The interesting systems-level question here is whether the FDA approval pipeline was designed for a world where a single drug class can generate this much demand this fast.
Traditional pharma economics assumes the patent holder can supply the market. GLP-1s broke that assumption — Novo Nordisk and Lilly literally could not manufacture enough to meet demand, which created the shortage that let compounders in legally.
Now the shortage is declared over, so compounders lose their legal basis. But "shortage over" is doing a lot of work in that sentence. It means the brand manufacturers say they can supply, not that the drug is accessible to most people who would benefit from it at a price they can afford.
The deeper tension: FDA's framework is binary (approved or not) but the actual risk landscape is continuous. A compounded semaglutide from an inspected 503A pharmacy with proper testing is a very different risk profile than something mixed in someone's garage. Treating them identically under enforcement seems like it optimizes for regulatory clarity over public health outcomes.
"Demand" is not a good metric for proper medical or safety review. There is constant demand for products that promise amazing things, but they should not be approved more rapidly because of their claims until they have gone through the proper process and reviews to show both that they do what they claim and that they do not have other serious side effects or consequences.
We're talking about allowing an "essentially" generic version of an existing FDA approved drug made by licensed compounding pharmacies that has been legally distributed for years due to the shortage. If it's safe enough for people to take in a shortage then it's probably safe enough for people to take in a not shortage.
I don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
Well, 67% of Americans are overweight and the mandatory drug costs $1k. So premiums must be $670 per person or higher to cover nothing but this drug. The drug manufacturers will know that the insurers must provide it so they’ll use the highest price they used at scale: $1k.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
You’re putting more things I. The FDA’s regulatory basket than the law intends.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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
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.
After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
I would silly things to hold onto a steady supply of pentadeca arginate. It has completely eliminated lingering effects of joint and ligament injury and has enabled me to exercise like a normal person. If you have the money it is very easy to acquire a year or twos worth from multiple sources.
What makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
It's opaque, and limited. They buy the raws from China just like everyone else, then reconstitute them, fill vials, and drop them in the mail. They'll only provide a COA if you ask them to, and it will just be one basic mass/purity test most often.
In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results.
I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now.
Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing.
> I highly recommend checking out the terms of trumprx.gov
The website is very good marketing for people who don't typically follow drug pricing. Here is more about why the only folks who will benefit are those without insurance—but those people will find better prices in several places, sometimes significantly better prices [1]. Further, it's likely that they're already finding those prices, since the website prices are no better than what you can get today outside fertility medication; and fertility medications are neither new, nor the most expensive part of that process.
This site has nothing to do with the effective subsidies that Americans provide to the world, and it will change nothing about that. The major thing that would help all Americans, negotiating for drug prices, has been neutered by the current administration. In fact, an executive order has specifically lengthened the amount of time that new drugs will be able to charge higher prices to Americans [2].
We should all be very careful in parsing news items that are not in our field of expertise.
The most effective use of public funds would be to simply buy out the patent and give it out for free. It will save so much in future medical costs it's a no-brainer.
It can't possibly be a net positive. The first pill costs $1B and subsequent ones costs 50 cents. Yes, the U.S. pays more, but the result can only be some combination of 1) other countries also paying more and 2) fewer new drugs.
And 3) US consumers pay less for pharmaceuticals. Together this might be a net positive for US consumers (even if they get fewer new drugs out of the bargain).
Why are you so sure that isn't a net positive? Maybe we're spending too much money on inventing drugs that would be better spent on building houses or feeding the poor.
> On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
It's often up to the employer whether these meds are covered - many insurers just offer it as an option to check or not check.
That said, even at 3-6k/year, it wouldn't surprise me if these drugs were net savings to cover for a lot of patients due to their extremely positive effects as preventative care.
Yeah, my employer changed insurance a few months ago from UHC to Cigna.
Cigna is terrible, even worse than UHC, I'm not happy that we have them but that's a whole separate rant I don't care to get into right now, but one thing I was really annoyed by was that UHC covered Zepbound, but then Cigna didn't. They actually wouldn't cover any GLP-1s unless you are already diabetic, so my wife had to stop.
I initially blamed Cigna for this, but eventually I found out that my employer deliberately opted out of it, so now I'm mad at my employer and Cigna.
We've had to use a compounding pharmacy for my wife to continue her terzepazide, which has worked fine and at least thus far hasn't been an issue, but I knew that these things were on borrowed time due to their kind of gray legality.
>On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes.
I'm not understanding this part. If these drugs have solved obesity and the whole host of associated diseases, including the number one killer; heart disease, shouldn't the insurance companies be clambering over each other to cover these drugs and heavily encouraging their use considering the cost reduction on the overall health system.
And if the incentives are misaligned with insurance companies why are governments not handing out GLP-1s to anyone who asks?
For chronic diseases that tend to be caused by obesity, the expensive bits tend to be towards retirement aged people - or are so disabling that people drop out of the workforce early.
In either case the vast majority of those costs will be incurred by either Medicare or Medicaid. Or at least the next insurer in line as the typical worker doesn’t spend an entire career at the same firm with the same insurance provider.
By the time any cost savings benefits have been realized (call it a decade later), chances are that insured patient is long gone and all they were was an additional expense.
By the time government gets involved you have someone who has been obese all their life and the damage is largely already done. Even if you paid for the meds now, the savings are limited.
Given the market already though - these drugs will be affordable to the average working person within a few years
Your employer (large employers usually dictate what is covered by their insurance benefit offerings) may not care much about whether you end up with obesity-related diseases in your 60s and above.
The major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess.
India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses.
Was my glucose under control without glp-1's? Yeah I could manage an a1c of 5.4-5.6 with metformin but I was still hovering near 300 lbs.
With glp-1's I'm down over 50 lbs, my a1c is a much more manageable around 4.0-4.5 and it makes it much easier to exercise and portion control is a huge benefit. Not to mention a buncha other things like triglicerides and blood pressure have come down due to exercise and eating better. it sucks i have to take it forever, but at the same time i feel a ton better physically, and if i loose 50 more lbs, and labs continue to show improvement, i can reduce the cocktail of other meds I'm on my doc says.
Cigna denied me at first until my doc appealed twice. Cigna wouldnt cover because i wasnt a full diabetic so wasnt on insulin. I would've had to pay close to $1k a month to take it otherwise. Thank goodness for a tenacious doctor!
> I would've had to pay close to $1k a month to take it otherwise.
If your frame of reference for GLP-1 prices is in like, 2024 or earlier, check prices again. They've come down a lot. You can get tirzepatide from Lilly without insurance coverage for under $500/mo (a little less for the smaller doses): https://investor.lilly.com/news-releases/news-release-detail...
I've been taking metformin off-label for weight loss, and it's been working well. I'm a little annoyed that I have to resort to off label stuff because I too have Cigna and I have not been successful at getting them to cover it.
I think it's more my employer's fault than anything else; fortunately metformin actually seems to be doing the job. They won't cover that either but even without insurance it's so cheap that it's not worth complaining about.
It was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
They’re down to hundreds a month, now, with a coupon.
I can’t say I disagree with insurance not being willing to pay those costs (apart from diabetes patients etc.). I bet a large part of the reason you can get the name brands cheaper now is because they did the math they’d make more that way than they could squeeze out of insurance companies.
Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
I was receiving compounded Semaglutide (Wegovy generic) from Victory Pharmacy, a brick & mortar compounding pharmacy, in Austin for $150/mo, then $200/mo, and finally I stopped when it reached $250/mo. I have SSDI and Medicare but it wasn't covered and it's still not covered for pharmacologically-induced obesity or weight gain. If I developed diabetes, then it would be covered as Ozempic (lower dose). I'm having to go without because of bureaucratic gatekeeping and discrimination and because of opportunists cash grabs by pharmaceutical companies' price gouging.
Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.
The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.
If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to
>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
...violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to...
Well actually, there are lawsuits in the works because the Philips CPAP machine had toxic foam which would break down and increase the risk of cancer.
Well you either remove all the bureaucracy around drug testing and approval and make it cheap to develop a new drug, or you prevent drug makers from making money if they are successful at developing a new molecule. But if you do both, all you will get is zero research. Right now it takes 10s of billions in R&D budget to bring new molecules to the market, which is insane.
Yep in other countries CPAPs are over the counter. In America you need to go to a sleep lab for a wasteful overnight sleep study (sometimes two!) that costs thousands. And then have appointments with a “doctor” who provides no useful help but is necessary for the prescription. All for the machine to figure out its own optimal settings anyways. Total racket and regulatory capture.
As long as the company that did the research and the medical professional gets paid the same amount. I’m completely OK with cutting out the insurance and the bureaucracy and other non-value add middleman, but the value add partners need to get paid for this to be sustainable.
Patent laws exist for a reason. It’s so people that come up with paradigm changing ideas and inventions can get rich off of it. This is something we want to maintain.
Can you please explain (TFA doesn't mention patent laws, just unregulated drugs)? For example, my understanding is that semaglutide is protected by patent in the US - I had assumed HIMS was including semaglutide in some of their formulations under an agreement with the patent holder, but I guess that's not correct?
Side note, I'm all for the true innovators being able to patent drugs (like semaglutide) that they put a lot of research dollars into, but seriously fuck all these additional "method of delivery" and "formulation" patents that are bullshit that just get added on later by the patent holder solely as a way to try to restrict the entry of generics into the market after the original patent expires.
Everyone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.
There is zero need to “pirate” ozempic (semaglutide) as there are already US alternatives on the market (Tirzepatide) and about to be more (Retatrutide) that outperform all other medications in the class.
Just have insurers stop insuring ozempic/wegovy but have them insure mounjaro/zepbound and it’s a done deal. No need to even ban it.
Two can play at the game, and the EU was probably closer to starting it.
The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing.
At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes.
I'm quite convinced that:
(A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end.
(B) Denmark and most of EU and large parts of the world would never recognize an annexation.
(C) Congress in the US wouldn't recognize the annexation.
(D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off.
(E) Russia and China would be thrilled.
It was an allround shit show.
Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides.
But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?
The real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
I thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
this was bound to happen with the number of compounding pharmacies getting into the glp-1 game. from a risk side, it’s a total mess it’s basically impossible for insurers to model long-term liability when the supply chain for these drugs is a black box. fda had to drop the hammer before the claims started flying.
The compound pharmacies are the leeches I have the least amount of sympathy for. While Lilly may gouge on the price, at least they can claim to have invented the drug. Some compound pharmacy buying $20 worth of API from China and selling it reconstituted for at least 10x that is just raking in huge profit, and they did none of the R&D.
What the FDA will probably have trouble cracking down on are the vendors selling lyophilized peptides direct to the public. And the number of people going that route goes up dramatically over time.
It is wild that it took until 2026 for this to happen.
In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.
Compounding pharmacies are selling compound, not "for research only" peptides. That's a different thing, even if they probably get the API (drug itself) from the same sources.
I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think Hims is selling RCs. They're violating Novo's (or Lilly's) patents.
It is wild to me that compounding pharmacies continued to sell these in violation of patents even after the expiration of the FDA supply shortfall status last year -- but I suppose there's so much money in it they don't want to give it up.
Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not.
It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer.
There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.
There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process.
Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from.
The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.
Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].
Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
> Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?
The interesting systems-level question here is whether the FDA approval pipeline was designed for a world where a single drug class can generate this much demand this fast.
Traditional pharma economics assumes the patent holder can supply the market. GLP-1s broke that assumption — Novo Nordisk and Lilly literally could not manufacture enough to meet demand, which created the shortage that let compounders in legally.
Now the shortage is declared over, so compounders lose their legal basis. But "shortage over" is doing a lot of work in that sentence. It means the brand manufacturers say they can supply, not that the drug is accessible to most people who would benefit from it at a price they can afford.
The deeper tension: FDA's framework is binary (approved or not) but the actual risk landscape is continuous. A compounded semaglutide from an inspected 503A pharmacy with proper testing is a very different risk profile than something mixed in someone's garage. Treating them identically under enforcement seems like it optimizes for regulatory clarity over public health outcomes.
"Demand" is not a good metric for proper medical or safety review. There is constant demand for products that promise amazing things, but they should not be approved more rapidly because of their claims until they have gone through the proper process and reviews to show both that they do what they claim and that they do not have other serious side effects or consequences.
We're talking about allowing an "essentially" generic version of an existing FDA approved drug made by licensed compounding pharmacies that has been legally distributed for years due to the shortage. If it's safe enough for people to take in a shortage then it's probably safe enough for people to take in a not shortage.
I don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
Because it is $1K/month, it would raise premiums too much. When it is $100/month like in most other countries, then let's talk.
PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
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Well, 67% of Americans are overweight and the mandatory drug costs $1k. So premiums must be $670 per person or higher to cover nothing but this drug. The drug manufacturers will know that the insurers must provide it so they’ll use the highest price they used at scale: $1k.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
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Because not all overweight individuals have the same risk profile thus don’t get the same benefit.
Insurance companies are allowed to limit access to more expensive therapies unless cheaper therapies have been tried and have failed.
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Because being fat is mostly a lifestyle choice.
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You’re putting more things I. The FDA’s regulatory basket than the law intends.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
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.
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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.
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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...
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.
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> 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.
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.
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> 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.
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.
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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.
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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.
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.
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> 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?
Were people not previously paying what they cost? It sounds like that's the concept we're getting rid of here.
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.
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A distinction without a difference...
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.
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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?
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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.
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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.
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.
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
> 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.
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After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
I would silly things to hold onto a steady supply of pentadeca arginate. It has completely eliminated lingering effects of joint and ligament injury and has enabled me to exercise like a normal person. If you have the money it is very easy to acquire a year or twos worth from multiple sources.
Are you using it for a specific injury or generally for anti-aging like people often do? What dose?
What makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
It's opaque, and limited. They buy the raws from China just like everyone else, then reconstitute them, fill vials, and drop them in the mail. They'll only provide a COA if you ask them to, and it will just be one basic mass/purity test most often.
In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results.
I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
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The situation is basically this -
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now.
Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing.
https://www.healthcompiler.com/cost-plus-drugs-vs-trumprx-ho...
> I highly recommend checking out the terms of trumprx.gov
The website is very good marketing for people who don't typically follow drug pricing. Here is more about why the only folks who will benefit are those without insurance—but those people will find better prices in several places, sometimes significantly better prices [1]. Further, it's likely that they're already finding those prices, since the website prices are no better than what you can get today outside fertility medication; and fertility medications are neither new, nor the most expensive part of that process.
This site has nothing to do with the effective subsidies that Americans provide to the world, and it will change nothing about that. The major thing that would help all Americans, negotiating for drug prices, has been neutered by the current administration. In fact, an executive order has specifically lengthened the amount of time that new drugs will be able to charge higher prices to Americans [2].
We should all be very careful in parsing news items that are not in our field of expertise.
1. https://www.nytimes.com/2026/02/05/health/trumprx-online-dru...
2. https://www.kff.org/medicare/the-effect-of-delaying-the-sele...
Can you explain from first principles how the US market gaining MFN pricing does not benefit Americans? Open to changing my mind
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> unless you are at serious risk of diabetes
The US obesity rate is in the 40% range.
The most effective use of public funds would be to simply buy out the patent and give it out for free. It will save so much in future medical costs it's a no-brainer.
> hopefully that’s a net positive
It can't possibly be a net positive. The first pill costs $1B and subsequent ones costs 50 cents. Yes, the U.S. pays more, but the result can only be some combination of 1) other countries also paying more and 2) fewer new drugs.
And 3) US consumers pay less for pharmaceuticals. Together this might be a net positive for US consumers (even if they get fewer new drugs out of the bargain).
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Why are you so sure that isn't a net positive? Maybe we're spending too much money on inventing drugs that would be better spent on building houses or feeding the poor.
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> On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
It's often up to the employer whether these meds are covered - many insurers just offer it as an option to check or not check.
That said, even at 3-6k/year, it wouldn't surprise me if these drugs were net savings to cover for a lot of patients due to their extremely positive effects as preventative care.
Yeah, my employer changed insurance a few months ago from UHC to Cigna.
Cigna is terrible, even worse than UHC, I'm not happy that we have them but that's a whole separate rant I don't care to get into right now, but one thing I was really annoyed by was that UHC covered Zepbound, but then Cigna didn't. They actually wouldn't cover any GLP-1s unless you are already diabetic, so my wife had to stop.
I initially blamed Cigna for this, but eventually I found out that my employer deliberately opted out of it, so now I'm mad at my employer and Cigna.
We've had to use a compounding pharmacy for my wife to continue her terzepazide, which has worked fine and at least thus far hasn't been an issue, but I knew that these things were on borrowed time due to their kind of gray legality.
Novo will also sell you the auto-injector Wegovy directly starting at $199/month. And the pill starting at $149/month.
Good. Now we just need to cut out the doctors. No reason this medications shouldn't be over the counter.
>On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes.
I'm not understanding this part. If these drugs have solved obesity and the whole host of associated diseases, including the number one killer; heart disease, shouldn't the insurance companies be clambering over each other to cover these drugs and heavily encouraging their use considering the cost reduction on the overall health system.
And if the incentives are misaligned with insurance companies why are governments not handing out GLP-1s to anyone who asks?
For chronic diseases that tend to be caused by obesity, the expensive bits tend to be towards retirement aged people - or are so disabling that people drop out of the workforce early.
In either case the vast majority of those costs will be incurred by either Medicare or Medicaid. Or at least the next insurer in line as the typical worker doesn’t spend an entire career at the same firm with the same insurance provider.
By the time any cost savings benefits have been realized (call it a decade later), chances are that insured patient is long gone and all they were was an additional expense.
By the time government gets involved you have someone who has been obese all their life and the damage is largely already done. Even if you paid for the meds now, the savings are limited.
Given the market already though - these drugs will be affordable to the average working person within a few years
Your employer (large employers usually dictate what is covered by their insurance benefit offerings) may not care much about whether you end up with obesity-related diseases in your 60s and above.
>why are governments not handing out GLP-1s to anyone who asks?
Governments require consensus, which makes them slow. It took decades to phase out leaded gasoline.
The major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess.
India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses.
Welcome to a trade war.
It’s unfortunate that shutting these companies down will result in less people gaining access to the drug.
GLP-1’s might be the best thing to happen to medicine this decade - I personally want everyone who would benefit from it to have access.
Was my glucose under control without glp-1's? Yeah I could manage an a1c of 5.4-5.6 with metformin but I was still hovering near 300 lbs.
With glp-1's I'm down over 50 lbs, my a1c is a much more manageable around 4.0-4.5 and it makes it much easier to exercise and portion control is a huge benefit. Not to mention a buncha other things like triglicerides and blood pressure have come down due to exercise and eating better. it sucks i have to take it forever, but at the same time i feel a ton better physically, and if i loose 50 more lbs, and labs continue to show improvement, i can reduce the cocktail of other meds I'm on my doc says.
Cigna denied me at first until my doc appealed twice. Cigna wouldnt cover because i wasnt a full diabetic so wasnt on insulin. I would've had to pay close to $1k a month to take it otherwise. Thank goodness for a tenacious doctor!
> I would've had to pay close to $1k a month to take it otherwise.
If your frame of reference for GLP-1 prices is in like, 2024 or earlier, check prices again. They've come down a lot. You can get tirzepatide from Lilly without insurance coverage for under $500/mo (a little less for the smaller doses): https://investor.lilly.com/news-releases/news-release-detail...
I've been taking metformin off-label for weight loss, and it's been working well. I'm a little annoyed that I have to resort to off label stuff because I too have Cigna and I have not been successful at getting them to cover it.
I think it's more my employer's fault than anything else; fortunately metformin actually seems to be doing the job. They won't cover that either but even without insurance it's so cheap that it's not worth complaining about.
It was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
They’re down to hundreds a month, now, with a coupon.
I can’t say I disagree with insurance not being willing to pay those costs (apart from diabetes patients etc.). I bet a large part of the reason you can get the name brands cheaper now is because they did the math they’d make more that way than they could squeeze out of insurance companies.
Also, on a personal level it rubs me the wrong way to have my insurance premiums go towards something that people could just do themselves, from something they did to themselves. I know many will disagree, of course, and there are other examples (say, lung cancer treatments) that are similar.
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I was receiving compounded Semaglutide (Wegovy generic) from Victory Pharmacy, a brick & mortar compounding pharmacy, in Austin for $150/mo, then $200/mo, and finally I stopped when it reached $250/mo. I have SSDI and Medicare but it wasn't covered and it's still not covered for pharmacologically-induced obesity or weight gain. If I developed diabetes, then it would be covered as Ozempic (lower dose). I'm having to go without because of bureaucratic gatekeeping and discrimination and because of opportunists cash grabs by pharmaceutical companies' price gouging.
Do you have diabetes, heart disease, or another condition necessitating a GLP-1?
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For comedic relief on the GLP-1 issues, highly recommend "South Park: The End of Obesity" special.
https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity
This is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.
>blantatly skirting patent laws
Why is this a bad thing? The quickest way to fix the medical/insurance/bureaucracy complex is to just allow people to sell direct to consumer.
The best (worst) example of this is CPAP. Ideally you'd just be able to go and buy one for $300, but instead there is a complex around "necessity" and "prescription", which creates an effective monopoly where the exact same hardware can be sold at different price points with software locked features.
If even a "simple" mechanical device like this which violates no patents and can't materially harm a person in any way can be restricted on grounds of paternalistic "safety", then one would be right to remain skeptical of the claim that the FDA is restricting action against unauthorized semaglutide knockoffs to
>safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
In Italy, you can walk into a shop and buy as many contacts as you like.
In the US, if you haven't paid your annual tithing to get a hall pass from an optometrist, the FDA won't let you.
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Well actually, there are lawsuits in the works because the Philips CPAP machine had toxic foam which would break down and increase the risk of cancer.
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Well you either remove all the bureaucracy around drug testing and approval and make it cheap to develop a new drug, or you prevent drug makers from making money if they are successful at developing a new molecule. But if you do both, all you will get is zero research. Right now it takes 10s of billions in R&D budget to bring new molecules to the market, which is insane.
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Why is it bad when companies break the law? We have patent laws for a reason (to incentivize enormously expensive drug development).
Novo and Lilly already sell direct to the consumer! Yes, you need a prescription, but once you have one you can buy straight from the manufacturer.
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Yep in other countries CPAPs are over the counter. In America you need to go to a sleep lab for a wasteful overnight sleep study (sometimes two!) that costs thousands. And then have appointments with a “doctor” who provides no useful help but is necessary for the prescription. All for the machine to figure out its own optimal settings anyways. Total racket and regulatory capture.
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As long as the company that did the research and the medical professional gets paid the same amount. I’m completely OK with cutting out the insurance and the bureaucracy and other non-value add middleman, but the value add partners need to get paid for this to be sustainable.
Patent laws exist for a reason. It’s so people that come up with paradigm changing ideas and inventions can get rich off of it. This is something we want to maintain.
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> blantatly skirting patent laws
Can you please explain (TFA doesn't mention patent laws, just unregulated drugs)? For example, my understanding is that semaglutide is protected by patent in the US - I had assumed HIMS was including semaglutide in some of their formulations under an agreement with the patent holder, but I guess that's not correct?
Side note, I'm all for the true innovators being able to patent drugs (like semaglutide) that they put a lot of research dollars into, but seriously fuck all these additional "method of delivery" and "formulation" patents that are bullshit that just get added on later by the patent holder solely as a way to try to restrict the entry of generics into the market after the original patent expires.
Everyone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
> blantatly skirting patent laws
Implied but not explicitly stated in the FDA announcement: the compounders’ real crime is not paying their protection money.
I’m generally happy to see IP disrespected.
Then you’ll eventually be generally unhappy to see no new medications come out.
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Mochi health too
As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.
https://en.wikipedia.org/wiki/Government_patent_use_(United_...
There is zero need to “pirate” ozempic (semaglutide) as there are already US alternatives on the market (Tirzepatide) and about to be more (Retatrutide) that outperform all other medications in the class.
Just have insurers stop insuring ozempic/wegovy but have them insure mounjaro/zepbound and it’s a done deal. No need to even ban it.
The responds of Denmark and or worse the EU invalidating US patents in retaliation is rather dangerous.
Dangerous? It'd be awesome. Think of the cheap products and services.
I hope they abolish DMCA anticircumvention law.
Sure, but not as dangerous as a literal military showdown which was also on the table.
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Two can play at the game, and the EU was probably closer to starting it.
The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing.
At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes.
I'm quite convinced that:
(A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end.
(B) Denmark and most of EU and large parts of the world would never recognize an annexation.
(C) Congress in the US wouldn't recognize the annexation.
(D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off.
(E) Russia and China would be thrilled.
It was an allround shit show.
Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides.
But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?
The real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
I thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
That’s part of the FDA scrutiny, it’s likely the Hims/Hers pills wouldn’t have much bioavailability, yet marketed as “same active ingredient”.
Ozempic lost its patent in Canada and a generic might be approved there soon.
this was bound to happen with the number of compounding pharmacies getting into the glp-1 game. from a risk side, it’s a total mess it’s basically impossible for insurers to model long-term liability when the supply chain for these drugs is a black box. fda had to drop the hammer before the claims started flying.
The compound pharmacies are the leeches I have the least amount of sympathy for. While Lilly may gouge on the price, at least they can claim to have invented the drug. Some compound pharmacy buying $20 worth of API from China and selling it reconstituted for at least 10x that is just raking in huge profit, and they did none of the R&D.
What the FDA will probably have trouble cracking down on are the vendors selling lyophilized peptides direct to the public. And the number of people going that route goes up dramatically over time.
Who are these unscrupulous vendors selling direct to the public? Please name them so I can avoid them for my own personal safety.
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We've been hearing these claims for a long time that they're going to crack down soon.
Oh no next you're going to tell me they're coming after the gas station dick pills.
It is wild that it took until 2026 for this to happen.
In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.
Compounding pharmacies are selling compound, not "for research only" peptides. That's a different thing, even if they probably get the API (drug itself) from the same sources.
I think this is compounding pharmacies selling legit semaglutide (or tirzepatide?), but doing the packaging (dilution in water) themselves. No? I don't think Hims is selling RCs. They're violating Novo's (or Lilly's) patents.
It is wild to me that compounding pharmacies continued to sell these in violation of patents even after the expiration of the FDA supply shortfall status last year -- but I suppose there's so much money in it they don't want to give it up.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-c...
Compounding pharmacies are getting the raw API from China. Some of them are getting it from FDA registered facilities in China. Some are not.
It should be more or less the same thing as the legit stuff, but it is made with a different process, with different excipients, etc. For those going the more legit route, FDA registered still does not mean FDA inspected or that the FDA has signed off on them as being a reputable manufacturer.
There has also been cases of compounding pharmacies offering reta and other unapproved peptides, resulting in the FDA sending lots of angry letters to state pharmacy certification boards.
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There is no way for a compounder to acquire “legit” semaglutide or Tirzepatide as novo and Lilly are the sole manufacturers of it using the FDA approved process.
Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from.
The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
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People are getting retatrutide from random websites (not what’s being shut down here) not from compounding pharmacies.
Totally fair point. I'm just surprised how poorly regulated this stuff is.
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Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
;) - https://www.reuters.com/business/healthcare-pharmaceuticals/...
What culminated these past 2 weeks will be a great FT Big Read to participate in later. Years of work.
And India wins again!
There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.
Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].
Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
[0] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[1] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[2] - https://www.whitehouse.gov/briefings-statements/2026/02/unit...
[3] - https://www.trump.com/residential-real-estate-portfolio/trum...
[4] - https://www.trump.com/residential-real-estate-portfolio/trum...
[5] - https://www.trump.com/residential-real-estate-portfolio/trum...
[6] - https://www.trump.com/residential-real-estate-portfolio/trum...
[7] - https://www.daines.senate.gov/2026/01/20/daines-travels-to-i...
[8] - https://governor.iowa.gov/press-release/2025-09-16/gov-reyno...
[9] - https://www.bloomberg.com/news/articles/2025-12-11/india-dra...
[10] - https://www.wsj.com/business/energy-oil/big-oil-is-offshorin...
[11] - https://www.bloomberg.com/news/features/2025-11-11/trump-s-h...
> Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
“This is not the flex you think it is.”
But thanks for keeping us informed.
You're welcome!
If you don't value IP and knowhow that's on you. Every piece of knowledge is valuable no matter what.
China did something similar 15 years ago when it was where India is today.
We also know how little it costs to lobby the US. Maybe the Chinese were a bit right - it's a bit like the late Qing period.
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HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?