A CRO managing a Shared System Risk Evaluation and Mitigation Strategies (REMS) sought ICON Regulatory Consulting Services’ support. Since 2016, ICON was contracted to establish and maintain a Type V Drug Master File for this client. This included maintenance, publishing and submission of major and minor amendments. The Shared System REMS included four innovative products and 200 generics of a prophylactic treatment to prevent post-operative complications in a specific patient cohort. In 2020 the FDA published new guidance on electronic formatted structured product labeling (SPL) which would become required for REMS documents from December 2022. The client asked ICON to prepare the REMS SPL in anticipation of the new requirements.

This was a new submission type with unique data elements not seen in traditional drug listing SPLs such as Elements to Assure Safe Use (ETASU) found within the REMS document. These elements had to be adapted to fit into the new specifications of the REMS SPL. The REMS SPL also requires additional information including a list of the applicants, approved applications and drug listings of the products that are covered by the REMS. While the FDA provided a sample with examples there was no full technical guide at the time. Only a few REMS SPLs had been submitted by this point and none had belonged to a Shared System REMS. The available software could not handle every new FDA REMS requirement. 

ICON’s Regulatory team prepared the SPL, manually coding the required SPL information when necessary. The documentation was quality checked before being disseminated to the client CRO. Close collaboration between ICON and the client ensured that feedback from the shared systems’ sponsors was gathered to ensure complete accuracy before sign-off. ICON shared the draft with the FDA to identify and resolve validation errors or technical oversights on the submission. Additionally, ICON asked the FDA for manual overrides for errors that could not be fixed due to validation rule limitations at the time. 

After getting the go-ahead from the client, sponsors and FDA, ICON submitted the first Shared System REMS SPL to the FDA, 22 months ahead of the mandated deadline. This was the first submitted SPL under the new guidelines. ICON continues to provide the client with regulatory support on Type V Master File and REMS SPL for this project. ICON updates the SPL annually with a growing list of shared systems participants, products and approved applications. These details are captured on existing databases and maintained on an ongoing basis. Additionally, ICON provides technical support to the client for their own REMS SPLs.