After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more
1/28/2016
/ Amarin ,
Anti-Kickback Statute ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Interstate Commerce ,
Jury Instructions ,
Medical Devices ,
Off-Label Promotion
On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
8/12/2015
/ Abbott Laboratories ,
Allergan Inc ,
Amarin ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs