4/4/16: Off-label marketing has been a common enforcement target for DOJ and the FDA, with prosecutions racking up billions of dollars for the US treasury. A recent settlement between FDA and Amarin Pharmaceuticals is likely to change the way life science companies market their products. Until the Amarin settlement, companies were prohibited from promoting their products for any use not specifically approved by FDA (“off-label”). The settlement with FDA opens the door to promoting products for uses beyond their FDA approvals within specific parameters. Click below for more information about the case and what it will mean to life science companies.
