Posted by randycupertino 3 hours ago
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.
The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
And canada. I have seen many commercials on hotel televisions for prescription drugs there.
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'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.
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...
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.
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?
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.
Are we cutting off people's access to meds or do they just not want to pay what they cost?
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.
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.
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.
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 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 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.
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...
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...
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.
Which drugs that haven't been invented yet do you think we should forego?
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.
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?
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
Governments require consensus, which makes them slow. It took decades to phase out leaded gasoline.
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.
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.
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!
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 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.
Our Obsession With Personal Responsibility Is Making Us Sick - https://jacobin.com/2026/02/health-inequality-individual-res... - February 6th, 2026
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.
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.
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.
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.
In the US I'm paying $200 just for the 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.
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.
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 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 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.
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 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.
...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.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.
Implied but not explicitly stated in the FDA announcement: the compounders’ real crime is not paying their protection money.
https://en.wikipedia.org/wiki/Government_patent_use_(United_...
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.
I hope they abolish DMCA anticircumvention law.
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.
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?
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.