Dr. Scott Gottlieb says the FDA appears to soften stance on a key requirement for home coronavirus tests
An apparent shift in thinking at the Food and Drug Administration could clear the way for more home coronavirus tests, according to Dr. Scott Gottlieb, the former FDA chief under President Donald Trump.
Gottlieb told CNBC on Friday that a barrier to bringing rapid, home tests for Covid-19 to the market has been an FDA requirement that results must be reported to local health officials.
“But FDA seems to have backed off that mandate,” Gottlieb said in a “Squawk Box” interview. “What they said on a call last week with stakeholders is, as long as the test is reliable and accurate, the FDA is not going to use the requirement to have to report the test result to a public-health authority as a way to keep the product off the market, as an absolute condition.”
The FDA and the Health and Human Services Department were not immediately available to respond to CNBC’s request for comment on Gottlieb’s interview.
Some of the at-home diagnostic tests for Covid-19 that are currently on the market, such as one from LabCorp, allow people to take their own nasal swab sample. However, the sample has to be sent back to one of the company’s labs where it is processed. The company said it takes one to two days, from the time the sample is received, to return results.
The possibility for rapid Covid-19 tests that can be done at home without reporting results to local health authorities would give people faster results so they could take all the necessary precautions to keep from spreading it further, Gottlieb said.
“That ultimately is going to get more testing into the hands of consumers, which in the near-term isn’t a bad thing. I think in the long run we want these results to be reported,” Gottlieb said. “But I think in the near term we want as many people to get tested as possible and get a result if they’re positive so they can know they’re positive and take the proper steps.”
If the home test results aren’t reported to local health authorities, that could skew local, state and U.S. testing results. It’s unclear how that would affect local efforts to trace cases and identify new trouble spots.
President Donald Trump has previously criticized the amount of testing for Covid-19 in the U.S., saying the only reason the country has the most confirmed cases of any nation in the world is because it does more testing. “If we tested half as much, those numbers would be down,” Trump said in a July interview on Fox News.
Many medical experts have rejected Trump’s assessment of coronavirus testing, with some describing it as misleading. The World Health Organization and several state health agencies say they need as much information on the outbreak as possible to head off new clusters of cases.
In late July, the FDA posted new guidance for test manufacturers of home Covid-19 tests. The FDA advised test makers to report results to health authorities, recommending several ways to send the data, including a mobile app or website “where reporting is easily facilitated.”
“FDA is open to alternative approaches to reporting that ensure appropriate reporting,” the document reads.
Some medical experts say the FDA requirements for bringing home tests to the market have been too cumbersome, deterring companies from developing products that could improve the country’s coronavirus response.
“In their guidance for how these tests could look, they essentially put an unreasonable bar to meet. And that has scared off all of the companies that could potentially be making these from actually even putting in an application for a lot of these tests,” Dr. Michael Mina, a professor of epidemiology at Harvard’s School of Public Health, told CNBC earlier this week.
Gottlieb offered an example of how reporting results for a home test could work, saying it could produce a read out that is “not interpretable until you flash your phone at it and take a picture.”
“Then it gives you the answer whether you’re positive or not and at the same time uploads the picture to a server so the results get reported,” he explained.
But the goal of rapid, at-home tests is that they would be relatively cheap and therefore accessible to broad sections of the U.S. That widespread availability is a trade-off compared with lab-based nasal swab tests that are considered to be the most accurate on the market.
A rapid home test that relies on photo technology or other workarounds to ensure results get reported, the tests become more complex and more costly, Gottlieb said. “You’re starting to get away from a $5 test and you’re looking at a $15 test.”
“There’s going to be manufacturers that come to market with these kinds of technologies that do require reporting, but I think you might first see some manufacturers try to come to the market with technologies where they don’t require reporting if the FDA doesn’t mandate it,” he said.
Gottlieb’s comments Friday follow news earlier this week that Abbott Laboratories had secured emergency approval from the FDA for a 15-minute coronavirus test that sells for $5. The U.S. government secured a deal for at least 150 million of those tests, with hopes to deploy them to nursing homes, schools or other high-risk populations.
“Right now, the government seems to have cornered the market on these tests … so there might not be a lot of supply in the marketplace for businesses to procure them,” Gottlieb said of Abbott’s new offering.
But Gottlieb said he expects to see more tests that are similar coming onto the market soon, explaining that “typically when FDA approves or authorizes something like this, they do it in waves.”
“So you see multiple products from the same genre come onto the market pretty much at the same time,” he said. “I think this allows testing to get into different kinds of settings and effectively democratize testing, move it into the workplace.”
— CNBC’s Will Feuer contributed to this report.
