Update: On March 9, 2016 FDA and Amarin reached a settlement of the issues:
"On March 8, Amarin filed a proposed Stipulation and Order of Settlement, resolving its constitutional and other claims. The proposed settlement requires FDA to be bound by the determinations in Amarin Pharma and, further, to “contact Amarin with specific concerns or objections [regarding] proposed communications about the off-label use of Vascepa that Amarin has not yet communicated to doctors in promotion . . . .” Amarin, meanwhile, must “assur[e] that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.”*
To: Vitamin Consultancy Contact List:
Amarin Pharma vs FDA
Injunction Issued 07 August 2015
United States District Court
Southern District of New York
"[T]ruthful and non-misleading commercial speech is constitutionally protected…"
Off-label pharmaceutical claims get First Amendment protection. What about structure & function or health claims for nutrients? Can FDA discriminate against nutrients because they are not FDA-approved, but rather grandfathered under DSHEA? Articles from the FDA Law Blog and from Nat Law Review explore the Amarin case. After reviewing the Injunction and several reports on it, I am of the opinion that “off label” use for Dietary Supplements cannot be prevented by FDA, so long as the claims are carefully presented as substantiated but not conclusive. That does not mean you can claim to “treat disease.” It does mean that social media chatter and consumer review marketing can now be a bit more adventurous…
Further, Nat Law Review noted:
And note especially the last sentence here:"In a clearly worded rebuke of FDA’s efforts to limit Caronia to the facts of that case, the Court made clear that Caronia meant what it said: “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” Caronia, 703 F.3d at 168-69. The court found that the FDA’s June 5th letter had not mooted the case and controversy before the court, slip op. at 42, noting that Amarin had never agreed to – and was not required to agree to – FDA’s proposed restrictions limiting communications on the use at issue to, inter alia, communications initiated by doctors, communications in “scientific” settings and communications not made by sales staff, noting that the reasons given in Caronia “apply across the board to all truthful and non-misleading promotional speech.” Slip op. at 51."
See more at: http://www.natlawreview.com/article/federal-court-grants-first-amendment-injunction-amarin-case#sthash.FMiQCarX.dpuf
The Court noted: