Amarin Corp Plc (AMRN)

[ggwpq]

Another article on 1st case,

"The third communication provision sets a deadline for the FDA's repeatedly delayed further guidance on off-label communication. Related to that, in the New York courtroom last Tuesday, off-label enforcement was the point of discussion. The argument did not go well for the FDA as the agency staunchly defended existing off-label marketing restrictions and refused to set a timetable for issuing guidance.

There, eminent First Amendment litigant Floyd Abrams argued for the plaintiff, drugmaker Amarin, that the court should file a preliminary injunction restraining the FDA from enforcing certain off-label restrictions on Amarin's marketing communications. The Amarin court challenge was set up by two major federal court decisions casting doubt on the constitutionality of off-label restrictions: the 2010 US Supreme Court decision, Sorrell v. IMS Health, striking limits on drug marketing in Vermont; and the 2013 federal appeals decision, US v. Caronia, invalidating the conviction of a drug detailer for sharing truthful and non-misleading information that was off-label.

Early in the argument, Abrams stipulated that Amarin intended to engage in proactive, promotional, off-label speech. Much of the subsequent discussion turned on what disclaimers needed to accompany that speech, not whether Amarin has a right to speak.

Later, the FDA's lawyer argued for a very narrow interpretation of Caronia, emphasizing that the decision turned on a faulty jury instruction. Paul Engelmayer, a federal judge for the US District Court for the Southern District of New York, disagreed, noting that the decision in his view stood for the proposition that truthful, non-misleading speech was constitutionally protected—even when it was proactive and promotional. A judicial order is expected within two to four weeks.

Bottom line, it was a good week for those seeking to expand treatment options to patients and to increase the communication about those options to clinicians. "

http://www.mmm-online.com/legalregulatory/21st-century-cures-amarin-court-case-advance/article/425992/