This action by the FDA to make this naloxone product available without a prescription will pave the way for the life-saving medication to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
More Accessible Naloxone
"We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential health care," Health and Human Services Secretary Xavier Becerra said. "Today's FDA action to allow access to naloxone without a prescription is another strong step forward in advancing HHS's Overdose Prevention Strategy."
HHS's Overdose Prevention Strategy expands the scope of the crisis response and promotes groundbreaking research and evidence-informed methods to improve the health and safety of our communities. The Overdose Prevention Strategy helps advance the Biden-Harris Administration's National Drug Control Strategy, which delivers on the call to action in President Biden's Unity Agenda for a whole-of-government approach to beat the overdose epidemic.
Over the past year, HHS took unprecedented steps to expand access to naloxone and other harm reduction interventions, such as:
- Permitting the use of federal funding for state and local public health departments to purchase naloxone,
- Focusing on state development of naloxone saturation plans,
- Issuing guidance aimed at making it easier for harm reduction programs to obtain and distribute naloxone to at-risk populations, and
- Prioritizing the review of nonprescription naloxone applications as appropriate.
Decreased Overdose Reports?
As a result of these actions, the latest CDC overdose data show a steady decrease or flattening of overdose reports for seven months in a row. To build on this progress, HHS is focused on expanding access to naloxone, connecting more people with addiction to treatment, supporting people in recovery, and reducing the supply of illicit drugs like fentanyl.
With FDA approval of nonprescription Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, HHS will launch a department-wide approach to work with stakeholders to implement the Narcan switch from prescription to nonprescription status, facilitate the continued availability of naloxone nasal spray products during the time needed to implement the transition, and help ensure appropriate coverage and continued access to all forms of naloxone.
Saving More Lives
In addition to being used by healthcare professionals, naloxone is increasingly being distributed to first responders, and family members who may witness and respond to an opioid overdose.
The availability of nonprescription and prescription naloxone could help to further increase its distribution and accessibility, potentially saving more lives and reducing the burden of opioid overdose on individuals, families, and communities.