A landmark appeals court ruling that the government cannot prosecute pharmaceutical manufacturers under the Food, Drug & Cosmetics Act (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 December 3, a panel of the Second Circuit US Court of Appeals said the government cannot prosecute manufacturers or their representatives under the...