Food and Drug Administration Overdose Prevention Framework
Overdose Prevention Activities
- FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
- FDA approves risk evaluation and mitigation strategy (REMS) modification, advancing new drug disposal option for opioid analgesics
- FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
The FDA Overdose Prevention Framework consists of four overarching priorities that align with the U.S. Department of Health & Human Services' Overdose Prevention Strategy to address the public health emergency as it continues to evolve. The overdose crisis is an evolving public health crisis; as such, FDA continues to evaluate our approach and make adjustments according to the latest available science and data.
FDA Overdose Prevention Framework
FDA’s Overdose Prevention Framework Priorities
- Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
- Encouraging harm reduction through innovation and education.
- Advancing development of evidence-based treatments for substance use disorders.
- Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.
Chronological information about significant FDA activities related to substance use and overdose prevention.
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare & Medicaid Services (CMS)
- Customs and Border Protection (CPB)
- Drug Enforcement Administration (DEA)
- Indian Health Service (IHS)
- Health & Human Services (HHS)
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Veterans Affairs (VA)
FDA Priorities
Supporting Primary Prevention
Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
Encouraging Harm Reduction
Encouraging harm reduction through innovation and education.
Advancing Evidence-Based Treatments
Advancing development of evidence-based treatments for substance use disorders.
Protecting the Public from Unapproved, Diverted, or Counterfeit Drugs presentin…
Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.