Thread by @HollyLynchez

FDA has issued first #EmergencyUseAuthorization for therapeutics to treat COVID-19 (rest have all been for in-vitro diagnostics, PPE, and other med devices). EUA issued to BARDA for hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile.

IMPT: Although some versions of chloroquine phosphate are approved by FDA for other indications, the CP covered by this EUA has NOT been approved at all. For hydroxychloroquine sulfate, the EUA appears to apply to approved versions (although of course not for COVID-19).

Oh, this is more IMPT: the actual authorization letter
fda.gov/media/136534/d…

Citation please? "[CP] and [HS] are currently recommended for treatment of hospitalized COVID-19 patients in several countries, and a number of national guidelines report incorporating recommendations regarding use of [CP] or [HS] in the setting of COVID-19."

EUA applies ONLY to treatment of patients for whom a clinical trial is not available or participation is not feasible. In this regard, more restrictive than off-label use, which docs can do regardless of trial eligibility (although not of this version of chloroquine phosphate).

Wonder how strictly that will be interpreted/applied, TBH.

Thanks for the helpful description of how the legal standard is met here...🙄

EUA applies exclusively to product distributed from the strategic national stockpile to public health authorities.

I understand legally why EUA would be used for the unapproved product. Trying to figure out why it's needed for the approved hydroxychloroquine, given availability of off-label use. Best guess at 12AM is EUA allows certain labeling to be included specific to COVID-19. @pzettler?

Here's that labeling:
For HCPs: fda.gov/media/136537/d…
For patients: fda.gov/media/136538/d…
(Also posted for chloroquine phosphate)

Public health authorities will be expected to have a process in place for adverse event monitoring and reporting to FDA through MedWatch "to the extent practicable given emergency circumstances"

At present, there is no process for collecting outcomes data under the EUA - but HHS will inform public health authorities if/when there is.

In terms of logistics, it appears that BARDA will distribute drug from the stockpile to state and local health departments, and HCPs (or healthcare systems) will request from them.

The HCP fact sheet says docs should visit clinicaltrials.gov to determine whether enrollment of the patient in a trial is more appropriate. So that's apparently entirely at the discretion of the treating physician, not BARDA, FDA, or health departments.

From the Press Release, Sandoz donated 30M doses of hydroxychloroquine sulfate and Bayer donated 1M doses of chloroquine phosphate to HHS, to be used either in hospitalized COVID-19 patients or in clinical trials.
hhs.gov/about/news/202…

Apparently the strategic national stockpile doesn't regularly stock either drug. SNS will work with FEMA to ship donated doses to states.

Government is working with manufacturers to secure more donations of these two drugs and to increase production to address supply issues facing patients who need the drugs for approved indications.

Last tweet: none of this bodes well for the clinical trials we need to figure out whether these products work for COVID-19.

https://twitter.com/SteveJoffe/status/1244421310593236993