Do REMS Really Work?

By Bart Cobert

Risk Evaluation and Mitigation Strategies (REMS) have been in place in the US for nearly five years and questions are now being asked whether they are achieving what they were designed for, namely, making drug use safer. The question is particularly striking in light of the changes that the European Union has put in place with their Risk Management Plans (RMPs) in the new Good PV Guidelines. These changes have made an already long, complex and detailed document into one that is even longer, more complex and hyper-detailed. There are questions raised in the EU whether this is overkill but that is not the topic for discussion here.

US REMS are actually rather simple. Firstly, not all drugs require them whereas in the EU all new and eventually all old drugs require some degree of an RMP. REMS basically come in three flavors (I simplify slightly):

• Medication Guides (MedGuides ) and/or Patient Package Inserts
• Communication Plans (Dear Doctor or Dear Health Care Provider letters and perhaps other communications through professional societies)
• Elements to Assure Safe Use (called ETASUs pronounced ee-tasooz)