May 29, 2016

First Amendment Prevails in Off-Label Use Debate

In Amarin Pharmaceutical vs. FDA, a preliminary injunction granted by the Southern District of New York prohibited the FDA from taking action against Amarin over truthful, non-misleading "off-label" statements about its prescription drug Vascepa. Vascepa was originally approved by the FDA to treat patients with "very high" triglyceride levels. Amarin sought to disclose truthful, non-misleading information to doctors that Vascepa could also be used to treat patients with "high" triglyceride levels. Recently, the parties advised the court a settlement was reached.

What It Means to You

The settlement appears to reflect the FDA's recognition that the First Amendment protects more speech than it has acknowledged to date; however, determining whether given speech is "truthful" and "not misleading" may raise additional issues.  What is certain is that this settlement is an important one because the FDA now has agreed that a manufacturer can engage in truthful, non-misleading promotion about off-label uses that fall outside the scope of its scientific and medical publications guidance.


 Amarin Pharmaceutical vs. FDA