Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments

The Association for Accessible Medicines (AAM) acknowledges the efforts of the Food and Drug Administration (FDA, or the Agency) on Docket Number FDA-2017-N-2903 regarding exploring present and future capabilities to evaluate the effectiveness of abuse deterrent opioids in the post market setting. As discussed further below, AAM commends the Agency for its ongoing efforts in mitigating the risk of misuse and abuse of prescription opioids, and offers several suggestions regarding this important public health issue.