This is from a conversation about the FDA press conference this morning with a friend who works in drug licensing/insurance/approval for a major hospital and knows the bureaucratic process much better than me:
Quote:
Basically FDA commissioner said they are moving for expanded access of plaquenil (h-cholroquine) for COVID-19.
It's an FDA-approved drug (malaria and auto-immune diseases), and a doctor can give it now off-label, so you can get this if your doctor is willing to give it to you. When the FDA approves drugs, they approve them for specific indications they don't approve drugs for just anything and everything (i.e. FDA approved labeling). plaquenil is approved, but not approved for COVID-19, so it would have to undergo long clinical trials to change approved indications/labeling.
Some insurance will not cover off-label use of drugs for medical practice. It's smart for FDA to push for expanded access because the doctors have to give the data on the patient back to the FDA. I
f a doctor uses plaquenil off label the doctor doesn't have to give the patient data back to the FDA. So in essence it looks like what the FDA is doing is going to make plaquenil available under expanded access and collect safety and efficacy data in real time, rather than the traditional clinical trial route. Smart move in my opinion.
