FDA previews 2019 plans to address opioid epidemic

Food and Drug Administration Commissioner Scott Gottlieb, M.D., yesterday announced the agency’s 2019 agenda to address the opioid epidemic. Among other actions, the agency is considering using its authority under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 to mandate short-duration packaging for outpatient dispensing of certain solid, oral dosage forms of immediate-release opioid analgesics to treat acute pain, and require manufacturers to develop technologies such as mail-back pouches to dispose of unused opioid medications. FDA also plans to announce changes to strengthen the Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl medicines, and issue updated guidance to promote the development of non-opioid drugs to treat pain.