Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling

A landmark appeals court ruling that the government cannot prosecute pharmaceutical manufacturers under the FD&C Act’s misbranding provisions solely for off-label promotion likely will reshape the FDA and Justice Department’s approach to bringing such actions but will not foreclose them, industry attorneys say.

In a 2-1 opinion issued Dec. 3, a panel of the Second Circuit U.S. Court of Appeals said the government cannot prosecute manufacturers or their representatives under the...