Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic

The US Food and Drug Administration (FDA) plays an important role in addressing the ongoing challenge of opioid abuse.¹ The agency is strongly committed to taking forceful action to address this public health crisis²—as reflected by FDA’s recent move to request that an oxymorphone formulation (Opana ER, Endo Pharmaceuticals) be taken off the market.³ Opioids present unique challenges: they have significant benefits when used as prescribed, yet cause enormous harm when misused and abused. Recognizing these challenges, FDA has been taking specific steps to ensure that decisions are science-based and made within a benefit-risk framework that evaluates not only the outcomes of prescription opioids when used as prescribed, but also the public health effects of inappropriate use. By ensuring that FDA’s decision-making tools are properly matched to the reality of how opioids are used—and misused or abused—the agency can do more to confront the crisis.