The FDA's Perpetual Process Machine

It might be time to review the massive damage that the FDA is doing by restricting the supply and use of tests for the SARS-CoV-2 virus.

Massive? With enough tests, the US could have avoided the enormous cost that this virus is imposing – at least 200,000 excess deaths and $8 trillion in lost output.

Here I’ll provide a recap with links about how the FDA responded to just a couple of issues since the start of the pandemic.

Approving a Virus Test That Worked

Many accounts have noted how the failure of the virus test developed by the CDC delayed the US response to the virus. The fact that has not gotten as much attention is that although the FDA promptly approved the broken test from the CDC, it took an excruciatingly long time to approve tests that actually worked.

Using Virus Tests

The other fact that is not widely recognized is that the FDA has aggressively pursued people who have “mis-used” tests, for example, by telling public health authorities what the test results were from an unapproved test.

The SCAN program — which was spun out of the Seattle Flu Study — is a joint effort between researchers and Seattle and King County’s public health department to capture the spread of the virus across the community.

The SCAN effort received emergency clearance for its work from Washington state in March, and was processing test results at certified clinical labs.

The researchers also appear to have misinterpreted the FDA’s guidance on home testing, which has shifted throughout the pandemic. The agency has sought to clamp down on such tests for months, at times sowing confusion in the market among startups. Many of the companies aimed to offer the tests as a partial solution to the nationwide testing shortage but ultimately pulled them from the market after the agency said in March it had not authorized any home test available for purchase.

But on May 11, after a series of updates to its home testing policy, the FDA again clarified its guidance, noting that even tests previously approved by states — including those that processed results in certified labs — needed express authorization from the federal government to continue their work. The next day, the researchers received a notice telling them to stop returning results and immediately complied, the SCAN spokesperson said …

The FDA’s position here is untenable,” said Eric Topol, director of the Scripps Research Translational Institute, which is also tracking the spread of coronavirus. “If they really wanted to foster progress rather than take down our best academic effort to study this virus, that’s what they would do.” (Statnews)

Testing People Who Do Not Have Symptoms

One June 16, the FDA offered new guidance, reminding everyone that there is still no test that is approved for broad testing of asymptomatic individuals.

It did announce a new template that anyone could use to submit an application to do broad testing. But as the experience with getting virus tests approved amply demonstrates, saying that an organization can apply for permission to do something is not the same as saying that it is legal to do it.

But to be fair, we have been assured that it is no longer necessary to send a hard copy of application materials via postal mail.