This is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.
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>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.
While we are in the minority, Zenni and many online optical shops recently decided they will not make you glasses if your prescription is over a certain power. In 2025 I broke $800 on frames+lenses and contacts.
You can't do the same in the US. They won't do an eye exam for you. That's the whole problem - glasses in the US are a medical device gated by a doctor, which is absurd.
...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...
European Respiratory society disagrees on the cancer risk fwiw https://www.ersnet.org/wp-content/uploads/2022/02/Update-on-... but yeah obviously degraded foam isn't good. The foam isn't actually a required part, it's just for sound reduction.
But I think that proves my point, the supposedly "rigorous" FDA review didn't flag concerns about foam in the airpath of something you breathe through, so what exactly is the approval process buying you? Philips issued a voluntary recall but resmed uses foam in their units too, and while they claim it's a different type of foam it seems there are better ways to engineer sound reduction than putting foam in the air channel and potentially breathing in microplastics.
Never heard the follow-up, so good to hear that it was potentially less hazardous than the initial reporting.
However, I am still mixed on the interpretation. I do not think the FDA is as good as say the NTSB, but I do think they will take lessons learned from a bad outcome. New medical products are likely to undergo additional scrutiny on any kinds of foams/solvents/whatever that are directly in the airway path. It is only because it is such a heavily regulated product that the entire product chain had to be stamped, certified, and traced so that such an investigation was possible. In a theoretical fly-by-night product offering, SKUs might be changing daily as the vendor can shave pennies off of the development price.
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.
Not to sound like a broken record, but they're also prescription-required in Germany, as are the accessories. My otherwise very by-the-books husband ended up buying grey-market masks in order to be able to try several styles before finding one that worked well for him.
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.
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.
> Patent laws exist for a reason
And maybe in this case they are functioning as intended.
Unfortunately, they are also leveraged to provide a moat and profits in situations where no innovation has occurred. (Eg, patents on one click shopping.)
My grandfather was one of the originators of the technology that became CPAP. He did not get rich from it.
The company he worked for probably did.
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.
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!
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.
The poor can pay for the drug development quite well. It takes a rich country to pay for all the regulatory capture.
Nah modern mega corps are free riding on all our backs. They use the power of the state and frivolous mechanisms like the broken patent system to create monopolistic situations for themselves.
Remind me from whenceforth come Bayer, Novo Nordisk, Moderna?
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.
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.
The main reason drug development is so enormously expensive because the FDA makes it that way with their paranoid risk averse regulatory process and insanely restrictive requirements on what requires a doctor prescription.
> because the FDA makes it that way with their paranoid risk averse regulatory process
FDA is constrained by Congress here. Its function (safety and efficacy in advance of marketing) is required by legislation dating to the 60s. Feel free to advocate for Congress to change the law, but it isn't obvious it would be popular with Americans.
> insanely restrictive requirements on what requires a doctor prescription.
I don't think OTC vs Rx rules have much if any impact on drug development expenses.
OTC vs Rx has massive impact on sales volume which has a massive effect on pricing.
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.
Yes, bootleggers can undercut legit competitors, providing a boon for consumers.
In this case, Novo developed the drug. In your view, why does Hims get credit for "the greatest good to public health in a century" and not the company that sank over $10B into developing Ozempic?
Of course, Novo faces competition from Lilly and every other pharma company in the world and continues to lower prices in the face of this competition.
And they provide a valuable service to their customers, I have a very positive association with various drug dealers I've had over the years. Say what you want but they're literally out on the streets serving their local community. For a more HN example, people in the real world are extremely pro piracy and view the people cracking DRM as doing a public good.
I fully expect the state to take action against the, to me, very obvious will of the people who are actively seeking out and purchasing these products. Clearly folks don't respect the legitimacy of IP rights in the same way they respect property rights since nobody blinks when buying compounded GLP but at the same time wouldn't shoplift at their local BestBuy.
So yeah the government's response isn't surprising but you won't see me cheering them on, and I don't think you should either. You literally stand to lose from it.
> 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.
I’m generally happy to see IP disrespected.
Then you’ll eventually be generally unhappy to see no new medications come out.
A significant change to IP doesn't necessarily mean the world stops working on things. It just pivots us to a new set of problems.
China disrespects IP and has the fastest growth of anywhere, and has medications
China tries to steal IP, but otherwise has a functioning IP system including for drugs Chinese companies make.
And China’s growth is about 5% in 2025, which isn’t close in the least to the fastest (Vietnam at 17%).
And China has medications because of other countries with IP (mostly Europe and US). So if the US gets rid of IP, the. A very large part of new drugs won’t happen.
I don't care about the numbers, I care about the growth. They went from zero to high speed trains linking all major cities in a decade. They went from manufacturing cheap slop knockoffs of American products to top–of–the–line locally–designed products in about the same time. They make their own semiconductors now.
There seems to be an explosion of drugs for fat loss. No signs of slowing down.
> 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