Managing the Risks of Medicines: An Examination of FDA’s Application of Criteria for Requiring a REMS

In September 2016, the Food and Drug Administration (FDA) published a draft guidance for industry, FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, that detailed the factors the Agency considers in determining when a Risk Evaluation and Mitigation Strategy (REMS) is necessary. The objective of this study was to determine how the FDA has applied these criteria for newly approved drugs. For the 3-year period, 2015-2017, which included a full year of FDA approvals both before and after the issuance of the draft guidance, publicly available FDA reviews were analyzed for all 113 approved products using the criteria outlined in the guidance. Of the 113 products approved, 5 required a REMS. The most cited reasons for not requiring a REMS for the remaining 108 drugs were that risks could be managed via professional labeling (87%), physicians (primarily specialists) were familiar with the management of the risks (76%), the risk profile was similar to other non-REMS marketed products (45%), products were used in a controlled setting (inpatient, infusion center) (30%), and/or safety concerns would be further evaluated by a postmarket study (14%). A review of Agency risk evaluations indicate that whether physicians are sufficiently familiar with and capable of managing a risk and that the health care setting where the product is administered is conducive to such management are leading factors in determining whether or not to require a REMS