As Antibody Tests Flood The Market, House Panel Steps In

Illinois Democrat Raja Krishnamoorthi, who chairs the House Oversight subcommittee on Economic and Consumer Policy, says the FDA is unable to validate the accuracy of serology tests

LULU GARCIA-NAVARRO, HOST:

There are two types of tests taking place right now. The ones we just heard about happen when you're worried you might have a live infection. The others are antibody tests, also called serological tests. Antibody tests try and see who was infected in the past, and some officials hope they can be used to decide who can safely go back to work because they have some kind of immunity.

There are now more than a hundred different types of antibody tests available here. Typically, it would take months or even longer to get approval from the Food and Drug Administration, which regulates medical products. But after criticism for slowing down the process, President Trump removed approval barriers, allowing companies to take their antibody tests straight to market. Now a House oversight subcommittee has raised the alarm, saying that after a briefing by federal officials, they found the FDA is unable to validate the accuracy of these tests.

Illinois Democrat Representative Raja Krishnamoorthi chairs the House Oversight Subcommittee on Economic and Consumer Policy, and he joins us now from Schaumburg, Ill.

Good morning.

RAJA KRISHNAMOORTHI: Hey. Good morning, Lulu.

GARCIA-NAVARRO: So as I mentioned, your committee was briefed by officials about antibody tests coming onto the market. What did they tell you?

KRISHNAMOORTHI: Well, they basically told us that there are two paths that makers of these tests can utilize to get their tests sold. One is to basically get authorization from the FDA to sell them, and four companies have taken advantage of that. And then the other is not to get any authorization from the FDA and go ahead and sell them. And 107 have taken advantage of that. And unfortunately, a Wild West of unregulated tests are now proliferating. And our biggest concerns are that they're unreliable, inaccurate and, in many cases, making fraudulent claims about their testing results.

GARCIA-NAVARRO: But isn't there a bit of a problem here? - because on the one hand, there was a lot of criticism that the Trump administration and the FDA was just holding the reins too tight and that they weren't getting tests out to people who needed them. And now there's this other complaint that there's just too many tests and there's not enough oversight. It can sound like it's unclear, really, which direction the government should go on.

KRISHNAMOORTHI: Well, I think that, you know, because the serological tests are so important and because the Trump administration is really premising the reopening of the economy on these tests, it's important that the tests be accurate and that the test-makers not make any fraudulent claims about them. There is a way to go about balancing the need to get a lot of testing out there with the need for, you know, making sure that they're accurate, and that's called the emergency use authorization route. That allows makers to even begin using and selling the tests at the same time that they're seeking authorization.

GARCIA-NAVARRO: On Friday, the FDA administrator Stephen Hahn was asked about the antibody tests over which you've raised the alarm. Here's what he said at the White House briefing.

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STEPHEN HAHN: We provided flexibility. What we've told manufacturers is that in order to market in the U.S., they have to validate their tests. They have to tell us that they validated their tests. And in the package insert, they have to let people know - end users, labs, et cetera - that those tests were not authorized by FDA.

GARCIA-NAVARRO: Does this reassure you in any way?

KRISHNAMOORTHI: No, because what he's basically saying is that these makers have to self-validate. And because of this kind of voluntary compliance type of regimen, there's absolutely no incentive for a junk test-maker to actually produce their results to the FDA.

GARCIA-NAVARRO: So what would you advise people to do?

KRISHNAMOORTHI: I think right now, only use a test that has been authorized by the FDA. They've listed the handful of tests that have actually been authorized on their website. I think the FDA needs to take action to clear the market of all unauthorized tests. They should require authorization before any of these tests are sold, and then they need to put out clear standards as to what characterizes a good test. And what do you do with the test results? That's the most important thing from a consumer standpoint. You know, that's where the FDA really needs to step up.

GARCIA-NAVARRO: Representative Raja Krishnamoorthi chairs the House Oversight Subcommittee on Economic and Consumer Policy.

Thank you very much.

KRISHNAMOORTHI: Thank you, Lulu.

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