The Enforcement of Risk Evaluation and Mitigation Strategy (REMS)

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 available to the government, the key is to avoid scrutiny in the first instance. This
article provides tips on how to minimize risk for drugs subject to REMS.