Industry Victorious in Landmark Off-Label Promotion Ruling

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

In what industry insiders are calling a “landmark decision,” on Friday, August 7, the Second Circuit granted for Amarin Pharmaceuticals’ motion for a preliminary injunction in an off-label promotion case, ruling that certain truthful, non-misleading statements about off-label uses are constitutionally protected under the First Amendment.

In reaching his decision, Judge Paul Engelmayor relied on the same court’s 2012 decision in U.S. v. Caronia, which overturned the conviction of a pharmaceutical sales representative for his off-label promotion comprised of truthful speech.

So far, it is unclear how widespread the effects of Amarin will be and many anticipate that the FDA will appeal, but it is a notable boon for drug and device-makers on this front nonetheless.

The product involved in this particular case, an omega-3 drug called Vascepa, has many unique attributes may keep this case narrower in its application than is currently hoped. For one thing, Vascepa has an especially strong and long-established safety profile, with its safety deemed equivalent to the placebo in clinical research. This fact certainly helps to alleviate the burden of providing all accompanying warning and risk information on potential off-label speakers and reflects a quality that most prescription drugs on the market can’t claim.

David Gibbons over at FDA Law Blog wrote on the decision in greater detail here: A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion.