The Collapse of the FDA

There's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.

They were illegal up until quasi recently… mid 90s IIRC. I believe it was right around the time of Viagra - probably not a coincidence.

I’m very familiar with this space, specifically parenteral manufacturing.

The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.

As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.

And truly it gets worse every year…

It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.

  *He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*

If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.

> No one wants to fix the problem.

That’s not what wedge issues are for. They’re not meant to be solved, because then they’re used up, and there’s airtime to fill in the meantime.

yeah, because unless you legitimately have heavy metal poisoning, the side effects DEFINITELY aren't worth it

Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."

Excellent statement, but who is the "great man" who once said this?

Important quote! Citation?

I was just saying this today. I’m originally from the DC bubble. It’s been bad for a LONG time. Entire companies designed to fight and win government contracts so that they can milk the government until retirement. SAIC comes to mind.

These agencies haven’t been able to do their actual jobs in ages. Trump is doing what he said he was going to do (unpopular as that is) and we’ll have to figure out how to build back better (or whatever that term was).

I don’t agree with anything he’s doing but I do see opportunities in it. If we can survive without these departments until then.

What's oppressive about FDA? Be specific.

I see this argument of "oh it's been happening for a long time" getting thrown around a lot, and it feels like a really non-good-faith point of view that seems to ignore the administration directly targeting these institutions for destruction.

Yes, poor management is a big problem that could be seen as an intentional structural issue, but this is a totally different ball game that's being played right now.

Before the wreckage this administration has created consumes us, that is. Like when our next round of influenza is especially bad but we've destroyed so much public health infrastructure that the US is the last to respond to the crisis, and the state authorities have to turn elsewhere for help -- to WHO or even to China -- to bail us out.

It’s easy to hand out money when you are not the one paying, and have no consequences for success or failure. Feeling justified and righteous is the icing on the cake

I am referencing the grotesque overregulation, and hence ridiculous costs and greatly reduced supply, of medical innovations such as new drugs.