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.
Overdose Prevention Activities Timeline
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](/files/styles/medium_3/public/OpiodsWords_Supporting_1600x900_220714.png?itok=pDVZi6rO)
Supporting Primary Prevention
Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
![Encouraging](/files/styles/medium_3/public/OpiodsWords_Encouraging_1600x900_220714.png?itok=KO3G9oih)
Encouraging Harm Reduction
Encouraging harm reduction through innovation and education.
![Advancing](/files/styles/medium_3/public/OpiodsWords_Advancing_1600x900_220714.png?itok=rfPBYc3v)
Advancing Evidence-Based Treatments
Advancing development of evidence-based treatments for substance use disorders.
![Protecting](/files/styles/medium_3/public/OpiodsWords_Protecting_1600x900_220714.png?itok=tg2i3mmY)
Protecting the Public from Unapproved, Diverted, or Counterfeit Drugs presentin…
Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.