Comment by pfisherman
17 days ago
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.
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.
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...
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.
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.
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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.
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?
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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...
You can do anything you want when you get a bunch of “noctor” NPs on your payroll to rubber stamp drugs for “patients” nonstop.
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.
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.
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.
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.
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.
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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?
> 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.
> 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.
Not quite, the physicians or NPs or whomever will actively coach you on how to correctly answer their (very simplistic) questionnaires to get the drug you want. And if you fill it out incorrectly, they'll tell you what to correct and offer you a chance to "review your answers for accuracy".
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.
The marketing isn't for the drugs.
They market the service that gives you the drugs with the smallest oversight possible. These services are becoming popular among people who shouldn't be taking GLP-1s (eating disorders, body dysmorphia, people who are too thin but want to lose more weight) because most of their providers are just trying to write prescriptions as fast as possible to collect their payments.
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But they still market regardless. They probably constitute 50% of the medical ads I see now
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>> The US is the only country, aside from New Zealand
And canada. I have seen many commercials on hotel televisions for prescription drugs there.
In the UK there's a lot of TV advertising for "weight loss medication" that never refers to any drug by name. But if you look at the small print, it refers to "Orlistat", which is technically available without a prescription. Of course, nobody (or few) actually want Orlistat or end up being prescribed it after the consultation.
Canada's laws around this are...odd.
The law prohibits ads from simultaneously naming a prescription drug and its therapeutic use. So you might see an ad pushing a specific drug, but it will never say what it's used for. Or you might see an ad where people talk about treatments for a condition but never mention the drug, just saying talk to your doctor.
Sometimes they get around this subtly. In one ad a number of overweight actors discuss how much they love a specific drug, but it's never mentioned what it's for but is implied.
And of course when US channels are simulcast in Canada, US ads just run as is.
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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.
It is still not legal in Canada. Someone must have been flouting the law.
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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.
No… The rest of the first world countries as a counter example.
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I like it.
I'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.
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.
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.
> experienced their shots being less effective
People report this with HPLC tested stuff that is proven to be of the same purity/concentration too, "feels" reports are notoriously unreliable in medicine.
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You had the choice to go the expensive route and you took it. Don't tell other people they can't make their own choices too.
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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.
What do you mean "try them on the general population?" Who is forcing anyone to take any of this?
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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.
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?
Yes. Drugs are too damn expensive and innovation is too damn slow. Better to allow higher risk options. And if you don't like it, you are always free not to use them.
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I'd argue more harm is done by any delays in approval
> 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?
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.
This is not really the correct way to think about this.
Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable.
This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability.
As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this.
Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment.
This is actually extremely important in the drug context due to the aforementioned abysmal profitability.
Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere.
But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development.
It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.
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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.
Were people not previously paying what they cost? It sounds like that's the concept we're getting rid of here.
A distinction without a difference...
> The rules and laws are there for a good reason.
"To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"
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
> 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.
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.
> 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.
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.
Eli Lilly will categorically state it is impossible for the compounders to be using the same API as they are due to being the sole source of manufacturing for it on the planet.
From what I can tell they are technically correct. The FDA approved method of manufacturing the peptide chain is different than the Chinese sources these compounders are sourcing from. It may not make an actual biological difference (and hefty evidence of millions of people on it show there is unlikely to be a material difference) but it’s not the same as a generic medication being approved.
This is about as Wild West as most of us have lived through for the U.S. drug market.
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I don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.