Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics | FDA

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics | FDA

Statement from Acting FDA Commissioner Ned Sharpless, M.D. and Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s benefit-risk framework for evaluating opioid analgesics

Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains a top public health priority for the FDA. The agency continues to take new steps to confront this crisis, while also paying careful attention to the needs of patients in accessing appropriate pain management. Opioids present unique challenges: they have benefits when used as prescribed yet have very serious risks and can cause enormous harm when misused and abused. We’ve had a robust public debate over the years, engaging the pain and addiction communities, academia, health care professionals and policymakers on developing a framework to help evaluate the benefit-risk considerations specific to prescription opioids that not only serves ...

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