[roywiggins]

It's basically a regulatory arbitrage, see here:

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.

[jfengel]

Any idea why they'd change their mind about point 4?

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?

[Aurornis]

They didn't change their minds. The enforcement was consistent. It's the companies who scaled up their production to mass market levels who prompted the action.

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.

[xp84]

Whoever isn’t making their profits when people buy them this way is directing the FDA to act. You can bet on it.

[estearum]

As they should.

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.

[nostrebored]

So millions of Americans should deal with years of obesity because Novo is a disaster, insurance coverage is ridiculous (any insurer accurately charging for the purpose of risk mitigation should be paying people to take GLP-1s, when instead they are out of coverage for most plans), and there exists no government body to do what you’ve said?

[kldg]

While I'm sympathetic to this argument, I should point out patent time to expiration for medicine in the US is pretty inoffensive (relative to how bad it could be, like software patents), and we already have plenty of drugs for excreting excess. We get a big basket of drugs into public domain each year, and government would be wise to publicly celebrate this, I think; would help with the general sense of impending doom citizens feel.

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.

[estearum]

What do you mean "there exists no government body to do what you've said?"

HHS could do it tomorrow.

[phil21]

Because “this” is about the biggest in-your-face blatant disregard for FDA rules that has quite literally ever existed in history. The scale is unprecedented.

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.