It’s the American Way? –

Jan. 6, 2020 – Over a period of several months, both the FDA and the DoD were either unwilling or unable to articulate to me how an opioid made it onto a list supposedly reserved for life-saving medical products, when acute pain is not a life-threatening condition. (Medications that manage chronic pain can indeed be life-saving for patients who might otherwise be driven to suicide over time, but Dsuvia’s whole thing is that it’s for very short-term use only; you’re not even supposed to take it home.) The DoD offered conflicting or off-topic answers or else punted to the FDA, which separately declined repeated requests for comment on how the terms of the collaboration applied to Dsuvia. A DoD representative variously emailed me that the Department had told the FDA the opioid was a priority item under the new collaboration, and that, “After checking, there was no formal request from DoD for expedited FDA action under that statute, but DoD strongly supports the FDA approval of Sufentinel [sic].”

Full Story @Gizmodo


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