Transcripts For CSPAN FDA Commissioner Dr. Hahn USAFacts Fo

Steve, can you explain to us why you decided this is the moment to put together a project like this . Started fourfort with the aim to understand the government better are the governments own numbers owny the governments numbers. Where does the money come from and where is it spent. The security and Exchange Commission requires this very factual document required called the 10k report. Journey andn this we really learned a lot at the federal, state, and local level. What about the need for hard in the and real data middle of the situation the countries . Country is in. It is more essential than ever. Government data has a hard time staying current. If you look at the recent numbers on the Affordable Care act, they are three years out of date. Right now, we struggle to have uptotheminute data about the coronavirus and its impact on the economy. And if you are sitting at the federal level, you want to see those things consolidated in real time, which is very difficult to do now since the primary place this data is collected is that the county level at the county level. Last month, you announced you be donating 25 million to fight the effect of this epidemic. You are doing it in a targeted way in places like your own city of seattle. What is the role of philanthropy when we are up against this kind of crisis. It builds on our general philanthropic focus on kids and families in need. I would say that the work we have done so far falls into a few areas. Filling in gaps on the medical side. There is a shortage right now nose swabs. And before the government can step in, this weird supply chains going on. In china, lets get the chain moving. Lets accelerate testing. Tests 50 of everybody in the state, and now they can test everybody who enters the hospital each day. Collaborativeing the mayors fund in l. A. For example. We have found a number of organizations stepping into the gaps such as food pantries or other things. We stepped in their. There. Focused on social service agencies, which are Small Businesses. But they are not Small Businesses that are wellequipped to apply for ppe funds so theres a number of areas we found to jump in. A big role for an isanization like usa fact helping people get their arms around both the size of the challenge and how quickly this virus has been moving. Here that imelapse found. [no audio] most important topics going. But it would require Real Software and real legwork to collect data from the county. Have programs that go through and scrape data off of county websites and then put together. Even the cdc uses our database for a number of things because we are scrounging around on local data. Presenting that is, but also putting it in a form where parties have been able to use it. Certainly, the graphic shows quite vividly the explosion in the disease and variations. Washingtony here in was one of the explosions of the virus. You can see that over and down to the county level, which is most accurate. We have another graphic here which really demonstrates the shortcomings of the government response thus far, which is of course the cares act aired. Ct you talk a little bit about that . They are all arguing over what the second tranche of funding should look like. The great thing about democracy is that people will go through and figure that out what we can show you here is that for families that are in the middle class. People define it differently, im going to define it as families in the middle 20 . Make betweenonly 33000 and 63,000 a year as a family. We have Government Data on all of this. What does family spend money on, you can see here the amount for food, housing, and a variety of needs. The stimulus check is in green. It barely covers food costs and housing costs for somebody in the middle of the spectrum. As we get to the 40 of people less affluent than that, these needs stay fixed. , onen all, it says to me month of peoples needs are covered and we are going to face crisis quite quickly. Unemployment will obviously help in some businesses, but 1200 is not necessarily go that far does not necessarily go so far. 386 for health care. One of the most immediate effects we have seen in the last month is our Health Care System is completely overwhelmed by the epidemic. Could you talk a little bit about that. We have another graphic here about the shape of the Health Care System. Is this equipped to deal with an emergency like this one . Almost tripling over the last several decades in terms of cost per person. If you look at the number of hospital beds, they have come down by a factor of two. In terms of Health Care Industry getting more effective, you need to have a different kind of a plan for a pandemic like this. If you can take these numbers and aggregate, if i work at the federal level, having a real strategy for this is important, given the pressures and health care and the needs to serve in a situation like the pandemic. Steve, we really appreciate you taking time with us this talking with us about what is an exciting and necessary project at this moment. We will turn now to my colleague, who will talk with stephen hahn about the updates and testing. But first, a short video. This has been a very fastmoving outbreak and we have to take this day by day. The primary issue here is the safety and welfare of American People. That has to come first. We see light at the end of the tunnel. Dr. Fauci and dr. Birx have said that. We see the incredible resiliency of the American People with all of the mitigation factors. I think there is great hope. Good morning. Im bob. Good to be with you for Washington Post life. Live. I am joined by stephen hahn, commissioner of the fda. He oversees efforts on public health, drug approval and medical testing. So much forank you being with us today. Thank you for having me. We have heard a lot from anders about this interview the top question for almost will a reliable Antibody Test be available for use across the nation . Test is a test that detects a persons Natural Immunity after having had the virus. Afteris a timing issue which the test would work. The reason i bring it up is it has its role but it is based on the timing of when the antibody would develop. The fdas role is to evaluate thetest and determine reliability and read and reproducibility of the test. As part of our flexibility in march we permitted laboratories to develop test and come to market and use them as long as they validated the test. 84 companies and labs have told us they are doing that. We expect more to come to the oversightere fda has of the testing characteristics and has the stamp of approval with fda so we can expect more companies to come through and we are working actively. I have several calls a week with Library Laboratory Tech Developers to make sure they have the samples they need and getting through roadblocks of the test. You expressed concern about tests to comeda in without a full review. Do you continue to have these concerns . Beginning, whether it was with drugs or ppe or tests, we are always trying to strike a balance between Regulatory Oversight and flexibility. Are concerned on if we can rely on the tests that are out there . Comes to theompany process at fda, we put our stamp of approval behind it. It means we have looked at the data and seen validation and know that it is reproducible. Those are the ones we can stand behind. We have reached out to those who have come to market and asked us to send them their test. Some have and some have not. In partnership with the nih and cdc, we are per we are performing validation studies and we commit to being transparent about the data. People should be cautious about not backed up are by fda emergency use authorization. That is on our website. If they have not, it is incumbent upon the lab to do independent validation. Decision the fdas allow this to unfold . We provided flexibility so they could be more testing on the market but the caveat is whoever uses the tests right do independent validation. There is a shortage of asthma drugs and ventilators for those patients. How will you fix the problem . Generic anded a new continue to review applications and will will work with to recreate the supply and expedite the approval of applications before us. Sedative drugs are an important issue. One of them was recently added to the shortage list. It has been on and off the list for some time but recently was added back because of issues around the patients. We are finding alternatives we can recommend hospitals and working with manufacturers to increase supply. The drug shortage list has been in place for some time and there are several factors related to drug shortages including increased demand and precursors. For the asthma and sedative drugs it is about increased demand and one of the things fda does is talk with manufacturers and finds where supply is and marry them. We work with hospitals to trying to find supplies around the country where maybe demand is not as large. Readers are talking about potential drugs for the virus. Are cder. He cde do they have the appropriate resources at the moment to properly evaluate covid drug candidates . In theave seen a surge applications to the agency for potential drugs that are being considered for covid19. We took an all hands approach at the agency call a Covid Treatment Acceleration Program where we brought people from , and wehe Agency Brought them to the table a month ago and prior to that head already been working on this. I am confident in the scientific expertise of the people at fda. They are wonderful and have looked at applications and prioritize them and have been making decisions based on data and science. I was on a call this morning with the team that is doing the i can tell you science is being applied very well. We are using a datadriven do not have ae significant lag in assessing applications. This is dependent on sponsors bring a data. We want to make sure they have the right information so we can make the appropriate decisions for americans. Is there a chance you will go beyond our borders and work with foreign agencies . Absolutely. We have relationships around the world and are participating in that. Vaccineort for development, we want to develop a master protocol which is where vaccines canerent be entered into the protocol. Sing a similar approach it is an efficient way of looking at multiple vaccines. That is one example. In terms of the drugs on your do you see an expansion of trials on the japanese antiviral . We have seen applications and we approved to go forward with a trial. We have been working with sponsors on the childs. When they come on the trials. When they come to us, we do not delay. I expect to see more of that in the area. Is there anything under consideration for approval that we are not talking about that you think will be important . There are many. We are getting hundreds of applications and prioritizing them where we think science is best. We look at every application. Limited by confidential information and i cannot speak to anything not in Public Domain but we have tremendous academics, manufacturers, drug innovators looking at a wide range. Mitigation efforts are working but we have to keep pushing forward aggressively because we need to make sure we have all available resources as we move forward. Drugs get fdathe approval, will the traditional fda rules and regulations be relaxed in any way . Atwe are going to look everything and be as flexible as possible. This is another point of risk versus benefit. In an emergency situation, our job is to assist the risk assess the risk and benefit. Valuedetermine it is of and the benefit outweighs the risk, we will move forward. We are taking this on a casebycase business casebycase basis. You are a longtime medical professional. You are part of a meeting at the white house on hydroxychloroquine. Do you feel pressured by the to bringse in any way hydroxychloroquine toward approval . Othero not feel pressure than the urgency of the situation around covid19. My white house conversations have been very professional and i have repeatedly told everyone that i can promise america that we use science and data to drive our decisions always. That is our solemn promise and we will keep it. Emergency authorization for fda was not pressured from the outside on hydroxychloroquine . We received a lot of donated and one ofse in this the legal parts of the agreement for the donation was to have emergency use authorization. We used the data published about hydroxychloroquine to drive the decision. That did not mean fda has authorized the use of the drug for the treatment of the virus but it allows the drug to come into the system so it can be used for a Clinical Trial and for doctors to prescribe if they see fit. Science tog data and make these decisions. Gotten anecdotal reports of heart conditions and side effects from hydroxychloroquine. Should people use caution . Nothing is more important than the doctorpatient relationship and that relationship has to take place between them. What medications the patient is on, do they have an underlying heart condition. Hydroxychloroquine has been used for years for lupus and is safe. But when combined with other drugs there might be an increased risk of heart complication so doctors need to be aware of this and make a decision that is best for the patient. Have thers and nurses interest of the patients at heart and that relationship is sacred. The president has been talking about trying to reopen parts of the country and the economy around may 1. Are you comfortable with that decision and the push to move toward may 1 as a reopening date . Datais is going to be a and science driven decision. I have been proud of the task force and how the doctors have come together with everyone, governors, congress, the white house, to have collaborative discussions. A lot of give and take and discussion about this. The recommendations the president has will be fully informed by our science and data. Any metric on testing you want to see before that happens . I want to see the appropriate use of testing in this setting. I know task force doctors have worked very hard to determine the appropriate role for testing. Hotspotsry, areas with where people are infected at a higher prevalence. There are different geographic areas and we must individualize for that. A 22yearold who is healthy is different in terms of how a Health Care Provider will address that versus someone who was older who might be on other medications. It is complicated and it is the interface of economic, political, health, and safety. Hahn, thank you very much for your time. Thank you. My best to the American People. We will be back next week with more programming. Home, wegh we are at will do our best to provide you with the conversations about people making decisions in the country. While the coronavirus pandemic is having an impact on the schedule, members will not be back for legislative business until may 4. Senate majority dealer leader Mitch Mcconnell has announced the same, two weeks after it was originally scheduled to return. Members have been advised of sufficient notice to return to capitol hill if legislation was to be considered before may 4. Watch live coverage of the house on cspan. See the senate on cspan2. On friday,terview Chuck Schumer spoke about the interim covid19 relief package, saying, were having discussions. Speakers followed Speaker Pelosi staff, my staff, and secretary mnuchin. Theyre going to continue through the weekend and i dont see any reason why we cant come to an agreement. Late friday night, democrats sent a new offer to treasury secretary mnuchin in the negotiations to get the Small Business Paycheck Protection Program refunded. The author offer would provide 1. 5 lien dollars for state and federal funding, including money for federal banks, underserved populations, hospital, and money for testing. All month on cspan, were featuring the winners of our studentcam documentary competition. Middle and High School Students created videos answering the wantion, what issue do you most the president ial candidates to address . And in the midst of these challenging times, i have some exciting news. A team of talented High School Students from Long Beach Polytechnic High School are the first place winners in cspans National Documentary competition, studentcam. Cspan partners every year with spectrum for this competition, which has dunes create short