FDA Commissioner: ‘Having Wildly Inaccurate Tests’ Worse Than Having No Test

By Melanie Arter | April 13, 2020 | 4:09pm EDT
(Photo by JIM WATSON/AFP via Getty Images)
(Photo by JIM WATSON/AFP via Getty Images)

(CNSNews.com) - Food and Drug Administration Commissioner Dr. Stephen Hahn told NBC’s “Meet the Press” on Sunday having “wildly inaccurate” coronavirus tests is worse than having no testing at all.

“We're in April. It seems as if this testing problem has been over two months now, and we're still looking for innovation here. What went wrong?” NBC’s Chuck Todd said. “Other countries are testing at a higher rate. What went wrong? I know we initially blew it with the CDC. Is this the delay -- I mean, the delay that you were able to -- with lifting regulations, is that the reason we're in this situation?”


“I think there's going to be plenty of time to look back on this, and I think that's going to be really important. What I can tell you -- what FDA did is we started working with test developers on January 22nd. And, Chuck, it's really important to remember that these tests have to be valid, and accurate, and reliable. So the science behind these has to be the right science. We've seen reports in other countries where the tests haven't been that accurate, and in many ways, having an inaccurate test is worse than actually having a test,” Hahn said.

The commissioner said he has not felt political pressure to tone down sounding alarms, and he’s never exerted political pressure on the FDA.

“Where we do feel pressure is on the urgency of the situation. You pointed that out earlier in this conversation, and I think that's right. This is a rapidly moving -- it's a novel coronavirus, and we have had to respond to that as information has come into us. So there is an urgency around this, but I have not received political pressure to have FDA make one decision versus another,” he said.

“I know you are going to be approving some antibody tests soon. There's been some reports out of South Korea and their Centers for Disease Control that some of these antibody tests aren't working. Some people seem to -- they thought were antibodies and they get -- they end up getting the virus. Not -- asymptomatic the first time but symptomatic the second time. I know we keep learning more about this virus. Are you concerned these antibody tests won't work?” Todd asked.

“I am concerned that some of the antibody tests that are on the market that haven't gone through the FDA scientific review may not be as accurate as we'd like them to be. We've authorized one antibody test already, and I can assure the American people that what we're doing is using data and science to look at those tests to make sure that they're valid, they're accurate, and they're reproducible,” Hahn said.

“We know, Chuck, that no test is 100% perfect, but what we don't want are wildly inaccurate tests, because, as I said before, that's going to be much worse - having wildly inaccurate tests than having no test,” he said.

MRC Store