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Comment by andrewla | Hacker News Reader

I don't think this is true.

Henry's, one of the compounding pharmacies, says that they get the chemicals from legitimate licensed producers of feedstock [1].

There is a compounding loophole, but there is no loophole for patent encumbrances -- if a compounding pharmacy is violating NN's intellectual property, then can just sue them directly; they don't have to pursue the regulatory crackdown they're going for now.

There are companies that do grey/black market reconstitutions, like Pivotal Peptides. But they are not compounders. The compounders are legally selling the real thing directly to customers. Do you have a specific source that indicates that any compounding pharmacy is getting its feedstock illegally from China?

[1] https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/..., discovered via https://www.astralcodexten.com/p/the-compounding-loophole

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You're massively misunderstanding that Reddit post, and it doesn't help that the 'HenryMedsInfo' account is misconstruing how the pharma manufacturing supply chain works.

For one, the FDA does not 'license' any manufacturer, period. They do enforce safety and quality standards, but this is not controlled through some sort of a general license, and operates on a per-facility basis.

DMF listing (which isn't a 'license') does not necessarily have any relation to whether that manufacturer is supplying a brand name provider.

The 'license' that account is posting about a complete fiction. There is not a license granted here in any government context, nor a license between NN and the manufacturers the post discusses.

> The compounders are legally selling the real thing directly to customers.

This is debatable. They are not selling 'OEM' NN product to consumers.

Also - stop talking about 'feedstock'. It's weird. It's not standard industry lingo and obscures whatever the hell it is you're talking about (precursors? lyophilized product? something else?)

I'll stop saying feedstock -- I thought I saw that in the astralcodexten article but I am mistaken.

When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow. The reddit post was the closest thing I've seen to an answer to the question "where are they getting it".

So if they are not getting it from producers under license from NN, where are they getting it? Why isn't the legality of that path under active legal attack? There must be some fig leaf at least that they can use to say how they got the substance when the patent is still in force, otherwise judges would immediately shut them down with an injunction.

>When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow

>So if they are not getting it from producers under license from NN, where are they getting it?

They're obtaining it from pharma labs with the right equipment and talent to produce it. The synthesis process is well understood, it's not like it's a Novo Nordisk secret.

> Why isn't the legality of that path under active legal attack?

It is.

My understanding is that a significant number of them are getting them from Chinese manufacturers (that are also selling them to other Chinese companies, that then sell them to individuals, more resellers, or compounding pharmacies)

I've got a high enough risk tolerance that I've got lyophilized tirzepatide on the way from a Chinese seller. Even if I send one of the vials off to be tested, it will still be cheaper than I can get it from a compounding pharmacy in the US.

For at least some compounding pharmacies, their source for semaglutide is crushed Rybelsus pills.

See, for example:

https://a4pc.org/2024-04/mass-confusion/

https://subsema.com/wp-content/uploads/2024/05/White-Paper-S...

https://mynextgenrx.com/wp-content/uploads/2024/03/Compounde...

Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then?

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...

Hey, thanks -- this is great stuff!

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.

You can just search for the the phrase "Novo Nordisk v [company name]". For example:

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 are Eli Lilly and Novo Nordisk suing compounding pharmacies, then?

> 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.

You misunderstood my question. I'm pointing out that the compounding pharmacies and the med spas that buy from them are not getting it from any sort of official source - thus them getting sued. Having spoken to owners of compounding pharmacies, they are getting it from the Chinese manufacturers as well - not from other sources.

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.

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