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...
If The ‘SIUU’ Fits: The New Vocabulary Of US FDA ‘Off-Label’ Policy
An updated US FDA policy governing dissemination of ‘off-label’ journal reprints and other scientific communications suggests the agency feels on firmer legal ground to reaffirm some guardrails. It also expands the regulatory vocabulary to include ‘scientific information on unapproved uses,’ or SIUU.
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.