FDA Guidance Offers Important REMS Definitions

FDA Headquarters

A new guidance from the U.S. Food and Drug Administration (FDA) provides the agency’s latest thinking on how it defines the types of changes to approved risk evaluation and mitigation strategies (REMS) for the monitoring of medications with a high potential for serious adverse effects, how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.

The guidance drills down on what types of changes to REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS (changes that may be implemented following notification to the FDA).

A REMS is a required risk management plan that uses tools beyond the prescribing information (the package insert) to ensure that the benefits of certain drugs outweigh their risks. If the FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh its risks, the agency is authorized to require a REMS for such drugs under section 505-1 of the Food, Drug, and Cosmetic (FD&C) Act. Section 505-1(g) and (h) includes provisions regarding the assessment and modification of an approved REMS.

An application holder may propose a REMS modification at any time. In addition, when the FDA determines that a modification of a REMS is necessary to ensure that the benefits of a drug outweigh its risks or to minimize the burden on the healthcare delivery system of complying with the REMS, the FDA has the authority to require that the application holder submit a proposed modification to a REMS under section 505-1(g) of the FD&C Act.

Author: Michael Causey