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.
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.
Before people get excited that the FDA approved something, how much testing have the FDA done on this product and how many other tests have they declined to authorize?
Right now, FDA approved means about as much as Probably not immediately lethal.
As I stated in my comment, the difference may only be the label. But the FDA article clearly differentiates them and explicitly discusses how the approvals vs EUA are different for each.
I had heard that the FDA rejected the outside the US data, stating it would not be sufficient for approval. They are supposed to be in constant communication with the regulators, so nobody is submitted EUA until its basically a sure thing.
Considering the FDA constantly approves things that have tiny affects bet and placebo, yet have massive side effects with genuine risks, I wouldn't really take any ok from the FDA as proof of safety anyway.
The FDA approves things based on the purpose they were presented to the FDA/market for.
It isn't based on danger, it is based on evidence backed disclosure of the danger.
In the specific use the company told the FDA about, it passed, and that will usually happen with some objections or outright denial. The denial didn't happen and that isn't article worthy.
I don't believe he's saying he would not use the product BECAUSE the FDA has approved it, but rather FDA approval has not always been the best indicator that a particular product is indeed safe.
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
If the FDA views its role as evaluating for harms only and not efficacy, then this isn't itself necessarily a contradiction.
That doesn't change the fact that this approval is deeply disheartening and tells us the FDA is cool with any random product claims so long as they don't actively hurt people.
But, hey, for all those folks who glory in the good ol' days when men were men and radium was a cure-all, the good news is at this rate we'll be back to snake oil and patent medicine in no time!
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.
Wasn't trying to answer your question...just pointing out that FDA approval means fuck-all. Seems you've put quite a bit of value to it either way. Good luck on your path.
> 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.
Every drug is approved based on a risk vs. benefit analysis. The FDA can't know exactly what will happen when the drug is approved since you can't test a drug on every patient prior to approval (that would be unethical).
No one should be surprised when a few drugs are pulled off the market post-launch. I would argue the FDA didn't make a mistake here and the system works.
reply