FDA Commissioner Says Panel Must Review COVID Vaccine

JOHN WHYTE: You’re watching “Coronavirus in Context.” I’m Dr. John Whyte, chief medical officer at WebMD. Today I’m joined by Dr. Stephen Hahn. He’s the commissioner of the US Food and Drug Administration. Dr. Hahn, thanks for joining me.

STEPHEN M HAHN: John, thank you. Really appreciate the opportunity, and it’s great to be part of this webcast.

JOHN WHYTE: Well, Dr. Hahn, let’s start with the obvious. We know what’s on people’s mind. They want to know when a vaccine’s approved that it’s going to be safe. So how can you assure the American public that the approval process is going to be free of political interference?

Nota original: WebMD https://www.webmd.com/coronavirus-in-context/video/stephen-hahn

STEPHEN M HAHN: John, this is a really important question, and I think you’re absolutely right. Part of, um, instilling confidence in the American people, um, about the safety and effectiveness of a vaccine is to talk about what criteria FDA has established for those factors– safety and effectiveness– um, but also what are– what’s the information about the process? Will it be transparent? Will it be open to the public?

So from my perspective, giving as much information about that, um, as– as we can will be very important to instilling confidence. And, I mean, if you want, I can go through the process that we’ve established, um, as well as some of the information behind the data that we’re gonna need to see–


STEPHEN M HAHN: –to make a decision.

JOHN WHYTE: No, I think that would be great, because as you and I know, typically the process in terms of submission of data, uh, is not completely transparent in– in terms of the part of the manufacturer. And there’s reasons for why that is, but how is this process going to be transparent when there is a large number of the public that are more interested in these particular products than they would be in, you know, perhaps a diabetes medicine or medicine, you know, for the heart. So yeah, walk us through that process for approval or authorization. And I’d love it if you could, you know, explain to people the difference between what an emergency use authorization is versus full approval.

STEPHEN M HAHN: So John, let me– let me start off with the distinction between an EUA, or emergency use authorization, and BLA, which is the biological license, which is the standard way that a vaccine would get approved or licensed by FDA. So as you know, we have experts at FDA in our vaccine division and the Center for Biologics and Evaluation Research who do this for a living. They are great scientists, doctors, nurses, pharmacists, statisticians.

And they look at the primary information, the raw data that come from clinical trials on vaccines. And they make a decision about a couple of factors. One is the safety. The other is the effectiveness, and the third is information about the manufacturing. And there’s a number of different acronyms we use for that, but that’s not really important.

What it is is, are we confident that the manufacturing is of high quality and that every lot, every vaccine that comes off the– the– the manufacturing plant actually has a high level of consistency and quality associated with it? So those are the data that we would look at, regardless of whether it’s an emergency use authorization or a biological license application to us.

Now, a biological license application is something that usually, um, uh, takes some time, uh, when we get the data. And I’ll start with a– a sponsor, which is a manufacturer and developer of a vaccine conducts clinical trials. And there’s multiple stages of the clinical trials. It’s where we are now with several of the vaccine candidates. They’re in the phase three of these trials, and that is looking at a comparison between placebo and vaccine.

When that sponsor determines that its data are mature enough, uh, to submit to the FDA, they will submit an application– either an EUA, this authorization, or this BLA. And the BLA process usually takes months. There is extensive look at particularly the manufacturing quality side of things, um, as well as the safety and effectiveness. And typically there’d be a longer, uh, period that– that the data would be looked at, um, during the clinical trial, um, with– particularly with respect to looking for safety events.

Now, our EUA, or the emergency use authorization, throughout this pandemic is in statute. It’s in law. And what it provides the FDA the authority to do is, in a public health emergency where people may be dying of a disease, we can make a decision based upon the risk-benefit assessment of any medical products in front of us. We can also go back with additional data and change that decision should that be necessary.

With a vaccine, it’s a little different than a therapy, because this is going to be given to people who are presumably healthy, who don’t actually have COVID-19. So that changes the balance somewhat for us. So we– we’ve listed a couple of criteria that recently came out in the vaccine guides. One is we will need to see effectiveness and safety data from at least one well-designed and performed clinical trial that is robust and that shows data that are clear and compelling.

We’ve already said that we would look at a floor of 50% efficacy. Now, remember, that’s a floor, not a ceiling. And, of course, we want to see high efficacy if possible, but the floor will be 50%.

JOHN WHYTE: Give people a reference for that, because some folks have–

STEPHEN M HAHN: Ah, good point.

JOHN WHYTE: –you know, latched onto that in terms of, is– is 50% good? Is it consistent with many other vaccines? Maybe compare it to– to influenza. We know pneumonia– Pneumovax can be 90% effective. So explain to us that 50%, because I think people get confused by that.

STEPHEN M HAHN: John, that’s a really good point, and we’ll use flu as an example. And as we know, there’s a lot of mutations that can occur with the flu virus, and so, um, it varies from year to year. But for example, last year’s flu vaccine efficacy was around 30%. In some years, it can be high as 50% to 60%. We felt for this public health emergency that the most appropriate for what our scientists did was 50%. So that should give you some perspective on that.


STEPHEN M HAHN: With respect to safety, what we said was, from the last dose– and in some cases, there are two doses of vaccine. In some cases, there are one– from the last dose of vaccine, we would need to see follow up data of a minimum of two months after the last dose of the vaccine in at least 50– well, in the– in the median, which is, you know, 50% of the– the volunteers who are on the trial. And so–

JOHN WHYTE: I think it’s– and 15,000 people. Is that right?

STEPHEN M HAHN: You got it. So that’s exactly right. So it’s a trial of 30,000. And then 15,000 receive placebo. 15,000 receive the active vaccine.

And the reason that’s important is because our data show us that, within the typical vaccine process and the typical review of data, that the significant and overwhelming majority of– of toxicities or side effects are seen within that period of time. Now, we added something else to just make sure that we could ensure safety. And that is we require a very robust program to look at additional safety after or if a vaccine is approved or authorized.

So in this case, in the EUA, we want to see this minimum amount of safety data, but then we’re going to be very close in terms of our observation of any additional safety events.

JOHN WHYTE: So that– in a different market, they’re going to do–


JOHN WHYTE: –assessment of safety.

STEPHEN M HAHN: That’s correct.

JOHN WHYTE: But so Dr. Hahn, you know, some people have said, you know, let’s say there’s 30,000 people in the trial. Half of them, you know, receive vaccination– 15,000. You could have a– a rare side effect that’s 1 in 20,000, and you may not see that. And we’re going from 30,000– I’ll give you 30,000– to 300 million.

So how does that play in the role of safety? Because I’ll tell you, on the surveying that we’ve been doing at WebMD, people are very concerned about, you know, getting it in the first three months. Everyone’s saying, I’ll let you, Dr. Hahn, get it, and see how you do. We all can’t be doing that.


JOHN WHYTE: So it’s like, how does that play into it when we’re going from, you know, 30,000 to a magnitude, you now, of 10, maybe even 100? How does that work?

STEPHEN M HAHN: So a couple of things. One is, um, our safety database isn’t just from, uh, the randomized clinical trial. Remember, for some of these vaccines which started in humans back in the spring, we have safety data from those individuals, as well. So we’ll look at those totality of data.

The other thing that we’re going to do, obviously, is this very active post marketing assessment program, and we’re going to do a very aggressive approach to that. And also remember this won’t be given to 100 or 300 million people in the first three, six months. Um, there will be a rollout plan associated with this as the manufacturing runs up. And so what we’ll want to do– and again, I don’t want to prejudge this is going to happen. It all depends upon the data.

And remember, the data are going to be looked at by our scientists, but also a vaccine advisory committee. So I think our scientists feel that, given the fact that we do have a– a robust, uh, safety database up till now plus the size of these trials, which are– are larger than many trials for vaccines in the past, and the surveillance afterwards, that we can have, uh, confidence around the safety. Now, that being said, we really do have to look at the data and look at it very closely.

And then I think the final point that I would make with respect to this is that this is, again, risk-benefit. So John, if we look at– and I’m being hypothetical here. I don’t know any data. We haven’t seen the data. But if you look at the current situation, anywhere between 800 and 1,000 people are dying per day in the United States, let alone worldwide from COVID-19.

If there is a highly effective vaccine that appears safe in this data set that we’re talking about, we will consider– I’m not saying we’ll do it, but we would consider authorization in order– if the data suggested, to prevent additional deaths associated with COVID-19. Now, I will not prejudge, and this is not my saying that we will do it. I’m just saying that this is what FDA does. This is our charge– is to look at the risk-benefit ratio. If we do not feel that the data are supportive of enough– and safety, we won’t authorize. That is for sure.

JOHN WHYTE: Well, there is a public health emergency, so you kind of described the– the scenario. Uh, you know, some of the companies have reported some preliminary data. How likely is it that there will be an emergency use authorization for certain categories of people based on that risk benefit profile?

STEPHEN M HAHN: Well, it could happen. You know, John, I was a cancer doctor before I became FDA commissioner, and I told people all the time I don’t have a crystal ball, and I don’t have a crystal ball on this one. You could imagine a scenario where we look at the data, and we’d identify exactly what you’re describing. But again, we don’t know until we see the data.


STEPHEN M HAHN: And when we see the data, we will be very transparent about our assessment of it, which brings me to another point, and that is we will have a vaccine advisory committee meeting for any of the applications we receive. Um, the acronym, as you know, John, is VRBPAC, Vaccines and Related Biological Products Advisory Committee. And there will be a transparent, open to the public discussion about the data regarding safety and effectiveness. And yesterday, we posted on our website the meeting materials for October 22, 2020, uh, meeting. And we now–

JOHN WHYTE: Now, no data is going to be presented there. Is that correct?

STEPHEN M HAHN: No data will be presented there at this time.

JOHN WHYTE: All right.

STEPHEN M HAHN: It’s just to discuss the general development of COVID-19 vaccines. Now, while it’s not intended to discuss any particular vaccine candidate, we are also, as an agency, prepared to rapidly schedule additional meetings.


STEPHEN M HAHN: Or if we do get the submission of a BLA or an EUA application to us, but this purpose is to discuss, in general, our approach, including the criteria that I just discussed.


STEPHEN M HAHN: And we want feedback from vaccine experts and public health experts about this. So–

JOHN WHYTE: And the public will be able to comment. Uh, and we can put a– you know, a link to the site.


JOHN WHYTE: You and I know that term, docket, but outside of the area, people don’t know what that means. So can you explain to people? Because the public wants to be involved and wants to have input, especially as we think about criteria. So everyone’s not going to be able to– to log on on October 22 or on future dates. So can– can you explain, you know, how people can participate so we can let them know?

STEPHEN M HAHN: Yes, and we’re planning to establish that docket– docket this week. And that is in– kind of a portal to allow for public comment on the meeting. It’s why we released the meeting materials ahead of time, so people can look at those.

And so the questions you’re asking me about, how confident can we be about safety? We want the feedback. We want other experts. We want the public to comment on this, because that is an important part of our decision making as we look at the risk-benefit.

So I can tell you the docket number. Um, if that helps, we can certainly provide that to you.

JOHN WHYTE: Absolutely.

STEPHEN M HAHN: We can– we can push that out. That would be great.

JOHN WHYTE: Us as well.

STEPHEN M HAHN: And you– public providers, stakeholders can provide public comment to us, uh, for this meeting. Um, and we will review all of those public comments, uh, because this dialogue, as I said, is very important.

JOHN WHYTE: I– I do want to ask one clarifying question. So is it correct to say that no vaccine candidate would be authorized or approved without input from an advisory committee?

STEPHEN M HAHN: That is absolutely correct, John.

JOHN WHYTE: So then–

STEPHEN M HAHN: And another thing that I’d like to say to that is that the decision regarding a vaccine will be made by our career scientists in the Centers for Biologics, uh, Evaluation and Research. And they will do it based upon the data and the science that are presented to us in any application that we might receive. That is how we plan to do it.

We plan to be transparent, um, in our either authorization or approval about the data we used and the rationale, the patient populations, all the things that we’ve discussed here. Um, that will be transparent as part of our decision process.

JOHN WHYTE: So then let’s talk about timeline. I’m sure people are going to wonder after hearing this. So now we have this two month period, primarily for safety issues to make sure that there aren’t adverse events. But then we’re also hearing that an advisory committee will look at the data, uh, and answer questions about it. And just to clarify, advisory committees don’t always vote up or down, yes or no about approval authorization, but they will provide input.

So what does that do for the timeline? Is it– is it still possible that a– a candidate could be approved or authorized by the end of the year?

STEPHEN M HAHN: So it’s possible, um, but again, don’t– I will not speculate on it, John, because I don’t know when the data will be mature from a clinical trial and when we’ll receive an application. What I can promise the American people is that, when we receive an application, our scientists will review it. We will schedule a meeting, and that meeting will be open and transparent. And then when we make a decision, we will be open and transparent about the data we used to make that decision.

Um, the time frame will depend upon the complexity and the amount of data we receive, the questions that we’re going to have to ask. John, you were at the agency. You know that this is very much a rolling and give and take process.


STEPHEN M HAHN: We– we look at the raw data. Um–

JOHN WHYTE: And data are great, Dr. Hahn. Though people interpret it differently, and that’s where some challenges arise, isn’t it? You and I can look at the same data and come to different conclusions as to what’s effective and appropriate, especially when we’re looking at, you know, 50% in terms of, you know, how are we measuring success.

STEPHEN M HAHN: That’s absolutely right. It’s why the transparency around this is important, and it’s why that vaccine advisory committee is so important, because it allows us to have other points of view that we can incorporate into our decision making. And that is something that we want.

JOHN WHYTE: And– and Dr. Hahn, you and your teams have been very involved in, you know, the issue of therapeutics. And, you know, I can joke with you. You’re an oncologist, as you said. Your concept of risk might be different than mine, uh, as an internist.

But when we think about vaccines and therapeutics, a lot of people had been saying for a long time, well, we can’t open up anything until we have a vaccine. Kids can’t go back to school. Businesses can’t reopen. Is– is that misplaced, and we have to balance vaccine development with also where we are in terms of therapeutics, drug treatments?

STEPHEN M HAHN: Absolutely. And– and not only balance it was therapeutics, John, but balance it with the common sense public health measures that we need to mitigate the spread– the community spread of the disease– mask wearing, social distancing, avoiding large crowds, um, and either inside, more importantly, but outside also, and protecting the vulnerable. We can’t forget that our first line of defense has been and continues to be those commonsense public health measures, but you’re absolutely right.

We’ve talked a lot about other therapies, and, you know, certainly top of mind recently has been antibody therapies. And as a potential approach, and even as a bridge to vaccines, those are going to be very, very important for us to consider. And again, we’re– we’re going to have to look at the science and data behind it, but that does allow us to– to carefully consider the vaccine side of things, because the more therapeutics are available, the more that that obviously will help in terms of saving lives. And at the end of the day, John, as we mentioned, in a public health emergency, it’s about doing everything we can in an expeditious way, but also a safe way to save lives.

JOHN WHYTE: Well, you know, in many ways, it’s a story of innovation. You know, in February and March, we really had nothing to talk about therapeutics in terms of, uh, COVID-19, and here we’re talking about different strategies, not just remdesivir, and dexamethasone, and monoclonal antibodies, but some other therapies as you know.

But I want to come back to monoclonal antibodies, because you brought it up, because it is– I’m sure you’re aware people are searching that online right now. But outside of a clinical trial, it is very difficult, is it not, to get monoclonal antibodies as treatment? There is a compassionate use policy, but those, you know, policies tend to be, you know, pretty strict. What can you tell folks that may, you know, have a loved one that has moderate to severe COVID-19, or they themselves, and they want to consider the role of monoclonal antibodies in their treatment?

STEPHEN M HAHN: Well, first of all, I would strongly encourage the enrollment in a clinical trial. The clinical trials will be our gold standard for looking at the safety and efficacy of any therapeutic in COVID-19. Now, that being said, there may not be a clinical trial available. Now, in that situation, the– this does allow for the application of a compassionate use, but you’re right. That has to be done through a company, and many of them have policies in place to restrict that, particularly because they want to facilitate the clinical trials.

Um, so this is, again, a doctor-patient discussion that needs to– to take place. But as you know, we have not authorized or approved any monoclonal antibody at this point. We consider them investigational, and we do encourage enrollments in the clinical trials, because that’s how we’re gonna get the data to determine the safety net we see in those agents.

Now, we know these agents have been effective in other infectious diseases in the past, so I think there’s a lot of, uh, promise there that– that– that many in the medical community think may be present. But again, FDA’s job is going to look at the data that come from those clinical trials.

JOHN WHYTE: Right. And we really do have to look at the data, as you point out, because monoclonal antibodies have been tried in other diseases with mixed results, you know, along the years. I wanted to give you an opportunity to talk about what the FDA is doing about fraudulent products. You can’t go online and not see, you know, some product that is being marketed as a cure, and there are new cures for COVID. There are no approved treatments. Um, so what is the FDA doing, and what guidance can you give?

STEPHEN M HAHN: John, this is a really important subject to the agency. You know, you’re having been there, you realize that, um, there are bad actors that take advantage of situations like this public health emergency. Early on in the, uh, pandemic, we stood up a task force to actually look at this. We had partnered with retailers online, uh, in particular, um, and had surveilled, uh, the– the– the internet and other places to– to determine, um, whether there are fraudulent products that are being, um, marketed to individuals around the country and the world.

Unfortunately, that has been the case, and we have sent many warning letters. We have partnered with the Department of Justice on this, and we will continue to do that. We ask the public to help us. In our public facing web page, we have information about fraudulent products and how they can be reported to us. We welcome anyone to do this.

Our partnership with online retailers has been very, very good. They have helped us in this effort to prevent fraudulent products. It is not OK for someone to market a product that has not been authorized for COVID-19. And it is just simply not OK, and we will be very aggressive in pursuit of that.

John, one– one product that I do want to mention in particular is on hand sanitizers. As you know, early on in the pandemic, because hand sanitizers were one way, in the absence of soap and water, uh, to prevent the spread through hands of– of infectious diseases. Um, we had a shortages of hand sanitizers. And, uh, unfortunately– well, fortunately we found it, but unfortunately there were events where we found hand sanitizers that contained a type of alcohol that could be dangerous to people. And that alcohol is methanol.

We identified that in our assessment of these products, and we have over 70 products listed on our web page. So I would encourage you– and we can provide you, John, with the link to that– that web page. I would encourage those who are still out purchasing hand sanitizers to make sure that they look at this do not purchase list, because that’s an example of where adulterated products, products that have– that don’t have the proper ingredients would find its way onto the market. It’s a little bit separate than fraudulent claims, but still part and parcel of our approach to protect the American public.

JOHN WHYTE: We’re covering everything you do, Dr. Hahn. We’re doing vaccines. We’re doing therapeutics. We’re doing over-the-counter.

So we’ve got to touch on testing before I let you go. And, you know, people are struggling with this idea. I want speed, and I want accuracy. And it’s– let’s be honest. It’s hard right now to have both. So what can you tell people about where we are in testing, in terms of rapid testing, you know, PCR?

And– and I want to give you credit. As you know, other commissioners have always talked about, too, you– you know, you either approve something too fast or too slow. It’s always that balance–


JOHN WHYTE: –that, you know, you, you know, have related that we have to focus on. But on testing, it’s speed versus accuracy. So where are we on testing?

STEPHEN M HAHN: So I’m going to start a little bit at the beginning, John, if you don’t mind.


STEPHEN M HAHN: When– when the public health emergency started and the CDC developed its test, one thing to remember is that we didn’t have a lot– fortunately, a lot of people in the country who had COVID-19. So when you think about how does one develop a test for strep throat or flu, you have people who have the disease. You have people who don’t have the disease. You have people who have another respiratory illness.

And you– you evaluate your tests in real human beings who have that illness and who don’t. And then you can see, OK, the test picked it up in people who had it 99% of the time. It didn’t pick it up in people who had a different type of a sore throat or illness. And that allows you to look at the operating characteristics, and you can do this, you know, on a– a large group of people.

We didn’t have that luxury as a nation early on in this pandemic. So we used what was called contrived samples, which is you take a sample from someone who doesn’t have the disease, and you add the virus into it, or you don’t. Or you had flu virus or strep to it, and then you evaluate your test.

And the samples were limited. There were some limitations on the– the– the virus, as well, in terms of being able to get that to developers. But we saw tests that had reasonable, um, accuracy and reasonable reliability and reproducibility. That authorization proceeded.

Now, we then used real world evidence. So you’re using this test, this PCR test, if you will. How is it actually working in the real world where doctors don’t have the luxury of worrying about a– a controlled setting? They have to actually take a sample from someone who’s sick–


STEPHEN M HAHN: –to determine whether they had COVID or not. So that gave us great insight into the operating characteristics of the test– the sensitivity, the specificity. We then used those data to work with developers to actually refine what we were seeing with the test.

Now, early on, we worked with developers on these PCR tests– polymerase chain reaction tests– just sort of a standard test, the diagnosis of RNA that is–

JOHN WHYTE: Highly accurate.

STEPHEN M HAHN: Yes, and highly accurate, often very sensitive. We then moved to point of care tests, because we realized that we needed rapidity, because some of the PCR tests initially took a while to actually run. And you couldn’t do it in the volumes that we needed to do it initially. The point of care test, as you know, like the rapid strep and rapid flu, allow you to do it quickly.

But we also know from experience that they tend not to have the sensitivity that the other tests have, that the PCR tests have. So we moved to that, and, again, did the same iteration. Let’s test, but then let’s also look in real world setting and update as needed.

And then finally, we have moved– not finally, but we’ve moved to these antigen tests, which are fortunately less expensive, and also rapid. But also have a lower sensitivity in general. We established criteria at that point because we had more experience in what we wanted to see.

And what we’ve seen with the most recent tests that have been authorized is much more robustness with respect to sensitivity and specificity, which is really a testament to the private sector, um, and to the laboratories around the country who have been developing these tests. What I can tell you now is that FDA is dedicating its resources– and we have hundreds, if not thousands of applications in front of us. We’re dedicating our resources to point of care–


STEPHEN M HAHN: –rapid, um, and, uh, and– and tests that can be done with home collection, and ultimately with at-home testing. And as you can imagine, that’s a whole nother step, right?


STEPHEN M HAHN: Because you want to make sure that it’s easy to read, that people can interpret it, because being un– unable to do that is problematic. So we’re really using the experience we’ve learned over this period of time to then inform the subsequent development with– with manufacturers and developers of these tests. And– and that’s where we’re putting our resources.

JOHN WHYTE: Dr. Hahn, I do think one clarification that we can give viewers are relating to which type of test, whether it’s, you know, rapid, the antigen, you know, point of care is some of these tests are more designed and certainly more accurate when people have symptoms versus those that, you know, are used for screening. Can you speak a little to that? Because I don’t think there’s enough information out there for consumers in terms of how to interpret the results based on the population that they’re designed– symptomatic, asymptomatic. Could you clarify that for folks?

STEPHEN M HAHN: John, you could come back and work at FDA. Um, uh, this is exactly correct. So when you think about it, how were these tests developed? These tests were developed in people that we suspect– not we, but medical care providers suspected had the disease.


STEPHEN M HAHN: So there was some clinical indication. It didn’t necessarily have to be the fever. It could be exposure, for example, but there was some clinical indication that the person might have the disease. So this is what we call prior probability. You’re looking at a group of people who you think might have it, and that’s, of course, probably higher than in a random sample of people who are asymptomatic that you may be screening for the disease.

And so the direct application of the science from a test that’s been developed for a symptomatic, pre-symptomatic, or suspected person who had a COVID-19 would be different for a variety of reasons. And so what we’ve asked– and we’ve had this come from a couple of different developers– if you’re looking to have your test authorized for asymptomatics and for screenings, really what you should do is show us the data. And throughout this pandemic, we’ve been flexible about that.

Our labeling is about what the data showed, but we are very happy to work with developers to say, OK, now test this, let’s say, in nursing home workers. You come in. You want a nursing home worker tested once a week to screen for COVID-19.

Let’s do that study. Let’s look at the operating characteristics in that setting. And you need to do it in a low prevalence environment, one where there isn’t a lot of disease in the community– community, and in a high prevalence environment, where there is, where you might have a higher risk of– so we’re going to use the data to guide those decisions, John. At the moment, our EUAs are labeled– our authorizations are labeled based upon the data we have. And of course, we completely encourage providers to look at that labeling, and also to work with the manufacturers and understand what those tests have been authorized for.

JOHN WHYTE: Well, let’s be honest, Dr. Hahn, most physicians, other providers aren’t gonna look at the label, which you and I know technically isn’t– isn’t called the label. So it’s really for– gonna be most accurate in those that, you know, we suspect have disease, as opposed to mass screening in their current iteration. Is that right?

STEPHEN M HAHN: So– so there are some tests that have been looked at in the asymptomatic side, so– uh, but you’re right. The tests were– were designed and authorized based upon suspected cases of– of this– uh, of this virus. And so what we need to do is continue to collect data and inform our decisions.

And the other thing that I think is really important– because you’re right. As a clinician, I would never have looked at the label on a test, but what I would have done is, if I got a test that didn’t make sense clinically to me–


STEPHEN M HAHN: –I would repeat the test.


STEPHEN M HAHN: And we don’t always have the luxury of time to do that.


STEPHEN M HAHN: But that’s something that I strongly recommend people consider. Use your clinical judgment. Use a clinical situation, and then– and then that also can be done.

JOHN WHYTE: And I think that’s an important message for our listening audience about what’s the role of the test, and how do you interpret the test? And– and finally, I want to ask you about morale, the hard working, you know, scientists and other health professionals. We’ve been asking that, um, you know, for the heads of the agencies, you know, within HHS– you know, it– tell us about the morale.

And, you know, let’s be honest. It– it– I’m sure it can be challenging if one feels there is an attack on science, if one reads that it’s a political hit job in terms of trying to put out good information. How are people feeling?

STEPHEN M HAHN: So throughout this pandemic, our folks at FDA, 17,000 plus– and John, you know them yourself personally– have been absolutely remarkable. They have stepped up to the plate to serve the American public.

John, our workload has doubled during this pandemic. So not only are we working on COVID-19, but all of our regular work– cancer drug approvals–


STEPHEN M HAHN: –cardiac drugs– all of our user fee deadlines. We’re– we’re meeting those– those– those parameters and those deadlines. We’re doing our regular work, and at the same time, we’re responding to the public health crisis.

These are remarkable public servants. They have not looked back. They have stepped up to the plate, and they’ve done tremendous work.

So of course, one’s tired. There’s a large workload. We’re trying to stay focused on the public health, uh, commitment that we all have. And, of course, I think, you know, the external– externalities that we always hear in the press and elsewhere, it– it does take a toll. There’s no question about it.

One thing I can tell you, though, that I am incredibly proud of is the amazing resiliency of our folks. We spent a lot of time– the leadership, center directors– focusing on how we can help build resiliency, but also how we can best support our incredible staff at FDA. I want to tell your listeners, but the entire American public, America’s FDA is there for them. They have been there for them. They do nothing except use science and data to make decisions.

They’ve done that up to now. We will continue to do that. I have absolute confidence and faith in them, and I am incredibly proud of them as a work force.

JOHN WHYTE: Well, Dr. Hahn, I want to thank you for taking the time. And, you know, I want to clarify to our audience there were no questions that were off limits in our discussion today. You’ve been very gracious with your time, and– and I want to thank you for clarifying, um, and providing answers for what’s on people’s mind, as well as the dedicated work that– you and, you know, the thousands of people that work at FDA literally all over the globe. Um, So thank you, Dr. Hahn.

STEPHEN M HAHN: John, thank you. And my– I really appreciate, uh, you and your organization in asking these questions. You know, we talked a little bit about what increases trust– transparency. It’s being able to answer the questions that need to be answered, and I appreciate you’re doing that. Thank you.

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