>>Q: In your opinion, would a drug company run into resistance from the FDA if it wanted to add a warning to its drug label?
Yes. If as I suggested (1) drug companies started asking for broad, comprehensive warnings as a response to litigation to defend themselves from liability (2), I suspect (I am not privy to FDA thinking) FDA would refuse. That would set the companies up to defend themselves by saying that the request was made and the FDA refused to give the warning. They would then claim preemption. So it seems to me you are driven back to the same policy question - to preempt or not. If the FDA did give the warning then the defense would be that failure to warn cannot be pleaded.
I am not saying that a science based request to the FDA would be denied - at least I would not expect that.
I can tell you that when the risk/cost of litigation becomes sizable, companies go to great lengths to avoid them - unreasonable lengths. Bad law imposes undue burdens on commerce which society ultimately bears.
ij
(1) I do not agree. Assuming your statement is correct. Would we really want companies asking for additional warnings in the label JUST to fend off liability for something that is not a learning from the studies? That is what you should expect if that is the only way for a company to defend themselves from creative lawyering. Once FDA issues the label, it should stand for something. Enough on that.
(2) In fact, this was one of the arguments made by the FDA to support preemption.
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