[ab_testing]

I think the real surprise is that hims was able to sell the drug without approval in the first place. I do not support gatekeeping drugs from generic makers but their supply chain should be inspected just like any body else. The fact that they were able to sell a drug for so long without approval shows that something is really broken in the process.

[entangledqubit]

I was under the impression that they were initially allowed to produce the drugs since they were on FDA drug shortage lists. As expected, the compounders scaled up their pipelines to meet demand and now that the drugs have been taken off the shortage list the compounders are incentivized to figure out how to keep things legal. (Of course, they should have had clean supply chains this whole time.)

I'm curious if one of these outfits got bought out to end the supply shortage.

Related: https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...

[xp84]

I don’t think this is about inspecting supply chains, or keeping anybody safe. It’s about somebody’s profits. Other times it’s about the FDA’s incredibly overconservative approach, which keeps many meds you can buy OTC everywhere else, Rx only here, and keeps other drugs available elsewhere illegal here. Even for people facing terminal illness.

[throwaway290]

if it helps people facing terminal illness it doesn't mean it should be OTC. "facing terminal illness" probably needs strong stuff. something required for that can harm the normal guy. it's not like Vit D supplement.

[roywiggins]

It's basically a regulatory arbitrage, see here:

https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how...

> they get away with it because:

> In-house prescription

> legally registered 503A compounding pharmacy that is not selling bulk (individual prescription quantities)

> They can argue clinically distrinct compounding

> FDA does limited enforcement unless its unsafe or mass bulk production

Point 4 seems not to be holding anymore.

[jfengel]

Any idea why they'd change their mind about point 4?

The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?

[dhosek]

There was a good Planet Money episode which went into what was behind all of this.

https://www.npr.org/2025/08/22/nx-s1-5511707/ozempic-zepboun...

[kotaKat]

You can do anything you want when you get a bunch of “noctor” NPs on your payroll to rubber stamp drugs for “patients” nonstop.

[dboreham]

The fact that they could sell in the first place I think implies some corruption occurred at some point in the past that permitted them to do so (not necessarily by them, but someone must have lobbied for "compounding" since that afaik doesn't exist in other proper countries). Then they failed to pay the necessary bribe to be allowed to continue. To be fair, the bribe would have been very large given the GLP-1 manufacturers' position in the pension savings of ordinary Americans.

[cthalupa]

Compounding pharmacies are in many ways just a continuation of the original apothecaries and pharmacies, and the US is hardly the only country with the legal framework that allows this.

Australia was basically a carbon copy of the US in this regard until 2024, but they have specifically started targeting a lot of the "wellness" compounding that includes peptides, GLP-1s, etc. since then.

Germany has two classes of pharmacy that are nearly the exact same as 503A and 503B compounders in the US

Canada is similar but stricter about the big pharmacies turning into de facto manufacturers, pumping out huge quantities for downstream compounders and clinics, which is what happened in the US.

Lots of other countries that you might not consider "proper countries" (whatever that means) follow a very similar system to the US, and lots of countries that allow some form of compounding, like the UK through their "specials" program, but it's much more centralized - basically cutting out the 503A compounders in the US.

Fundamentally compounding pharmacies offer pretty important services - there are people out there that would literally not be able to take the most effective medication for their condition without the compounding pharmacies making formulation changes that the larger manufacturers might not have incentive to make. Their existence quite literally saves lives. So it becomes a matter of not making that so restrictive that you wind up killing people due to restricted access vs. letting it get abused in situations like we're seeing today with tirzepatide and semaglutide.

[FireBeyond]

When dealing with depression I suffered ED. So I looked at Hims.

They have a fairly cavalier attitude to medication administration at best - the goal is sell, sell, sell.

I filled out the questionnaire on symptoms prior to my virtual physician interview...

"Based on your answers to questions 3, 4 and 8, this would not meet the criteria for prescription. You would need to answer differently. Would you like a minute or two to review your answers for accuracy?"

These places are effectively online pill mills.

[Spooky23]

Hims is mostly marketing. They are using compounding pharmacies to fulfill orders. Compounders are a shady industry in general, and most the GLP places are using Florida pharmacies, which are notoriously extra shady, as Floridas regulatory function is deliberately incompetent.

Compounders are primarily regulated at the state level, and regulatory effectiveness varies. The more legit ones are mostly buying Rybelsus (the pill version of Ozempic for Type 2 diabetes) at wholesale and crushing it. The shadier ones are using precursors, sourcing from questionable & unregulated suppliers or watering down does and adding stuff like vitamin B-12.

The FDA has more limited jurisdiction, and they have been busy firing people.

The federal attention probably has more to do with whatever grift POTUS has going with Eli Lily and Novo Nordisk. Both companies are about to scale up their daily tablet versions of Wegovy and Zepbound at lower price points, and that availability will push the cost of compounded injectables way down.

[nostrebored]

They are adding B12 as a way to say that it’s tailored to individuals and not available.

I’ve used mainly compounded medicine over the last five years and find the fervent dislike that people have for compounders bizarre.

If you look into generic regulation in the US, the standards are already through the floor. I’d rather work with someone who has a more direct financial incentive to not fuck up.

[wolfi1]

that reminds me, as in Canada the semaglutide patent expired, Sandoz said they will put a generic on the market in Canada, could that be imported into the US and be sold?