[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.

[xp84]

No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.

It’s a separate dysfunction than their obsession with making things Rx-only, such as for example, an albuterol inhaler. In Mexico you can just grab one at a drugstore.

[Aurornis]

> No, what I mean is it takes pulling teeth to get someone who would die anyway, the ability to try experimental drugs even with a doctor’s prescription.

This topic came up in another online community (which I'm intentionally not mentioning) a lot a few years ago. I left a comment about why giving experimental drugs to terminally ill patients is not a simple or obvious idea like many would assume. I got some very long, very intense replies from someone who was dying of a type of cancer who believed he had a good shot at recovery if he could get his hands on an experimental drug. He had all of the links and papers to prove it.

I remember trying to take it all in and reconsider my position.

A few years later, there was a post from his wife that he had died. It was a very sad situation. I clicked some of her links and found that he had a blog where he had written a lot. He actually did go through with the process of requesting the experimental drug and his request was granted. However, the drug not only didn't work, it had caused some irreversible damage to his body that made his final months a lot more painful and difficult than they had to be.

Apparently the "compassionate use" exemptions are not as hard to get as the anti-FDA writers have led us to believe. The harder part is often getting the companies to provide the drugs, because they know the risk profiles and uncertainties better than anyone and aren't always interested in letting terminally ill patients experiment on themselves outside of the process.

[squigz]

Sounds like you might be talking about Jake Seliger, and indeed, his and Bess' fight to get treatments was rather eye-opening for me too.

Jake's blog where he posted throughout his entire illness: https://jakeseliger.com/

Bess' blog: https://bessstillman.substack.com/

It was a heartbreaking story to follow, and one that hit me a lot harder than I thought it would when Jake died.

[throwaway290]

experimantal, not fully proven drugs available to help terminally ill patients (which should be true) needs first to make sure the patient is terminally ill. it is not about making them available OTC to anyone who asks. because what happens then is free for all, scams and corporate experimentation on live population.

[estearum]

Anyone can read about the requirements for Expanded Access/"compassionate use" here: https://www.fda.gov/news-events/expanded-access/expanded-acc...

IMO this all seems very reasonable.

What specifically do you think is problematic about this, and how do you propose that we mitigate companies from preying on desperate patients while making it easier for patients in need?

[SR2Z]

What about drugs that were initially prescribed, but have to be taken for a long time?

A long time ago I had a Lexapro prescription. This is a very, very common drug and is on the list of the WHO's essentials for bootstrapping a healthcare system.

Then I quit my job and spent a few months unemployed. I was no longer seeing the psych who prescribed them and I was not covered by health insurance.

The last few refills my prescription had? Walgreens bumped the price to $200 a bottle, and unless I paid another doctor there was no way to keep taking the medication I'd been on for two years.

Mind you, this drug is old and generics are CHEAP. I've also got all the knowledge I need to take it safely because I have been.

Instead of doing that, I made the decision to quit rather than deal with the doctor mafia. We let people buy industrial chemicals on the Internet and trust they're not gonna kill themselves with it, but somehow my situation was an unacceptable risk?

[throwaway290]

it's implied that country should have a working healthcare system too.

[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?

[Aurornis]

They didn't change their minds. The enforcement was consistent. It's the companies who scaled up their production to mass market levels who prompted the action.

There have been several examples in the past 5-6 years of the FDA loosening regulations to benefit patients and companies rushing in to abuse the opportunity at scale.

Another one that comes to mind is when the FDA loosened restrictions on telehealth prescribing of controlled substances during COVID. Several companies saw this as an opportunity to set up digital pill mills, advertising on TikTok and offering Adderall prescriptions as a service. Nurse practitioners were paid up to $60,000 per month to write prescriptions as fast as they could without interacting with patients.

[xp84]

Whoever isn’t making their profits when people buy them this way is directing the FDA to act. You can bet on it.

[estearum]

As they should.

The companies who bet several billions of dollars in literal decades of research on this stuff should absolutely be swimming in cash until the end of their days. Hims & Hers should be sued into oblivion for stealing the rewards of other companies' ingenuity, risk-taking, and dedication toward helping patients.

I am highly sympathetic to the argument that the government should just buy these patents and mass manufacture to increase availability, or just buy guarantee order vast amounts to scale up manufacturing and distribute cheaply, but the idea that a different private company ought to be able to profit in the way Hims & Hers has is absolutely flatly fucking insane.

[nostrebored]

So millions of Americans should deal with years of obesity because Novo is a disaster, insurance coverage is ridiculous (any insurer accurately charging for the purpose of risk mitigation should be paying people to take GLP-1s, when instead they are out of coverage for most plans), and there exists no government body to do what you’ve said?

[kldg]

While I'm sympathetic to this argument, I should point out patent time to expiration for medicine in the US is pretty inoffensive (relative to how bad it could be, like software patents), and we already have plenty of drugs for excreting excess. We get a big basket of drugs into public domain each year, and government would be wise to publicly celebrate this, I think; would help with the general sense of impending doom citizens feel.

Semaglutide molecule patent will expire in 2031 here (many caveats to this). For the most part, you can get any pill ~15+ years old for ~nothing without insurance, but associated devices like auto-injectors can extend this due to goofy rules; I expect execs thoughtfully considered medical patent law when deciding to initially trial and release GLP-1s as an injection.

[estearum]

What do you mean "there exists no government body to do what you've said?"

HHS could do it tomorrow.

[phil21]

Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.

If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.

Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.

[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.

[Spooky23]

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

Yes, adding B12 is a regulatory fig leaf. So is bribing public officials: https://www.cnbc.com/2025/01/07/hims-hers-donates-1-million-...

[nostrebored]

https://www.quiverquant.com/lobbying/stock/NVO/

Sure, and Novo spent 2M last quarter on lobbying. Nobody in this industry comes out looking wonderful. But the compounders who are meeting demand are not Hims & Hers.

[Spooky23]

Totally the same. Enjoy your bone broth.

[nostrebored]

Is liking bone broth supposed to be some sort of dog whistle?

I am open to being convinced that I’m wrong here, but you’re doing a pretty terrible job.

[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?