Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

As the FDA continues to forcefully confront the opioid crisis, rationalizing prescribing practices and ensuring safe and appropriate use of these powerful medications remains a cornerstone of our efforts. More appropriate prescribing can reduce the rate of new addiction and mitigate the serious, and sometimes deadly, risks associated with opioids. To confront this crisis, we continue to use all facets of our regulatory authority. This includes requiring Risk Evaluation and Mitigation Strategy (REMS) programs to ensure the benefits of a medication outweigh its risks. In the context of opioids, these REMS programs and related requirements can in part help us strike a balance between reducing the rate of new addiction by decreasing exposure to ...