Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced. It remains the biggest public health crisis facing the FDA. The toll of addiction, in lost lives and broken families, touches every community in America. Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.

At the FDA, we’ve worked to learn from past mistakes, and we intend to make sure that we’re acting forcefully enough to address new threats that could extend this crisis. Addressing the opioid crisis is a top priority of the Secretary of Health and Human Services and the entire Administration. The FDA is a key part of that effort.

We’re a deliberative, science-based agency. We calibrate our policy and regulatory actions carefully, based on rigorous evidence that can often take many months and even years to collect. This defines our gold standard for regulatory decisions. But given the scope of this crisis, and its human toll, we’ve committed to act more quickly as we confront new risks. We’ve changed our approach and are taking a much more aggressive approach to regulatory action. At the FDA, we’ve committed to taking more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl that’s contributing to overdose deaths, or the continued prevalence of prescriptions being written for durations of use that are too long for the clinical circumstances for which they’re intended. We’ve changed the way we’re tackling these issues and stepped up our intervention when it comes to opioids. In this epidemic, waiting for the accumulation of definitive evidence of harm left us a step behind a crisis that was evolving quickly, and sometimes furtively, in vulnerable communities that were too often being tragically ignored.

To address this crisis differently, and more definitively, we’ve taken decisive steps in recent years, and have additional actions already underway for 2019, with more steps planned to begin this year.

For more information, please visit: 2019 Priorities for Combatting Opioid Epidemic.