Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more
On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more
After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more
On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more
In a split decision today, a panel of the Second Circuit Court of Appeals overturned ? on First Amendment grounds ? the criminal conviction of a pharmaceutical sales representative who had promoted Jazz Pharmaceutical’s Xyrem...more