Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling
Executive Summary
In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.
You may also be interested in...
False Claims Act Defenses Boosted By Amarin Decision, Attorney Says
First Amendment victory in off-label promotion case means criminal penalties and successful private qui tam actions could be less likely.
FDA May Cut Its Losses In Amarin Off-Label Promotion Case
Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.
FDA May Cut Its Losses In Amarin Off-Label Promotion Case
Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.