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tv   FDA Commissioner Dr. Stephen Hahn Discusses Coronavirus Response  CSPAN  January 8, 2021 3:18pm-4:17pm EST

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presidency, susan ford bales, daughter of president gerald ford and bet fi ford -- betty ford reflect on the ford family's time in the white house. watch american history tv this weekend on c-span3. >> you're watching c-span, your unfiltered view of government. c-span was created by america's cable television companies in 1979. today, we're brought to you by these television companies who provide c-span to viewers as a public service. >> f.d.a. commissioner steven hong reviewed the coronavirus response. implications of new coronavirus strains and challenges sur rounding vaccination distribution. he mentioned the efforts involving food safety, and e
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cigarette regulations. >> dr. hahn was sworn in on december 17, 2019. he's a physician, a scientist, a health care leader, with an extensive background in patient care, academic research and executive leadership. dr. hahn is a dedicated physician having trained in medical oncology and radiation oncology. thank you so much for being with us today and now i turn it over to you for your opening remarks. dr. hahn: thank you for that kind introduction and thank you for hosting me today at this breakfast series. i have been looking forward to this. it is an honor to be part of this long tradition of important and rigorous discussions on public policy and public health and i also want to echo my thanks to the press for what they've done to bring information to the american people that is so important,
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particularly during a public health emergency. as always, the new year brings with it a healthy dose of optimism and hope for new beginnings. this year i believe this promise arrives with some tangible developments in the form of scientific advances to help bring the covid-19 pandemic under control. this is notwithstanding the events of this week which were, of course, very sad and very difficult for our country. over the past year, our nation has confronted an extraordinary challenge and pain. communities and families have faced turmoil and tragedy and we've seen extraordinary examples of courage and resolve. the f.d.a. has been at the center of the government's efforts to combat this public health emergency and it too has faced professional and personal challenges. we have worked hard to meet these challenges with unprecedented scientific effort and diligence. the agency's work load increased significantly to meet the extraordinary demands of
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covid-19 on the order of approximately doubling of our normal work. our work force responded in kind taking on these new challenges while continuing to fulfill our mission critical responsibilities. i'd like to address both aspects of this commitment and i'll start by give jug a small stampling of some of our noncovid related achievements from the past year. our foods team worked diligently to address food supply issues in this crisis and support employees and employers in covid effective -- covid affected food industries resume operation safely. we know that food security is national security. it's a significant component of that at the same time these career staff also advanced important initiatives related to food safety generally. in july, we announced the new era of smarter food safety blueprint which outlines the steps that f.d.a. will take over the next decade to create a more digital, traceable, safer food system.
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and we released the 2020 leafy greens action plan to outline a collaborative action oriented approach to enhancing the safety of leafy greens and helping prevent the recurrence of -- recurrent nature of outbreaks of toxin producing e. coli, a significant problem in this country over the last several years. our center for veterinary medicine, c.v.m., made history with the approval of the first animal biotechnology product were food and biomedical use, a milestone for scientific innovation, and that was the safe pig. we pioneered several products to treat,ing more or prevent serious diseases in animals an provide important guidance to animal drug sponsor, promoting innovation to facilitate the cooperate of new animal drugs. i want to take a bit of time to talk about our center for tobacco products and of course when i first became commissioner
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13 months ago, we all expected the epidemic of e cigarette use among our kids to be one of the major topics facing us. of course not knowing that covid-19 was about to come to the country. but it has continued its science-based approach to regulating abevolving tobacco landscape and protect the public, especially kids from the harms associated with tobacco product use. this year we issued the final rule requiring new health warnings on cigarette packages and cigarette advertisements which when implements will be the most significant changes to cigarette labels in more than 35 years. we also continue to address the alarming increase in e cigarette use among our youth, marking a mile tone this fall, september 9, with the premarket review submission deadline for certain teen tobacco products including e cigarettes. we have received thousand of aply cages for premarket review
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and substantial equivalents and are going through those now. we have taken numerous compliance actions against products targetted to young people. i also want to note that the policy that was put in place in anuary and the recent nyts survey for youth use of e cigarettes shows some favorable data. that was also released on september 9. what those data showed and all these data were pre-covid, was that among high schoolers and or middle schoolers that was a 1.8 million person, child, reduction in the use of e-cigarettes. we have 3.6 million still using e-cigarettes and have a ways to go but i think that shows the commitment of the agency to helping get rid of this epidemic because we know that kids who aring reusers of e-cigarettes go on to use combustible tobacco products. our office of regulatory affairs
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continued to work with states and the c.d.c. to investigate the thousands of lung injuries an deaths associated with vaping and continued our multiyear effort to revitalize laboratories nationwide which are the cornerstone of investigative work. we have been active on the inspection front despite the issues related to the pandemic and we have performed another mission critical inspections and continue to do that. we've expanded our working relationship with the u.s. customs and border patrol, with a new memorandum of understanding that will allow our agencies to maximize inspections, investigations and detection capabilities at the international mail facilities and other ports of entry. we have been very active in reducing the distribution of fraudulent covid-related products to consumers. in march we launched our operation quack act which identified 1,100 fraudulent
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medical products related to covid-19. the team has reviewed thousands of websites an online marketplace listings. this continues to be an ongoing effort as we continue to see these illegal efforts to sell products to unsuspecting americans. another effort called operation dirty hands increased screening of potentially adulterated shipments of sanitizers and we have been very public about that and have listings on our website of hand sanitizers to avoid. this of course is in addition to our normal enforcement efforts by office of criminal investigation, which last year initiated more than 600 criminal investigations targeting violations of the law related to f.d.a. regulated products. our medical products centers continue to do -- to fulfill their normal responsibilities as well as address the public health emergency. our center for drug evaluation reseerge approved 53 novel drugs as well as many new uses for already approved f.d.a. drugs.
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e cover infectious diseases, cardiovascular, endocrine, not to mention cancer. more than half of these approvals will help patients with rare diseases, many of which there is no previous f.d.a. approved treatment. of course we continue to ensure our work is ongoing with respect to cost-saving drugs and needed medications, approving or tentatively approving more than 00 generic drugs including 65 first generics. our centers for disease and devices and radiologic health or cdrh had a busy year supporting the agency's response citing a key role in the emergency use authorization of diagnostic tests, personal protective equipment, ventilators and other devices. we permitted marketing outside of covid-19 more than 100 novel medical devices, including the first cardiac ultra sound software that uses artificial intelligence to guide the user
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to capture quality diagnostic images. we also saw cdhr launch the digital health center of excellence. i think this will be an important step in the future furthering the agency's overarching dedication to digital health and urge you to look into this further. our centers for biologic, in addition to its monumental work on covid-19 vaccine, also approve maryland important biological products and kept the nation's blood supply safe in a time when we saw that there were challenges in the blood collection scene, particularly related to covid-19. and i should also point out that remarkable achievement the agency has maintained in terms of meeting its goals for the review of applications for medical products in the pandemic real toiv recent years. so for example, in f.y. 2020, we met most of our user fee goals for drugs by taking timely action on at least 90% of brand,
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generic an biosimilar drug applications even during the pandemic an even though we had a doubling of our work load. this represents the tip of the iceberg of what i consider substantial achievements of the agency and i am so enormously proud of the contributions of our entire f.d.a. work force who have made significant sacrifices, understanding of course that many americans have during this incredibly difficult time. we've also done an enormous amount of essential work for the sars-cove 2 virus -- for the sars-cov-2 virus response, including pretchings and treatment of covid-19 and we have attempted to have an open and transparent process and more to come on that as we look back on our response to the covid-19 pandemic. but we have ensure thaurd our north star has been and remains that our decisions are firmly guided by science and we want these to be guided by science
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through an open and transparent process. these decisions have helped to provide answers to the nation who are eager for them and we also want to build confidence and trust in the products we want to call many national fears are residing. anxieties. other candidate vaccines are in development. moving these across the finish line in record time. applications of this size usually take us months. it is important to underscore this was the result of months of hard work and planning.
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we continue to monitor the landscape of vaccines in partnership with the cdc. manynes are one of the products we have authorized. i believe we stay true to our mission. we continue to examine the design and conduct of political trials. we think this issue is so important. we want to protect all of .merica
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we must represent all americans. we continue to examine. .ata sources we plan to continue those efforts. and determine how they will increase the accuracy of the decisions we make. in the furtherance of our last april, may, and june, we had a pandemic preparedness plan. realized that this was unprecedented effort by the agency. backso learned that a look through the process would allow us to learn the lessons, keep the things that we did well, and move forward with some potential changes.
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we have been very busy. i believe we have made significant process. i eagerly anticipated the opportunity to immerse myself in an agency that is science-based. i was nuts appointed.
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i went to give my thanks to americans who have been dedicated throughout this pandemic. i am happy to answer questions. >> thank you very much. we have several people lined up. let me remind everyone to signal if you have a question.
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would you like to ask your question? >> why don't you go ahead? >> what will happen to the vaccines authorized once that emergency use expires? what will be reviewed then that was not reviewed earlier? dr. hahn: thank you for the question. there are two key components. in addition to the thousands of pages we reviewed.
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more manufacturing data. one of the things that is important is when we look this, we will have a .teady stream we are committed to that. we have asked for commitment. >> thank you very much. let me turn to another question. >> thank you very much. stood byhe agency have
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the authorization schedule for the vaccines. what do you think is not being ?one now that could be known data, scienceeed to be able to justify any deviation. 98% of the subjects who participated in the clinical trial received both doses of the vaccine. we do not have a robust data set it would be of the same level.
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that being said, we think it is completely legitimate to look at it scientifically. we want to see data with that. we are working closely with the company. i have been working with the coronavirus task force. most of the states have 35%
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.tilization texas has used an age-based approach. this will go a long way to using the vaccines appropriately. we are working very closely to make sure that manufacturing ramp-up is done as quickly as possible. and as safely as possible. >> thank you for the question and the answer. do you expect to see hospitals performing more elective surgeries in the first half of
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2021 if more patients become vaccinated? dr. hahn: i will put on my previous hat of being an executive. as we approach more people being , i absolutely believe that will be the case. i don't have a crystal ball. i have been wrong before. i cannot say there are no hazards. but i think that would be a good guess moving forward. get to that can point sooner rather than later as we vaccinate more people. to herd immunity, i think we will see an acceleration of that. there are procedures that need to be done.
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we need to make sure we have the capacity to do that. this is why mitigation efforts are so important now. the healthilience in care system to take care of women with breast cancer who need surgery to take care of the men and women who need heart surgery. it is very important that we follow those approaches at this point. >> thank you very much. adm. mullen: -- >> i wanted to ask about some leaders across the country who have said they will continue to use the curative test. because something is better than nothing. i was curious if you think it is appropriate to continue to use that test. good question.
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or fda does not endorse prohibit the use of any product like that. they use the data in the science to guide those decisions. i would recommend that they look at the data and science behind that. there are paths moving forward. provided guidance. we absolutely must issue the safety warnings. there are ways with repeat testing and confirmation testing that can be employed. to get around some of the issues
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we are seeing. we will continue to issue the safety warning. we think it is very important that any end user of the test look at the data in the science. we are very willing to help with that. g update a you are able to share today? to then: i will go back center and see what we can release that is not confidential commercial information. >> thank you. >> thank you very much. >> thank you for speaking with me today. question is pretty general. the commissioner
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through a tumble to us time for the country. the white house has attacked you at times. are there things you wish you had done differently. dr. hahn: thank you. this has been an unprecedented time for the agency. i did not expect to be in a pandemic. number ofa externalities that have been thrown our way. i have been reliant on the science and the data. we have revised those decisions of more science and data has come down.
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i am very proud of that. , ournk moving forward initiative will identify these areas. how clinical trials are conducted. we can strengthen and improve our response. proud of thely agency and its response. the last fewin months when we have seen unprecedented challenges to the use of science and decision-making. regrets when it comes to those issues. >> i was hoping you could talk a little bit about the u.k. variant.
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does as of now as it relates to tests and how they react to that virus. know people said so far it looks like most molecular test can still pick it up. but what about other types of tests? what are you doing to get a sense of how these will work? dr. hahn: really important question. fda has been monitoring the landscape for genetic variance of this virus since the early summer. we have been analyzing variance with respect to our databases. i concur with the infectious disease societies assessment. viruses like to mutate. we need to be vigilant about it. we are looking at if any of the
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authorized tests might be dirty screens. ways of screening for the variant. i think it is unlikely that any test will be 100% for being screening for the variant. which of the tests will help us see these in a person. and to use genetic sequencing for that. i think we need to step up our genetic sequencing to keep track of this moving forward. we are focused on that. we have spent a lot of time looking at point-of-care antigen test. that?se variance effect we are working on that issue right now.
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the pcr molecular test can detect the genetic code of the virus. where's the antigen test tests proteins produced by the virus. those assessments are in the works. it is encouraging what we know about the molecular test. this is work that is ongoing. very important. stay tuned over the next couple weeks as we move over. thank you so much. >> earlier this week we talked a bit about this.
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does the fda have a sense of when this might occur? can we speed up trials? a really important question. let me give you some background. in our guidance for vaccine authorization, what we said was in the initial trials, the is the clinical endpoint.
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prevention of disease. , is there a becomes level of antibodies or innate immunity that, if you achieve it , that correlates with this? there is the prevention of covid-19 and there is the prevention of transmission. there is the relationship. for that work to occur over the next week. clinical trials could be modified. we call them bridging studies.
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we are hoping to do that relatively soon. but we need the data. if you did not have the great protection we see from the moderna and pfizer vaccines, we could be giving a false impression to americans. >> thank you very much. there are a couple of spots that have just opened up. if you want to get in, now is your chance. >> i wanted to ask a question
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about looking forward to a few of the things you think the biden administration should do thet off the bat to improve pandemic response and vaccine update. will you be advising them after january 20? dr. hahn: it would be presumptuous of me to tell the incoming administration what to do. i can tell you some of the things i think would be reasonable. i had an opportunity to talk to the transition team. that will be up to the incoming administration. we need to continue our science-based approach. evaluation to have these rooted in science.
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from that and make any mistake with respects to allocating these vaccines based on anything but the science and the data. the north star of fda is data. i have no reason to think that will not be the case. in respect moving forward. i would strongly encourage that we move forward with giving states the opportunity to be more expansive in that they can give -- or they can give the vaccine to as supplies become more available. issue to get as many people vaccinated as
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quickly as possible. let me follow up on that for a minute to make sure. more say a little bit about being more expansive. it?do you see are you arguing for more privatization or less privatization? dr. hahn: i think we heard from the secretary about prioritization. frontline workers, police, firemen, food workers.
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those are very reasonable to follow. we heard in the press that some folks have said they are waiting to get all of their health care workers vaccinated. is reasonable to expand that out. not going outside of the guard rails of the recommendation. maybe going down to the next level. the governors know what is going on in their states. it has to be a science driven approach. we are very happy to have this discussion with the various entities about this. you may have recently seen a report. had a dose of the
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vaccine that they had to throw out. they offered it to a georgetown law student. that is a pragmatic approach. you have the opportunity to vaccinate someone, that is a reasonable decision to make. , when you arering talking about studying a one dose version, there was some you doion in a meeting these parts of studies.
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you would give half of the placebos and the other a one dose. there are volunteers who have already been assembled. i wonder if that has been discussed. if that is a possibility. dr. hahn: i cannot speak to a company. what i can tell you is all of these approaches are on the table for discussion.
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it is a reasonable thing to consider. we have to consider the ethical dimensions of this. many of these participants signed an original consent form. that has to be carefully considered. the agency is open to all of these discussions. as long as the appropriate nickel trials are followed. we have been hearing about these different approaches. we agree that these questions need to be asked and answered. this is a question i get asked a lot. ,da says, with all of the money
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why can we twist some arms to get them to do what we want to do? dr. hahn: you bring up a really important point. there is a very bright line. we will maintain that line. we will continue it. we also have responsibility to these clinical practices. absolutely follow these practices. authority to say yes or no.
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this is really a question for a. >> are you diligent about not giving input in this regard? diligent in are think this is the appropriate way to move forward. >> let's turn to a follow-up. kuiper taking another question from me.
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what can the fda do to help with that? dr. hahn: i cannot talk about specific companies. the me give you a few examples. this is the responsibility of the fda. these are the building blocks of these vaccines. many of these vaccines are not as simple as other manufactured audits. the complicated nature of this .irus
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one of our job is to work with sponsors and work with shannon. they may be used for other medical products. one of our core responsibilities is to identify those. we need to ensure that is done.
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in a high-quality way americans are used do. if a sponsor said they would help,, we want to be flexible with them. >> you said you are responsible for figuring out how to do prioritization. dr. hahn: i would not want to prejudge that.
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there are a lot of tools in the toolbox. >> we will try to take in a few quick ones. >> thank you for taking a question for me again. i want to ask how you are approaching what astrazeneca has said. i know you said you cannot talk about company specifically. the original trial was 62% efficacy. dr. hahn: i will talk generally, not specifically. see is data from
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well performed clinical trials. we want to see clear and compelling evidence. we will continue to see that data. we want to make sure that we number crunch the data on rn. it is why the fda looks line by line. we want to look at the data from one large trial. and do our own numbercrunching. after that i am absolutely confident.
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>> thank you for taking questions. months, you've talked about data and science, not politics, guiding decisions. years there have been proposals for having ways to insulate those forces. making it a separate agency. you near the end of your tenure and you are reflecting on your time on the job, do you think those kind of structural protect thed help fda's independent? dr. hahn: that is a very timely question. i think this is a really good opportunity for the nation to
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look at the issues you bring up. important for the fda to remain a dependent body. we need to think very carefully. i look forward to participating in the conversation. we have faced unprecedented challenges this year. we have worked really hard. to maintain independence. we have to think through the unintended consequences. i very much look forward to having that conversation and having that discussion. we should not run away from
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having that conversation in the future. question ask one the moderator. one of the things i was intrigued by was your analysis of how you see the handoff to the next administration. and what you will be sharing with them. one of the issues you're well aware of is people of color have a great deal of distrust in the process. they have been distrustful of process.cal trial an uncertain in many cases on the guidance around vaccine approval. what would you say to the incoming ministration about what you have learned? dr. hahn: really superb question. what i would recommend is we continue to acknowledge this is
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a real issue. this is not something that is made up. this is real. it is legitimate. we have to acknowledge it. we have to take it head-on. it is a moral imperative. rootedisions have to be in all of america. not just one group. those from socioeconomic groups who are not always represented in clinical trials. if we do not do that, i consider it a failure. engagement and discussion and honest conversations that are sometimes very difficult. thatof these communities
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addressed trustful are the communities that are suffering the most. we need to roll up our sleeves and have this conversation. we had very good representation from folks who are not usually at the table. we have been public about that. that helps. people in those communities were very vocal. they asked the appropriate questions. it is something that i want to dedicate myself moving forward. >> we appreciate the answer to that.
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what will you do next? >> i will take some time off. there have been challenges there as well. i have not made any decisions.
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they have been through this pandemic. they understand this on a personal and professional level. i'm so proud to have represented it. there are things our agency could do in a different way moving forward. i know the agency is committed to that. i look forward to working as a private citizen. i want to thank the american people. they have been great and their response to this. that is our way. before we have full vaccinations. that is the way we will get through this. continue to protect the
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vulnerable. my thanks to all of america as we move forward to the pandemic. thank you very much for your service. for your comments. you standingeciate up for the career scientists inside of the fda who have been under such extraordinary pressure. they did not fold or bend. they always kept to the siren -- science. story ofhis is a purism. as we close out, we ask that you take the time to complete the brief evaluation survey you will receive after the broadcast. we really take your comments seriously. we are your servants.
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it is our response ability to media andrt commentators as they try to network and communicate these important concepts and advancements. we thank you for being a part of it. thank you for joining us today. see you next time. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit ncicap.org] [captions copyright national cable satellite corp. 2021] >> you're watching c-span, your unfiltered view of government. by america'seated television companies in 1979. today, we are brought to you by the television companies. as a public service. ♪ >> book tv has top nonfiction
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