FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Generics Will Find it Harder to Implement REMS Reforms, AAM Says

April 11, 2019
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The FDA’s proposed guidance on Risk Evaluation Mitigation Strategies (REMS) will be much easier for brand-name drugmakers to implement than for generic manufacturers, the Association for Accessible Medicines said.

Sharing of safety data “can get very complex when the data has to be pooled among multiple sponsors within a class of products,” AAM said in a written comment on a draft REMS assessment guidance the agency issued in January.

As an example, the association pointed to the REMS for transmucosal immediate-release fentanyl. “One way the sponsors were able to mitigate data pooling issues was to list adverse events by product type rather than by product-specific basis,” AAM said, calling for agency guidance on how this type of data should be broken down in a way that will be useful for the agency but not overly burdensome to sponsors.

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