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Impact Of Risk Evaluation And Mitigation Strategies On Generic Approvals Of US Pharmaceutical Products
Jennifer Kao1, Victor L Van de Wiele2, Reed F Beall3
1Jennifer Kao, University of California Los Angeles, Los Angeles, California.
Health Affairs (Project Hope)
|October 6, 2025
Summary
Risk Evaluation and Mitigation Strategy (REMS) programs may delay generic drug approvals. Our study found REMS were associated with a 25% delay, impacting access to affordable medications.
Area of Science:
- Pharmaceutical Sciences
- Health Policy
- Regulatory Science
Background:
- Risk Evaluation and Mitigation Strategy (REMS) programs are mandated for high-risk medications to balance benefits against potential risks.
- Concerns exist that REMS implementation may inadvertently hinder the timely market entry of generic drug alternatives.
Purpose of the Study:
- To investigate the impact of REMS programs on the approval timelines of generic medications.
- To quantify the delay, if any, in generic drug approvals attributable to REMS.
Main Methods:
- Analysis of a dataset comprising novel small-molecule drugs approved between 2000 and 2013.
- Linking initial drug approvals to subsequent generic drug approval dates up to 2024.
- Statistical modeling to control for factors including patent length, approval timing, indication, boxed warnings, orphan drug status, and drug utilization.
Main Results:
- The presence of a REMS program was significantly associated with a 25% delay in generic drug approval.
- This delay was observed after accounting for various confounding variables related to drug characteristics and market factors.
Conclusions:
- REMS programs, while crucial for drug safety, appear to introduce a notable delay in generic drug accessibility.
- Findings suggest a need for regulatory strategies to streamline generic approvals without compromising patient safety for high-risk medications.
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