> It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.

The other side of this is:

1) Since the FDA is a monopoly, it's entirely possible (and probably demonstrable) that they've set the wrong bars, which could have fatal consequences.

2) It's arguable that the costs imposed by the FDA may have fatal consequences themselves, in the form we're seeing today, where life-saving drugs (antibiotics, in this case) can't be developed because of them.

I'm interested in hearing your response to the above two points. I'd also be interested to hear what you'd think of a "de-fanged" FDA wherein they are able to approve or disapprove medications, but are not able to enforce those decisions. People would be allowed to do with their own bodies as they please, but they'd be able to reference the FDA to make those decisions.