Traditional pharma economics assumes the patent holder can supply the market. GLP-1s broke that assumption — Novo Nordisk and Lilly literally could not manufacture enough to meet demand, which created the shortage that let compounders in legally.
Now the shortage is declared over, so compounders lose their legal basis. But "shortage over" is doing a lot of work in that sentence. It means the brand manufacturers say they can supply, not that the drug is accessible to most people who would benefit from it at a price they can afford.
The deeper tension: FDA's framework is binary (approved or not) but the actual risk landscape is continuous. A compounded semaglutide from an inspected 503A pharmacy with proper testing is a very different risk profile than something mixed in someone's garage. Treating them identically under enforcement seems like it optimizes for regulatory clarity over public health outcomes.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
Insurance companies have to pay $100k+ per month for medicine for anemic people, and many other much higher cost medicines. Why is a couple hundred dollars to fix THE single biggest cause of future healthcare expenses (diabetes, high blood pressure, and cholesterol) not covered?
https://www.desmoinesregister.com/story/news/health/2017/05/...
Insurers routinely pay for $1M+ NICU babies, $100k+ heart surgeries, yada yada, but the US government draws the line at medicine that costs $200 per month that prevents hundreds of thousands of dollars in future spend?
I can’t make it make sense, unless the junk food/alcohol/restaurant/sugar caffeine drink lobby has their tentacles deep in the government.
I think the easiest answer is found by looking towards religion. Gluttony being one of the seven deadly sins. Obesity is seen as a moral problem by a lot of people, so paying for its treatment would be broadly unpopular. People who cannot control their appetite need to suffer.
PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
For people making how much? Low income people are jumping through the hoops to get SNAP. $100 for them is a lot, and which they might just not have. And for insurance it would be cheaper long-run than dealing with diabetes, etc.
Anyway, why a such "submarine" attack on the $100 GLP-1 sources and why now? Well, one way of thinking would be that Trump RX just went online and there, thanks to the well known Trump's care about people's needs, the GLP-1 is $350, so one has to remove the $100 competitors.
It’s a case of trying to get so many consumers buying that regulators are scared to touch you due to blowback. Much like Uber did.
If I were Trump for a day I'd force Lilly to sell the tirzepatide patent to the federal government (I'd even pay them a fair amount) and then make it a generic. Maybe a subsidized generic, even. Then in a decade or so the citizenry might actually be okay naming things after me. Though it might require dialing back some other activities, but whatever.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
For decades now, every single healthcare study seems to say overconsumption is the root cause, and now that there is a way to combat it, the government is saying the fix to overconsumption at a few hundred dollars per month is not worth it?
Insurance companies are allowed to limit access to more expensive therapies unless cheaper therapies have been tried and have failed.
Medicare Part D (outpatient drugs) has wide latitude on what medicines they cover - it's actually smart for patients to shop their Part D plans if they are taking an expensive, chronic medication.
The only classes of drugs that Part D plans must included are:
Part D sponsor formularies must include all or substantially all drugs in the immunosuppressant (for prophylaxis of organ transplant rejection), antidepressant, antipsychotic, anticonvulsant, antiretroviral, and antineoplastic classes. (Page 28)
https://www.cms.gov/medicare/prescription-drug-coverage/pres...
It's always the intellectual bankrupt response to blame individuals for a systemic problem
Quite the contrary with segments of modern society trying to normalize obesity.
> It’s a personal choice to have that extra donut or cola.
It's food designed to be addictive and making you eat more than you need. It's a problem that needs to be solved with regulation.
But yes, blaming it on a character fault is as I said the intellectual bankrupt take, and also the take by the lobbyist of those companies
I also believe that we don't live in a vacuum and context matters. The fact that we consistently see people who have a lifetime of being a healthy weight gain significant weight when they move to countries with high obesity rates means that there obviously is something more to this than just "have more willpower bro"
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
I've had great success with BPC-157 and tendon issues, but I try to use it sparingly - no history of cancer, but everyone has no history of cancer until they do - and try to rehab any injuries with slow heavy eccentrics, etc., and only go for the BPC when that isn't making any improvement.
In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results.
I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
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...
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...
Are you claiming that the new website is offering lower prices than patients are paying after their co-pay? That is not the case outside the example I presented; moreover, the way the website is organized, there will be no pressure for prices to remain competitive after the initial media attention dies away.
I agree that a hypothetical case where we were paying lower prices would be better for us—but this remains an unrealized hypothetical. One way for us to pay lower prices would be to allow our government to negotiate prices for Medicare/Medicaid recipients, and that is exactly the thing that has been hampered.
It’s about external, global pricing dynamics. The site clearly isn’t going to be able to give clean payor/pbm/gov subsidized pricing tables - that is almost an impossible exercise in our system.
What the agreement does accomplish is saying Americans will not pay $1150/mo while EU pays $400/mo while Argentina pays $120/mo.
It guarantees drugs will be greater than or equal to US pricing abroad which effectively forces pharma to find deeper profits outside of the US, or lower prices for all countries to acquire demand.
That is extremely effective. Now it’s up to a really complex group of people to figure out what that means inside our weird system of pharma/pbm/rebates/insurance/medicare.
But that’s not what trumprx is aiming to solve for right?
Correct
> What the agreement does [...]
This is hypothetical and does not exist. It also is not going to happen, politically, because drug companies are currently expecting to charge US prices in the US, while charging lower, non-US prices outside the US.
> That is extremely effective
This is hypothetical—and, as I've said, the attempt that the Inflation Reduction Act made toward this was watered down by an executive order. To be fair, the negotiation mechanism is still in place, and its existence must be influencing drug pricing already.
More generally, price controls lead to less supply. Drug price controls will result in fewer new drugs. Minimum wage laws result in no workers doing work that is worth less than minimum wage. Anti- price gouging laws result in less bottled water and fewer generators after a hurricane. The principle is universal despite promises of delightful state run grocery stores.
Praise for price-gouging: https://www.grumpy-economist.com/p/praise-for-price-gouging
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.
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.
Cigna is terrible, even worse than UHC, I'm not happy that we have them but that's a whole separate rant I don't care to get into right now, but one thing I was really annoyed by was that UHC covered Zepbound, but then Cigna didn't. They actually wouldn't cover any GLP-1s unless you are already diabetic, so my wife had to stop.
I initially blamed Cigna for this, but eventually I found out that my employer deliberately opted out of it, so now I'm mad at my employer and Cigna.
We've had to use a compounding pharmacy for my wife to continue her terzepazide, which has worked fine and at least thus far hasn't been an issue, but I knew that these things were on borrowed time due to their kind of gray legality.
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
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 think it's more my employer's fault than anything else; fortunately metformin actually seems to be doing the job. They won't cover that either but even without insurance it's so cheap that it's not worth complaining about.
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.
I don't do this as much as others, but as someone who has suffered from Major Depressive Disorder [1], it can be really easy to eat your feelings away. When I've had really bad depressive episodes, I don't want to cook, I don't want a fucking salad, I mostly just want to feel bad about myself and I end up getting a huge meal at Taco Bell and sadly eating that. Doing that one day isn't that bad. Even doing that two days isn't that bad, but when you have a long extended depressive episode, it can easily become a pattern of weeks where you're getting unhealthy fast food every day.
I know a lot of people act like depression is a moral failing as well [2], but I personally don't think that, and it feels like obesity can be a symptom of major depression. If you ever watch "My 600lb Life", you'll see that a lot of the people on there are really going through serious mental disorders and/or dealing from PTSD from sexual abuse, and the overeating can come as a result from that.
I guess I just feel like it's reductive to say "they did this to themselves". The human brain and human psychology are complicated and irritating.
[1] Fortunately my current set of meds has really helped...medical science is pretty cool sometimes!
[2] Not saying that you said that, to be clear.
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.
At the end of 2023 and the beginning of 2024, I lost about 60lbs, and it was a basic calorie counting thing. For me, it wasn't too hard; I was able to get used to the hunger and after about a month the feeling of wanting to eat all the time was somewhat tolerable.
In May of 2024, I started taking Pristiq, and one of the side effects is a huge increase in appetite. Like you said, I would feel "full" in the sense that my stomach wouldn't fit anymore matter, but I was always hungry and pretty much perpetually craving sweets. I would get a whole large pizza for lunch, a large meal at Popeyes for dinner, and chase it down with snack cakes, and I would still be "hungry" the entire time.
I managed to undo all the progress I had made with my dieting and a bit extra, and it was kind of weird. It's not really "hard" to know what to do. Obviously everyone knows to eat less processed food, focus more on protein and fiber, etc, but despite me "knowing" this, it was strangely hard to actually do it.
I'm very thankful that I found out about Metformin. I'm not diabetic and never have been, but it's prescribed off-label for weight loss, and according to my doctor it can be useful in the particular case of "canceling out the appetite-increase from medication", and to my surprise it worked shockingly well. I'm still not quite down to my diet weight yet, but I'm down about 30lbs in the four months I've been taking it, and I don't really feel hungry all the time. I still enjoy eating unhealthy food, but food is considerably more transactional now: I eat food because I need energy to survive. I budget about 200 calories lower than what my smartwatch says I burn during the day. It's much easier to treat food as a more utilitarian necessity.
If anyone here is in the unfortunately situation of not having their insurance covering GLP-1 medication, I highly recommend seeing if you can get your doctor to prescribe metformin. It's been out of patent for decades and cost on the order of ~$5 a month [2] and there are very few side effects [2], so it's a relatively low-risk experiment.
[1] Not a referral link https://pharmacy.amazon.com/Metformin-Generic-Glucophage-Ext...
[2] And potential benefits apparently! https://www.health.harvard.edu/blog/is-metformin-a-wonder-dr...
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
Are GLP-1s so much more effective that we should make an exception to the general principle, maximizing healthcare resources by providing the cheapest effective treatment? I kinda think so, but I have a conflict of interest, and I can understand why others might think that money is better spent elsewhere.
Hypertension, sleep apnea, high cholesterol, etc are all common in the general population and exacerbated or even caused by the physical and lifestyle conditions that beget obesity.
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?
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.
...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...
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.
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.
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.
If you and me both buy the same car, but i'm better at negotiating than you and get a lower price, I'm not free riding because you 'funded the design of the car with the extra money you paid', you are just bad at negotiation.
When we all negotiate lower prices, we get fewer new drugs. Maybe that's better than the status quo (for Americans). Maybe it isn't.
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.
If you actually know what it was then answer how does limiting non-electioneering advertisements from PACs for 30 days out of the year changes anything?
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.
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.
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.
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.
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.
In anycase, India generally doesnt honor product patents for pharma. Right now, Indian pharma cos are court empowered to churn out GLP-1.
Everyone knows that we are gonna have 10$ GLP-1 before 2027 coming out of India.
https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity
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.
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...
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.
Can you elaborate more on this? I hadn't heard about it.
https://www.fda.gov/inspections-compliance-enforcement-and-c...
https://www.fda.gov/inspections-compliance-enforcement-and-c...
(German biz): https://www.fda.gov/inspections-compliance-enforcement-and-c...
Every other source is acquiring the APIs from China and effectively buying from the same sources that the random sites selling a vial of lypholized “research chemical” powder are getting it from.
The huge compounding companies might skip the lypholization step and mix it directly due to cost savings at scale, but it’s effectively the same sources you could buy direct from China from if you spent a bit of time researching.
I think what’s happening now is about right. FDA approval process for the vast majority of people, and make those who want to play drug astronaut biohacker find it via underground methods. No reason to crack down super hard on such folks since the societal impact is likely net positive - unlike fentanyl or what have you.
Perhaps there could be better enforcement for the folks being totally blatant about it as it risks going “mainstream” and hitting people who don’t have informed consent, but I imagine that’s coming as law enforcement catches up.
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.
If you want to know who else to avoid, join the Discord the vendor links to from their web page and ask around in the general discussion topics, people will share.
Nexaph does not lyophilize in the US despite Cain's claims - if you're buying from Nexaph, do so because they're popular and well tested by 3rd parties, but not off of anything they're saying about themselves. Hell, just go to the About page and you can find an artifact from back when Cain was lying about Nexaph being a chinese pharma company that had mRNA vaccine production experience.
That's also why the "presale" periods are cheaper - just letting them know how many vials to put in an order for.
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...
“This is not the flex you think it is.”
But thanks for keeping us informed.
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.
What culminated these past 2 weeks will be a great FT Big Read to participate in later. Years of work.
There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.
In my opinion there two things going on here that I strongly feel are true.
1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.
I'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...
A long time ago I had a Lexapro prescription. This is a very, very common drug and is on the list of the WHO's essentials for bootstrapping a healthcare system.
Then I quit my job and spent a few months unemployed. I was no longer seeing the psych who prescribed them and I was not covered by health insurance.
The last few refills my prescription had? Walgreens bumped the price to $200 a bottle, and unless I paid another doctor there was no way to keep taking the medication I'd been on for two years.
Mind you, this drug is old and generics are CHEAP. I've also got all the knowledge I need to take it safely because I have been.
Instead of doing that, I made the decision to quit rather than deal with the doctor mafia. We let people buy industrial chemicals on the Internet and trust they're not gonna kill themselves with it, but somehow my situation was an unacceptable risk?
It’s a separate dysfunction than their obsession with making things Rx-only, such as for example, an albuterol inhaler. In Mexico you can just grab one at a drugstore.
This topic came up in another online community (which I'm intentionally not mentioning) a lot a few years ago. I left a comment about why giving experimental drugs to terminally ill patients is not a simple or obvious idea like many would assume. I got some very long, very intense replies from someone who was dying of a type of cancer who believed he had a good shot at recovery if he could get his hands on an experimental drug. He had all of the links and papers to prove it.
I remember trying to take it all in and reconsider my position.
A few years later, there was a post from his wife that he had died. It was a very sad situation. I clicked some of her links and found that he had a blog where he had written a lot. He actually did go through with the process of requesting the experimental drug and his request was granted. However, the drug not only didn't work, it had caused some irreversible damage to his body that made his final months a lot more painful and difficult than they had to be.
Apparently the "compassionate use" exemptions are not as hard to get as the anti-FDA writers have led us to believe. The harder part is often getting the companies to provide the drugs, because they know the risk profiles and uncertainties better than anyone and aren't always interested in letting terminally ill patients experiment on themselves outside of the process.
Jake's blog where he posted throughout his entire illness: https://jakeseliger.com/
Bess' blog: https://bessstillman.substack.com/
It was a heartbreaking story to follow, and one that hit me a lot harder than I thought it would when Jake died.
IMO this all seems very reasonable.
What specifically do you think is problematic about this, and how do you propose that we mitigate companies from preying on desperate patients while making it easier for patients in need?
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?
There have been several examples in the past 5-6 years of the FDA loosening regulations to benefit patients and companies rushing in to abuse the opportunity at scale.
Another one that comes to mind is when the FDA loosened restrictions on telehealth prescribing of controlled substances during COVID. Several companies saw this as an opportunity to set up digital pill mills, advertising on TikTok and offering Adderall prescriptions as a service. Nurse practitioners were paid up to $60,000 per month to write prescriptions as fast as they could without interacting with patients.
The companies who bet several billions of dollars in literal decades of research on this stuff should absolutely be swimming in cash until the end of their days. Hims & Hers should be sued into oblivion for stealing the rewards of other companies' ingenuity, risk-taking, and dedication toward helping patients.
I am highly sympathetic to the argument that the government should just buy these patents and mass manufacture to increase availability, or just buy guarantee order vast amounts to scale up manufacturing and distribute cheaply, but the idea that a different private company ought to be able to profit in the way Hims & Hers has is absolutely flatly fucking insane.
Semaglutide molecule patent will expire in 2031 here (many caveats to this). For the most part, you can get any pill ~15+ years old for ~nothing without insurance, but associated devices like auto-injectors can extend this due to goofy rules; I expect execs thoughtfully considered medical patent law when deciding to initially trial and release GLP-1s as an injection.
HHS could do it tomorrow.
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.
They have a fairly cavalier attitude to medication administration at best - the goal is sell, sell, sell.
I filled out the questionnaire on symptoms prior to my virtual physician interview...
"Based on your answers to questions 3, 4 and 8, this would not meet the criteria for prescription. You would need to answer differently. Would you like a minute or two to review your answers for accuracy?"
These places are effectively online pill mills.
https://www.npr.org/2025/08/22/nx-s1-5511707/ozempic-zepboun...
Compounders are primarily regulated at the state level, and regulatory effectiveness varies. The more legit ones are mostly buying Rybelsus (the pill version of Ozempic for Type 2 diabetes) at wholesale and crushing it. The shadier ones are using precursors, sourcing from questionable & unregulated suppliers or watering down does and adding stuff like vitamin B-12.
The FDA has more limited jurisdiction, and they have been busy firing people.
The federal attention probably has more to do with whatever grift POTUS has going with Eli Lily and Novo Nordisk. Both companies are about to scale up their daily tablet versions of Wegovy and Zepbound at lower price points, and that availability will push the cost of compounded injectables way down.
I’ve used mainly compounded medicine over the last five years and find the fervent dislike that people have for compounders bizarre.
If you look into generic regulation in the US, the standards are already through the floor. I’d rather work with someone who has a more direct financial incentive to not fuck up.
Yes, adding B12 is a regulatory fig leaf. So is bribing public officials: https://www.cnbc.com/2025/01/07/hims-hers-donates-1-million-...
Sure, and Novo spent 2M last quarter on lobbying. Nobody in this industry comes out looking wonderful. But the compounders who are meeting demand are not Hims & Hers.
Australia was basically a carbon copy of the US in this regard until 2024, but they have specifically started targeting a lot of the "wellness" compounding that includes peptides, GLP-1s, etc. since then.
Germany has two classes of pharmacy that are nearly the exact same as 503A and 503B compounders in the US
Canada is similar but stricter about the big pharmacies turning into de facto manufacturers, pumping out huge quantities for downstream compounders and clinics, which is what happened in the US.
Lots of other countries that you might not consider "proper countries" (whatever that means) follow a very similar system to the US, and lots of countries that allow some form of compounding, like the UK through their "specials" program, but it's much more centralized - basically cutting out the 503A compounders in the US.
Fundamentally compounding pharmacies offer pretty important services - there are people out there that would literally not be able to take the most effective medication for their condition without the compounding pharmacies making formulation changes that the larger manufacturers might not have incentive to make. Their existence quite literally saves lives. So it becomes a matter of not making that so restrictive that you wind up killing people due to restricted access vs. letting it get abused in situations like we're seeing today with tirzepatide and semaglutide.
The US is the only country, aside from New Zealand, that allows direct-to-consumer marketing of prescription only medicines.
What interesting here is that Hims & Hers are able to skirt the pharmaceutical marketing regulations. They are able to blanket the world in their ads whereas pharma companies have to abide by strict safety information requirements in their commercials. Him/Hers give literally zero safety and side effect info.
The other weird thing is that the companies like Hims/Hers are basically dial a script. You call them and get whatever you want. They probably deny no one and don't turn anyone away. Unethical and lacks physician oversight.
They market the service that gives you the drugs with the smallest oversight possible. These services are becoming popular among people who shouldn't be taking GLP-1s (eating disorders, body dysmorphia, people who are too thin but want to lose more weight) because most of their providers are just trying to write prescriptions as fast as possible to collect their payments.
GLP-1 drugs range from $100-$200 a month from mail order compounding pharmacies, or $500 a month on "discount" plans from the drug makers.
This change to FDA enforcement is going to prevent a lot of people from getting help.
The positive impact of GLP-1 drugs is huge, but the price is out of reach for most people. The people who most benefit, elderly obese people at high risk of injury due to falls, who have a low quality of life from morbid obesity, are least able to afford access to the drugs.
These compounding pharmacies were improving a lot of lives.
Unfortunately he stays somewhat relevant because he drapes himself in an American flag.
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.
Much better than the one where everybody is like I asked my doctor about Flugeltrophen.
I'm on one medication I wouldn't have know could help me without seeing ads. It's improved my life.
Antibiotics are definitely prescription-only, as are birth control and morning after ("Plan B") pills. I was once able to talk an airport pharmacy into selling me an albuterol inhaler without a script in hand, but only when I promised that I'd had it before and explained how to use it, and that I was about to get on a flight.
People report this with HPLC tested stuff that is proven to be of the same purity/concentration too, "feels" reports are notoriously unreliable in medicine.
Yes, they can 'prove' what is in something to the limits of the physics.
However, the human in the loop is quite frail for most operators. In that, these very fancy and very expensive instruments are mostly run by high school grads and serviced by field engineers with a huge backlog.
For a first time one off test of something's composition, I'd go for at least 3 companies and preferably you have a history with them. This stuff is terribly complicated and misinterpretation is shockingly common. If the tech hasn't used the standards before then your at the mercy of fate.
Like, we have 5 (!) places on the home screen that do the exact same function of ending a run because when we try to consolidate it to just 1, our customers freak out and can't find where the button went to. Granted they pay $100k+ per instrument plus service plan, so we add it back in no question ( and this is life critical equipment in many cases), but I hope that shows how embedded to routine these operators get.
But they basically test the same 12ish compounds day in and day out, with another couple of dozen making up the remainder. They don't have most of the worries that you are referring to - first time for a tech running a specific set of standards, limited experience interpreting them, etc., and when people head to head their results against different labs, they are consistent.
I also think people should be able to source from the grey market if they can figure it out. This means they understand the risks and likely take measures like ensuring their compounds are properly tested before injecting them.
I’d feel differently if I didn’t understand how the average medspa gets their product and the corners they cut. I honestly trust some outright black market dealers better than most of those shops. They actually do testing on their product before shipping it. Likely sourced from exactly the same manufacturer as the guy in the locker room buys from.
So long as the choices are informed I agree. The issue is hims/hers puts a fancy veneer of “sanctioned medical system” on top of what amounts to a black market. They are laundering and obscuring the risk and many patients simply do not understand this fact.
It’s the difference between buying Xanax from a legit pharmacy vs a street dealer. The street dealer transaction you understand the risks involved and are making an informed decision. If you thought you were buying from a legit pharmaceutical company but they ended up just rebranding the same shit the street dealer is selling from his wholesaler - that is not informed consent even a little bit.
There is something in the middle here but some HLPC testing I’ve seen of supposed legit compounding pharmacies hasn’t been great for these drugs.
For a long time in this country, a flesh-eating bacteria infection required an amputation. In Russia and Eastern Europe, it was easily treatable with bacteriophages and people normally kept their limbs. There's still no process for approving a bacteriophage treatment in this country for general use.
Our system is ossified to protect big pharma and doctors. Liberalization is needed; hims and their like need to be regulated, but with a lighter touch than the current requirements.
They should be allowed to make bad choices like they are everywhere else.
Compounded drugs have higher rates of bacterial problems, doses being too high or low, and other issues.
Someone I know worked for a company that took over a poorly run compounding pharmacy and cleaned up their process. Some of the stories I've heard have made me want to avoid compounded medications wherever possible.
Are we cutting off people's access to meds or do they just not want to pay what they cost?
Pharma is ultra R&D heavy so yes, medications are deeply profitable on a per-pill cost to manufacture basis. However, drug companies by and large are not extremely profitable. This is because to produce a single drug (which is high-margin from point of production), they have to sink billions of dollars into literally thousands of other drug candidates to figure out which ones are viable.
This is all "real, legitimate cost," as is reflected in their rather abysmal overall profitability.
As for the disparity between US and foreign markets, it's a basic tenet of commercialization to sell to every buyer at the highest price they'll accept, so long as that price is above your price to produce. All sorts of companies engage in "price discrimination" to achieve this. For example, cereal manufacturers will sell their own brand at $4/box, and sell the exact same product in a store brand box for $3.25/box. A lot of products in your local retail stores do this.
Overall, no one is really hurt by this per se. Every consumer is making a transaction they're willing to make, and the company is making the most money it can in aggregate, which actually gives it room to push the price at every price point lower than it would be able to if it could only sell to a single segment.
This is actually extremely important in the drug context due to the aforementioned abysmal profitability.
Let's take Trump's attempt to force a Most Favored Nation (MFN) clause onto drug manufacturers which guarantees US consumers pay the same price as the lowest price internationally. The intended effect is for US prices to come down to the level paid elsewhere.
But here's Pfizer CEO: "When [we] do the math, shall we reduce the US price to France’s level or stop supplying France? We [will] stop supplying France. So they will stay without new medicines. The system will force us not to be able to accept the lower prices.”
Not only does this obviously not result in lower US prices, but it very possibly results in higher US prices (since now there is less net revenue from lower priced consumers) and, more troubling in the pharma case, there is now even less net revenue coming in to justify new drug development.
It's hard to overstate how asinine this entire endeavor is. US consumers certainly pay too-high prices for drugs, but this intervention does very little to actually address that problem. The much more proximal issue is the incredible degree of intermediation in the US market between payers, providers, PBMs, GPOs, and more.
Maybe in Pfizer’s portfolio this is true. However, I just watched the Amazon Pharmacy pricing for GLP-1s drop substantially immediately following this. I think you may be being too black and white on claiming this categorically does not work.
Businesses will adapt pricing models, obviously this hurts Pfizer in some way, but Lilly and Novo found the new system was worth negotiating into. Like most things - when people say “always” or “never” - it’s reducing the spectrum of possibilities
It has nearly nothing to do with government action. These will be the most profitable medications ever invented once the dust settles and it’s a game of price optimization right now.
Not only are there multiple current-generation GLP-1s on the market (Novo's and Lilly's), but there are at least 2 or 3 more generations approaching the market.
Here's the thing: yes, you may "very possibly" be right, but that means you may also "very possibly" be wrong. The truth is, we don't know, and we can't really trust the CEO of any business to openly admit that they could tolerate a policy disadvantageous to them. So how would you suggest testing the case where you're wrong?
There is no world in which lower overall revenues does not reduce R&D spend.
There is no world in which lower R&D spend does not reduce the number and quality of new drugs.
This doesn't require trusting anyone about anything other than trusting that pharma companies are generally profit-seeking and therefore an MFN clause imposed by USG will create less optimal pricing (for the pharma companies' own incentives) than currently exists.
The exact price changes that happen in different localities that net out to "less revenue → less R&D → fewer drugs" is hard to predict, but the fact that it will be lower and it nets out to "less revenue → less R&D → fewer drugs" is absolutely predictable.
Please suggest an alternative outcome, if you can think of one.
This person is a less than neutral source in an industry that's already infamous for lying through its teeth to grind out every red cent from its customers. I would lend precisely zero credence to what he says when he's trying to justify why his poor billion dollar company wouldn't be able to lighten up on its wholesale fleecing of American customers.
You don't need to trust anything except that left to their own devices, those greedy pharma companies will price as efficiently as possible in order to maximize revenues. Despite this revenue maximization, the industry as a whole is nearly uninvestable.
Any deviation from the optimal pricing will reduce their overall revenues, which will obviously make the industry even less investable.
In an R&D heavy sector means they will no longer make new products, i.e. no new breakthrough medications that you or I or our parents or children may need.
Sure, I doubt Pfizer et al will just outright stop selling medications to France. Far more likely they will both reduce US prices and raise EU+ prices, but this still ultimately results in fewer drugs for fewer people today, and definitely much slower innovation toward new drugs by virtue of having less cash on hand and much worse expected ROI.
You do not need "trust" whatsoever, this is just basic logic.
If you want to understand how Americans should actually reduce drug prices, you can start to get an idea here: https://news.ycombinator.com/item?id=46933520
This is my point – quoting the man on what he says will happen is pointless because he's just using scary hypotheticals to make the best case to keep the cash hose turned on. He's not some altruistic saint bestowing new formulations upon the world if only he had more money, he's a slimeball pharma CEO trying to balance that R&D with reaping maximum profits.
Would lowering prices for Americans mean the world has less R&D bankrolled by American consumers? Probably. But the current situation is untenable.
The thrust of the comment above is that you do not need to trust him.
Back at you bub. My original comment was addressing why a quote from the guy who would be most affected by drug prices changing is hog wash, and you skillfully dodged my whole point to talk about R&D, investments and revenue. I didn't write my comment to dive into those things, I wrote it to point out that Pfizer's CEO would say anything if it means his company will get more money.
Fine! Why is that relevant to me?
Just because you're starting from the prior of "pharma CEOs are liars" doesn't mean everyone else is. Some people find it quite helpful to hear from the most powerful and most informed people on issues they want to learn about, even if you have to discount them due to conflicted interests (spoiler alert: nearly everyone who's well-informed on an issue will have some type of conflict to be discounted).
Evidently you are fine writing the words of Pfizer's CEO down to zero value, which is fine!
That's why I provided an alternative path by which applying your own critical thinking skills would get you to the same conclusion.
"Applying basic logic gets me to a similar conclusion as Pfizer's CEO, but Pfizer's CEO is a liar and conflicted and can't be trusted, therefore... [ ??? ]"
Edit in response to your edit: Don't act as if I introduced revenue/investment/R&D/etc after you raised the issue about Bourla's quote. That was the entire basis of the conversation from the start. Profoundly low-quality contribution to just chime in with "pharma CEO is conflicted." Yeah, everyone is aware of that. That's why there's an entire comment around the quote.
> That's why I provided an alternative path by which applying your own critical thinking skills would get you to the same conclusion.
To be clear, the only thing I've taken issue with here is his own words and how you've quoted him. I don't believe I've said anything regarding your overall position on drug prices and pharma profits, so it's weird that you're attacking me like I've specifically taken a position against it.
Understood. Have a good day!
Fix the demand side and the supply side will adjust.
Americans pick their employer. Their employer picks their health plan. Their health plan picks which drugs are covered and which doctors and pharmacies they can use.
With the "innovation" of vertical integration between insurers, healthcare providers, and PBMs, there is effectively zero incentive for health insurers to manage costs, because those costs show up as revenue for their own subsidiaries. This is actually hugely advantageous for insurers because they are required by law to spend a certain percentage (~80%) of their members' premiums on healthcare goods and services, not profit or business development.
Well... if you own the pharmacies, the PBMs, the GPOs, and especially the healthcare providers... you can arbitrarily siphon money at any % rate you want while increasing the gross dollar intake by simply raising prices at your subsidiary companies!
All of this is well documented. Here are a few places to start:
https://www.statnews.com/unitedhealth-group-investigation-he...
https://hntrbrk.com/pbmgpo/
https://www.wsj.com/health/healthcare/unitedhealth-medicare-...
The US is a funny thing: no issue cutting access to Healthcare in general, education, healthy food etc.
But it is all the rage when a pill can undo people's bad habits.
"To be circumvented. Regards, Uber, Microsoft, Meta, Google, Antropic, OpenAI, AirBnB and others"
And ANDA absolutely does require supply chain inspections, first at approval then random inspections there after.
Whats Hims and Hers was doing was compounding (turning the chemical into a formulation patients can take) under an exception due to limited supply. Supply issues are over, so they can not longer compound.
I do t think anything is wrong with the US system here. These patients got access under a temporary exception, they have the option to obtain a supply through other channels going forward. If affordability is an issue, the manufacturers have several programs that make these drugs affordablez
Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.
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-...
This is a pretty good example of how "testing requirements" tend to be reactionary and effectively useless.
Vapes contained Vitamin E because the sellers were cutting the product with it, the same way drug dealers cut drugs with starch or sugar or something worse. It wasn't a manufacturing mistake, they were adding it on purpose to rip off the customer. It makes sense for that to be a crime -- it's fraud and negligence -- so the argument comes that we should require testing for it.
But if you add a test for something like that, they either cut it with something else that the test won't show (which might be even worse) or they add the cutting agent to the distribution pipeline somewhere after the point where the testing requirement is imposed. Testing for something works against mistakes, not purposeful behavior.
Meanwhile the people doing it were probably idiots who didn't know it would cause physiological harmful and thought they were just ripping people off, so then the argument comes that we should be testing to make sure they're not doing that. Except there is no generic test for every possible problem, so at the point they first started adding it, the government would have had no reason to test for that in particular, and by the time it becomes generally known that adding that substance is harmful, they'd have stopped adding it because they don't want to be sued or arrested when their customers have those symptoms and then permanently testing everything for something everybody has already independently stopped doing is a waste of resources.
The problem is people want the generic test that could catch every possible problem and that isn't a real thing, and there is no point in doing the specific test for something that has already stopped happening.
They are already an unhealthy vice for one thing. They do not require a prescription and are sold over the counter to anyone who presents an ID showing they are of age.
Those vapes were also largely made by relatively fly-by-night manufacturers selling into mostly shady retail shops. Additionally there was (still is? Haven’t kept up on it) no real consensus that vitamin E acetate was a dangerous chemical unfit for purpose.
This is the first time in my lifetime that I can recall of major companies blatantly end-arounding the entire pharmaceutical approval process for a prescription drug. Full on advertising their disregard for the rules on public airwaves and everything.
FDA being slow to react to a public health concern due to an adulterated over the counter product imo is not the same category. This is literally telling the FDA and major pharma “come at me bro” and expecting the delay to be profitable enough to offset any future penalties.
It does not seem as egregious as the risk of getting medication made in other countries. As far as I know, all the patented medicine comes from barely audited factories in places like India anyway.
Like FAA rules, FDA rules are written in someone’s blood. Someone died for those rules so we don’t have to experience the same consequences.
They were talking about a whole different set of rules.