How to Deal with Changes to Third-Party Vendors?

Recommendation

5/6 June 2024

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The FDA is requesting feedback on factors the agency should consider in relation to modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors ("REMS administrators"). In particular, the agency is interested in feedback on any input drug companies should receive and consider before implementing such changes. Comments can be submitted either in electronic or written form by 21 July 2023.

Background

A REMS is a required risk management strategy that employs tools beyond prescribing information to ensure that the benefits of a drug outweigh its risks. A REMS may include, for example, a Medication Guide to provide risk information to patients. The FDA may also require certain elements to assure safe use (ETASU) to mitigate a specific serious risk listed in the drug labeling. When applicants develop a REMS with ETASU they often involve third-party vendors to design operational components. These third-party vendors may perform a variety of tasks for the REMS program, including building and operating a centralized database or repository (e.g., website or web portal), and they provide the technological means for pharmacies and other dispensers to perform the necessary verifications at the point of dispensing. Thus, in many cases, the "REMS administrator" performs critical tasks which directly impact patient access to the drug.

FDA's Request for Comments

An applicant's decision to change a "REMS administrator" may affect the whole REMS system including the potential to cause significant disruptions in the operations of the program. The FDA is therefore in particular interested in receiving comments on the following topics:

• Input that the applicant and/or REMS administrator should obtain prior to developing and implementing a new REMS system.
• Whether the sponsor and/or REMS administrator should conduct testing of the changes to the operation of the REMS system prior to full implementation (e.g., user acceptance testing and assessment of REMS data flows, including whether REMS data from the existing REMS system can be timely and successfully transferred to a new REMS system).
• Amount of time needed to transition actors (e.g. patients, prescribers, pharmacies, and wholesalers) from one REMS system to another REMS system, and the factors that go into that time frame.
• Whether the sponsor and/or the REMS administrator should conduct a Failure Modes and Effects Analysis (FMEA) to identify and plan for system failures. This includes providing for adequate support services in the event that the system fails to work as intended following full implementation of the new REMS system.
• Metrics that the sponsor should capture to evaluate whether the REMS system was successfully and efficiently implemented.

More information is available at FDA's website in Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies; Establishment of a Public Docket; Request for Comments.