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Food And Drug Administration Seeks To Expand Treatment For Coronavirus

DAVID GREENE, HOST:

The Food and Drug Administration is right at the center of the effort to find a vaccine for COVID-19.

(SOUNDBITE OF ARCHIVED RECORDING)

PRESIDENT DONALD TRUMP: What the FDA is doing is incredible. They've done things in times that were not even thinkable. And I've directed the FDA to eliminate outdated rules and bureaucracy so this work can proceed rapidly, quickly and, I mean, fast.

GREENE: So where does this effort stand? Well, early this morning, I asked the FDA commissioner, Dr. Stephen Hahn.

STEPHEN HAHN: 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. And...

GREENE: We're still looking at more than a year, though, is that safe to say?

HAHN: 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.

GREENE: So in the meantime, the FDA is looking at other drugs, ones used to treat different ailments, to see if they might help people who are sick with the coronavirus. And that includes drugs like chloroquine, which is used to treat malaria. Doctors could write prescriptions for that drug right now for patients with COVID-19, but the FDA commissioner told me he does not necessarily recommend that yet.

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

GREENE: Right.

HAHN: 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. The - you know, I'm going to put my doctor hat on, not my FDA hat, David, if that's OK.

GREENE: OK. Sure.

HAHN: 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 se. 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 through what's called expanded access, where 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. And...

GREENE: But 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?

HAHN: 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. But...

GREENE: So should they? I mean, are you telling them that they should if they have a patient who's really suffering?

HAHN: 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.

GREENE: And when does that start?

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

GREENE: 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?

HAHN: 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.

GREENE: I want to just ask, 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 - it's a lot of confusion, some missteps by the CDC. It took your agency to 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?

HAHN: So I think a couple things are really important for the American public to understand about this. One is FDA started working with CDC on January 9. That's a fact. 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 22, 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. Remember...

GREENE: Yeah, I mean, hospitals and labs needed...

HAHN: But remember...

GREENE: ...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?

HAHN: We were working with over 100 developers of tests during that period of time, including commercial laboratories. And David, it's really important to understand, getting an accurate and reliable test on the market is 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% percent 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.

GREENE: But 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?

HAHN: So 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.

GREENE: Why did other countries beat us?

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

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

HAHN: 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.

GREENE: Was more leadership needed here from the White House?

HAHN: We have worked very closely with the coronavirus taskforce. 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.

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

HAHN: I can speak to that from an FDA point of view, and I can tell you this - we are a 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 who are working around the clock on this.

GREENE: I - 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?

HAHN: What I can understand is that this is a rapidly evolving situation, and Americans are hearing 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.

GREENE: Dr. Stephen Hahn is the commissioner of the FDA. Dr. Hahn, thank you so, so much for your time this morning.

HAHN: Thank you, David. You all take care. Transcript provided by NPR, Copyright NPR.