At a White House Coronavirus Task Force meeting Wednesday, President Donald Trump presented a bold — and completely false — attempt to blame former President Barack Obama for the current lack of testing capacity for coronavirus, which public health officials have said for weeks is leaving them in the dark as to the true nature of the virus’ threat.
“The Obama administration made a decision on testing that turned out to be very detrimental to what we’re doing,” Trump said. “And we undid that decision a few days ago so that the testing can take place in a much more rapid and accurate fashion.”
Later, when someone asked for clarification, Vice President Mike Pence attempted his own version of the claim. “The last administration asserted FDA jurisdiction over testing, and the development of tests like this. And, Bob, the President changed that on Saturday,” Pence said, passing the mic to Centers for Disease Control Director Robert Redfield.
“In the past, we used to be able to have laboratories that could develop what we call ‘Laboratory Developed Tests’ and be able to apply them for clinical purposes. And in the previous administration that became regulated,” the director said.
And on Thursday, yet another administration official — Health Secretary Alex Azar — exerted his own effort trying to back Trump up.
“Since the Obama administration, if you are developing a clinical lab test like this, as CDC did, you need to go FDA and get approval, and emergency use authorization, to send this test out,” Azar said. “What we said on Saturday is that if you are a certified clinical lab able to handle high-complexity tests […] you may develop your own test, and you do not have to wait for us to approve it for you to start using it in patients.”
If something sounds a little funny about blaming the Obama administration for the Trump administration’s testing problems, you’re not alone.
“I was very confused by what President Trump said,” said Rachel Sachs, an associate professor of law at Washington University in St. Louis specializing in intellectual property law, food and drug regulation, and health law.
Redford’s comment, Sachs said, “still made no sense to me.”
The reason it didn’t make sense, Sachs and others say, is that Obama didn’t implement the rules in question. Rather, they’re spelled out in a George W. Bush-era law that dates back to the anthrax scare of the early aughts, as Missouri School of Law professor Erika Lietzan wrote in the blog Objective Intent.
In short, when the Health secretary declares a public health emergency, laboratories that typically develop their own tests (literally, “Laboratory-Developed Tests” or LDTs) face a higher bar for “emergency use authorization,” or EUAs, than they normally deal with from the FDA.
There’s much debate on the extent to which these lab tests should be regulated, but in the context of coronavirus — when the CDC’s own tests were impacted by glitchy results and slow manufacturing — public health officials urged the FDA to let labs like the one at the University of Washington use their own LDTs, in order to expand testing capacity.
On Saturday, FDA Commissioner Stephen Hahn did just that, allowing scientists to use their own tests before receiving emergency approval rather than waiting for the CDC’s tests to reach them.
Asked why University of Washington scientists hadn’t used their own tests until the past couple of days, the virologist leading the team for the university made no mention of Obama.
“We weren’t authorized to perform testing until Saturday,” he said.
The Obama administration FDA did consider, for a few years, instituting new regulations that would have placed more scrutiny on LDTs. But the proposal never actually went into effect and the FDA abandoned the effort in 2016.
“The FDA never completed that process,” Ana K. Stankovic, a biotech consultant who previously worked at the CDC and medical device giant Becton Dickinson, told TPM. “There was never a decision that Laboratory Developed Tests will undergo FDA approval.”
“It’s possible someone conflated the relationship between the EUA and LDTs with that draft guidance, but it’s not something the Obama administration did,” Sachs said. “The EUA legislation predates the Obama administration.”
“It seems like there’s been a lot of disorganization and lack of coordination on the federal level for quite some time,” she added.
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