NEW: As COVID-19 spreads, we’re learning more about the missteps early in the outbreak that could’ve kept it under wraps. One key hindrance: a long, technical document called the EMERGENCY USE AUTHORIZATION, issued by the Food and Drug Administration on Feb. 4. 1/x
EUAs are supposed to short-circuit the FDA’s long, arduous approval process in the event of a fast-moving outbreak. But this was no typical outbreak, and the requirements were still restrictive enough to keep both public and private labs from rolling tests out quickly. 2/
For example, the CDC has to retest all positive/inconclusive cases--so far more than 1,000. That has slowed down reporting and taken up valuable testing bandwidth. Also, the EUA has tight rules for private labs that want to start testing on their own. 3/
The FDA says it did this to minimize false positives. (In response to questions, a spokeswoman sent this March 7 speech by Commissioner Hahn: fda.gov/news-events/sp…)
The CDC says it can only do what it's told by the FDA.
The CDC says it can only do what it's told by the FDA.
But the CDC hasn’t been turning up many false positives. And at some point, there’s a trade-off between perfect accuracy and speed, which turned out to be more critical in this outbreak than during Zika, ZARS, H1N1 etc. 5/
Former FDA official Josh Sharfstein: "I think they might’ve been operating under a different paradigm, that it was like Ebola...If you were to go back in time and tell the FDA 'you’ve got a month to get a million tests ready,' I imagine they wouldn't have chosen this strategy" 6/
Anyway read the story, from me and the brilliant/CDC-speak fluent @CarolineYLChen: propublica.org/article/the-fd…
Also shout-out to a great story by @SuzyKhimm and @strickdc focusing on the other way the EUA has screwed up the process, by delaying private labs that want to run their own tests: nbcnews.com/health/health-…
