Plaintiffs could not predicate RICO and state consumer fraud claims on what are, in essence, misbranding claims, absent allegations that [defendant] made false or deceptive statements. This is because off-label promotion is not inherently fraudulent; truthful off-label promotion of drugs does not violate RICO or state consumer protection laws. Rather, it violates the FDCA. But the law is very clear in that only the federal government, and not a private plaintiff, may enforce the FDCA.
In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, No. 2:08-ml-01934-PSG-AGR. slip op. at 9 (C.D. Cal. June 17, 2009). Now we don't think the FDA can prosecute truthful off-label promotion either, given the First Amendment, but private attempts to penalize truthful scientific speech are even more dangerous, given that they are subject to no enforcement standards whatever.