The FDA has just announced that it’s green lighting the mass production of hydroxychloroquine by pharmacies in order to meet the demand for treatment of coronavirus as well as the normal diseases it treats:
FDA prioritized adding hydroxychloroquine sulfate to category 1 in its Interim Policy on Compounding for outsourcing facilities. We do not intend to object to certain facilities using it to make drugs as long as other conditions of the FD&C Act are met. https://t.co/NVTZlPra7q
— Dr. Stephen M. Hahn (@SteveFDA) March 26, 2020
A drug and health policy journalist at Bloomberlaw helps us understand what this means:
THREAD: Here's what this means in English, why it matters, and how it's another example of FDA weighing heavily on the pharmacy community during #COVID2019 (1/7) https://t.co/DFLIQtLGL3
— Jacquie Lee (@_jacquie_lee) March 26, 2020
What FDA did was add the malaria drug Trump keeps touting as a potential covid19 treatment, hydroxychloroquine, to a special list of drugs.
Certain pharmacies can now make big batches of it & sell it to health care facilities w/out getting dinged by FDA (2/7)
— Jacquie Lee (@_jacquie_lee) March 26, 2020
Since Trump keeps pushing the malaria drug, it's been hoarded & places around the US have spot shortages
It doesn't ONLY treat malaria. It treats lupus, rheumatoid arthritis& other conditions. A lot of those people now can't get it bc everyone is buying it for #COVID2019 (3/7)
— Jacquie Lee (@_jacquie_lee) March 26, 2020
ANYWAY, back to FDA's move this week
Now that more facilities can help make hydrochloroquine, it could help ease shortages around the US&more patients can get it
This is not the 1st time FDA is relying on pharmacists/compounding facilities to step in during #COVID2019 (5/7)
— Jacquie Lee (@_jacquie_lee) March 26, 2020
FDA has sent out 3 guidances on hand sanitizer in the last few weeks, all of them encouraging pharmacists, other trained people to make it to prevent potential dangerous home batches made by your average Joe (6/7)
— Jacquie Lee (@_jacquie_lee) March 26, 2020
In the past the FDA & these pharmacists tweaking drugs for patients(or larger facilities making big batches) have had a complicated relationship bc FDA is wary of safety&facilities being up to snuff
So it's interesting to see FDA be reliant on them now during a pandemic (7/7)
— Jacquie Lee (@_jacquie_lee) March 26, 2020