Transcript: Full Transcript With FDA Commissioner Stephen Hahn

Mar 20, 2020
Originally published on March 20, 2020 11:34 am

Food and Drug Administration Commissioner Stephen Hahn speaks with NPR's David Greene about the development of a vaccine and the use of existing drugs to treat COVID-19. Here, a transcript of their full interview.

Morning Edition host David Greene: So obviously a vaccine against this virus offers the best public health defense. What is your agency doing to speed up the process of getting a vaccine tested and deployed?

FDA Commissioner Stephen Hahn: So as you probably know, David, a vaccine candidate vaccine was put into a Phase One trial, and that's the earliest of phases of trials to safety trial on Monday. So really record speed there, David, in terms of getting a vaccine to a virus and as you know, it's — the safety is really critical here, which is why we have to be careful about the development. But very quick development, as I mentioned yesterday, realistically, we're looking at a year to get a vaccine up and running and available. So you may ask why is safety so important? It's always important, of course, with any therapy or prevention, such as a vaccine. But remember, the vaccines are given to people who don't have the disease, who are otherwise healthy. So the safety consideration is very significant. After the safety phase of this, then it gets moved to can the vaccine elicit an immune response? Which of course, we would consider to be protective against the virus. So multiple steps that have to take place, they have to be done under controlled conditions, so that we can make sure that we have the right answer.

We're still looking more than a year, though. Is that is that safe to say?

I think it's realistic to talk about a year. It could be longer. But, yes, I think it's reasonable to say that. The folks at the FDA, I mentioned yesterday, 17,000 strong, working around the clock to try to expedite all of these things.

Andto get it going as quickly as possible. While that vaccine is in the works, you've also been talking about using existing drugs that could help treat COVID-19. How soon could people expect to be able to use these kinds of drugs if, you know, if at least one of them is already approved for other uses?

Right. And, David, thank you for commenting on that. We're looking at repurpose drugs. So as I mentioned yesterday, innovators around the world, the country, are coming forward with potential ideas and we're looking at all of them. And what we'll do — what we can do — is if there is an already approved drug, the good news about that is that we have an understanding of its safety profile.

This would be like chloroquine, which is approved for — to treat malaria, right?

Chloroquine. That's right. There are other drugs that have some effect on the immune system that are being looked at with respect to reducing inflammation related to this virus, because, as you know, in the more latter stages of the disease, there's inflammation in the lungs.

But so — could doctors prescribe chloroquine soon? I mean, are we talking about days? If if this is something that that has already been approved to treat malaria, it's presumably safe. I mean, why not — why not now?

So a doctor could write a prescription. I'm a doctor.

Right.

And you could write a prescription for a drug that's an off label. FDA does not regulate the practice of medicine, the doctor's got to make that decision based upon individual patient situation. You know, I'm going to put my doctor hat on, not my FDA hat, David, if that's OK. So I'm a doctor and I'm seeing a patient and I'm thinking about this. You know, what I want to know is what are the data behind this? And I mentioned this yesterday because it's such an important thing for a doctor — right drug, right patient, right dose, right time. And the problem with the current situation is that we don't have all the facts. We don't have all of the data per say now. Some of the reports are encouraging and we're gathering all those data. And what we'd like to do is to make this particular drug available to what's called expanded access. We're going to have the ability to do what's called a pragmatic trial. Doctors can prescribe and use it. And then we'll collect those data. But I mentioned yesterday, and David I think this is so important — I'm a cancer doctor and you always want to provide hope. And I do very much believe there's hope here from a therapeutic point of view. But you don't want to promote false hope.

But that kind of that kind of process you're talking about, I mean, I know obviously safety is so important. But when it comes — we're in a health crisis where people are describing having a shortage of hospital beds. I mean, if we're going to get to a point really soon where there are that many sick people, doesn't the risk assessment change? I mean, can't you speed up the kind of things you're talking about to get these kind of drugs to people right now?

Yes, David, you're right. The risk calculus changes. And this is an individual doctor decision. We'll be providing — not we FDA — but the CDC will be providing some guidance about that with respect to potential therapeutic options. But you're right. I mean, absolutely. And this is a drug that's available to physicians to prescribe now.

Soshould they? I mean, are you telling them that they should if they have a patient who is really suffering?

I am not saying that. What I'm saying is an individual doctor has to incorporate the data to make the decision for their individual patients. And one of the ways we're going to try to make this available on a more widespread basis is through this expanded access approach.

And when does that start?

So we're working on that now where obviously supply and availability of a drug is an issue. But there is an all-of-government approach on this.

Well, I guess I just wonder, I mean, President Trump said yesterday he's clearing red tape like no one before has ever done. What's an example of that? I mean, you say it's an all-of-government approach, but if you can't say like we're gonna get this process that could get this drug out there much faster going — like why not — why not today?

So, David, an example of this is the rapidity with which a vaccine has been developed and has started in phase one trials. That's a very rapid timetable that's taken place. And with respect to the other issue, again, we really can't speculate, we have to have facts. And when you ask me a question, I have to be certain of my answer. And that doesn't mean that people aren't working on this. That doesn't mean that around the clock efforts aren't being made. What I can't do, what's one of the worst things that you can do in a medical situation that's urgent is to provide information that isn't accurate. So I'm not going to do that because I don't think that that's right for the American people. But I want to assure the American people that the FDA and this all-of-government approach, frankly, all-of-America approach, really working hard 24/7. Lots of scientists and researchers and doctors and nurses and pharmacists are on this effort.

Can I just ask Dr. Hahn, I mean, the president talked about clearing red tape yesterday. What is one specific example of some red tape that he has cleared for your agency?

So he has asked us to stick to science and data, but at the same time, remove barriers. So there are some regulations around waiting periods for certain types of therapies that have been put in place in the past that we can consider waiving and have considered and will consider waiving to actually expedite approval as long as we think it does not pose excess risk. Because you have articulated it very well, David, and that is in an urgent situation, the risk-benefit calculus changes. So if we feel like a particular approach, like I just described, sort of a holding of something for 60 days, is not going to provide great benefit to the American people and still going to ensure safety, we're going to get rid of that one.

I want to just ask them in a similar vein about testing. I mean, your boss, the secretary of Health and Human Services, declared coronavirus a public health emergency in January. And then there were a lot of confusion, some missteps by the CDC, it took your agency till the end of February, I believe, to give qualified hospitals and academic labs the latitude they needed to start testing for coronavirus. How did this happen?

So I think a couple of things are really important for the American public to understand about this. One is the FDA started working with CDC on January 9. That's a fact. The CDC obtained the viral sequence. Then they subsequently obtained patient samples, all of which are important and necessary for developing a diagnostic test. And CDC developed that test in a very short period of time. So, you know, we had been working since January, January 22nd, to be precise, with developers of tests and have done so throughout this period of time. And, you know, this is a rapidly evolving situation. We have responded to stakeholders when we got feedback about the necessity to provide more regulatory flexibility. The end of February guidance we provided, we did that, that was directly in response to requests from developers so that it could ease the pathway for the development of diagnostic tests.

I mean, hospitals and labs needed that decision from the FDA, which you made at the end of February. Why couldn't that same decision have been made in January if you knew that this was such a crisis?

We were working with over 100 developers of tests during that period of time, including commercial laboratories. And David, it's really important understand getting an accurate and reliable test on the market's important. Our team can provide you with an abstract that was recently published in the literature about a test that was performed in another country that demonstrated a 47% false positive rate. Now, think about that, David. What that means is that if you had a positive test, it was pretty close to a flip of a coin as to whether it was real or not. And that's not to beat up that one test. It's just to point out to you that this is not as simple as folks might think. Our manufacturers that we've been working with throughout these last couple of months have told us that it normally takes them six months to develop a test and they've done it in four to six weeks in collaboration with the FDA.

Do you regret not being able to make that decision sooner? That gave labs and hospitals around the country the latitude they needed to develop these tests?

That decision is a relatively small segment of the diagnostic testing world. We had been working with all of those folks over this period of time and continue to do that. And again, as I said, when we had feedback from the stakeholders that they would like that flexibility, that that would help them, we did that.

Why did other countries beat us?

I ... can't comment on what's happened in other countries, David.

I mean, they've been doing more testing than we've been able to do.

I don't have access to those data. I mentioned to you that one abstract which our people can give you, with respect to that. So I don't want to speculate on what the tests that they've done are and how they've performed. What I can tell you is that we've been focused on making sure the most reliable, accurate and reproducible tests are available to the American people.

Was more leadership needed here from the White House?

We have worked very closely with the coronavirus task force. Vice President Pence has done a terrific job. I've been personally involved in those meetings and I have been very impressed with the leadership from Vice President Pence and from the entire White House. David, I've been involved in situations in medicine before that were crises that were significant situations. It isn't the first time that that's happened to me, although not, certainly not of this magnitude or scale. And I can tell you that I've been very impressed with the leadership and with the great approach that Vice President Pence has taken with the task force.

But in retrospect, I mean, could there have been a more coherent strategy that might have avoided some of the some of the delays?

I can speak to that from an FDA point of view. And I can tell you this: We are learning organization. We are always and I mean always looking for ways to improve. And we have responded to feedback from stakeholders on the therapeutic, the vaccine and the test development side. We will always incorporate that. And when there's an opportunity to do a look back, we will do that because we always want to do what's best for the American people. But I have to tell you, 17,000 strong, incredible scientists, doctors, nurses, pharmacists, are working around the clock on this effort.

With all due respect to all of that great work that you're talking about, I mean, can you understand why Americans who are very scared right now don't necessarily want to hear, you know, we're learning as we go?

What I can understand is that this is a rapidly evolving situation, and Americans are sharing a lot of information from different directions. We have a framework that we use and have used for many years in response to outbreaks like this. We have followed that, but we have adapted as this has changed. I think what the American people understand from what I'm hearing on the ground is that this is a very different outbreak than we have seen in the past and that evolving our approach to this is really important.

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