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FDA's Role In Coronavirus Testing Guidelines Released By White House


This week, more states - including Texas, Ohio and Iowa - are announcing plans to ease stay-at-home orders. But health experts agree that if the whole of the U.S. economy is to open up, there has to be widespread testing. The White House has released a blueprint to help states ramp up those programs. And the Food and Drug Administration has an important role to play. It authorizes medical tests, treatments and vaccines. Dr. Stephen Hahn is the FDA's commissioner, and he is on the line with us now. Commissioner, thank you very much for making the time this morning.

STEPHEN HAHN: Rachel, good morning and thank you for having me.

MARTIN: We know, by this point, that widespread testing is just critical before the country can reopen. But we have to ask, why is it that three months after the first U.S. case of the coronavirus states still don't have all the tests they need?

HAHN: So we are working very closely with the states. And I think it's important to remember that this has been an unprecedented ramp up in testing that this country has never seen before. We have certainly heard from the states that - particularly around supplies and their capacity - that they need both more information and more of the supplies. And that's something that we're working on very closely with them to get them the needed supplies and also to help identify that capacity. Because we believe that there's significant unlocked capacity. The other thing, Rachel, I just want to highlight is that we have more than 300 test developers who are working with us to get new tests online. So we are working very hard at FDA with them to get these tests online to further increase capacity.

MARTIN: But can you explain just what has been the holdup? I mean, it's one thing to get tests into the hands of hospitals that need them, but it's all the other supplies that are necessary to run those tests. And those are the kind of supplies that hospitals just don't have.

HAHN: If the hospitals - the states who we're in partnership with through this have identified where those supplies are needed. And I've certainly spoken to my colleagues around the country and identified with them where those are needed as well. And I think, again, Rachel this is an unprecedented increase in the amount of tests that have been done. If you think about it, from a handful six to eight weeks ago to over 5 million, I don't know if that's ever been done in this country, but it made a pretty significant stress on the supply chain. That's not an excuse; it's just what it is. And so that's our job is to help figure out where those gaps are in the supply chain and try to get those supplies to the states. It's been an ongoing conversation with the governors every day to try to make sure we fill those gaps.

MARTIN: Do you think there should be universal testing?

HAHN: I participated in the White House Task Force blueprint for testing. I'm comfortable where we are now, but that being said, this is guidance. And also we are working with the states. Every state is going to have a different situation depending upon the prevalence of the disease, their population, all those factors. And so what we want to do is be able to help them and have some flexibility around that as they help us decide what's the appropriate amount of testing. You know, as a physician, I think about - it's kind of unprecedented for someone to walk in your office and say I want a test and for, you know, that situation to continue across the country. And so we really need to make sure that we have a science and medicine-driven approach to this as we understand more about the disease. And it's been a great relationship with the state health directors to try to figure that out for each of the states. And we'll continue to do that for sure.

MARTIN: I want to ask about antibody testing. There've been a lot of reports about this. It can show who has already been exposed to the virus and who might as a result be resistant to catching it in the future. All these antibody tests have hit the market, but they have done so without the usual FDA vetting. And there are reports now of unreliable tests that may be doing more harm than good by giving false results - these antibody tests. What is the FDA doing to address that?

HAHN: So we issued some guidance to provide regulatory flexibility. And as typical in a - or usual in an emergency, a public health emergency, it's striking a balance between making sure the resources are there - in this case antibody testing - with, of course, wanting to make sure that these are accurate, reliable and reproducible tests. We've approved eight. We've authorized eight serology tests and have a number in the pipeline as well with developers. But what we've said to manufacturers is that you can come to market but you must validate. You must tell us you validated. And then your package insert must give the appropriate information about the test.

MARTIN: Explain what that means - requiring that they validate.

HAHN: So that's what would be done typically in the emergency use authorization. So what we would normally look at is validation data. So let's - and this is a really important point about antibodies. You have to take a number of samples from people who have had coronavirus and who haven't and in the best-case scenario, someone who might have had the flu but not coronavirus. And then you'd test your antibody test against that to make sure that a true positive is true positive and a true negative is true negative. And that sort of validation is the sort of testing that gets done. The more samples you have, the greater confidence you have in that. And so one of the things that our policy has done is to allow the states to take some of these tests and do their own validation. We're incorporating that data...


HAHN: ...In our review process as well, which has been really helpful and expanded our ability to increase access to the tests.

MARTIN: But bottom line, you're comfortable with just making these tests available despite not going through the regular FDA hoops. I want to move on because, on Friday, the FDA released a statement saying it was, quote, "concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus." Do you attribute that increased use to President Trump's comments touting these drugs as a possible treatment?

HAHN: So we were aware - even before President Trump's comments - that there was pressure on the supply chain around hydroxychloroquine and prescriptions being made by providers for this. You know, there's been reports in the literature about hydroxychloroquine - with or without azithromycin - being a benefit for patients with COVID-19. And so we were aware of that. We certainly wanted to make sure there was enough drug supply in the system. Bottom line - this is a doctor-patient decision that has to be made. We want to provide that information to doctors about safety risks.

MARTIN: All right. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, we'll have you back on the show again, sir. Thank you so much for your time.

HAHN: Thanks, Rachel. You all take care. Transcript provided by NPR, Copyright NPR.

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