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Comment by nerdsniper | Hacker News Reader

It probably is legal at the moment, but the rules may be changed to make it illegal. But also Uber and Lyft were super illegal when they were invested in. To some extent, YCombinator partners are on the record[0] supporting the idea of their startups doing illegal things.

Generally they'll frame this as challenging outdated regulations, but they acknowledge that the founders whose strategies they fully support sometimes come into office hours and discuss how they're worried that the strategy puts them at risk of going to jail.

There are different kinds of illegal, and Hims/Hers may end up getting blocked from their current business model, or they may end up entrenching new ways for consumers to get affordable care. The jury is very much still out.

0: https://www.youtube.com/watch?v=Hm-ZIiwiN1o&t=8m46s

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Pretty sure it's illegal. You can get peptides (even GLP-1's) legally from various sources for "Research Purposes", but they're marked as "Not For Human Consumption" (even though, on the sly, I'm sure they're aware people are buying these for human consumption and they provide purity tests etc.) What makes it illegal though, is when you say it is for human consumption, or worse market it as a treatment for a disease. That's when you actually need FDA approval.

Compounding pharmacies generally operate outside of what we typically think of when we think of "FDA approval".

> Hims/Hers may end up getting blocked from their current business model, or they may end up entrenching new ways for consumers to get affordable care

Well, no: the thing that's a lot cheaper is a placebo at best, and they were just referred to the DOJ for prosecution.

The rest is more expensive

Hims offered semaglutide for $99/month. That’s a 90% discount on unsubsidized consumer prices for injectable semaglutide. I also don’t see any evidence that they sold a placebo, but I’m just catching up now, perhaps I missed where they’re selling something with a different active ingredient which does not work.

Its in the article that you didn't read lol

I've since read TFA, as well as many other articles, official correspondence, and case law around the issue. I understand that without the additional ingredients of SNAC/sodium caprate/sodium caprylate, the bioavailability is probably too low to have a clinical effect at oral doses <15mg/day.

I read the actual FDA referral to the DOJ. They don't mention anything about any of what this article touches on. It's not clear that the referral makes correct claims about anything illegal going on. In statements, the FDA says that compounding pharmacies "cannot state compounded drugs use the same active ingredient as the FDA-approved drugs". That's a very brand-new interpretation of rules, and might not stand up to judicial scrutiny. In the context of "shouldn't investors have known that Hims business model is illegal??" -- it makes sense that investors couldn't have known ahead of time that the FDA would claim this.

https://www.fda.gov/inspections-compliance-enforcement-and-c...

i haven't read the article. is the question, can hims ship a clone of 25mg oral wegovy? yes, it can.

> ... at oral doses <15mg/day.

well it's not a clone of rybelsus, it's a clone of wegovy 25mg. so i suppose it will be bioavailable at 25mg.

> That's a very brand-new interpretation of rules

this is true. Tidmarsh, the whole Novo Nordisk deal with Trump, it's now about, well we'll do the patent enforcement we didn't want to do before. The simple fact of the matter is, these are lifestyle products, so it's not so black and white if they ought to have the same patent and payment protections as typical therapeutics.

> well it's not a clone of rybelsus, it's a clone of wegovy 25mg. so i suppose it will be bioavailable at 25mg.

No. RTFA. Feed it into an LLM with the first thought off the top of your head. Skim it quick. Whatever. (tl;dr: the clone skips the ingredient that makes the contents bioavailable)

i have a feeling that what actually happened is that absence of the ingredient in the text that the article is talking about is a documentation error, and that's why the FDA makes no mention about it at all (as you discovered). i think the thing that is getting shipped has the ingredient and this is a nothingburger.

indeed, the only evidence that the clone is missing the ingredients is the guy read a Reuters article about it, and asked the chatbot (presumably) to do research. the clones in this sector are pretty faithful. i'm going to chalk it up to, "declined to elaborate" doesn't mean, as the author insinuates, that Hims has a bad clone, i think they just didn't answer the question and there's nothing more to this.

this is coming from my place as knowing a lot about this sector and the simple fact of the matter is, they just make a clone and they do it faithfully.

“What’s more likely is they’re sitting on an unknown breakthrough that took pharmaceutical companies billions and years and just launched.” - you sure you read it this time?

Not sure why you're being downvoted, it was clear they hadn't based on their post, and they admit they didn't.

> Hims offered semaglutide for $99/month. That’s a 90% discount on unsubsidized consumer prices for injectable semaglutide.

It's not a 90% discount. Novo charges $350/mo or less.

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