FDA announces final Guidance on REMS: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary

Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled "REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary."  This guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several developed to fulfill performance goals that FDA agreed to satisfy in the reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act (PDUFA) V). 

This guidance finalizes the draft guidance, “FDA’s Application of Statutory Factors in Determining When a REMS is Necessary,” issued in September 2016. FDA considered all the public comments received on the draft and made clarifying edits.  The comments were mainly related to how FDA weights the six factors when determining if a REMS is necessary, how FDA applies the six factors, and recommending that FDA expand on which REMS elements or tools sponsors should use when the agency determines that a REMS is necessary.  Additionally, FDA made edits to streamline the guidance, removed extraneous background information, and modify the title for clarity. FDA thanks those who took the time to comment.