The FDA Is Hurting Our COVID-19 Response Too

While the failure by the CDC to quickly release a COVID-19 PCR test has been condemned–correctly*–and even Dr. Tony Fauci of NIH is coming under attack, the FDA, on the whole, seems to have been ignored, but they really shouldn’t be. Not only did they delay approval of the COVID-19 PCR test after the CDC tests needed to be altered, but the FDA is still making it too difficult to adopt new testing technologies (boldface mine):

Back in early May, a team of scientists at Rutgers University developed a Covid-19 test that relies on saliva rather than swabs. Romer says, “the FDA said Rutgers can do it but nobody else can do it.”

In other words, rather than promulgate a standard saliva testing procedure that labs around the country could emulate, authorization still needs to be done individual lab by individual lab. So the Rutgers breakthrough never led to a massive expansion of saliva testing. Instead, we have Rutgers and now a separate lab at UC Berkeley which last week started submitting the paperwork to the FDA. The state of Nebraska successfully used pooled testing (where you test a whole bunch of people’s samples at once) to get around capacity constraints, but they were technically breaking the law and school districts don’t want to follow them.

In political terms, the regulatory issues and the fiscal issues are closely linked. If public health agencies announced that mass surveillance testing is useful for educational institutions and technologically possible to boot, that would only heighten the question of why the federal government isn’t appropriating the money that’s needed.

As to why there has been an unwillingness to approve other procedures, Yglesias’ last sentence appears to answer itself.

Right now, we need more deployment. The standard protocol of lab-by-lab approval is taking too long.

Even though I think Romer’s plan for testing is far too optimistic about the capacity to conduct ten of millions of tests–shockingly, an economist assumes a can opener–we could be doing far more testing that involes far less infrastructure overhead, if we could adopt saliva-based testing. But the FDA is getting in the way, again.

This is all the more ridiculous as the Trump administration routinely ignores regulation and law, not to mention Congressional subpoenas, for a host of other things, but for this, they apparently have their hands tied.

Almost like there’s a plana horrifying plan.

*The CDC made the exact same error they made with Zika virus testing (and, that, at least can be defended–given the region and the symptoms, there were multiple viruses that can be symptomatically similar), and learned nothing from those mistakes, including the need for a fallback plan. Awful, and is one more instance of a lack of accountability in American society. Why this also appears to have disappeared into the memory hole escapes me.

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1 Response to The FDA Is Hurting Our COVID-19 Response Too

  1. preaction says:

    Surprised Fauci didn’t remember “Drugs in bodies”…

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