The DC Circuit today held 2-1 that the FDA's proposed graphic labeling for cigarettes is unconstitutional under the First Amendment. R.J. Reynolds Co. v. FDA, No 11-5332, slip op. (D.C. Cir. Aug. 24, 2012). While it's a much different analysis than restrictions on truthful off-label promotion, the FDA's regulation fell under the Central Hudson test usually applied to commercial speech. Slip op. at 28-30. We think that the court's discussion of the second Central Hudson prong - the "direct advancement" test - id. at 24- has some relevance to the Agency's off-label speech prohibition. The court required proof of "direct cause" to satisfy that prong, and we doubt that the FDA has any more evidence of such cause to support its off-label ban than it did for its graphic warnings. The agency's characterization of data as "suggestive" was only another way of saying it was "mere speculation and conjecture." Id. at 26.
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.