FDA Considering OTC Naloxone Distribution

On November 15th, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, to facilitate the development and approval of nonprescription naloxone products. The notice includes a preliminary assessment stating that certain naloxone drug products of up to 4 milligrams nasal spray and up to 2 mg autoinjector for intramuscular or subcutaneous use may be “approvable as safe and effective for nonprescription use.” In the notice, FDA encourages manufactures to contact the agency to initiate discussions about switching from prescription to over the counter. To support its final determination, FDA requests additional data and comments on the safe and effective use of nonprescription naloxone hydrochloride injection and higher dose nonprescription naloxone products, the potential consequences of switching naloxone products from prescription to nonprescription, and the actions that FDA should consider to address any consequences. In a press release, FDA Commissioner Dr. Robert M. Califf said, “Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone. The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

Articles & Resources

Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments

FDA – FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

DEA Hosts Regional Summits for Fentanyl Awareness

Last week, the Drug Enforcement Administration (DEA) hosted a series of regional summits to hear from families who have lost loved ones to fentanyl poisoning and raise awareness of the dangers of fentanyl. The Family Summits, which build upon the inaugural summit held this past summer, provided an opportunity for DEA to learn from families about their experiences with fentanyl and to provide participants resources to support local fentanyl prevention efforts. During a Family Summit held in Washington, D.C., DEA Administrator Anne Milgram said “The passion, commitment and incredible work these families are doing to prevent others from experiencing the profound pain of losing a loved one to a fentanyl poisoning inspires all of us at DEA. They have made it their mission to save lives. Their efforts are, and will remain, an integral part of DEA’s outreach, prevention and education programs. The family summits are one of the ways DEA is working to meet this moment.”

Articles & Resources

DEA – DEA Joins with Families Across the Country to Increase Awareness about the Dangers of Fentanyl

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

CNN – Opioid Crisis Fast Facts

Forbes – Vaccine Targeting Effects Of Fentanyl Developed By Researchers—It Could Help Tackle Opioid Misuse

KTUL – Cherokee Nation fights opioid epidemic

Physician’s Weekly – West Virginia’s Opioid Crisis and Pain Management

PLOS Digital Health – Prescription quantity and duration predict progression from acute to chronic opioid use in opioid-naïve Medicaid patients

Scientific American – The Opioid Epidemic Now Kills More Black People Than White Ones because of Unequal Access to Treatment

STAT – Fentanyl isn’t just causing overdoses. It’s making it harder to start addiction treatment

STAT – Top U.S. addiction researcher calls for broad deregulation of methadone

The Hill – Lifesaving treatment can curb overdoses — Congress must act now

U.S. Department of Justice – Opioid Affected Youth Initiative Webinar: Trauma, Victimization, and Substance Use Disorder: Trends and Promising Practices to Facilitate Youth Resilience

Walmart – Walmart Announces Nationwide Opioid Settlement Framework

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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