REMS Myths and Facts
In 2007, Congress gave the Food and Drug Administration (FDA) the authority to use Risk Evaluation and Mitigation Strategies (REMS) in order to protect patients taking certain high-risk medicines. Yet, since then, the sense of urgency that led to these drug safety protections has been replaced by a number of misperceptions about the role of REMS in preserving patient access to medicines.
To help end the confusion, here are the up-to-date facts to dispel common myths about REMS.
[i] Soliris Prescribing Information. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM217725.pdf (Accessed September 29, 2015).