Post Caronia: Is a new paradigm needed for off-label medication usage?

In United States v. Caronia (2012), a criminal misbranding, off-label promotion case, the Second Circuit ruled that the Food and Drug Administration’s (FDA) enforcement of pharmaceutical manufacturers violates the First Amendment. Pharmaceutical manufacturers view Caronia as a watershed for the end of deference to FDA’s oversight role as arbiter of off-label medication usage determinations and perhaps, the beginning of the demise of preemption. The central constitutional question is can FDA’s off-label promotion prohibition withstand First Amendment scrutiny of free speech in general and commercial speech in particular? Is a new paradigm required to promulgate a framework of laws and regulations that will minimize healthcare costs and patient injuries while allowing truthful off-label promotion?