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Addiction Policy Forum endorses OTC Naloxone; Presents to the FDA

APF Executive Director Jessica Hulsey spoke before a Joint meeting of the Nonprescription Drugs and the Anesthetic and Analgesic Drug Products Advisory Committees on an application to offer naloxone over-the-counter on Wednesday, February 15, 2023. The Committees voted unanimously to recommend that the US Food & Drug Administration allow Narcan to be sold without a prescription.

Addiction Policy Forum voiced support for accessing naloxone over-the-couter, which could help expand access to the lifesaving medication nationwide. Jessica also raised several areas of concern from the patient, caregiver and practitioner community, including:

  1. Supplement not supplant. Ensure that the shift to over-the-counter does not affect the funding and resources for free naloxone and active distribution of naloxone to at-risk populations and key professionals and stakeholders, including harm reduction programs handing out naloxone to at-risk clients, hospitals or emergency departments, and distribution to individuals released from prison and jail.

  2. Affordability. Given the prevalence of fentanyl in most illicit drugs, multiple doses of naloxone are frequently required to reverse an overdose. This creates a significant financial barrier for most American households. We urge FDA and industry to ensure that the price point does not create a financial barrier for American families.

  3. Linkage to care. The current Opioid Education and Naloxone Distribution (OEND) systems funded nationwide makes free naloxone available to families and friends, to first responders, jails and prisons to harm reduction organizations. The distribution system creates a “touchpoint” with a healthcare professional, addiction specialist, or well-informed volunteer. Naloxone is lifesaving. It is a critical step to saving a life, but must include follow-up with treatment to prevent another overdose and connect the individual with care.

Prior to the Joint meeting, the Addiction Policy Forum held a Stakeholder Listening Session comprised of addiction psychiatrists, individuals in recovery, family members, corrections and criminal justice practitioners, and harm reduction leaders to collect feedback from diverse perspectives in the field.

Hulsey's comments were quoted in a New York Times article:

"The price of the drug and insurance coverage were not issues before the panel, but they were raised during the public comments section of the hearing. Jessica Hulsey, the executive director of the Addiction Policy Forum, said that over-the-counter availability of Narcan should not replace funding for distribution of free Narcan to people who use drugs, especially those in high-risk populations, including prisoners.

She also raised concern about how Narcan would be showcased on the shelves. “Will it be behind the counter at a pharmacy?” she asked. “In lockboxes with razors and other products?” she added, pointing out that such placements could further stigmatize Narcan and its potential customers.

Ms. Hulsey noted that, with the probable widespread release of the spray, staff at pharmacies and supermarkets should be trained in how to treat Narcan customers respectfully, not only to help dispel stigma but to encourage purchases of the lifesaving medication."

The FDA is expected to make a final decision by March 29.


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