WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is working to prevent drug overdoses and reduce deaths caused by substance use disorder. This is a big problem in the United States that affects many people and families. In August 2022, the FDA announced its Overdose Prevention Framework, which includes new actions to prevent drug overdoses and reduce addiction.

The FDA has commissioned a report from The Ohio State University to review its work in preventing opioid-related deaths and reducing addiction. The report recommends that the FDA continue implementing the recommendations made by the 2017 National Academies for Sciences, Engineering, and Medicine (NASEM) report, consider seeking additional authorities from Congress to review the advertising and promotion of opioid products and increase transparency to promote public trust.

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The FDA is already taking steps to combat this emergency, including strengthening evidence generation, holding advisory committee meetings to evaluate the long-term efficacy of opioid analgesics, and exploring the need for new authorities for opioid approval standards. The FDA is also working with multiple partner organizations to better understand and combat the opioid crisis.

The FDA’s efforts are focused on opioid regulation by the Center for Drug Evaluation and Research, but all elements of the agency are involved in this effort. The FDA is committed to preventing drug overdoses and reducing addiction in the United States.

  • According to the Centers for Disease Control and Prevention (CDC), there were 93,331 drug overdose deaths in the United States in 2020.
  • This represents a 29.4% increase from the 72,151 overdose deaths that occurred in 2019.
  • Synthetic opioids (primarily illicitly manufactured fentanyl) were the primary driver of the increase in overdose deaths, accounting for 69.5% of all overdose deaths in 2020.
  • Overdose deaths involving cocaine and psychostimulants such as methamphetamine also increased in 2020.