If we're just letting doctors yolo* off-label, i have no problem with that, but that functionally relegates FDA protections to testing risk profile at some particular dose regimen, with a bunch of extra bullshit tacked on that is highly inefficient process for off-label use even if partially applicable.

It's pretty clear if you're allowing off-label use you can just gate dose-risk profile at one gate and then just add additional gates for on-label uses if you want to approve one.

Of course the issue is the FDA regulator gets the hammer and damned if anything goes wrong but nothing good happens to them if they approve something. So they have no real incentive to approve anything except ideological satisfaction to whatever extent it lives within their mind, plus whatever revolving door benefits industry is offering them.

Probably best to reward the FDA employees for approving good drugs so that the prisoners' dilemma doesn't always fall back to erring on the side of denials, and being easier on them for taking some risk that approves bad drugs to the point they're willing to take some risk to let potentially good drugs through. The regulator doesn't get to see all the bad they cause by not approving drugs because that's invisible, and that's the unintended consequence of their activities and something they're not really held to account for.

* --------- re: below due to throttling -------

>Doctors aren't yoloing it.

If you take offense, call it whatever the hell you want, I was using it in the context of using a drug for a non-approved off-label use. You're making no legal distinction, it's not an FDA approved use and telling the FDA you have some evidence elsewhere but you won't be going through the process to approve it doesn't mean dick to the approval process anymore than my disapproved use of the world "yolo" to refer to same does. If the best my counterparties have is disapproving of "yolo" I rest my case.

Hospitals and universities repurposing drugs at 90% lower cost