FDA Gives More Testing Sign-Off

March 13, 2020 3:06 p.m.
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New York state and city officials have been pressing the FDA for days to sign off both on new tests but also automated testing. They seem to have finally gotten the authorization today. They’ve also gotten the sign-off to have the state approve testing additional capacity within the state. I know I’m focusing a lot on New York. It’s a location of major spread. But I’m also doing so because the issues are relevant to and often paralleled by the same things happening in states around the country.

This is obviously good news. But it also raises the question of why it took this long. In yesterday’s New York City press conference, Mayor DeBlasio for the first time suggested that if the sign-off didn’t come soon the City would disregard the need for FDA approval and proceed on its own. In other words, openly break the law.

We all know that there are very good reasons why random people can’t market tests for disease. The FDA is in charge of approving the reliability and safety of tests. Obviously, we’re in a unique and very grave situation. But at least for New York state, we’re talking about state laboratories and top flight hospital labs. Ordinarily they should all be regulated by the FDA. But these are entities that should be able to make reasonable judgments about the quality of their tests on their own. Again, not under normal circumstances but given the scale of the public emergency, they should be able to make that call, at least on a provisional basis.

We’re in a big, big national public health crisis. This approval, particularly for running automated tests which dramatically increases the possible scale, only came today. We’re going to need to understand why it has been so slow. Again, one of the big, big sign-offs only happened this morning.

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