Subsys Makes A Bad Impression On FDA REMS Panel Members

CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.

FDA’s advisory committee review of the transmucosal immediate release fentanyl (TIRF) risk evaluation and mitigation strategy was a mixed bag of observations, recommendations, and opinions, but one thing was clear: Subsys made a bad impression on the panel.

The TIRF REMS has been viewed as a model of how other class-wide or shared REMS could work. The tone of this meeting was very different. It featured varying opinions on everything ranging from “hard-wiring” requirements to ensure only cancer patients can access the drugs to the duration and rigor of education prescribers should be given as part of the certification program mandated by the REMS

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