The acronym REMS stands for Risk Evaluation and Mitigation Strategy, a component of approval that may be required when the FDA determines that additional information beyond prescribing information is necessary to ensure that the benefits of a drug outweigh its risks. Authorized under section 505-1 of the FD&C Act, a REMS may include any or all of the following:
- A Medication Guide (or patient package insert) to provide risk information to patients;
- A communication plan to disseminate risk information to health care providers;
- A variety of Elements To Assure Safe Use (ETASU) – examples of ETASU include requirements that health care providers who prescribe the drug have particular training or experience, that patients using the drug be monitored, or that the drug be dispensed to patients with evidence or other documentation of safe-use conditions.
Fortunately there are guidances available to assist sponsors when the agency has notified them their drug requires a REMS. The draft guidance Development of a Shared System REMS provides information on how sponsors of an ANDA may work with the sponsor of the Reference Listed Drug and related drug product sponsors to develop a Single Shared System (SSS) REMS (consisting of a single set of REMS materials that cover more than one drug product). The benefits of such a single system for patients and providers using the various drug products are obvious. The draft guidance Waivers of the Single, Shared System REMS Requirement explains the factors FDA will consider in evaluating a request for a waiver of the SSS requirement and makes recommendations on the content of waiver requests. Finally, the draft guidance Survey Methodologies to Assess REMS Goals That Relate to Knowledge explains how to conduct REMS assessment surveys to evaluate patient and provider knowledge of REMS-related information. Every proposed REMS must be routinely assessed for whether the strategy is meeting its goals or whether it should be modified, and those assessments must be submitted to the agency on a preapproved schedule.
FDA nerds wishing to read more details about the application of the REMS program should refer to MAPP 6703.1, Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures (issued by the Office Of Surveillance AND Epidemiology). The MAPP gives specific details on the administration of the program that can be useful in sponsor assessments of business risk around agency interactions on REMS.
Text Copyright © 2019 Katrina Rogers