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          FDA Insight: Fighting COVID-19 at the FDAFDA Insight FDA Insight: Fighting COVID-19 at the FDA
  
  	
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 FDA Commissioner Dr. Stephen Hahn, and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah discuss FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.

FDA Insight: Episode 1 – Transcript

**>> Anand Shah:** Welcome to our new podcast, FDA Insight. I'm Dr. Anand Shah, deputy commissioner for medical and scientific affairs at the FDA. And it's my pleasure to be here this morning with Dr. Steve Hahn, commissioner of food and drugs. Welcome to our inaugural show.

**>> Stephen Hahn:** Anand, I'm so happy to be here and excited that we're starting this podcast. I'd be happy to join FDA Insight as much as I can.

**>> Anand Shah:** You're always welcome to join. And the goal of our podcast is to educate our many stakeholders about the products that we regulate, the issues we face, and the processes that we follow in everyday plain language. We'll be discussing COVID-19 and non-COVID-19 related topics. And our primary audience here is patients and consumers but also the healthcare community. Both the Commissioner and I regard education as a critical part of our jobs at the FDA. We go back over a decade when we both worked together at the University of Pennsylvania. And after serving most recently at CMS, it's great to return to FDA and rejoin you, Steve, on the FDA team.

As soon as I joined FDA, it became crystal clear to me, and I know that you've also had the same impression, that the people who work with us at the FDA are simply extraordinary. They apply their knowledge and insights into fulfilling a singular mission, the protection of the consumer, and the advancement of public health. The breadth of FDA's oversight, 20 percent of consumer spending, is very wide and touches on the lives of every American. I look forward to recording many podcasts, breaking down FDA actions into plain language, and providing insight for patients, consumers, and healthcare professionals.

Today, we'll go over where we are in the fight against COVID-19 and dive into what's top of mind for many Americans, our drug development process for COVID-19. With that, Steve, tell us a little bit about FDA's focus throughout the COVID-19 pandemic.

**>> Stephen Hahn:** Yeah, thanks Anand. This is a really important topic, and I'm happy that we're sharing this with the American people. From day one, FDA has taken an active leadership in the all of government -- frankly, all of America response to the pandemic. And that really has been inspired by the resiliency of the American people. I'm just so proud of what the American people have done, as well as the incredible innovators and developers we have in this country. We have certainly worked very closely with the private sector and they have responded greatly to this pandemic.

So let me just sort of break down a few things that we're doing. We facilitate medical products, the development of those medical products, and we work with developers, innovators, the private sector, and these products are for the diagnosis, treatment, and prevention of COVID-19. Now, we do that outside of COVID-19, but that's been a particular focus during this pandemic.

We also mitigate any potential medical product and food shortages. Now as you probably know, throughout this pandemic we've been faced with spot shortages, food for example, but certainly medical products, and a significant issue related to personal protective equipment. And one of our jobs is to actually work with an all of government response to address that. We ensure the safety and quality of FDA regulated products. That's a really important priority for us. You've heard us say multiple times that FDA's responsible for the safety, effectiveness, and accuracy of medical products, and this is a core principle for us. And we provide the industries that we regulate the tools and flexibility to do the same.

So one of the things that we've learned from this pandemic is that this is a collaboration with industry. We are the regulator, but we do want to provide the tools to facilitate the development of these great products to fight COVID-19. And finally, I'll just mention that one of the core strengths of FDA is that we're a learning organization. It's not just the way we respond to this crisis, but in our ability to really learn from everything that we've done so far and apply that experience to the future. Not just for COVID-19, but for all of our responsibilities.

**>> Anand Shah:** Steve, let's take a deep dive on drugs for COVID-19. We hear about drugs for COVID every day in the news. Can you go over what is FDA's role in developing a treatment for coronavirus and, of course, the question everyone wants to know, how long will it be before we see a treatment that can be used broadly in most patients?

**>> Stephen Hahn:** So from the very beginning of this pandemic, we worked very closely with those involved in the drug development process. And I think it's important to take a step back and ask the question who are those people, who are those players who are involved in the drug development process? And that includes government. So for example, NIH and CDC would have some input, as well. But certainly academia, so our great academic hospitals and medical centers around the country, drug developers, and really the private sector, the pharmaceutical industry, and others.

And we are working very hard to continue to accelerate and facilitate the development of safe and effective drug therapy for COVID-19. And we're also doing this on the vaccine side, as many know, and we look forward to exploring that topic in an upcoming podcast that is top of mind for many Americans since vaccines are the way that we'll eventually defeat this virus in the future.

So just to get back to drug development, we have more than 144 clinical trials in this country underway with specific agents to fight COVID-19. And I'll just give you an example. Early on in the pandemic we worked with NIH on ways we could do clinical trials to get answers on the virus more quickly.

Now as the audience may or may not know, clinical trials are platforms where we enroll people who have COVID -19 in a specific clinical trial to ask a question about what's the best way to treat it. So an example would be, we have a drug where we can look and ask the question will this help cure or mitigate COVID-19? That'll be a clinical trial. It's done in a very structured way. And what we did with working with the NIH is that we developed what was called a platform trial where you could basically do a broad trial and plug in multiple different treatments at the same time, with different patient groups. And that way you can study multiple different drugs all at the same time, and much more efficiently, and quickly study those.

Now this is an example of something that we really need to push into the future for other types of therapies if you think about therapies for rheumatoid diseases, or for arthritis, or for cancers, it's something that we should continue to look at.

**>> Anand Shah:** So you mentioned clinical trials, which are so critical for drug development, especially to generate high quality data that the FDA and scientists can use to make decisions. You and I have both enrolled patients on clinical trials in treating patients with cancer, which in turn helped our understanding of science, but how can the agency make the concept of a clinical trial, as well as our own internal processes, more understandable and transparent to the American people?

**>> Stephen Hahn:** Well I think you're -- what you've highlighted there is really important. Transparency is key, information is key, and this is a great start, this podcast. To describe what a clinical trial is, to continue to give information about what it means to be on a clinical trial. Because there will be Americans that will be asked by their providers to consider being on a clinical trial and what that means is that this is a very structured way of asking and answering a question.

Our fundamental job at FDA is to evaluate new drugs before they can be made available to the American public. We've been doing this throughout the lifetime of FDA. We support and we guide. We provide information to America's innovators, the scientists, and those who develop drugs, to help get them there faster to American providers and patients. But we always maintain regulatory independence. We give that information, we provide the guidance, the investigators perform the trials, but we ultimately have to make that decision about the safety and effectiveness of a new drug, whether that's for COVID-19, or for any other disease. FDA's physician-scientists, chemists, pharmacologists, nurses, all of our groups review the data that we receive from these clinical trials, and we make an independent review. And we make that review to determine if there is substantial evidence that the drug is effective and that it's safe. And that's a really important primary responsibility of the FDA.

And I can't tell you when we'll have treatment for COVID-19, but a lot of great work in this country is in progress, and I am confident about our ability to find appropriate therapies.

**>> Anand Shah:** So Steve, you've shared insights about our drug development process, including clinical trials. Let's focus briefly on a drug that many Americans have heard of in the news but may only have partial information. There's been a lot of discussion surrounding the use of a drug called Remdesivir, which has received an emergency use authorization from the agency for use in certain severely ill patients with COVID-19. What is this drug? Can a patient get this at their local pharmacy? How should it be used? And in which patients?

**>> Stephen Hahn:** Well, Anand, there's been a lot in the press about this drug Remdesivir. And just to be clear, Remdesivir is what we call an anti-viral. It's a drug that is specifically targeted against the virus, in this case COVID-19. But we call it an investigational drug because it has not yet received formal approval from FDA for safety and effectiveness in COVID-19. What it has received, which you have pointed out, is something called emergency use authorization.

And you heard this maybe bandied about in the media and on TV as EUA. And let me describe what this is. When a public health emergency hits, like COVID-19, this infectious disease outbreak, there may be, and typically is, an urgent need for medical products to diagnose, treat, or prevent the disease. And in that situation, we have the authority to use a special type of authorization called emergency use. And we use that in the Remdesivir case, and I'll explain why. And this allows us to provide Americans with more timely access to drugs, tests, or other critical medical products that may help during the emergency.

Now we do this very urgently and very quickly because the pandemic is moving so quickly. But our job is to look at the available data, and to balance the known and potential risks of these products with the potential public health benefits, and we make that calculus. Are the benefits outweighing the risks? If they do, we provide this temporary authorization called emergency use authorization.

**>> Anand Shah:** And so it's because Remdesivir showed some promise in a clinical trial to shorten the time to recovery in some very sick patients, specifically those that are hospitalized, that FDA was able to authorize its use by issuing the EUA?

**>> Stephen Hahn:** Anand, that's exactly right. We had preliminary data from a study that was performed by the NIH. It provided that information. We felt very confident about the safety, and the effectiveness of the drug in the emergency use authorization setting, and so we went ahead and provided that. Now this is a drug used to treat very sick hospitalized patients. So with respect to the question of can you get this at your pharmacy? The answer is no. This is not an outpatient drug at the moment. It is authorized for use in hospitalized sick patients.

And of course, the safety and effectiveness, the more finalized data, the more complete data set, is being continued in clinical trials. And we'll look at those data in the future when they're available.

**>> Anand Shah:** So Remdesivir is one of the many drugs under investigation for COVID, but the American people are eagerly awaiting an approved treatment from FDA. I know you've often said how important it is to provide hope but not false hope. I'm certain people want your insight here. How optimistic are you about the development of an FDA approved treatment for COVID-19?

**>> Stephen Hahn:** The short answer is I am optimistic. Of course, I can't give a definitive answer because that depends on the science and the data, but we have great people working on this. As you know, Anand, I spent my entire career as a physician and scientist caring for patients with cancer and have always very highly valued a commitment to good data, and sound science. And I feel right at home working with the scientists at FDA because I know that they also share that value, that commitment, and they will tolerate -- we will tolerate nothing less than a commitment to sound science and excellent data.

This has been and will continue to be a guidepost for all of our decisions, now and in the future. And we certainly understand that speed is important in an outbreak like COVID-19, but so are safety, accuracy, and effectiveness.

**>> Anand Shah:** Thank you, Steve, it was really great having your insight today. That wraps up our conversation. Our very first but definitely more to come.

**>> Stephen Hahn:** This has been a great experience, Anand. Thank you very much for the time. I'd love to come back and talk more about what we're doing at FDA.

**>> Anand Shah:** Yes, and in the weeks ahead, we'll discuss vaccine development, food safety, sunscreen, and other topics that we at FDA work on every day. We also plan to discuss the protective steps that people should take as we seek to bring this pandemic further into containment and what FDA is doing to anticipate and prepare for future needs. If you want to hear more, please subscribe to FDA Insight on Apple Podcasts, Google Play, or your podcast app of choice.

Thanks for listening, and we'll be back soon. It was great having you today here, Steve. I hope you'll join me again soon.

**>> Stephen Hahn:** Well thanks, Anand, and thanks to our listeners. Let's do it again.

[end of transcript]

                                                                                  Content current as of:
      06/23/2020FDA Insight
 
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