[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]
The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia. Caronia was promoting Xyrem, approved for narcolepsy, for off-label uses, which is prohibited by FDA. He was criminally charged and convicted, but the Second Circuit held this prohibition constitutionally suspect.
Leading off was Aaron Kesselheim. Aaron started off describing the FDA’s prohibition on off-label promotion. Off-label promotion prohibition is based on the requirement of substantial evidence for efficacy. There are some safe-harbors, like distributing papers, but generally off-label promotion is prohibited because promotion drives prescription patterns, and off-label promotion for unapproved uses can have significant negative consequences. FDA has negotiated many major settlements, totaling billions of dollars in recent years. In this context, the Caronia decision is troubling from a public health point of view, even if not particularly surprising given the history of commercial free speech doctrine.
Aaron described four ways forward for the FDA after Caronia. First, the government could rely more heavily on written materials as evidence, arguing that it is part of the label. Second, the government could change the prosecutorial language, using speech as evidence of an attempt to misbrand, rather than prosecuting for speech; this might not be enough to fix the problem. Third, the government could prosecute off-label promotion as false and misleading speech, but that requires hard case-by-case evaluations. Fourth, the government could better argue that the Central Hudson test for commercial free speech is met.
Next, Chris Robertson also took Caronia as a jumping-off point, noting that Caronia was actually convicted of conspiracy to introduce a misbranded drug into interstate commerce – though the Second Circuit held he was actually convicted for his speech. Caronia comes in the wake of robust First Amendment jurisprudence from the Supreme Court, including Citizens United, Sorrell, Stevens, Alvarez, and Fox v. FCC, and thus might be a harbinger of this reasoning spreading across the country. In addition, the reasoning of Caronia could potentially apply equally to drugs with no approved use, and thus undermine the entire FDCA (since what is defined as a drug is determined by label claims).