4 Issues To Watch In Amarin's Off-Label Marketing Suit

Law360, New York (May 12, 2015, 7:20 PM EDT) -- Amarin Pharma Inc.'s constitutional challenge to U.S. Food and Drug Administration restrictions on off-label marketing will explore important questions for False Claims Act suits and criminal punishment of drugmakers, including free speech rights and the FDA's duty to set clear rules before cracking down.

Here are four important issues to watch:

Caronia Clarity May Emerge

Amarin’s suit last week was filed in New York federal court, which falls under the jurisdiction of the Second Circuit. As a result, it could help to clarify the still-murky impact of the circuit’s 2012 ruling in U.S. v. Caronia, which found that a drug salesman was...

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