10 ms·
FDA intends to take action against non-FDA-approved GLP-1 drugs
- bickfordb 9mo agoOzempic lost its patent in Canada and a generic might be approved there soon.
- randycupertino 9mo agoThis is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.
- J7jKW2AAsgXhWm 9mo agoMochi health too
- teaearlgraycold 9mo agoI’m generally happy to see IP disrespected.
- Auracle 9mo agoThen you’ll eventually be generally unhappy to see no new medications come out.
- junofan 9mo agoThere seems to be an explosion of drugs for fat loss. No signs of slowing down.
- direwolf20 9mo agoChina disrespects IP and has the fastest growth of anywhere, and has medications
- refurb 9mo agoChina 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.
- direwolf20 9mo agoI 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.
- refurb 9mo agoI care about the absolute level of development, not the change. The fact that China wasted decades on a failed economic ideology explains why they were so undeveloped up until the 1980's. If anything, China is simply catching up (in some ways) to developed countries. While certainly admirable, achieving what has already been done in other places isn't that impressive.
- teaearlgraycold 9mo agoA significant change to IP doesn't necessarily mean the world stops working on things. It just pivots us to a new set of problems.
- raincom 9mo agoEveryone can make their own compounding drug in their basements, thanks to Telegram and other hidden platforms: source sema/tirz, get bac water, mix them.
- krackers 9mo ago>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.
- loeg 9mo agoWhy 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.
- selectively 9mo agoThat'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.
- pfdietz 9mo agoThe 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.
- selectively 9mo ago
- hn_throwaway_99 9mo ago> 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.
- mullingitover 9mo ago> blantatly skirting patent laws Implied but not explicitly stated in the FDA announcement: the compounders’ real crime is not paying their protection money.
- mindslight 9mo agoIs there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?
- cj 9mo agoIt’s unfortunate that shutting these companies down will result in less people gaining access to the drug. GLP-1’s might be the best thing to happen to medicine this decade - I personally want everyone who would benefit from it to have access.
- notesinthefield 9mo agoIt was infuriating trying to get Wegovy via insurance. My doctor made three appeals, all denied. Out of pocket it wouldve been $1600/mo. Ive been getting semaglutide from compounding pharmacies for the last year and half for $149-$200. I have lost 97lbs, come back to running 30 miles a week after several major knee injuries made even a mile jog a multiday recovery effort. I absolutely get the regulatory stance but the name brands are absolutely unaffordable.
- bdcravens 9mo agoDo you have diabetes, heart disease, or another condition necessitating a GLP-1?
- SOLAR_FIELDS 9mo agoWhy is obesity not considered a necessitating condition? It often carries the comorbidities you just mentioned. Should not exclude people just because they haven’t had these specific health problems (yet) but will eventually have them.
- bdcravens 9mo agoWhile I tend to agree, insurance companies don't see it that way. They need a doctor to indicate a necessity to treat a condition, as opposed to it being the easiest way to treat it. For example, I have to take digestive enzymes to digest my food (pancreatic insufficiency). For someone with an unusually high metabolism, they would also give them a leg up on gaining weight, even though there are other approaches to gaining that weight. However in many cases, the insurance company wouldn't cover their prescription when they will mine.
- tptacek 9mo agoIt is wild that it took until 2026 for this to happen. In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.
- cj 9mo agoPeople are getting retatrutide from random websites (not what’s being shut down here) not from compounding pharmacies.
- tptacek 9mo agoTotally fair point. I'm just surprised how poorly regulated this stuff is.
- loeg 9mo agoThe regulation is pretty clear? We just don't choose to blackhole shady foreign (in this case, Chinese) companies from the American internet as a matter of policy. And cannot effectively screen all imports.
- rootusrootus 9mo agoHard to regulate. A lot of the retatrutide sold today is marketed on Discord & Telegram groups and paid for with crypto. It is infeasible for customs to open every last package entering the US, so this avenue will continue to work. The only gov't that could realistically stop it (for a while at least) is the Chinese. And they do, occasionally, shut down a manufacturer for a while. Though not because they are shipping GLP1s to the states.
- phil21 9mo agoIt’s regulated quite tightly. But if you can’t shut down the illicit street drug market you aren’t going to be able to shut down the illicit make-your-life-better black market either. 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.
- pfisherman 9mo agoFDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval. There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name. In my opinion there two things going on here that I strongly feel are true. 1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits. 2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.
- lotsofpulp 9mo ago> The rules and laws are there for a good reason Are they? This example seems to be a clear contradiction of your first point. Stuff like this weakens the authority and credibility of the FDA, allowing legitimacy to people like RFK.
- deleted 9mo ago[deleted]
- Dylan16807 9mo agoIf the description in the first comment isn't missing anything important, and this could be fixed with some paperwork and inspections, then I don't think taking action makes the FDA look bad. The particular complaint of "cannot state compounded drugs use the same active ingredient" is weird but if it only applies to marketing then sure crack down on that too.
- wmf 9mo agoI don't think this is about paperwork. They are presumably violating patents by not buying these drugs from the patent owners.
- 9mo ago
- SilverElfin 9mo agoGiven how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.
- alephnerd 9mo ago;) - https://www.reuters.com/business/healthcare-pharmaceuticals/eli-lilly-allows-cipla-sell-weight-loss-drug-under-new-brand-india-2025-10-23/ https://www.reuters.com/business/healthcare-pharmaceuticals/... What culminated these past 2 weeks will be a great FT Big Read to participate in later. Years of work.
- throw31977 9mo agoAs an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too. https://en.wikipedia.org/wiki/Government_patent_use_(United_States) https://en.wikipedia.org/wiki/Government_patent_use_(United_...
- Retric 9mo agoThe responds of Denmark and or worse the EU invalidating US patents in retaliation is rather dangerous.
- throw31977 9mo agoSure, but not as dangerous as a literal military showdown which was also on the table.
- jopsen 9mo agoLol, a military showdown where a few hundred people are killed might be horrible. Leave the US with an island it doesn't recognize as its own (because Congress wouldn't) and that isn't recognized as US by most of the rest of the world. Would economic ties between the US and Europe be broken as a result? Probably, but maybe everybody else decides that this will be resolved peacefully in the UN. And the can is kicked down the road, until Trump kicks the can. Because ending economic ties between Europe and the US would mean a massive depression on both sides. Massive assets lost and written off. Goodbye pension. Economic meltdown might be worse than a military showdown in the Arctic. Casualties from an economic conflict would be worse.
- direwolf20 9mo agoDangerous? It'd be awesome. Think of the cheap products and services. I hope they abolish DMCA anticircumvention law.
- jopsen 9mo agoTwo can play at the game, and the EU was probably closer to starting it. The EU trade bazooka measure (Anti-Coercion Instrument) allows the EU to legally suspend patents, copyright, etc. if a member state is threatened, for example using tarifs. Which the US was a actively doing. At the end of day, it doesn't matter the Danish government cannot surrender. Following WW2 it was made illegal for the government to do so. And voters would never support, not would Trump have the patience for Danish constitutional changes. I'm quite convinced that: (A) An invasion would have been a shooting matter. Even if the shooting would eventually come to an end. (B) Denmark and most of EU and large parts of the world would never recognize an annexation. (C) Congress in the US wouldn't recognize the annexation. (D) EU and US would be both have entirely unnecessary and massive depression as massive assets would be seized or written off. (E) Russia and China would be thrilled. It was an allround shit show. Trying to go further would have upended economic ties across the Atlantic. Causing massive economic depression on both sides. But at the specific measures of parents: HUGE parts of US economy is Intellectual Property -- how dumb would the US have to be to declare IP laws invalid?
- alephnerd 9mo agoAnd India wins again! There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US. Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8]. Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back. [0] - https://www.reuters.com/business/healthcare-pharmaceuticals/eli-lilly-allows-cipla-sell-weight-loss-drug-under-new-brand-india-2025-10-23/ https://www.reuters.com/business/healthcare-pharmaceuticals/... [1] - https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-gears-up-december-ozempic-launch-india-sources-say-2025-12-03/ https://www.reuters.com/business/healthcare-pharmaceuticals/... [2] - https://www.whitehouse.gov/briefings-statements/2026/02/united-states-india-joint-statement/ https://www.whitehouse.gov/briefings-statements/2026/02/unit... [3] - https://www.trump.com/residential-real-estate-portfolio/trump-tower-delhi-ncr-india https://www.trump.com/residential-real-estate-portfolio/trum... [4] - https://www.trump.com/residential-real-estate-portfolio/trump-towers-pune-india https://www.trump.com/residential-real-estate-portfolio/trum... [5] - https://www.trump.com/residential-real-estate-portfolio/trump-tower-mumbai-india https://www.trump.com/residential-real-estate-portfolio/trum... [6] - https://www.trump.com/residential-real-estate-portfolio/trump-residences-gurgaon https://www.trump.com/residential-real-estate-portfolio/trum... [7] - https://www.daines.senate.gov/2026/01/20/daines-travels-to-india-to-advocate-for-montanas-pulse-crops-and-reaffirm-u-s-india-strategic-partnership/ https://www.daines.senate.gov/2026/01/20/daines-travels-to-i... [8] - https://governor.iowa.gov/press-release/2025-09-16/gov-reynolds-returns-india-trade-and-investment-mission https://governor.iowa.gov/press-release/2025-09-16/gov-reyno... [9] - https://www.bloomberg.com/news/articles/2025-12-11/india-draws-52-billion-from-amazon-microsoft-in-tech-expansion https://www.bloomberg.com/news/articles/2025-12-11/india-dra... [10] - https://www.wsj.com/business/energy-oil/big-oil-is-offshoring-its-prized-engineering-jobs-to-india-2e487fd0?st=6e6u1D&reflink=article_copyURL_share https://www.wsj.com/business/energy-oil/big-oil-is-offshorin... [11] - https://www.bloomberg.com/news/features/2025-11-11/trump-s-h-1b-visa-curbs-banks-to-add-more-finance-specialist-jobs-in-india https://www.bloomberg.com/news/features/2025-11-11/trump-s-h...
- engelo_b 9mo ago[dead]
- pvab3 9mo agoWe've been hearing these claims for a long time that they're going to crack down soon.
- rootusrootus 9mo agoThe compound pharmacies are the leeches I have the least amount of sympathy for. While Lilly may gouge on the price, at least they can claim to have invented the drug. Some compound pharmacy buying $20 worth of API from China and selling it reconstituted for at least 10x that is just raking in huge profit, and they did none of the R&D. What the FDA will probably have trouble cracking down on are the vendors selling lyophilized peptides direct to the public. And the number of people going that route goes up dramatically over time.
- terminalshort 9mo agoWho are these unscrupulous vendors selling direct to the public? Please name them so I can avoid them for my own personal safety.
- rootusrootus 9mo agoThe Atlantic did a write-up in December [0] about retatrutide availability and they named at least one well known vendor (who also sells tirzepatide, semaglutide, and all the other usual peptides). Not the cheapest vendor, but well known, does the batch lyophilization in the US, still takes credit cards, and gets pretty solid group test participation due to their popularity. And if you know how their pre-sales work, the price premium isn't too terrible, worth it for the test participation IMO. 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. [0] https://archive.ph/n0daP https://archive.ph/n0daP
- 9mo ago
- elamje 9mo agoThe situation is basically this - Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities. They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them. On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch. Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities. I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.
- alephnerd 9mo agoThe major Indian generics manufacturers have all signed branding and IP agreements with Lilly and Novo as well, so the only people that are hurt are consumers I guess. India wins (because Indian pharma gets IP and branding transfers). The Trump admin wins (the right strategic lobbying was done). The GOP wins (strategic tariffs on Iowa, North Dakota, and Montana lentil and soybean oil exports were about to kick off in India after they were hit by similar tariffs from China). The American consumer (who voted for Trump) loses. Welcome to a trade war.
- calvano915 9mo ago> I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Brief research indicates otherwise unless you're talking about a handful of Brand name Rx. For generics, CostPlus and other options are still better pricing. https://www.healthcompiler.com/cost-plus-drugs-vs-trumprx-how-to-save-on-prescription-medications-in-2026 https://www.healthcompiler.com/cost-plus-drugs-vs-trumprx-ho...
- 9mo ago
- tokyobreakfast 9mo agoOh no next you're going to tell me they're coming after the gas station dick pills.
- ecommerceguy 9mo agoHIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?
- valerie003 9mo ago[dead]
- rootusrootus 9mo agoAfter the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.) I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.
- cryzinger 9mo agoWhat makes you say that compounding pharmacies' testing is way more suspect? Curious because I know people who are still using compounding pharmacies (specifically mom-and-pop joints that might be able to evade crackdowns for a while longer) but have considered going grey market... maybe this is the sign to switch?
- rootusrootus 9mo agoIt's opaque, and limited. They buy the raws from China just like everyone else, then reconstitute them, fill vials, and drop them in the mail. They'll only provide a COA if you ask them to, and it will just be one basic mass/purity test most often. In the gray market, there are multiple mass/purity tests for a batch (to look for variation in fill, mostly), as well as tests for endotoxins, sterility, heavy metals, and fentanyl. Rarely (maybe never; I have certainly never seen it) will a compounder do these additional tests and provide the results. I think in general the well-known compounding pharmacies (e.g. Hallandale, BPI, couple others) are probably reputable enough to feel okay with. The mom & pop ones (or med spas) I'd be a lot more nervous about. Often ends up being someone who's just reconstituting vials in their living room, and maybe not with the quality controls you'd like to see.
- clarity_hacker 9mo ago[dead]
- lotsofpulp 9mo agoI don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
- Someone1234 9mo agoBecause it is $1K/month, it would raise premiums too much. When it is $100/month like in most other countries, then let's talk. PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
- sokoloff 9mo agoDo we really need insurance to cover $100/mo meds? Insurance already doesn’t cover OTC vitamins, right?
- trhway 9mo ago>Do we really need insurance to cover $100/mo meds? 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 $100 competitors.
- phil21 9mo agoIt’s not a submarine attack at all. If anything I bet you these compounders are surprised they haven’t been shut down already for blatantly violating the law. It’s a case of trying to get so many consumers buying that regulators are scared to touch you due to blowback. Much like Uber did.
- bilsbie 9mo agoI thought the pill form was actually pretty high tech to get the peptides through the digestive system. I don’t see how a compounding pharmacy would be able to produce it. Anyone know?
- TheJoeMan 9mo agoThat’s part of the FDA scrutiny, it’s likely the Hims/Hers pills wouldn’t have much bioavailability, yet marketed as “same active ingredient”.
- Aboutplants 9mo agoThe real question is will there be any ban on ads from gray/underground suppliers that openly advertise on Instagram? Or will Meta simply allow that to go on, exposing a lot of people to potentially harmful concoctions?
- 1659447091 9mo agoFor comedic relief on the GLP-1 issues, highly recommend "South Park: The End of Obesity" special. https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity https://en.wikipedia.org/wiki/South_Park:_The_End_of_Obesity
- sandGorgon 9mo agoYeah...so in India, the GLP patent owners went to court. however, it was deemed as patent expired in March 2026. In anycase, India generally doesnt honor product patents for pharma. Right now, Indian pharma cos are court empowered to churn out GLP-1. Everyone knows that we are gonna have 10$ GLP-1 before 2027 coming out of India.
- alephnerd 9mo agoThat's why the major Indian generics companies like Cipla have signed IP and branding exclusivity deals with Lilly and Novo so that they can continue to synthesize generic GLPs but Lilly and Novo can now export those to the US - it allows IP holders in the US to further enhancing margins while allowing Indian generics manufacturers to climb up the value chain thanks to transferred IP and knowhow.