BRIEF—FDA issues final Guidance on REMS

April 8, 2019

The US Food and Drug Administration on Thursday 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 the 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 the 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This guidance finalizes the draft guidance, “FDA’s Application of Statutory Factors in Determining When a REMS is Necessary,” issued in September 2016. The FDA considered all the public comments received on the draft and made clarifying edits.

The comments were mainly related to how the FDA weights the six factors when determining if a REMS is necessary, how the agency applies the six factors, and recommending that the FDA expand on which REMS elements or tools sponsors should use when the agency determines that a REMS is necessary.

Additionally, the FDA made edits to streamline the guidance, removed extraneous background information, and modify the title for clarity.