In addition to authoring a recent legal alert, Proactive Off-Label Promotion Can Be Protected Speech, Susan Burnett also provided comments in Law360's report discussing the Amarin Pharma Inc. v. U.S. Food and Drug Administration ruling in the article, "Amarin's Off-Label Victory Opens Door To More Injury Claims."
Though the New York federal court ruling upholds drugmakers rights to truthfully promote their products' unapproved uses, questions remain as to what constitutes as "truthful" and who decides.
In light of these questions, Susan points out that "a drug company would still have to tread extremely carefully in making any kind of off-label statements about their drug."