Nor can the FDA define for itself the "effectiveness" of its speech restrictions:
Allowing FDA to define “effectiveness” however it sees fit would not only render Central Hudson’s “substantial interest” requirement a complete nullity, but it would also eviscerate the requirement that any restriction “directly advance” that interest.Slip op. at 29. And there, at the end, lurks Sorrell: “[t]hat the [government] finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.” Slip op. at 30 (quoting Sorrell, 131 S.Ct. at 2671).
Off-label use is probably more prevalent than smoking these days. The most plausible argument for the FDA is that discouraging off-label promotion encourages submission of such uses to the Agency. That doesn't seem to have worked much, if at all. "FDA cannot get around the First Amendment by pleading incompetence or futility." Slip op. at 28-29.
Ouch. The First Amendment is coming.