Thread by @eturnermd1

Digging further in2 this confusing FDA-issued "Emergency Use Authorization" for chloroquine & hydroxychloroquine.

Link to Letter of Authorization (not letter of approval): fda.gov/media/136534/d…

FDA, agency w/in HHS, is granting authorization 2 another dept w/in HHS

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This refers only to supplies:

(1) in the Strategic National Stockpile

- not whatever drug might have already been in circulation

- necessary b/c the evidence-free hype about hydroxychloroquine has led to a run on it d rampant off-label use

(2) to public health authorities

Near the top of page 2, FDA makes clear that they have NOT APPROVED either drug for COVID-19

But wait! The FDA has said it's given "authorization" but it's also "not approved". WTF? See screenshot of thesaurus. In normal English, "approved" and "authorized" are interchangeable. How could anyone NOT be confused?

FDA then says what these drugs ARE & are NOT approved for. To further confuse folks, there is the issue of diff *versions* of these drugs. Now, maybe this is regulatory hair-splitting. My sense is that, despite this 'version' issue, I'd be confident in either drug for malaria

As far as I can tell, this is the main justification for this "Emergency Use Authorization" –– to facilitate its availability...

...as a 'Hail Mary pass' 4 patients
- very ill w COVID-19
- not candidates 4 clinical trials

...4 pts already taking it 4 FDA-approved indications

...FDA-approved indications such as (as shown in letter) lupus and rheumatoid arthritis. Many patients with these conditions who have been taking these drugs for years who can no longer get it because the pharmacies have been cleaned out thelancet.com/journals/lanrh…

FDA says "reasonable to believe" that these drugs "may be effective in treating COVID-19. Sure, they may be...and they may NOT be. The evidence isn't there yet either way.

Here's the argument for a Hail Mary pass (American football metaphor), an act of desperation. I am personally sympathetic to this argument in desperate situations.

OTOH this is the same argument made for off-label use, which was already possible without this "authorization"

If off-label use for COVID-19 was already possible, what, then, does this "EUA" accomplish?

1- increased availability of a drug that is in short supply d/t hype

2- Trump probably pressured his new FDA commissioner to "do something!!", so this gives him cover

...(cont'd)

...3- and this EUA surely confuses the 99.9% of prescribers and patients who––very understandably––conflate "authorization" with "approval", lending an undeserved veneer of efficacy: "If the FDA 'authorized' it, I should prescribe it!" Betting it'll be rx'd in mild cases, too.

I've just covered the first 2-1/2 pages of this 7-page EUA letter.

cc'ing folks savvier than I re FDA regulatory issues: @DrPeterLurie @SandyPondGCP @ABatemanHouse @RxRegA @cmrherder @ZacharyBrennan @CarolineYLChen @DavidHilzenrath @drJoshS @ScottGottliebMD @akesselheim

Just out on Twitter, news conference w FDA commissioner formally announcing the EUA.

https://twitter.com/US_FDA/status/1246551117242171399?s=20

The explanation he gives seems (IMHO) consistent with the above.

As an aside, his affect seems anxious, perhaps bc Trump is looming behind him. ("Satisfied, boss?😨")