Off-Label Use and Promotion Protected by Federal Court

A federal appeals court panel said on Monday, December 3, that prohibiting discussions between physicians and medical sales reps about off-label use of their products violates the First Amendment right to free speech. 

It’s also bad science, does not promote the public’s health and stifles innovation.  Off-label use is often the standard of care medicine.

“It only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed, ” wrote Judge Denny Chin for the 2-1 majority. “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.

“Off-label” marketing is prosecuted as a criminal offense. Pharmaceutical and device companies have paid tens of billions of dollars in fines to the government. Abbott Laboratories paid $1.6 billion, GlaxoSmithKline settled for $3 billion, Merck got nipped for $1 billion and Johnson & Johnson has set aside $1.7 billion to settle an ongoing prosecution. That’s money that could go towards innovation.

The case, United States of America v. Caronia, is sure to be appealed by the government to the full Second Circuit Court of Appeals in New York, and then to the U.S Supreme Court.

A Wall Street Journal editorial on December 5 said the decision “guts the FDA’s rationale for off-label speech regulation and could be a landmark that liberates companies and doctors to spread news about medical innovation.”