Transcripts For CSPAN2 FDA Commissioner Hahn On COVID-19 Treatment Vaccine 20240712

The Economic Club of new york is one of the nations leading nonpartisan forums for discussions on economic, social and political issues. This mission is as important today as we people together as a catalyst for conversation and innovation. We probably stand with our committees seeking inclusion and mutual understanding. Special welcome to guess of our members and lives of the Economic Clubs at chicago and washington d. C. Wouldve also been invited to join the webinar today as well as members of the Economic Clubs 2020 last the fellows. Before i began i would get like to thank our healthcare workers and our other frontline workers for all you do come particularly during these challenging times to keep us healthy and safe. Im not a letterworn in as the 25th commissioner of of food and drug on 2019. Dr. Hahn is a dedicated clinician having trained in both medical oncology and radiology. He was always carefully balance, executive management with clinical time to continue to serve oncology patients. His true passion. Prior to doing the fda dr. Hahn served as chief medical executive at the university of texas. Episode that cares caromont 140,000 patients a year. Before joining there he served as chair of the Radiation Oncology Department at the university of Pennsylvania School of medicine in 20052014. Dr. Hahn earned the rank of commander in the u. S. Public Health Service commissioned corps while at the National Institute of Health National Cancer Institute where he also completed a fellowship in medical oncology and radiation oncology. He also completed a a residency in internal Medicine University of california san francisco. Todays a conversation which i am fortunate to be moderating and he will end promptly at 1 00. I remind everyone there is media online so this is on the record conversation. Be with us a we set off like im getting this job december 2019, wow what a baptism of fire. Handling it . Mike, its an absolute plsure to be a today. Thank you for having me, and it certainly was trial by fire, no question about it. As you mentioned i was sworn in december 19 and i tended to spend my first 90100 days learning about the organization. Thats what a leader does. Certainly spent the first six weeks doing tha of course covid19 came to our shores. Sweat the same time learning about an organization that is complex but terrific, also addressing this issue from a leadership point ofso its been a challenge for everyone. Fda is at the forefront of the nations response to this because we are needing to get medical products in the hands of providers and consumers but i can say one thing ive relied upon is the incredible dedicated 18,000 plus staff at fda who are incredible dedicate and experience Public Servants and a further work around the clock to try to help get medical products in hands of the American People. Great. Sounds could you quickly go over the duties of the mission of the fda . Obviously we want to focus on covid19 during this conversation but just to give our members a s are. We are a Public Health Regulatory Agency. The products we regulate represent about 20 five of every dollar that American Consumer spend. The span of that is Devices Laboratory tests for example but cat scanners, radiological devices for delivering radiation for cancer. It also spans of things like drugs, all pharmaceuticals overthecounter drugs as well as vaccines and biologic cellular therapy. Then one important area is food because thats the in fda. Where responsible for about 80 of americas food supply, the other 20 is department of agriculture and food safety and security of the American Food supply is a National Security issue. As you can tell during the covid19 crisis where basically it was like seven thanksgivings strung together in terms of demand for food, that system had a lot of stress and we spent a lot of time making sure it was safe and secure. Sounds terrific. Lets turn to the topic du jour, e covid19 pandemic. The surgeons and the south and southwest are discouraging at a guess i had to question the ability and willingness of the nation to deal with the spread of this, which makes the development of therapeutics and ultimately a vaccine particularly critical. Where are we on both of those . So youre absolutely right. They have to be in the parallel tracks. Ill take therapeutics first such treatment for covid19. I think this is a great reflection of the incredible private sector that we have in this country the partnership we develop between government, public sector, the Academic Centers who have helped facilitate this. Over the last four four to five months we have seen new tools and the toolbox or providers. You mentioned a short seven months ago i was one of those providers and i want to echo what you said about thanks to the great heroes, because they really are doing incredible work for people. But we hav therapies now that we didnt have walk the pipeline is also robust and and i can tell you about some of that as well. We have drug calle does appear and bully in record time it went through a phase three rim does appear that affects the virus directly and that reduce patients. We also have tested emm expensive drug which was shown in a truck tok patients by 30 a remarkable r something called convalesceery this country that is run by the mayo clinic which allows us now come with over 50,000 people enrol that over 35,000 folks have been treated with that. What that is isthe antibodies fro has recov covid19 and administer that to some who is sick with covid19, and just to pitch out there to you recover from covid19, go donate plasma. We dont know yet whether its theres great event for the supply so please go donate. Mike we have over 140 Clinical Trials active, and more than 450 in the pipeline. So the pipeline is very robust new treatments. One other thing i would just like to point out about treatments is theres a type of antibody where you basically copy the Natural Immunity from someone who has recovered and you can synthetically create an antibody. Its work and other Infectious Diseases in the past. Those Clinical Trials are well underway and with great hope it will show a positive effect a great way for the data but by late summer, early falls and they can act as a bridge to vaccine because they can be given a treatment and provide community but they can also to prophylaxis to prevent someone from getting sick. Again we have to wait for the data. Vaccines, we have seen an incredible effort by u. S. Government great private sectore have in this country over 20 going to the late stages, phase three studies foraccines very soon. Thats great news for americans. I want to emphasize one point and that is fdas role in this is to provide assistance so manufacturers know what is going to expect in terms of developing. When we are absolutely an independent regulator and americans should understand that i hope un erstand that we will call balls and strikes on the data. Our job isther a vaccine is safe and effective. We make no prejudgment about that. We want to see the site and the data. We will look at that and an independent way and will make American People about the safety and effectiveness. I want to assure people fda is on the job about that. Thanks f that. Traditionally i guess the protocols for developing new vaccines take a rather long time. I heard somewhere that for years was the shortest time with which disease to get which disease that was but obviously it would be nice to shortcircuit that and i guess my question to you is is it lik to do i i think were focusing evid that. One of the hazards of this conversation is where people here shortcuts they think okay, shortcuts, whether its safe or effective. Im going to go point which is we are not come to take shortcuts at fda when will look at thee occurred are on the Clinical Development as well as the manufacturing side. So youre right in a typical situation you vaccine in a preclinical setting before you got humans. They jus data. You say its okay to go into humans. Say that looks safe. You go into the efficacy trial the effectiveness trial and then you go into this big large randomized trial. Thats a sequential what the sponsors and manufacturers have done is due with called the platform which were we can look at a number of different treatments all at the same time which makes it a more efficient aac to actually develop those. We also do whats called seamless which is you dont need to we can look at everything inime as we get those of data and then move move on to the next step or quickly. And finally which is perhaps the most important part,ain where the Public Private partnershi so important what manufacturers have done and what u. S. Government has support is whats called manufacturing at you are the ceo the of the company that is develop a vaccine. You are l the vaccine and kill till at the end of the day fda has seen all the data and says yes, your vaccine is license its safe and effective. That tes a couple of manufacture risk while youre doing your Clinical Trials you start making sure that you have the manufacturing capacity but also you start manufacturing the vaccine. So that you are ready when that decision is m if you combine the Clinical Development, the seamless trialonversation back and forth with fda as was the manufacturing at risk, what you have is an accelerated timetable but what you dont have an whats really important is at the end of the day fda still could use its expertise to look at the safety net to see the im optimistic about this. I encouraged by what i see but at the end of the day we call the balls and strikes in an objective fashion. Now there are a number of efforts under way i read some are 150 serious resea efforts, many of them we have invested together 5 billion mostly in Vaccine Research but plenty going on in europe and china as well. Is there any way to harmonize approvals between the agencies that would approveurope and our own . Typically, i guess what iv that the u. S. Process is than that done in other International Fair summary . Actually its the opposite, mike. If you look at new drug approv example about 70 of the new drug approvals in the world 70 are first done in the u. S. And fda. And our time to approval a shorter on average than any other Regulatory Agency in the world. That being said, we have number rantings of understanding and relationships with all of the really developed world regulatory agencies. I have a regular conversation with the headf h1 lessons that we learned into so for the future thathan has been in the past . Because we cannot let this we do things. I think we can orsit tha2nd