It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval.

I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken.

I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.