Do Drug Sales Have First Amendment Rights to Promote Off-Label Use?

In a court decision that could open the floodgates for drug promotion, an appellate court has thrown out the conviction of a drug salesman who promoted a drug for off-label use citing his free speech rights.

Alfred Caronia worked for Orphan Medical where he sold the narcolepsy drug Xyren. He was caught on tape promoting it for drowsiness and chronic fatigue even though it had only received FDA approval as a treatment for narcolepsy. Drug companies are prevented under the Food, Drug and Cosmetic Act from promoting a drug outside the scope of its approval.

Caronia was convicted in 2009 for illegally marketing Xyrem, but this week a three-judge panel of the U.S. Court of Appeals voted 2-to-1 to thrown out his conviction ruling he could not be punished for his speech.

The government is expected to appeal and the case could ultimately be reheard before the U.S. Supreme Court.

Most of the global drug companies have been convicted at one time or another, of off-label drug promotion. If this decision is allowed to stand it will be a major victory for drug makers.

This Second Circuit ruling applies to New York, Vermont and Connecticut and should not affect how drugs are marketed nationally.

Does this mean that lying about a drug is allowed under First Amendment and free speech? The ruling makes a distinction between a misleading and false statement and those that are a truthful discussion about off-label uses. That may be a distinction the FDA will need to address in the future.

The FDA’s marketing rules have led to billions in civil and criminal penalties in recent years – Medtronic has been accused of promoting INFUSE for off-label; GlaxoSmithKline was fined $3 billion for illegally promoting antidepressants; Johnson & Johnson was forced to pay $181 million over its marketing of the antipsychotic drug, Risperdal.

The outcome of this free speech question will likely tame the FDA from its regulatory watchdog status to one of a lapdog if it is allowed to stand. Stay tuned.