we could have mask production in the next crisis. Were here and we dont have it, so were facing the consequences of that decision. In addition, halyard, it is my understanding well, im running out of time. What im just going to say is, look, to doctors across america, you know, its easy for us to sit in washington, d. C. Whether were members of congress or members of agencies and talk in the abstract about people dying in our intensive care units, but when youre the physician at the bedside and there is a medication that has promise and that has a safety profile that we understand, doctors will use this medication off line. And thats whats happening. Whether thats right or wrong, it might take us years to prove, but in the meantime, people can die. So i yield back. The gentlemans time is expired. Its a pleasure to recognize the gentleman from maryland, mr. Sar baines, for his five minutes of questions. Thank you, doctor, for standing before this committee. Our Government Works to promote effective government and protect Public Health. That was your charge and you took it seriously. Unfortunately the record shows that your superiors at hhs and potentially beyond, instead of valuing your expertise and experience, squandered it in ways your repeated calls from china and to find supplies and respiratories and swabs. You dismissed your science based warning. They dismissed your concerns of the stampeding of hydroxychloroquine, i heard about it today. To find treatments with little therapeut therapeutic value. Particularly you are pleased for action in the early days of the pandemic may have saved thousands of lives. I want to thank you for coming forward and i want to thank you for blowing on the whistle to this pandemic. I am sure there are specific conversations and emails and moment in time that you remember they happen yesterday, Inflection Point if the response to your warning is heeded, things may have been different. I am sure they haunt you and keep you up at night. In january of this year, tell me one moment where you had that one sinking moment where you did not get the response that you are hoping to get. We are in deep the world is. We need to act and i push that forward to the highest level i could at hhs and i got no response. I knew we are going to have crisis for our healthcare workers because we were not taking action. That was our last opportunity to turn on that production to save the lives of healthcare workers. It all adds up to one conclusion, it did not have to be this way. There was another path things could have gone differently. The federal response to the pandemic could have been much more effective. So here we are at a moment in our country needs the expertise and science based guidance that you and others offered to us. These voices are too often being ignored. Things are upside down. While so many made the wrong call still have a job. It means science and reasons are also being cast aside. It is an attitude that deprive our country in this critical moment of any real chance of getting ahead of this pandemic. Hopefully we can learn from this. There is time to put strategici into our strategy to help fight covid19. The federal response has got to get smarter. It has to put science ahead and politics and wish fuful thinkin. Our committee will continue to press for that in the days ahead. I know you want to look forward. Tell us what can we do now to learn from the mistakes of january and march and make sure we navigate through this crisis. Congress member, we need power leadership. We need to unleash the voices of the scientists and our Public Health system in the United States so they can be heard. Their guidances need to be listened to. We need to be able to convey that information to the American Public so they have the truth about their real risk and dire consequences of this virus and they have the truth about the consequences of their actions if they dont follow those guidanc guidanc guidances. With dont have a point of leadership and we dont have a master plan. Those two things are critical. I would enchurge congress toen sure there is oversight of this response. And without proper oversight of those dollars, i am concerned there could be misdirected and lost and not put to the right find. I urge congress to encourage those oversights and how it is being spent and used appropriately in that pandemic. Thank you for that caution, i yield back. Pleasure to recognize the gentlewoman from indiana, miss brooks. Thank you chairwoman. Dr. Bright, with all due respect, Vice President was named for the pandemic which was a recommendation bipartisan blue stu study, with all due respect i believe there is that coordination and part of what i am very, very concerned relative to this hearing is that the impression being made that there is no plan and in fact thats part of what the reauthorization that i work closely with you and so many of us relied on you all to share with us what we need to do to reauthorize and most of members of congress do not know what it was. Was members of congress, the American Public did not know we had Strategic National stockpiles and we may be short of some of these things until this all hit. We did get that reauthorized and it was signed into law of june of 19. We rely on your expertise and you became director in 2016. And you mentioned in the n 11h1 pandemic of not enough masks. We had a discussion about this. They didnt really know that. We as members of this committee did not know and we are not told of these shortages of masks as we work through reauthorization of this important law. Were you aware of this issue and did you push hhs to maintain mask production of the National Stockpile before this happens in january . Before 2017, we had an annual review of the stockpile. Since we moved this Strategic National stockpile from the cdc management, we have not yet had an inner agency across departmental review of the supplies in that Strategic National stockpile. There has always been limited funding and never enough to stock up the stockpile. Do you know gregg berral . I do. Did you have conversation with him from 2009 until 2020 about what was in the Strategic National stockpile in. Absolutely. We met on a monthly basis and each year they reviewed and prioritized items that should be purchased by the national sto stockpi stockpile. That body i directed for some time and made recommendations. The Strategic National stockpiles responsibility to make this purchase. Does barta participate in femsy . That is plan that experts like yourself participates in. I want people to know there have been plans that femsy had forth 2017 2018 femsy plan. Did you participate in that plan . I did, many of us did. It was our first time our country put forth these plans. Many said it was landmark and same thing with femsy putting forth many plans. I want the American People to know that a lot of folks over a long period of time have been focused but yet we did not still