Off-Label Promotion Seems On Track: Judge Supportive Of Amarin, Skeptical Of FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Oral arguments didn't go particularly well for the agency in its effort to limit what Amarin can tell doctors about unapproved use of Vascepa.
You may also be interested in...
FDA First Amendment Litigation: Will Amarin Case Break The Log Jam?
Courts have issued mixed rulings in cases challenging FDA restrictions on drug promotion, but with oral arguments set for July 7, Amarin’s suit could provide a definitive answer on what companies can tell physicians.
Teva’s ‘Skinny Label’ Dispute Edges Toward Supreme Court With Government’s Backing
US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after missed prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.