[pfisherman]

FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval.

There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.

In my opinion there two things going on here that I strongly feel are true.

1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.

[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.

[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.

[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.

[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.

[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?

[beejiu]

> 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.

[randycupertino]

> The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.

What interesting here is that Hims & Hers are able to skirt the pharmaceutical marketing regulations. They are able to blanket the world in their ads whereas pharma companies have to abide by strict safety information requirements in their commercials. Him/Hers give literally zero safety and side effect info.

The other weird thing is that the companies like Hims/Hers are basically dial a script. You call them and get whatever you want. They probably deny no one and don't turn anyone away. Unethical and lacks physician oversight.

[cowsandmilk]

GLP-1 drugs don’t require marketing. There are tons of people who have been prescribed them and aren’t being covered by insurance. Both Novo and Eli Lily are now selling them direct to consumers with prescriptions that don’t have insurance coverage.

[sandworm101]

>> The US is the only country, aside from New Zealand

And canada. I have seen many commercials on hotel televisions for prescription drugs there.

[Schiendelman]

I thought this was true, but I got direct marketing for prescription medicine in Canada a few weeks ago. I don't think this claim is accurate anymore.

[bpodgursky]

This is a vacuous statement because in much of the world (ie most of the developing world), there's no such thing as "prescription only" medicine, people can buy whatever they want over the counter.

[BurningFrog]

I like it.

I'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.

[terminalshort]

Where is the evidence that anyone has been harmed by these unapproved GLP1s? Until I see that I will assume the government is 100% in the wrong.

[Fezzik]

I just started taking Wegovy. Went the regulated route through my doctor, getting a prescription. She’s been monitoring loads of patients and noted that some of her patients going the ‘compound’ route had, in fact, had allergic reactions to their shots, or experienced their shots being less effective, after months of no problems. Nothing life threatening. But the fact is there is no oversight to what the GLP-1 is compounded with.

[arzke]

This is precisely why we have clinical studies. We want to measure the efficiency and the innocuousness of drugs. You seem to imply we should just go ahead and try those directly on the general population.

[Aurornis]

The individually compounded versions have a higher risk because there's a person involved who can make mistakes, as opposed to a carefully controlled and tested manufacturing line.

Compounded drugs have higher rates of bacterial problems, doses being too high or low, and other issues.

Someone I know worked for a company that took over a poorly run compounding pharmacy and cleaned up their process. Some of the stories I've heard have made me want to avoid compounded medications wherever possible.

[ryan_n]

So you think it's better to wait until people are harmed than for companies to go through the proper approval process for these drugs?

[khuey]

> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

Are we cutting off people's access to meds or do they just not want to pay what they cost?

[ronsor]

To be fair, most medication in the US is overpriced due to patents and what not. The "cost" is hardly the real, legitimate cost and generally inflated 1000%+ compared to other countries.

[wan23]

At some point when the compounding was ramping up it was difficult to get the drugs even with a prescription and being willing to pay the full no-insurance price. Nowadays you can mostly get it, but insurance coverage is spotty. Because of weird incentives, the no-insurance prices of drugs are highly inflated so the amount that they cost isn't a realistic price for most people to afford. The manufacturers offer coupons but the conditions on them, and the fact that they still leave you with a pretty inflated price tag means that the compounded versions like what HIMS sell are the most cost effective option for a lot of people - it's still highly marked up, but to a level that is manageable for way more people.

[sixothree]

Were people not previously paying what they cost? It sounds like that's the concept we're getting rid of here.

[ridgeguy]

A distinction without a difference...

[hulitu]

> The rules and laws are there for a good reason.

"To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"

[refurb]

ANDA is for drugs that have gotten off patent. Semaglutide has not gone off patent in the US. It won’t until 2032 at the earliest.

And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.

Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.

I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez

[tossandthrow]

> Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.

The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc.

But it is all the rage when a pill can undo people's bad habits.

[ekianjo]

You are misrepresenting the FDA post. They focus on the fact that the API was not approved for use, which means removing the marketing authorisation is something perfectly fine to do. All API sources need FDA inspections proving the GMP practices are respected and compliant.

[lotsofpulp]

> The rules and laws are there for a good reason

Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.

[Dylan16807]

If the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad.

The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.