First Amendment Suit From Pacira Challenges FDA Labeling Interpretation

Following in Amarin Pharmaceuticals Inc.’s footsteps, Pacira Pharmaceuticals Inc. is trying to bypass FDA and get a court ruling okaying its promotion of the post-surgical pain treatment Exparel (bupivacaine liposome injectable suspension).

While Amarin was pursuing completely off-label speech – hoping to communicate data that FDA didn't approve – the question in the Exparel case involves FDA’s reading of the drug’s approved...