First Amendment: Green Light to Off-Label Statements

First Amendment Free Speech-Federal Ct. Gives Green Light to Off-Label Statements

Amarin Pharma Inc v. U.S. Food and Drug Administration, Southern District of New York, No. 1:15-cv-3588. The link to the court opinion is below. It is important to review the Complete Response Letter FDA sent April 27, 2015 to Amarin and relied on by the court.

A New York federal judge ruled August 7 that Amarin Pharma Inc. has a constitutional right to make certain truthful and non-misleading statements about off-label uses of the omega-3 drug Vascepa thus impacting on FDAs restrictions on product marketing of unapproved uses for drugs. In its Complaint for the preliminary injunction, Amarin set forth that the statements were intended for healthcare professionals. This is the same circuit that decided Caronia. The Caronia decision was discussed and or referenced about 88 times in the opinion.

Federal U.S. District Judge Paul A. Engelmayer granted Amarin Pharma Inc.’s motion for a preliminary injunction. The court ruled on August 7 that the company can make certain statements about Vascepa’s potential benefits for patients with “persistently high triglycerides” as long as the statements are truthful and non-misleading.

Issues Raised and Next Steps- What should FDA do? Should FDA “look the other way and turn its back” and permit such off-label statements as long as they are truthful and non-misleading? Should FDA revisit off-label restrictions? Should FDA determine a less arduous approach to approvals of a new use for an already approved drug product ? Should FDA and industry as stakeholders collaborate-and if so how? There are no crystal clear straightforward solutions. In the end, FDA still must uphold the tenets of the Federal Food, Drug and Cosmetic Act which is to protect the public.

Link to Court Opinion Amarin Pharma, Inc. V. U. S. FDA

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