“The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision.” (Sheppard Mullin) Earlier this month, the Ninth Circuit issued an opinion that sends an important warning to pharmaceutical manufacturers: the First Amendment doesn’t protect off-label marketing… Read more »
“In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, ‘We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an… Read more »
Little known fact: apparently, you can also win a gold medal in trademark infringement at the Olympics. Of course, you likely won’t see much coverage of the event (Saturday morning at 7:30, squeezed between the lawn bowling and potato sack races?), but the U.S. and International Olympic Committees take very seriously any infringement upon their… Read more »
