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Letter to the FDA Opposing Marketing Authorization of AvertD for Identifying Patients at Increased Genetic Risk of Opioid Use Disorder

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In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA to deny marketing authorization for AvertD — and any future marketing applications for similar genetic tests for assessing opioid use disorder (OUD) risk — because the device has no clinical utility for predicting the risk of developing OUD, and it relies on the false and dangerous assumption that there is a subset of patients at high risk of developing OUD who can be readily identified.

December 19, 2022, FDA response letter.