FDA issues two guidances related to shared system Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) issued two guidances today related to shared system risk evaluation and mitigation strategies (REMS). A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage risks associated with a drug. Under section 505-1 of the Food, Drug, and Cosmetic Act, the FDA has the authority to require a manufacturer to develop a REMS when the FDA determines it necessary to ensure that the benefits of a drug outweigh its risks.  REMS programs can be important mechanisms to mitigate serious risks and bring drugs to market that otherwise would not be approvable.  REMS can also be complex and challenging to establish and run. FDA is issuing two guidances designed to help industry navigate these challenges: Development of a Shared System REMS and Waivers of the Single, Shared System REMS Requirement.  These guidances are designed, respectively, to provide recommendations on the development of a shared system REMS, and to clarify for industry under what conditions FDA will consider granting a waiver of the statutory requirement that an applicant for a generic drug, and its reference listed drug, use a single shared system for a REMS with elements to assure safe use (ETASU), as well as the process for submitting such a request to the FDA.  Please see the Commissioner’s Statement for more information. Other REMS-related guidances that may be of interest include:  Guidance for Industry: Use of a Drug Master File (DMF) for Shared System REMS Submissions - Use of the DMF is an efficient method for sponsors to coordinate the submission of shared system REMS-related files to FDA. Revised Draft Guidance for Industry on Format and Content of a Risk Evaluation and Mitigation Strategy Document -  This guidance establishes a new REMS document template, designed to make a REMS document easier to write, review and read.  FDA’s Application of Statutory Factors in Determining When a REMS is Necessary. This guidance explains FDA’s current application of previously articulated risk management principles and considerations under the REMS regulatory paradigm.