Photo of Saul Perloff (US)

As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article.  Shortly afterward, Amarin and the government entered settlement talks.  August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin’s suit against the FDA.

On December 18, the FDA announced a long-anticipated proposed amendment to the prescription drug and biological product labeling regulations requiring electronic distribution of prescribing information intended for healthcare professionals. 79 Fed. Reg. 75506 (Dec. 18, 2014). Currently, this prescribing information