Court Clears Way for Off-Label Promotion of Drugs

The drug Xyrem, which is a central nervous system depressant, got a powerful marketing boost and its salesman a get-out-of-jail free card when a federal appellate court ruled that drug companies could market “the truthful off-label promotion of FDA-approved prescription drugs.”

The quite lengthy decision has enormous implications for the world of pharmaceutical advertising. It could pave the way for drug companies to actively promote the off-label uses of their FDA-approved drugs.

The 2^nd Circuit’s December 3, 2012 ruling involved pharmaceutical salesman Alfred Caronia, who was criminally charged and convicted of conspiracy to introduce a misbranded drug into interstate commerce. Caronia was convicted in November 2009 of promoting Xyrem, a drug approved by the FDA solely to treat narcolepsy, for unapproved uses, including muscle disorders, chronic pain, and fibromyalgia, as well as for unapproved populations (i.e., kids under 16).

Caronia appealed his conviction, arguing that he had a right under the First Amendment to market the off-label use of an approved prescription drug. The federal government argued that Mr. Caronia’s off-label promotion of Xyrem was illegal under the Federal Food, Drug and Cosmetic Act (FDCA).

In overturning the guilty verdict, the 2^nd Circuit explained, among other things, that Caronia’s promotion of off-label drug use was not false or misleading and did not concern an illegal activity (since FDA-approved drugs can be legally prescribed by doctors for unapproved uses).

Thus, a happy Caronia was let off the hook and pharmaceutical companies are combing through the decision to explore legal avenues to market off-label uses of drugs.