The Risk of RFK’s FDA

I wasn’t planning to write this week. I’m on vacation in Singapore and Indonesia, and I told myself Drugstore Cowboy could take a breather. But as I sat awake in bed the other night trying to fight the 12-hour time difference, I scrolled past a headline that I just couldn’t let go:

Animal hair and bugs in a sterile drug facility. That’s not a joke. It’s in the FDA’s inspection report…

This isn’t some strip-mall compounder or a little-used overseas manufacturing facility. It’s a flagship US plant in Indiana, in Novo Nordisk’s portfolio, that fills vials and syringes for Novo, Regeneron, Scholar Rock, and “virtually all the biopharmaceutical companies,” according to Regeneron’s CEO. It’s one of the hidden engines of American drug supply. And yet the FDA’s findings read like something out of a bad episode of Kitchen Nightmares.

The FDA didn’t just find one stray whisker and call it a day. The 22-page Form 483 inspection report catalogued repeated failures:

These weren’t even first-time slip-ups. Inspectors have been flagging issues at this plant since 2022 (when it was producing COVID vaccines!). Regeneron has already seen multiple FDA approval delays for its blockbuster Macular Degeneration drug, Eylea, thanks to this facility’s problems.

But somehow — the plant keeps running.

If you’ve been reading Drugstore Cowboy, you might think I’m staunchly anti-compounding and pro-Big Pharma. After all, I’ve written plenty about how unsafe compounded GLP-1 injectables can be, and how it gets even sketchier when startups turn loopholes into profit machines. I’ve openly advocated for buying commercially manufactured drugs over alternatives whenever possible.

But let me be clear: I’m not here to wave the Big Pharma flag. I don’t feel great about siding with companies who regularly gouge patients and manipulate markets. And I don’t believe all compounding is dangerous either. My goal is simply to call out the parts of the system that most people never see — and to tell the truth about where safety begins and ends.

This story is a perfect reminder: commercial drug manufacturing is not immune to cutting corners. Big plants can fail just as badly as compounders.

There is nothing these companies wouldn’t do to save a few bucks. Like I say every week… Healthcare is a business!!!

The difference isn’t about who makes the drugs. It’s about who’s watching them.

The FDA is supposed to be that watchdog. But it’s stretched impossibly thin. The agency regulates an industry worth trillions with a fraction of the manpower it needs. It can inspect plants, issue reports, and demand corrective actions. But it can’t be everywhere, and it doesn’t always have the teeth — or the political cover — to shut facilities down.

That’s why this inspection report matters. Not because you need to panic that your insulin or Ozempic is full of bug juice. But because it shows how fragile the oversight is. Problems can pile up for years. Inspections can flag them again and again. And yet the same plants keep cranking out product, because the system tolerates imperfection so long as the assembly line keeps moving.

This is where politics enters the picture.

Under Trump, the FDA has been repeatedly undermined. Dozens of senior scientists have left, morale has cratered, and “cutting FDA red tape” has become a rallying cry. Now RFK Jr. is singing the same tune — bashing the FDA as corrupt and promising to tear it down even further.

It plays well on TV. Nobody likes bureaucrats. Everybody hates red tape. But here’s the reality: that red tape is what keeps cat hair, pests, and bacteria out of your medicine.

Every time the FDA gets gutted, what we lose isn’t just paperwork. We lose inspectors. We lose enforcement. We lose the ability to hold giant plants — even the ones in our own backyard like Novo’s in Indiana — to the highest possible standards.

So the next time you hear a politician promise to slash FDA oversight in the name of “freedom,” remember this headline. Freedom shouldn’t mean finding foreign matter floating in your syringe.

Drugs in the U.S. are still, by and large, safe. But “mostly safe” isn’t good enough when we’re talking about sterile injectables going into people’s eyes, veins, and lungs. Patients deserve more than “probably fine.” They deserve certainty.

And certainty doesn’t come from trusting Big Pharma to police itself. It comes from an FDA with the resources, manpower, and political will to demand excellence. The call to action here isn’t panic. It’s pressure — pressure on our government to fund the FDA properly, pressure on lawmakers to stop treating “oversight” as a dirty word, and pressure on all of us to remember that a safe drug supply isn’t guaranteed. It’s earned, one inspection at a time.

Bacteria in your vial isn’t a joke. It’s the price of an underfunded, undermined FDA.

The medications we inject, swallow, and drip into our eyes should be manufactured to the highest standards. Not almost. Not sometimes. Every time.

And that only happens if we demand more from the politicians we elect to look out for our safety.

See y’all when I return to American soil. Back to the beach for this cowboy.

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