REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary — Final Guidance

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Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and mitigation strategy (REMS) is necessary. This guidance clarifies how FDA determines whether a REMS is necessary to ensure that a drug is used in a way where its benefits outweigh its risks.


A REMS is one tool that FDA can develop and utilize to preserve a drug’s benefits while reducing its risks to an acceptable level. For example, a REMS may require health care providers who prescribe the drug to undergo specialized training, or mandate that the drug only be dispensed to patients in certain health care settings, such as hospitals, where the patient can be closely monitored. If FDA determines that a drug’s risks would exceed its benefits even if a REMS is required, FDA will not approve the drug.

Six Factors

Section 505-1(a)(1) of the FDCA requires FDA to consider six factors when determining whether a REMS should be required: (1) The seriousness and nature of known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug. (2) The expected benefit of the drug with respect to the disease or condition. (3) The seriousness of the disease or condition to be treated. (4) Whether the drug is a new molecular entity. (5) The expected or actual duration of treatment with the drug. (6) The estimated size of the population likely to use the drug.

No single factor is determinative, and the relative weight of each factor is a case-specific inquiry. In addition to the six factors listed above, FDA will also consider the potential burdens that a REMS may impose on patients and health care providers, and whether a REMS can be designed that adequately minimizes those burdens


As noted by Regulatory Focus, FDA received six comments on the draft guidance. Commenters sought further information from the FDA on how it weighs the six factors when determining a REMS is necessary. Other comments included minor clarifying remarks on how the factors are applied and comments asking FDA to expand on which REMS elements should be used when it is determined a REMS is necessary.


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