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FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.

While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.

To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to:

• Decrease unnecessary exposure to prescription opioids and prevent new addiction;
• Support the treatment of those with opioid use disorder;
• Foster the development of new and effective pain therapies; and
• Take action against those who contribute to the illegal importation and sale of opioid products.

Part of our regulatory authority efforts include requiring Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.

Today, we took further steps to strengthen the REMS program for...