Thread by @michaelmina_lab

The Solution

We need a new Pathway for Authorization at FDA

There are 3 primary bottlenecks in getting rapid tests authorized at FDA

None make sense biologically & remain for seemingly no reason but sheer stubbornness of FDA to not recognize this PUBLIC HEALTH EMERGENCY
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https://twitter.com/rickabright/status/1474188893008371712

1) We do not allow much better data already collected in Europe to be used for immediate EUA of the very best tests in use by millions in Europe.

But We should! - many of them are better than most of ours available in the US

Could increase tests by 100’s of millions in days

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2) FDA requires Rapid Ag tests compared to entirely different technology, w entirely different analyte that diminishes in a very different time scale.

This causes MASSIVE slow downs and hurdles with clinical trials for EUA

Compare rapid tests to a gold standard rapid test!!

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3) Allow ppl who know they are positive to be allowed to participate in the clinical trials

Why!!! In an emergency does FDA force companies to go find positive people who have no idea they are positive (takes a Very long time) vs quickly recruiting positive ppl?

Must stop

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4) Have a testing expert advisory committee inform the small group of FDA leaders on exactly what metrics are needed of new tests whose primary purpose is public health - not medicine.

We have this for vaccines and medicines - WHY not Tests - a crucial public health tool

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5) STOP allowing the key person responsible for the nations test EUAs, to have recently been a top executive of 1 of the only 2 companies able to secure an EUA for most ‘21

He created the first Rapid Ag test (Quidel Sofia) that FDA gave an EUA to!

Can’t make this stuff up!

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Here is the article that discusses the tweet above.

propublica.org/article/heres-…