On August 7, New York Federal Judge Paul A. Engelmayer granted Amarin Pharma Inc. (Amarin) a preliminary injunction “to ensure its ability to engage in truthful and non-misleading speech free from the threat of a misbranding action” by the Food and Drug Administration (FDA).
Amarin had brought a First Amendment challenge to FDA regulations that prohibit Amarin from making truthful statements about its product, Vascepa, to health care professionals. As the court held, even though FDA has approved Vascepa for one use, physicians have widely, and lawfully, prescribed the product for another; Judge Engelmayer acknowledged the widely recognized value of such off-label uses.
The FDA was not eager to test the First Amendment waters. In its June 8th letter responding to Amarin’s lawsuit, the agency attempted to dodge the constitutional challenge with a qualified acceptance of parts of Amarin’s proposed speech, recognizing it is permissible under the existing FDA guidelines. Now District Judge Engelmayer confirmed that the “FDA may not bring [a misbranding] action based on truthful promotional speech alone, consistent with the First Amendment.” (emphasis in the original)
For an in-depth analysis of the decision please read our colleagues’ post, “Amarin wins injunction against FDA over off-label marketing” on Norton Rose Fulbright’s The Brand Protection Blog.