What a load of crap…. Politicians voting but reading the bill.
Well. Even if this is the law I’d the land I have a legal work around. I believe right try is also the law of the land. If this were to come to fruition I would continue my practice the same way and if queried about “being allowed” I would make sure the chart reflected my awareness of off label use and invoke right to try. At that point there would be a test case in which I would be happy to participate and a deep bench of lawyers who would love to make the argument.
Remember. There are always work arounds. Even with off label use we might disagree with as colleagues, I think the vast majority of us would defend the right to exercise our learned judgments. What will come out of this is there will be some clear requirement to document that patient is aware of off label use.
I am going to guess FDA will realize what a pain in the ass this will turn iout to be for them and that will cause this to be walked back or simply not enforced.