Thread by @AlecStapp

1/ I wrote 3,000 words for The Dispatch on what exactly went wrong with coronavirus testing in the US

thedispatch.com/p/timeline-the…

2/ The first coronavirus case in the US and South Korea was detected on January 21.

South Korea quickly ramped up widespread testing.

Why did the US fail to do the same?

In short: the FDA dropped the ball.

3/ There have been 3 major regulatory barriers to scaling up testing

- obtaining an Emergency Use Authorization (EUA)
- being certified for high-complexity testing under CLIA
- complying with HIPAA Privacy Rule and the Common Rule related to protection of human research subjects

4/ HHS Secretary Alex Azar declared a public health emergency on Jan 31.

That action initiated a new requirement — labs that wanted to conduct their own coronavirus tests must first obtain an emergency use authorization (EUA) from the FDA.

5/ EUAs were intended to speed up the normal authorization process.

But in this case, labs that were already conducting their own tests needed to cease operations until they were granted an EUA.

By not waiving the EUA requirement, the FDA was actually slowing down testing.

6/ And obtaining an EUA was no easy task.

FDA required:

- validation by testing at least five known positive samples
- mailing a physical application on CD or thumb drive
- testing the protocol against MERS and SARS viruses

7/ On Feb 4, the FDA issued an EUA to the CDC for its testing protocol.

The FDA wouldn't issue another EUA to any other entity until Feb 29.

By only issuing a single EUA in the month following the emergency declaration, the FDA was putting all its eggs in one basket.

8/ And then they dropped the basket and all the eggs broke.

The CDC protocol failed when state and local public health labs tried to validate it.

The exact cause of failure is still under investigation, but a faulty reagent is suspected.

9/ On Feb 24, an association of more than a 100 state & local public health labs sent the FDA a letter begging for enforcement discretion.

The FDA said they should apply for an EUA instead.

5 days later, the FDA reversed its position & exempted advanced labs from the EUA req.

10/ But this exemption applied only to “laboratories that are certified to perform high-complexity testing consistent with requirements under CLIA.”

One researcher estimated 5,000 virology labs in the country met this standard.

Context: US has ~260,000 laboratory entities.

11/ On March 16, the FDA expanded the EUA exemption to all commercial manufacturers and labs (not just those certified to perform high-complexity testing under CLIA) & devolved regulatory oversight to the states.

"The FDA sped up the process by removing itself from the process."

12/ The FDA did the right thing when it expanded the EUA exemption to all labs and manufacturers and devolved regulatory oversight to the states.

The Department of Health and Human Services did the right thing when it waived certain provisions of the HIPAA Privacy Rule.

13/ But these actions were six weeks too late.

Speed, not perfection, must be the focus of pandemic response.

A distributed approach would be much more resilient to the inevitable mistakes and accidents inherent to crisis management.

14/ Instead, in this crisis, the FDA bet big on a single testing protocol from the CDC and burned its ships.

And when the “perfect” test failed spectacularly, everyone was left wishing for a way to retreat.