It is very hard to say that any patient should be allowed to opt-out of the FDA's regulation because almost without exception every patient that buys into snake-oil thinks it is a good idea that is worth a shot.
How do you distinguish between "this patient is making an informed decision to opt out and use this unapproved drug" and "this patient is an idiot who thinks that throwing money at a "doctor" to mainline bleach will cure his disease"?
How do you distinguish between "this patient is making an informed decision to opt out and use this unapproved drug" and "this patient is an idiot who thinks that throwing money at a "doctor" to mainline bleach will cure his disease"?