https://www.reuters.com/business/healthcare-pharmaceuticals/...
https://www.fiercepharma.com/pharma/lilly-files-complaints-a...
Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide?
https://www.fda.gov/drugs/postmarket-drug-safety-information...
I tried looking around at these links but I couldn't find the actual lawsuit itself, and I'm curious what they specifically say. There's a difference between saying that a compounding pharmacy is selling junk claiming that it is semaglutide (that is, making false claims that may reflect on NN when the substance is ineffective), vs. claims that the drug is being produced in violation of their intellectual property rights for the synthesis of the drug.
NOVO NORDISK INC. v AESTHETIC MAISON LLC and AESTHETIC CASA LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Nov...
NOVO NORDISK INC. v MEDIOAK PHARMACY LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Nov...
NOVO NORDISK A/S AND NOVO NORDISK INC. v BOF MEDICAL CENTER, INC.: https://www.safemedicines.org/wp-content/uploads/2019/09/Nov...
In the Aesthetic Maison and Medioak pharmacy cases, Novo Nordisk alleges that they're selling a product claiming to contain semaglutide without a prescription or FDA approval. In the BOF Medical case, they're claiming "trademark infringement, false advertising, and unfair competition."
They're not suing for damages, just injunctive relief ordering the defendants to stop. It doesn't look like it even matters to their cases whether the products contain real semaglutide.
> Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide?
because $
$$$$$$$$$$$$
that's why. not safety. MONEY.
while there may be some very shady sources of fake grey/black market semiglutide that should be avoided, there are also the legal "compounders" who produce white-ish/grey market semiglutide. in the later case, it's the same active ingredient. the FDA, in it's infinite infallible wisdom (and $$$$$$$ pressure from pharma) refuses to acknowledge that while there is a tiny risk that the different buffers, processing methods, delivery and non-active ingredients, etc. have "not been studied" and might not be "less effective", that these are really small risks. tiny.
i feel like the FDA deliberately conflates the dangers of questionable overseas knock-offs with the legitimately pure, regulated, legal products of compounders.
are these guys violating a patent or two? meh? (note: this is a tort, but is not illegal) so sue them. but is it safe? it's as safe as anything else the FDA allows.
meanwhile we keep supporting a system of patents in medicine (and software) that are actively doing exactly the opposite of what the system was put in place for: stifling innovation instead of encouraging it. padding the rich cats pockets instead of giving the small guys a chance.
I've swapped to buying from Chinese manufacturers and reconstituting my own so I'm not exactly lining the pockets of Eli Lilly or Novo Nordisk.