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Addendum to Yesterday's Off-Label Use Post

By James M. Beck and Mark Herrmann

Sometimes we just happen to speak too soon. That happened yesterday, with our "rant" about off-label promotion. If we'd just waited until a day later, we'd have been able to incorporate the new opinion on that subject from the Epogen/Aranesp litigation. Here's the money quote, from our perspective, in that opinion, about truthful off-label promotion:

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.

Full post as published by Drug and Device Law on June 19, 2009 (boomark / email).