You are downplaying the role of an emergency use authorization. "Reasonable belief" sounds experimental to me. Otherwise they would've had all the information needed for FDA approval, it wouldn't have been predicated on belief, and it wouldn't have been labeled emergency use.
Why are you so adverse to accepting the reality of the situation?
"The process for issuing an EUA is different than an FDA approval. Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval."[1]
> What is the difference between FDA approved and an emergency use authorization, from the perspective of the law?
> Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions[1]
The difference is that something pushed out under EUA is _not_ FDA approved. So any laws related to approved medicine, devices, vaccines, etc do not apply automatically to EUA products.
I have no idea how these things work, but what struck me is the "restrictive" tone in the EU ("We couldn't find an adequate study proving or disproving, therefore we assume it's dangerous until proven otherwise") vs. what I view as a "permissive" view in the US ("We couldn't find an adequate study proving or disproving, therefore we assume it's safe until proven otherwise").
When it comes to things I put in my body, I would personally prefer the EU approach.
Someone else answered correctly saying an EUA can't be issued if an already licensed drug can help. I would further that point by saying to actually go dig up the true source of that policy on the FDA's website in your country (not someone's summary or interpretation). It's a great exercise that will leave you with some sort of ground truth in this mess.
Same as in coding, you eventually reach a point where you learn that when in doubt, you must read the source.
I wasn't being literal. The point is the FDA is overly cautious to the point that they're harming the health of patients. Slight deviations between the US and EU are understandable, 10x is questionable.
EUA means Emergency Use Authorization. Emergency, yes, that's what Covid is. As such, leadership means taking some calculated risks. What FDA essentially does is "you can't get fired for buying IBM". They stick to "we don't have any data for this and that", "this is what the science shows", and people out there are dying. A perfect demonstration of lack of leadership.
Standard operating procedure at the FDA is to prohibit everything until it has undergone comprehensive testing. Since this virus didn't exist until recently, neither did the test, so even once the test existed it was illegal to use it and the words swift and efficient are not appropriate to describe the process for changing that.
People have been pointing out for years that the FDA's approach is excessively conservative, but the typical response is that they're doing it to save lives, even though there is a point past which being too conservative actually costs lives by keeping life-saving things off the market. This was a prominent example of that actually happening.
FDA approval or not was not the statement I made. Even in your link it expressly says they are still being distributed under the EUA not under normal law
This suggests FDA approval doesn’t say much about whether something works—presumably it still says something about safety. At any rate, whether or not FDA approval means much, to a certain subset of people it ostensibly did, since the objection that there was only an EUA was fairly common.
Funny how most people have zero idea what the difference between EUA and the "normal way" means. Buying FDA registered non-drugs and medical devices doesn't seem to bother as much so.
Does full FDA approval make a meaningful difference, though?
If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.
Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.
Yeah, I don't think it's good to grab onto anything in particular.
That being said, the risks with certain drugs are very low. Hydroxychloroquine has some serious side effects and appear to marginally improve results, hence they revoked the EUA.
- That forcing people to take a drug authorized under EUA with a relatively novel technology is a "basic safety measure"
- That people who didn't comply with this "basic" measure are not breathing virus particles all over you
I'll leave it to you to decide how good these assumptions are.
reply