> If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fai

> If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fails to get their treatment approved, it's often more illegal to sell it than if they just claimed it worked without trying to go through the proper channels. This is a regulation failure because a good regulatory framework shouldn’t allow this at all. It’s not about whether “the FDA’s hands are clean,” it’s about what system should be in place that gets us to the outcome we want. In my mind, this would be a place where ineffective treatments aren’t allowed (because why should they be?), but safety/efficacy is then traded off against what the patient needs. Coming from outside the USA, it sounds to me like the regulatory system isn’t achieving any of that? I think I agree with the broad thrust of what you’re putting forward, my issue only comes with the “guide” part. Medical experts need to be the ones leading the treatment because… well… they’re the experts. Don’t get me wrong, I can see how Americans distrust government after having a president suggest drinking bleach during Covid might work live on TV.