FDA reverses Obama-era rule in hopes of expanding supply of coronavirus test kits

One of the top priorities of the Trump administration’s response to the growing coronavirus outbreak in the United States is to ensure that there are sufficient test kits available to assess potentially sick individuals and determine if they are indeed infected with COVID-19.

The production of new test kits has been accelerated — and they are being distributed as rapidly as possible — but in the meantime, the Food and Drug Administration (FDA) has issued a rule change that allows certain types of certified clinical laboratories to develop and use their own coronavirus tests prior to obtaining full approval from the FDA, The Daily Caller reports.

Rule change to expand coronavirus testing

Previously, pursuant to a rule imposed during the Barack Obama administration, clinical diagnostic laboratories were only permitted to use tests and procedures that had already been pre-approved by the FDA.

Under an Emergency Use Authorization (EUA) necessitated by the recent public health crisis, however, the FDA announced on Saturday that it rolled back the Obama-era rule and would now permit labs certified under a set of rules referred to as Clinical Laboratory Improvement Amendments to develop and use tests of their own in the absence of test kits provided by the Centers for Disease Control and Prevention (CDC), Science magazine reported.

The change will allow such labs to use their newly developed diagnostic tests as long that the process for obtaining FDA approval has already begun, detailed records are kept of the test’s accuracy, and the FDA is kept informed of the validity of the tests before a final approval decision is made by the agency.

Critical flexibility

In a statement released in conjunction with the rule change, FDA Commissioner Stephen Hahn said he believes “this policy strikes the right balance during this public health emergency.”

“We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations,” he added. “This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

The FDA rule change was noted during a press briefing at the White House on Tuesday involving Vice President Mike Pence and the coronavirus task force team, which includes Commissioner Hahn. During the briefing, Hahn discussed the manner in which labs use the CDC-distributed test, explained that private corporations are currently ramping up production of the already-approved test, and expressed his hope that labs nationwide would have ample supplies of testing kits in the very near future.

“On Saturday, you know we issued an emergency use authorization, which provided a deregulatory and — regulatory flexibility approach to what’s called LDTs, or laboratory-developed tests,” Hahn said, according to a White House transcript. “That means X hospital in whatever state, whatever county, if they’re certified, can develop their own laboratory-based test. They notify us when that occurs, and then 15 days later provide us the validation data.”

He went on: “We use the same validation criteria. These are experienced laboratories, and we’ve already heard from four laboratories around the country that they’ve developed these tests and have started using those tests. So you can see this is a layered approach to increase our capacity.”

Removing roadblocks

President Donald Trump noted the FDA rule change himself during a meeting on Wednesday with airline executives to discuss the impact of the coronavirus on travel, saying, “The Obama administration made a decision on testing that turned out to be very detrimental to what we’re doing. And we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion.”

Indeed, hopefully, this FDA rule change and emergency flexibility will help ensure that certified clinical labs around the country are finally capable of diagnosing COVID-19 infections in a timely manner and that invaluable knowledge about the true prevalence and transmission modes of this illness can continue to be gathered.

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