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...
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.
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?
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.
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?
https://old.reddit.com/r/FamilyMedicine/comments/1nz5xkd/how...
> they get away with it because:
> In-house prescription
> legally registered 503A compounding pharmacy that is not selling bulk (individual prescription quantities)
> They can argue clinically distrinct compounding
> FDA does limited enforcement unless its unsafe or mass bulk production
Point 4 seems not to be holding anymore.
The regulatory agencies were understaffed for the work load even before recent layoffs. Why focus on this, of all the things they could put their effort into?
If there was a single thing an understaffed FDA would go after it would be the compounding pharmacies and that whole ecosystem blatantly thumbing their nose at it all.
Not that I agree with the rules - but if this is allowed it’s essentially an end-around the entire prescription drug regime as we know it.
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.
HHS could do it tomorrow.
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.
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.
https://www.npr.org/2025/08/22/nx-s1-5511707/ozempic-zepboun...
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.
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.
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.
I am open to being convinced that I’m wrong here, but you’re doing a pretty terrible job.