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NPR Health

Trump Administration Blocks FDA From Regulating Many New Medical Tests

AUDIE CORNISH, HOST:

The Trump administration is making it harder for the Food and Drug Administration to regulate an entire class of medical tests. The move raises concerns about the quality of new coronavirus tests as well as the independence of the FDA. Joining us now is NPR health correspondent Rob Stein, who's been reporting on this. And, Rob, exactly which tests are we speaking about here?

ROB STEIN, BYLINE: So they're called laboratory developed tests because they're developed by individual labs like those in big hospitals and universities, you know, big commercial labs for their own use as opposed to tests that are developed and sold and used by other labs. They're regulated to some degree by the government - as part of the government known as the Centers for Medicare and Medicaid Services. But these tests fall into a kind of a gray area when it comes to whether they're also regulated by the FDA. When the pandemic started, the FDA required these tests go through the same emergency authorization process as any other tests. And critics say that was a big mistake because it slowed down the development of two new tests when the country desperately needed as many tests as possible as fast as possible.

CORNISH: Now that the Trump administration has stepped in the middle of this, how exactly have they changed the policy?

STEIN: The Health and Human Services Department says labs no longer have to seek authorization from the FDA before they start using their tests. And this is a big deal, obviously, because it comes just as lots of new tests are in the pipeline to test people for the coronavirus, for COVID. So the move is being welcomed by some, like David Grenache of the American Association for Clinical Chemistry.

DAVID GRENACHE: It could help laboratories respond to the pandemic by allowing them to develop their own test, a lab-developed test. I'm quite pleased.

CORNISH: There's concern about this, and I want to better understand why because it's not as though tests won't be regulated at all.

STEIN: That's right. That's right. But one big concern is that, you know, lots of bad tests could start flooding the country. You know, critics point to what happened with antibody tests. I don't know if you remember. At first, the FDA didn't really regulate them. And what happened was lots of inaccurate and unreliable antibody tests were suddenly all over the place. The FDA finally had to step in and crack down on them.

You know, I talked to Peter Lurie about this. He's a former FDA official who now runs the Center for Science in the Public Interest.

PETER LURIE: The last thing we need at this moment in the pandemic is a bunch of tests that inaccurately label people as having the infection when they don't or tell people that they don't have it when they do. What we need is accurate testing, and the only way to get that is with proper involvement of the FDA. And without that level of scrutiny, I worry about having a Wild West out there with respect to these tests.

STEIN: Lurie also worries that the Trump administration may just be using the pandemic as kind of an excuse to weaken the FDA's power over tests. And this could lead to bad tests for all kinds of other things down the road.

CORNISH: So pointing to politics, essentially. I mean are there any other red flags here?

STEIN: Yeah, there are. Another big worry is about the integrity of the FDA and whether this might just be another example of the Trump administration sidelining government scientists. Here's Patricia Zettler from Ohio State University.

PATRICIA ZETTLER: I think we might worry about interference with FDA decision making on all kinds of things - on potential COVID drugs, on potential COVID vaccines, on basically any kind of COVID product that FDA is going to be reviewing.

STEIN: You know, I talked to two Trump administration officials late in the day today, and they defended the decision and say that there will still be oversight of these tests. And they're not going to let any bad test stay on the market. The FDA could go after them and block them if they see that's happening.

CORNISH: That's NPR's Rob Stein. Thanks.

STEIN: You bet. Transcript provided by NPR, Copyright NPR.