Hims Finally Crossed the Line

A lot of you probably expected me to write about TrumpRx this week.

But to be honest with you, I just don’t find it particularly interesting.

Not because it doesn’t matter, but because nothing about its launch revealed anything we didn’t already know. TrumpRx is a polished website that points patients toward existing manufacturers and providers. It didn’t rewrite drug law, change incentives, or meaningfully alter how medicine is developed or regulated in this country. It also isn’t going to have any impact on 99% of American consumers.

I’ll write more about it soon. But it’s not the most important story of the week.

What is important is what just happened with Hims & Hers, Novo Nordisk, and the FDA.

I would argue it’s the most important story in American healthcare in a very long time.

And if you haven’t been following along, have no fear. I’m going to tell you everything you need to know. Let’s start with what actually happened.

A few days ago, Hims announced plans to sell a $49 compounded oral version of a GLP-1 drug — essentially a pill version of Wegovy — even though no FDA-approved generic or compounded oral GLP-1 exists.

That alone was extraordinary.

Until now, compounded GLP-1s had almost exclusively been injectable, operating in a gray zone created by real drug shortages and weak enforcement. Novo Nordisk had only launched its FDA-approved oral GLP-1 weeks earlier. I recently wrote about how difficult that achievement was and why it could completely change the market.

Getting a GLP-1 to survive stomach acid and be absorbed through the gut is a major scientific challenge. It cannot be replicated casually.

So the announcement of a compounded oral version immediately raised serious red flags.

The FDA responded unusually fast and unusually forcefully, stating it would take “decisive” action against companies selling unapproved versions of brand-name drugs.

Around the same time, the Department of Health and Human Services referred Hims to the Department of Justice for investigation.

That escalation matters.
The DOJ does not get involved in routine regulatory disputes.

Novo Nordisk filed a lawsuit accusing Hims of patent infringement related to Wegovy.

This is a legal strategy Novo has historically avoided, because patent litigation carries real risk. If a court invalidates a patent, exclusivity can collapse overnight.

In other words: Novo chose the nuclear option.

Hims backed off the oral GLP-1 plan almost immediately.

They then released a public statement framing the lawsuit as a “blatant attack” by a Danish company on millions of Americans, accusing Big Pharma of weaponizing the legal system to limit consumer choice and undermine personalized care.

That statement is what most people saw.

It is also where the story became badly distorted.

The market noticed.

Hims’ stock dropped sharply following the FDA response, DOJ referral, and lawsuit — a clear signal that investors understood this wasn’t a routine spat, but a fundamental threat to the company’s business model.

At first glance, this looks like a familiar script:

Big Pharma versus a telehealth startup.
Patents versus access.
Profits versus patients.

But that framing misses the most important detail.

This is not a dispute over pricing.
It is not a debate about access.
And it is not a routine compounding controversy.

This is a direct test of whether FDA approval and drug patents still mean anything at all in the age of telehealth, venture capital, and social-media-driven medicine.

And it all comes down to one decision Hims made that fundamentally changed the rules.

For the past two-plus years, compounded injectable GLP-1s lived in a regulatory gray zone. That gray zone existed because of real shortages, weak enforcement, and a system never designed to handle telehealth companies operating at venture scale.

I’ve written about this extensively, so I won’t re-litigate the entire compounding debate here.

But one thing is critical to understand:

The moment Hims announced plans to sell a compounded oral GLP-1, this stopped being a compounding story and became something else entirely.

This is the line they crossed.

GLP-1 drugs like semaglutide are peptides. Peptides are large, fragile molecules. When swallowed, they are destroyed by stomach acid before they can enter the bloodstream.

This is not controversial. It’s basic pharmacology.

Novo Nordisk understood this problem so clearly that it spent roughly $2 billion acquiring Emisphere Technologies, the company that developed SNAC — a proprietary absorption-enhancing technology that allows oral semaglutide to survive the stomach long enough to be absorbed.

That technology is patented and only available to Novo Nordisk.
It is the entire reason an oral GLP-1 can exist as a safe and effective drug. Novo had to prove its safety and efficacy through long and expensive clinical trials.

So when Hims announced it would sell a compounded oral GLP-1, only a few explanations were plausible. Every single one creates serious legal problems.

Either:

There is no fourth option.

None of these paths are compatible with lawful compounding as it exists under U.S. drug law.

Make no mistake, this was a calculated bet that enforcement would lag long enough to make the risk worthwhile.

Compounding allows pharmacists to adjust dose, form, or excipients for individual patients when no commercially available alternative exists.

It does not allow companies to invent new pharmacology, bypass patents, or skip the FDA approval process.

You cannot personalize drug absorption.
You cannot personalize around patents.
You cannot personalize your way out of clinical trials.

The drug approval process exists to protect patients. The patent system exists to ensure companies are willing to invest billions to develop new medicines in the first place.

These are not bureaucratic obstacles.
They are the foundation of modern medicine.

If this were an isolated lapse in judgment, Hims might deserve the benefit of the doubt.

But the broader record suggests a pattern of pushing regulatory boundaries and minimizing consequences.

Earlier this year, the FDA issued a warning letter to a compounding pharmacy owned by Hims after inspectors found sanitation issues — including vermin in production areas — and failures to properly report a serious adverse event involving compounded semaglutide.

Hims characterized these issues as narrow or technical and declined to make the warning letter public.

This matters not because it proves malicious intent, but because it shows what happens when pharmacy becomes a growth strategy instead of a safety system.

When companies scale faster than regulatory infrastructure, something always gives.
In this case, it was caution. I have been warning about this in Drugstore Cowboy since the day I launched.

I don’t enjoy defending Big Pharma. Anyone who has read this newsletter knows that.

Drug pricing is broken. PBMs distort incentives. Patients are often the ones who pay the price. All of that is true.

But none of that changes the core issue here.

Patents and FDA approval are the deal society makes with drug developers. We grant a period of exclusivity in exchange for massive upfront investment, years of clinical trials, and real risk of failure.

Without that deal, the pipeline of new medicines collapses.

Novo reinvests its profits into developing the next generation of drugs.
Hims does not.

Hims’ model depends on exploiting existing innovations without paying the costs required to create them.

This lawsuit is not about protecting profit margins. It’s about preserving the sequence that makes medical progress possible.

If companies are allowed to rip off groundbreaking drugs the moment they hit the market, there is no reason to invest in the next one.

It should not have taken this long for the FDA to act.

Once the original GLP-1 shortages were resolved, large-scale, commercially marketed compounding should have ended. The “customized dose” justification was stretched far past its breaking point.

The most charitable explanation is that the FDA lacked the resources and political support to enforce the rules decisively.

But regulatory weakness does not legalize reckless behavior.

When enforcement disappears, the most aggressive actor sets the boundary.
Hims tested that boundary.
Now everyone else in the compounding gray market may pay the price.

I genuinely believe that this may lead to the end of compounded GLP-1s for every company in that business. Not just Hims.

I’m not alone in that belief.

GLP-1s are the first drugs to collide with social-media hype, telehealth scale, venture capital pressure, and cultural obsession all at once.

They won’t be the last.

This case will shape what happens next — not just for weight-loss drugs, but for peptides, biologics, and any future therapy that is expensive to develop and easy to market.

If this behavior were allowed to stand, FDA approval would become optional and patents would become suggestions.

That future does not end with cheaper medicine.
It ends with less of it.

Hims wants you to believe this is David versus Goliath.

It isn’t.

It’s a public company that mistook regulatory neglect for permission and assumed the rules didn’t apply to them. This week, they found out otherwise.

Access matters.
Affordability matters.
But above all else, patient safety matters as well as the advancement of medicine for all humankind.

I will be tracking this story very closely as it develops over the next few months (or years). You all should be too.

Ride on.

Alec Wade Ginsberg, PharmD, RPh
4th-Gen Pharmacist | Owner & COO, C.O. Bigelow
Founder, Drugstore Cowboy