The U.S. FDA’s intended use rule has been in flux for the past half-decade, with yet another draft rule making the rounds for comment. Despite any concerns that speech regarding off-label use might again be seen as a primary driver of prosecution, Sara Bloom, senior litigation counsel at the U.S. Department of Justice’s District of Massachusetts office, said distribution of the product in question is frequently the key feature where federal prosecutors are concerned. Bloom said communication of off-label use often serves primarily as a confirmatory element of the manufacturer’s intent rather than as the decisive part of the prosecution’s case.