Pharmaceutical companies' willingness and ability to engage in off-label promotion following Amarin Corp. PLC's First Amendment legal victory over FDA may depend upon the strength of the scientific evidence supporting the claims they wish to make and whether the agency has evaluated such data.
Off-Label Unleashed? Amarin Win Suggests Firms Still Need Strong Data To Skirt FDA
Court blesses combination of statements and disclosures that must accompany Vascepa promotions in a ruling that rejects FDA's narrow interpretation of 2012 Caronia case.