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# Changes Sought in REMS Logic Guidance
- URL: https://www.fdaweb.com/changes-sought-in-rems-logic-guidance/
- Published: 2024-08-14T12:00:00.000Z
- Updated: 2026-09-14T14:38:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157570

Pharmaceutical Research and Manufacturers of America (PhRMA) recommends that FDA revise its draft guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model to clarify several key elements. The PhRMA comment [letter](https://www.regulations.gov/comment/FDA-2024-D-1032-0006?ref=fdaweb.com) says that “many of the draft guidance’s recommendations are very broad and appear untethered to, and even inconsistent with, both statutory provisions regarding FDA’s REMS authority and existing regulatory practices for REMS submissions. The draft guidance also focuses on new REMS designed by following the logic model, as opposed to existing REMS for which the logic model may be less directly relevant, thus presenting the question of the extent to which the recommendations apply to existing programs. It also is unclear the extent to which, if any, FDA envisions the logic model being integrated into regulatory submissions.”

PhRMA calls for these changes:

- align the draft guidance recommendations more clearly with FDA’s REMS authority concerning deciding whether a REMS is warranted, designing the program’s elements, and evaluating their effectiveness;
- revise the draft guidance to clarify how the recommendations should be integrated into the regulatory approval process and discuss their applicability to existing REMS;
- provide additional guidance on identifying thresholds and key performance indicators for a REMS;
- expand on aspects of the guidance about the evaluation phase; and
- revise the draft to provide more detail about the recommended mapping tool.

The REMS Industry Consortium [says](https://www.regulations.gov/comment/FDA-2024-D-1032-0005?ref=fdaweb.com) it “applauds FDA’s efforts to provide applicants with a framework that can be applied to the design, implementation, and evaluation of a REMS program to link the elements of that program with the intended outcomes.” The consortium organizes its comments on four issues: implementing the REMS logic model guidance; addressing challenges in providing a single framework to all REMS programs; establishing standardized criteria and objectives for REMS logic models; and promoting timely and consistent communication between FDA and applicants.