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FDA intends to take action against non-FDA-approved GLP-1 drugs

142 points by randycupertino

by pfisherman

9 subcomments

FDA regulates the marketing of drugs and medical devices. This is a case of Hims and Hers (and other compounding pharmacies) marketing drugs without having been granted approval.
There is an abbreviated application for new drug approval (ANDA) pathway meant for generics, but it does not seem like H&H has gone this route. It does require you to open your supply chain up to inspections and to provide evidence that your generic version basically works the same as the brand name.
In my opinion there two things going on here that I strongly feel are true.
1. Something is systemically wrong in the US when we are cutting off people’s access to meds, like GLP-1s, which have profound health benefits.
2. Hims and Hers are also in the wrong. The rules and laws are there for a good reason. It is not just for us to arbitrarily pick and choose when to enforce them.

by clarity_hacker

3 subcomments

The interesting systems-level question here is whether the FDA approval pipeline was designed for a world where a single drug class can generate this much demand this fast.
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.

by rootusrootus

2 subcomments

After the first big crackdown on compound pharmacies, I have seen a lot of people go to gray market. Especially now that it has become pretty clear that the remaining compound pharmacies defying the FDA are getting their API from the same sources that we can buy it from directly, and their testing is way more suspect. On the gray market the batches of peptides are routinely subject to a battery of tests run by groups of volunteers, which is a lot more than what you can get from your chosen compound pharmacy (most will give you a COA, but that's already table stakes if you buy from a "research" vendor.)
I have noticed that the "research" vendors have started to tighten up their operations, especially the ones based in the US. A lot of people have seen the writing on the wall and expect it to become somewhat harder to get the peptides, and are stocking up. It's a running joke how many years worth of tirzepatide or retatrutide people have in the freezer. Once you've had the miracle drug, you won't risk being without it.

by elamje

9 subcomments

The situation is basically this -
Novo and Lilly spent billions making Semaglutide, Tirzepatide, and future formulations/modalities.
They are going to monetize this heavily while they have IP coverage. There is no world they will let HIMS or any compounding pharmacy of scale undercut them.
On the insurance front - expect your insurance to decline this forever unless you are at serious risk of diabetes. It would make you cost them $3-6k/yr more. Insurance premiums would rise for everyone if insurance was subsidizing this - no free lunch.
Fortunately, the prices are coming down. Amazon pharmacy has Wegovy in an auto-injector starting at $199 without insurance. And that’s delivered to your door in under 24 hrs in most major cities.
I highly recommend checking out the terms of trumprx.gov - not endorsing the entire government here, but it is actually working and quite cleverly written to ensure Americans are getting the lowest cost drugs in the world now. Historically, we subsidized R&D globally by allowing pharma to make most profits on Americans then have cheaper prices abroad. That is changing and hopefully that’s a net positive.

by cj

2 subcomments

It’s unfortunate that shutting these companies down will result in less people gaining access to the drug.
GLP-1’s might be the best thing to happen to medicine this decade - I personally want everyone who would benefit from it to have access.

by throw31977

3 subcomments

As an aside, I wonder why this wasn't discussed during the recent Greenland dispute. The US government basically legally pirate the drug, and it'd make a fairly large dent in Denmark's economy. It'd be a politically popular move too.
https://en.wikipedia.org/wiki/Government_patent_use_(United_...

by randycupertino

6 subcomments

This is big. HIMS and HERS and other companies are blantatly skirting patent laws under the guise of compounding.

by sandGorgon

1 subcomments

Yeah...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.

by tptacek

4 subcomments

It is wild that it took until 2026 for this to happen.
In the late 1990s, when my friends wanted mushrooms or 5MEO-DMT, they'd order from "Poisonous Non-Consumables" catalogs. Today, people are literally doing that (same words, even!), but for the next iteration of GLP1 drugs not yet on the wider market. Compounding pharmacies are selling "research chemicals", like in Bitcoin Mining Profit Calculator: Gaiden.

by bickfordb

0 subcomment

Ozempic lost its patent in Canada and a generic might be approved there soon.

by 1659447091

0 subcomment

For 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

by engelo_b

2 subcomments

this was bound to happen with the number of compounding pharmacies getting into the glp-1 game. from a risk side, it’s a total mess it’s basically impossible for insurers to model long-term liability when the supply chain for these drugs is a black box. fda had to drop the hammer before the claims started flying.

by tokyobreakfast

0 subcomment

Oh no next you're going to tell me they're coming after the gas station dick pills.

by Aboutplants

0 subcomment

The 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?

by bilsbie

1 subcomments

I 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?

by mindslight

0 subcomment

Is there a cash price for getting the government to shake down your competitors, the way there is for pardons ? Or is this type of service only available in exchange for equity stakes?

by SilverElfin

1 subcomments

Given how transactional this administration is, you can be confident that one set of companies donated to the administration or enriched the Trump family somehow, and the other set is facing regulatory attacks.

by alephnerd

1 subcomments

And India wins again!
There's a reason the major Indian generics manufacturers like Cipla have partnered with Ely Lilly [0] and Novo Nordisk [1] for exclusivity deals for GLP branding and IP even though it isn't required outside the US.
Keep screeching about H1Bs and offshoring while sweetheart deals are signed with the Trump admin [2] by lobbyng with the right leverage points [3][4][5][6] and threatening the right GOP ruled states with tariffs [7][8].
Thanks to Trump, India has finally began reversing the brain drain, and with it bringing Big Tech [9], Big Pharma (already mentioned), Big Oil [10], and Wall Street [11] back.
[0] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[1] - https://www.reuters.com/business/healthcare-pharmaceuticals/...
[2] - https://www.whitehouse.gov/briefings-statements/2026/02/unit...
[3] - https://www.trump.com/residential-real-estate-portfolio/trum...
[4] - https://www.trump.com/residential-real-estate-portfolio/trum...
[5] - https://www.trump.com/residential-real-estate-portfolio/trum...
[6] - https://www.trump.com/residential-real-estate-portfolio/trum...
[7] - https://www.daines.senate.gov/2026/01/20/daines-travels-to-i...
[8] - https://governor.iowa.gov/press-release/2025-09-16/gov-reyno...
[9] - https://www.bloomberg.com/news/articles/2025-12-11/india-dra...
[10] - https://www.wsj.com/business/energy-oil/big-oil-is-offshorin...
[11] - https://www.bloomberg.com/news/features/2025-11-11/trump-s-h...

by valerie003

0 subcomment

[dead]

by ecommerceguy

0 subcomment

HIMS has known this was coming for a very long time. How much has the CEO cashed out with ? I think i saw 133 million. Sounds criminal. Where is the Occupy Wall Street movement when shit like this happens?