1st Amendment Protects Truthful, Non-Misleading Statements Regarding Off-Label Use, N.Y. Federal Judge Rules

NEW YORK — Truthful and non-misleading statements made by drug makers regarding the off-label use of their prescription drugs are protected by the First Amendment, a New York federal judge has ruled.

In an Aug. 7 order, Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York ruled that the Food and Drug Administration may not bring misbranding charges against Amarin Pharma Inc. regarding off-label statements it makes regarding its fish oil Vascepa drug.

Amarin, a New Jersey-based biopharmaceutical company, developed Vascepa to improve cardiovascular health. In July 2012, the FDA approved the drug for …