This article describes the evolution of Risk Evaluation and Mitigation Strategy (REMS) from a safety program to an enforcement tool. The potential pitfalls related to promotional activities are exacerbated by the statutory tools and public health implications associated with REMS. Companies should take heed of two cases that resulted in multi-million dollar payments and criminal charges for failing to follow FDA-imposed REMS requirements. Given the powerful resources avai...

Due to multi-million-dollar (and sometimes billion-dollar) settlements, the vast majority of headlines regarding off-label promotion cases in recent years have involved drugs. Although less prominent, the US Food and Drug Administration (FDA) has steadily continued to act against medical device manufacturers for the same conduct, mostly in the form of Warning Letters. Between 1 May 2012, and 30 April 2013, FDA's Center for Devices and Radiological Health issued 24 Warning...