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.
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.
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.
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.
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 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.
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.
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?
Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.
If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.
Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
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.
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.
> This is about as Wild West as most of us have lived through for the U.S. drug market.
I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out.
To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
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.
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.
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.
> 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.
> 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.
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).
Well that's the choice. Allow drug companies to price discriminate so that poorer people can also buy the drugs or don't allow it and get more new drugs. It's not clear that drug companies are even going to retain low prices in other countries if it means that the US consumers will pay less.
Which drugs that haven't been invented yet do you think we should forego?
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.
>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...
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.
A fairly large portion of lung cancer patients didn't "do it to themselves" (about 20% and rising).
It remains to be seen how vaping impacts lung cancer,
I don't like the idea of finding reasons to penalize people for predicable life decisions that lead to treatment needs. Insurance companies have a lot of resources to make those predictions and if unshackled they aren't afraid of using them. Making construction workers, miners, or truck drivers pay more (or be denied outright) for insurance because their job has negative health effects would be bad for society.
> 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.
> 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.
The usual note for this is your insurance premiums were already going towards that, just indirectly by way of paying for heart disease treatments, diabetes management and other secondary effect of obesity.
But I'd also like to propose that "could just do themselves" is carrying a lot of assumptions that may not hold for any individual. A few years back now I started a medication with the side effect of appetite suppression, and I learned something about myself. To the best of my ability to recall, I had never before starting that medication not been hungry. "Full" to me was a physical sensation of being unable to fit more food physically in my stomach, but even when I was "full" I was hungry. Luckily for myself as a teen and young adult I had an incredibly high metabolism. I could eat 3 meals a day, 3-4 bowls of cereal and milk as an "afternoon snack" after school and some late evening snacks while watching TV and I still was in the "almost underweight" category. It was in this context, a time when I could go to a fast food restaurant and order two meals just for myself and stay well inside a healthy weight range that I learned to eat as an adult. Eventually though, the metabolism slowed down, and I started packing on weight but the hunger never subsided. Oh sure, as I got older the idea of and ability to eat an entire pizza by myself slowly went away, but hungry was always there, so I was still always eating and always eating more than I should have.
And I did manage to lose weight on my own many times. Through extremely strict self control and portion control, multiple times I managed to lose 25, 30 even 50lbs, one painstaking week at a time. Every day was strict tracking and weighing of everything I ate, and many days were hard battles of "I know I'm hungry, but I've already hit my limit for the day, so I can't eat more", and going to bed extremely hungry with the hope that when I woke the next morning that feeling would have subsided a little. And it worked each time, until inevitably something happened to disrupt the routines and habits built over the months. Maybe it was a set of family emergencies that had me eating on the run, unable to properly monitor everything and adding some "stress eating" on top of it. Maybe it was running into "the holidays" where calories are cheap and abundant even if you are still keeping track. And sometimes it was just being unable to sustain the high degree of willpower it required to keep myself on the schedule. And what takes month of carefully losing 1lb a week to do only takes a month or two to almost completely undo.
Hunger is probably the closest thing I've ever experienced to an addiction. I've thankfully never had to battle an addiction for anything else, but when it comes to hunger that eternal gnawing was ever present and the more weight I lost by sheer force of will, ever distracting. If the idea popped into my head after lunch that "I'd like a snack", it was an idea that would not leave my head until either I'd given in and gotten a snack or forced myself to not give in and waited until dinner. But that forcing meant dedicating ever larger parts of my mental energy away from my work and tasks at hand to just convincing myself to not go get the snack. And worse, when the time for dinner finally came, I was already feeling "hungry" on top of my normal hunger state, so often not eating the snack just meant delaying the excess consumption to dinner or having to continue that fight at dinner. If it sounds exhausting, in a lot of ways it was. But of course, like you said I can "just do" this. It's simple CI < CO math. And yet it never stuck, in part because unlike a lot of other unhealthy habits you can pick up in your life, you cant just not eat. Yes you can eat different things, or eat healthier, both of which can help with weight problems, but you can't stop eating. You have to eat, the hunger is always there and the same thing the hunger wants is the same thing you NEED to literally survive.
But that medication with its appetite suppressant effect was a game changer for me. For the first time in over 30 years, I actually felt full. Not physically stuffed, but "done eating". I could eat a small lunch and think to myself "that was good, and I feel satisfied". For the first time, when the idea of an afternoon snack popped into my head, I could remind myself that dinner was in 2 hours and I needed to make sure I had room to eat that so the snack could wait, and that would be the end of it, no fight necessary because the hunger wasn't gnawing at me the whole time. When I first started, I was concerned that the medication was giving me anxiety attacks because about 6PM every day, I'd start getting this feeling of my stomach tying itself in knots, and this sensation of "needing something". And after a week or so it occurred to me that what I was feeling for the first time in my life was the feeling of transitioning from having been full and satiated to being hungry again. I'd never not been hungry before. And I know that sounds insane, because it sounded insane to me then. Before taking the medication if you'd asked me if I know what it felt like to be full or to not be hungry I would tell you that I did. But apparently I didn't, and I didn't know that until I started that medication. And for the first time since the weight started coming on, the weight I've lost is staying lost.
So yes, you can "just" eat better and less and control your portions and not eat so much. But from personal experience, it's a hell of a lot easier to have that will power when your body is giving you the right signals and isn't constantly pushing you over the limits.
Why is obesity not considered a necessitating condition? It often carries the comorbidities you just mentioned. Should not exclude people just because they haven’t had these specific health problems (yet) but will eventually have them.
While I tend to agree, insurance companies don't see it that way. They need a doctor to indicate a necessity to treat a condition, as opposed to it being the easiest way to treat it.
For example, I have to take digestive enzymes to digest my food (pancreatic insufficiency). For someone with an unusually high metabolism, they would also give them a leg up on gaining weight, even though there are other approaches to gaining that weight. However in many cases, the insurance company wouldn't cover their prescription when they will mine.
As always it’s insurance nonsense. If incentives were aligned insurance companies would be lining up out the door to give this to obese people because they (the insurance companies) would eventually be on the hook for paying for the care of the conditions you just mentioned. It is very well demonstrated in literature that obese people have a much higher occurrence of these conditions than non obese people.
But the system is not set up with aligned incentives
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.
Going to Japan felt like living in the future. I could walk into any glasses store, and for $50 or less buy a pair of frames and lenses. If I didn't know my prescription, included in the price was an automated eye exam machine which'd figure it out in 2 or 3 minutes.
You can do the same in the US, zennioptical.com. You need to measure your PD which is very easy (Most optometry shops are hesitant to tell you your PD. And it's normally measured when you go to order the glasses, not as part of the initial eye exam.)
As for needing a prescription <1 year old, if your vision hasn't changed, just edit the date in the PDF. Same for contact lens prescriptions.
As part of the regular eye exam, they generally use an autorefractor machine on your current glasses and/or eyes to get a baseline before they manually fine tune with the 1/2 on the eye chart test. But yeah, you can't just get the quick prescription from the autorefractor like you talked about in Japan.
That's nice. The rest of the world has price caps on what these companies can charge for drugs.
It's one or the other. You can have your ''patents'' and ''intellectual property'' respected...but that requires you not charge an outrageously higher price in certain markets, like the US.
The rest of the world isn't free riding - the USA has just setup a market where there is very little bargaining power for consumers because of how the US medical market and insurance works.
Novo and Eli are still making plenty of money in Europe where these drugs cost a fraction of the price, and where there aren't other significant suppliers for GLP-1's like is being implied.
No, they're free-riding. If drug companies can't charge higher prices in the US, they will do less drug development. Everyone involved in the business/investing side of pharma knows this; it's not even an argument.
In a free-market approach to drug development, if the expected loss of attempting to develop as drug is negative, and the cost isn't too high, then there is an incentive to develop that.
The best public policy outcome in such an approach would be for losses to be only slightly negative. Positive or zero expected losses mean no drug development, and highly negative expected losses mean the drug is more expensive than necessary and reduces the accessibility of the drug.
However, current patent law allows companies to minimise their expected loss, with no controls to prevent highly negative expected losses.
There are alternative models - such as state funding of drug development. This model has benefit that it is possible to optimise more directly for measures like QALY Saved (Quality Adjusted Life Years Saved) - which drug sale revenue is an imperfect proxy for due to some diseases being more prevalent amongst affluent people, and because one-time cures can be high QALY Saved but lower revenue.
The complexity of state funding is it still has the free-rider problem at a international level (some states invest less per capita in funding). This is a problem which can be solved to an extent with treaties, and which doesn't need to be solved perfectly to do a lot of good.
That's why I pay Apple extra money to develop the next big thing. If I only pay the sticker price of the iPhone, there won't be any more innovative products. But if we all get together and pay double the sticker price, we'll get some true innovation!
That would require those same companies from not abusing our political process to obtain illegal political outcomes - outcomes that are unconstitutional - like Citizens United, which led to PHrMA dumping unimaginable money into bad faith political advertising/lobbying.
Until or unless they stop being bad actors, everyone should pirate their stuff. Free Luigi.
What percentage of global rich, obese people live in the US? This is the main market and the product would not exist if it could not command a high profit here. Besides that, I think the US prices are so high due to the insane medical insurance structure, not because the drug companies really make much more than in other countries.
As always, depends on the law. This is a bright line example of companies breaking the law to the direct tangible benefit of not only their customers but the population at large. Letting Novo Nordisk jack the price back up and deprive the vast majority of Americans access to the greatest good to public health in a century meanwhile is… maybe not the example you should be holding as the law working.
...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.
Or you pay them directly. Most countries have research funding. Since there's no way to know what you'll find or how long it will take, research doesn't fit well in the capitalist model. Makes much more sense to apply a fixed effort and accept whatever results come out, but only the government can do that — or a rich monopoly like Bell.
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.
Right I used CPAP as an example because it bypasses all arguments about "novel technology", "drug development" cost, or "need for safety". Even an ASV algorithm could probably be implemented as a ~graduate project since it seems to be a rather basic control algorithm (today with ML you could probably do even fancier things). It's basically a piece of pure technology that could be commoditized, manufactured and sold to people for < $300 in the way smartphones are. If something as "basic" as this can't be accomplished due to the regulatory environment then it's sort of pointless talking about anything more complex like pharma drugs.
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.
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?
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.
Lol, a military showdown where a few hundred people are killed might be horrible.
Leave the US with an island it doesn't recognize as its own (because Congress wouldn't) and that isn't recognized as US by most of the rest of the world.
Would economic ties between the US and Europe be broken as a result? Probably, but maybe everybody else decides that this will be resolved peacefully in the UN. And the can is kicked down the road, until Trump kicks the can.
Because ending economic ties between Europe and the US would mean a massive depression on both sides. Massive assets lost and written off. Goodbye pension.
Economic meltdown might be worse than a military showdown in the Arctic. Casualties from an economic conflict would be worse.
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?
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.
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.
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.
Hard to regulate. A lot of the retatrutide sold today is marketed on Discord & Telegram groups and paid for with crypto. It is infeasible for customs to open every last package entering the US, so this avenue will continue to work. The only gov't that could realistically stop it (for a while at least) is the Chinese. And they do, occasionally, shut down a manufacturer for a while. Though not because they are shipping GLP1s to the states.
The regulation is pretty clear? We just don't choose to blackhole shady foreign (in this case, Chinese) companies from the American internet as a matter of policy. And cannot effectively screen all imports.
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.
> 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.
But they still market regardless. They probably constitute 50% of the medical ads I see now
Make sure to tune into the superbowl tomorrow.
> a Hims & Hers Health (HIMS.N) (Super Bowl) commercial features a voiceover by rapper Common with the tag line "Rich People Live Longer"
At least I know kid rock won’t be there
Thankfully we have options - Kid Rock will be performing an alternative half-time show and it's available on X and Youtube @ 8PM.
Is there a Kalshi bet going about whether he'll perform his song about preferring underage girls?
Isn’t this a common rock star trope? Anthony Kiedis talks about a 14 yo who he slept with on tour.
Doesn’t really narrow it down
Yes. That is why I know he won’t be on for the Super Bowl. It’s also why I find the Super Bowl so appealing tomorrow night.
>> 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.
I like it.
I'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.
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 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.
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...
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?
Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.
If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.
Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
> 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.
> 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.
> This is about as Wild West as most of us have lived through for the U.S. drug market.
I don't know about that. I'm old enough to remember The Vaping Panic of 2019, where (medical and/or recreational) cannabis vape liquid was adulterated with Vitamin E acetate in industrial quantities, which caused widespread injury and death. The real cause was called out very quickly (thanks in part to investigative reporting by...WeedMaps[1]), but health departments flailed and spent months blaming it on Juul and teen e-cigarettes. The panic evaporated because right as the public health community realized what was happening, Covid broke out.
To this day, afaik no testing of vapes is required to ensure they don't contain this toxic ingredient.
[1] https://weedmaps.com/news/2019/10/why-vitamin-e-acetate-and-...
I don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.
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.
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.
> 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.
> 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...
> 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...
> 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).
Well that's the choice. Allow drug companies to price discriminate so that poorer people can also buy the drugs or don't allow it and get more new drugs. It's not clear that drug companies are even going to retain low prices in other countries if it means that the US consumers will pay less.
Which drugs that haven't been invented yet do you think we should forego?
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.
Anyone who's buying GLP-1 drugs can choose to give that money to the poor instead. What particular drug do you think shouldn't have been invented?
> 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.
Novo will also sell you the auto-injector Wegovy directly starting at $199/month. And the pill starting at $149/month.
>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.
Ozempic lost its patent in Canada and a generic might be approved there soon.
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...
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.
> lung cancer treatments
A fairly large portion of lung cancer patients didn't "do it to themselves" (about 20% and rising).
It remains to be seen how vaping impacts lung cancer,
I don't like the idea of finding reasons to penalize people for predicable life decisions that lead to treatment needs. Insurance companies have a lot of resources to make those predictions and if unshackled they aren't afraid of using them. Making construction workers, miners, or truck drivers pay more (or be denied outright) for insurance because their job has negative health effects would be bad for society.
They need to be in a separate risk pool. It isn’t a penalty.
People with high blood pressure could just try harder to relax, too.
> 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.
Our Obsession With Personal Responsibility Is Making Us Sick - https://jacobin.com/2026/02/health-inequality-individual-res... - February 6th, 2026
> 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.
The usual note for this is your insurance premiums were already going towards that, just indirectly by way of paying for heart disease treatments, diabetes management and other secondary effect of obesity.
But I'd also like to propose that "could just do themselves" is carrying a lot of assumptions that may not hold for any individual. A few years back now I started a medication with the side effect of appetite suppression, and I learned something about myself. To the best of my ability to recall, I had never before starting that medication not been hungry. "Full" to me was a physical sensation of being unable to fit more food physically in my stomach, but even when I was "full" I was hungry. Luckily for myself as a teen and young adult I had an incredibly high metabolism. I could eat 3 meals a day, 3-4 bowls of cereal and milk as an "afternoon snack" after school and some late evening snacks while watching TV and I still was in the "almost underweight" category. It was in this context, a time when I could go to a fast food restaurant and order two meals just for myself and stay well inside a healthy weight range that I learned to eat as an adult. Eventually though, the metabolism slowed down, and I started packing on weight but the hunger never subsided. Oh sure, as I got older the idea of and ability to eat an entire pizza by myself slowly went away, but hungry was always there, so I was still always eating and always eating more than I should have.
And I did manage to lose weight on my own many times. Through extremely strict self control and portion control, multiple times I managed to lose 25, 30 even 50lbs, one painstaking week at a time. Every day was strict tracking and weighing of everything I ate, and many days were hard battles of "I know I'm hungry, but I've already hit my limit for the day, so I can't eat more", and going to bed extremely hungry with the hope that when I woke the next morning that feeling would have subsided a little. And it worked each time, until inevitably something happened to disrupt the routines and habits built over the months. Maybe it was a set of family emergencies that had me eating on the run, unable to properly monitor everything and adding some "stress eating" on top of it. Maybe it was running into "the holidays" where calories are cheap and abundant even if you are still keeping track. And sometimes it was just being unable to sustain the high degree of willpower it required to keep myself on the schedule. And what takes month of carefully losing 1lb a week to do only takes a month or two to almost completely undo.
Hunger is probably the closest thing I've ever experienced to an addiction. I've thankfully never had to battle an addiction for anything else, but when it comes to hunger that eternal gnawing was ever present and the more weight I lost by sheer force of will, ever distracting. If the idea popped into my head after lunch that "I'd like a snack", it was an idea that would not leave my head until either I'd given in and gotten a snack or forced myself to not give in and waited until dinner. But that forcing meant dedicating ever larger parts of my mental energy away from my work and tasks at hand to just convincing myself to not go get the snack. And worse, when the time for dinner finally came, I was already feeling "hungry" on top of my normal hunger state, so often not eating the snack just meant delaying the excess consumption to dinner or having to continue that fight at dinner. If it sounds exhausting, in a lot of ways it was. But of course, like you said I can "just do" this. It's simple CI < CO math. And yet it never stuck, in part because unlike a lot of other unhealthy habits you can pick up in your life, you cant just not eat. Yes you can eat different things, or eat healthier, both of which can help with weight problems, but you can't stop eating. You have to eat, the hunger is always there and the same thing the hunger wants is the same thing you NEED to literally survive.
But that medication with its appetite suppressant effect was a game changer for me. For the first time in over 30 years, I actually felt full. Not physically stuffed, but "done eating". I could eat a small lunch and think to myself "that was good, and I feel satisfied". For the first time, when the idea of an afternoon snack popped into my head, I could remind myself that dinner was in 2 hours and I needed to make sure I had room to eat that so the snack could wait, and that would be the end of it, no fight necessary because the hunger wasn't gnawing at me the whole time. When I first started, I was concerned that the medication was giving me anxiety attacks because about 6PM every day, I'd start getting this feeling of my stomach tying itself in knots, and this sensation of "needing something". And after a week or so it occurred to me that what I was feeling for the first time in my life was the feeling of transitioning from having been full and satiated to being hungry again. I'd never not been hungry before. And I know that sounds insane, because it sounded insane to me then. Before taking the medication if you'd asked me if I know what it felt like to be full or to not be hungry I would tell you that I did. But apparently I didn't, and I didn't know that until I started that medication. And for the first time since the weight started coming on, the weight I've lost is staying lost.
So yes, you can "just" eat better and less and control your portions and not eat so much. But from personal experience, it's a hell of a lot easier to have that will power when your body is giving you the right signals and isn't constantly pushing you over the limits.
Do you have diabetes, heart disease, or another condition necessitating a GLP-1?
Why is obesity not considered a necessitating condition? It often carries the comorbidities you just mentioned. Should not exclude people just because they haven’t had these specific health problems (yet) but will eventually have them.
While I tend to agree, insurance companies don't see it that way. They need a doctor to indicate a necessity to treat a condition, as opposed to it being the easiest way to treat it.
For example, I have to take digestive enzymes to digest my food (pancreatic insufficiency). For someone with an unusually high metabolism, they would also give them a leg up on gaining weight, even though there are other approaches to gaining that weight. However in many cases, the insurance company wouldn't cover their prescription when they will mine.
As always it’s insurance nonsense. If incentives were aligned insurance companies would be lining up out the door to give this to obese people because they (the insurance companies) would eventually be on the hook for paying for the care of the conditions you just mentioned. It is very well demonstrated in literature that obese people have a much higher occurrence of these conditions than non obese people.
But the system is not set up with aligned incentives
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.
Going to Japan felt like living in the future. I could walk into any glasses store, and for $50 or less buy a pair of frames and lenses. If I didn't know my prescription, included in the price was an automated eye exam machine which'd figure it out in 2 or 3 minutes.
In the US I'm paying $200 just for the exam.
You can do the same in the US, zennioptical.com. You need to measure your PD which is very easy (Most optometry shops are hesitant to tell you your PD. And it's normally measured when you go to order the glasses, not as part of the initial eye exam.)
As for needing a prescription <1 year old, if your vision hasn't changed, just edit the date in the PDF. Same for contact lens prescriptions.
As part of the regular eye exam, they generally use an autorefractor machine on your current glasses and/or eyes to get a baseline before they manually fine tune with the 1/2 on the eye chart test. But yeah, you can't just get the quick prescription from the autorefractor like you talked about in Japan.
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.
That's nice. The rest of the world has price caps on what these companies can charge for drugs.
It's one or the other. You can have your ''patents'' and ''intellectual property'' respected...but that requires you not charge an outrageously higher price in certain markets, like the US.
The rest of the world is free riding.
The solution is a law preventing drug firms from pricing in the US higher than (some small multiple of) what it charges anyone else in the world.
> The rest of the world is free riding.
The rest of the world isn't free riding - the USA has just setup a market where there is very little bargaining power for consumers because of how the US medical market and insurance works.
Novo and Eli are still making plenty of money in Europe where these drugs cost a fraction of the price, and where there aren't other significant suppliers for GLP-1's like is being implied.
No, they're free-riding. If drug companies can't charge higher prices in the US, they will do less drug development. Everyone involved in the business/investing side of pharma knows this; it's not even an argument.
Somebody has to pay for the drugs development, the poor can't pay, if the rich (US) won't pay, there simply won't be any drug.
In a free-market approach to drug development, if the expected loss of attempting to develop as drug is negative, and the cost isn't too high, then there is an incentive to develop that.
The best public policy outcome in such an approach would be for losses to be only slightly negative. Positive or zero expected losses mean no drug development, and highly negative expected losses mean the drug is more expensive than necessary and reduces the accessibility of the drug.
However, current patent law allows companies to minimise their expected loss, with no controls to prevent highly negative expected losses.
There are alternative models - such as state funding of drug development. This model has benefit that it is possible to optimise more directly for measures like QALY Saved (Quality Adjusted Life Years Saved) - which drug sale revenue is an imperfect proxy for due to some diseases being more prevalent amongst affluent people, and because one-time cures can be high QALY Saved but lower revenue.
The complexity of state funding is it still has the free-rider problem at a international level (some states invest less per capita in funding). This is a problem which can be solved to an extent with treaties, and which doesn't need to be solved perfectly to do a lot of good.
That's why I pay Apple extra money to develop the next big thing. If I only pay the sticker price of the iPhone, there won't be any more innovative products. But if we all get together and pay double the sticker price, we'll get some true innovation!
The poor can pay for the drug development quite well. It takes a rich country to pay for all the regulatory capture.
Remind me from whenceforth come Bayer, Novo Nordisk, Moderna?
Remind me from whenceforth comes the money that they depend on to make a profit?
Nope.
That would require those same companies from not abusing our political process to obtain illegal political outcomes - outcomes that are unconstitutional - like Citizens United, which led to PHrMA dumping unimaginable money into bad faith political advertising/lobbying.
Until or unless they stop being bad actors, everyone should pirate their stuff. Free Luigi.
Holy non sequitur, batman.
Whenever someone cites Citizens United, I'm 99.9% sure they have no idea what that ruling was about.
In other words: you are a reactionary who thinks little of others. Noted.
What percentage of global rich, obese people live in the US? This is the main market and the product would not exist if it could not command a high profit here. Besides that, I think the US prices are so high due to the insane medical insurance structure, not because the drug companies really make much more than in other countries.
As always, depends on the law. This is a bright line example of companies breaking the law to the direct tangible benefit of not only their customers but the population at large. Letting Novo Nordisk jack the price back up and deprive the vast majority of Americans access to the greatest good to public health in a century meanwhile is… maybe not the example you should be holding as the law working.
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.
Or you pay them directly. Most countries have research funding. Since there's no way to know what you'll find or how long it will take, research doesn't fit well in the capitalist model. Makes much more sense to apply a fixed effort and accept whatever results come out, but only the government can do that — or a rich monopoly like Bell.
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.
Right I used CPAP as an example because it bypasses all arguments about "novel technology", "drug development" cost, or "need for safety". Even an ASV algorithm could probably be implemented as a ~graduate project since it seems to be a rather basic control algorithm (today with ML you could probably do even fancier things). It's basically a piece of pure technology that could be commoditized, manufactured and sold to people for < $300 in the way smartphones are. If something as "basic" as this can't be accomplished due to the regulatory environment then it's sort of pointless talking about anything more complex like pharma drugs.
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.
> 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.
Mochi health too
I’m generally happy to see IP disrespected.
Then you’ll eventually be generally unhappy to see no new medications come out.
China disrespects IP and has the fastest growth of anywhere, and has medications
There seems to be an explosion of drugs for fat loss. No signs of slowing down.
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?
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.
Lol, a military showdown where a few hundred people are killed might be horrible.
Leave the US with an island it doesn't recognize as its own (because Congress wouldn't) and that isn't recognized as US by most of the rest of the world.
Would economic ties between the US and Europe be broken as a result? Probably, but maybe everybody else decides that this will be resolved peacefully in the UN. And the can is kicked down the road, until Trump kicks the can.
Because ending economic ties between Europe and the US would mean a massive depression on both sides. Massive assets lost and written off. Goodbye pension.
Economic meltdown might be worse than a military showdown in the Arctic. Casualties from an economic conflict would be worse.
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?
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.
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.
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.
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.
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.
Hard to regulate. A lot of the retatrutide sold today is marketed on Discord & Telegram groups and paid for with crypto. It is infeasible for customs to open every last package entering the US, so this avenue will continue to work. The only gov't that could realistically stop it (for a while at least) is the Chinese. And they do, occasionally, shut down a manufacturer for a while. Though not because they are shipping GLP1s to the states.
The regulation is pretty clear? We just don't choose to blackhole shady foreign (in this case, Chinese) companies from the American internet as a matter of policy. And cannot effectively screen all imports.