If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad.
The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet.
From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved.
This is about as Wild West as most of us have lived through for the U.S. drug market.
> This is about as Wild West as most of us have lived through for the U.S. drug market.
I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out.
To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
> To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
This is a pretty good example of how "testing requirements" tend to be reactionary and effectively useless.
Vapes contained Vitamin E because the sellers were cutting the product with it, the same way drug dealers cut drugs with starch or sugar or something worse. It wasn't a manufacturing mistake, they were adding it on purpose to rip off the customer. It makes sense for that to be a crime -- it's fraud and negligence -- so the argument comes that we should require testing for it.
But if you add a test for something like that, they either cut it with something else that the test won't show (which might be even worse) or they add the cutting agent to the distribution pipeline somewhere after the point where the testing requirement is imposed. Testing for something works against mistakes, not purposeful behavior.
Meanwhile the people doing it were probably idiots who didn't know it would cause physiological harmful and thought they were just ripping people off, so then the argument comes that we should be testing to make sure they're not doing that. Except there is no generic test for every possible problem, so at the point they first started adding it, the government would have had no reason to test for that in particular, and by the time it becomes generally known that adding that substance is harmful, they'd have stopped adding it because they don't want to be sued or arrested when their customers have those symptoms and then permanently testing everything for something everybody has already independently stopped doing is a waste of resources.
The problem is people want the generic test that could catch every possible problem and that isn't a real thing, and there is no point in doing the specific test for something that has already stopped happening.
I wouldn’t put vapes in the same category as patented pharmaceuticals.
They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age.
Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose.
This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything.
FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.
That specific medicine is about a molecule that was insufficiently vetted.
It does not seem as egregious as the risk of getting medication made in other countries. As far as I know, all the patented medicine comes from barely audited factories in places like India anyway.
Yes yes, it's super beneficial to destroy the incentive for anyone to risk billions of dollars and decades of research to develop new breakthrough medications for people
As stated elsewhere, the competition in pharmaceuticals does not live (nor should it) in cost of production. It's in R&D. So no, pharma companies cannot systematically dump billions of dollars into developing new medical breakthroughs and then race to the bottom on production efficiency with unregulated pill mills from every backwater on the planet with an Internet connection and a parcel service.
At least, not if you want science to move forward in your lifetime. As a person who has used, currently uses, and will in the future use medicines, I really prefer that we don't eliminate the financial viability of efforts to continue making better ones.
The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.