Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS

January 16, 2019 Becky Hurt

Authored by: Mwango Kashoki, Vice-President - Technical, PAREXEL® Consulting

The FDA can require a Risk Evaluation and Mitigation Strategy (REMS) for certain drug or biologic products, including generics, to ensure that the benefits of the drugs outweigh their risks.  Developers of generic drugs whose reference listed drug (RLD) has an approved REMS with elements to assure safe use (ETASU) are required to use a “single, shared system” with the RLD, unless FDA waives this requirement and permits the generic drug to use a separate, comparable REMS program.  Generic drug developers should be aware of the requirements for establishing a shared REMS with the RLD application holder and requesting FDA waiver of a shared system, and the potential challenges that may arise.  


The FDA’s recently published draft guidance for industry, Development of a Shared System REMS, outlines the agency’s recommendations for how application holders can develop these programs.  Whereas the guidance does not discuss the business and legal negotiations between generic and RLD application holders that are necessary to reach agreement on a shared system REMS, the guidance does set forth key principles and considerations, including:

  1. FDA’s definitions of and distinction between the statutorily mandated “single, shared system REMS,” and a general “shared system REMS”

  2. Circumstances in which a FDA considers a shared system REMS is indicated and/or would be beneficial

  3. FDA’s role during the development of a shared system REMS, and interactions with application holders during the process

  4. Timeframes for various milestones during the shared system REMS development process, and procedures for submission of the proposed REMS to FDA for review and approval

Occasionally, establishment of single, shared system REMS between a generic drug developer and the RLD holder is not feasible.  For example, negotiations over the REMS may stall or completely fail.  The FDA guidance, Waivers of the Single, Shared System REMS Requirement, describes the circumstances under which FDA will grant such a waiver, and the considerations the agency makes in so doing. 

While FDA emphasizes in the guidance that there are considerable benefits to having a shared system REMS and encourages companies to work together to form a shared system REMS, the FDA also stresses that negotiations over REMS development should not adversely delay the approval of generic drugs.  Therefore, very importantly, the guidance provides timeframes and procedures for a generic applicant to request a waiver and submit a separate, comparable REMS program to support approval of their abbreviated new drug application (ANDA) within the GDUFA timeframe. 

PAREXEL Consulting’s team of subject-matter experts can provide: key advice to drug companies on how to successfully strategize your submission to FDA and can assist companies to address any REMS requirements, including submitting requests for waivers of the shared REMS requirement. 

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