Kendall Warden, Belmont Law, Class of 2024
On February 15, 2023, a federal advisory committee voted unanimously in favor of converting Narcan, the overdose reversal drug, from prescription to nonprescription status. The committee consisted of members of the Nonprescription Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, whose advisory opinions, although not binding upon the FDA, are usually followed.
Narcan, otherwise known as naloxone hydrochloride, is a lifesaving drug used to reverse known or suspected overdoses. Narcan injections have been used since 1971 as an opioid reversal agent in both hospitals and under health care provider supervision. Narcan Nasal Spray has been used as a prescription product for community use programs since 2016. Community use programs are typically without a patient-specific prescription requirement and designed for administration by individuals without medical training. However, community use programs are not the same as nonprescription use because they come with additional instructions and patient counseling.
The impact of the opioid crisis has been felt throughout the United States. Both accidental and intentional opioid overdoses have contributed to a major public health crisis and caused more than a million deaths. Between the years of 1999 and 2016 almost 9000 young adults passed away from opioid overdoses. 80,926 deaths occurred from opioid overdoes in 2021, up from more than 69,000 deaths in in 2020. Moving Narcan into nonprescription status would be a huge step forward for opioid overdose prevention efforts. Creating nonprescription options for Narcan will allow for greater distribution of the life sabing product which in turn will, hopefully, decrease the number of premature deaths stemming from opioid overdoses.
Currently, the prescription status drug is only available through a pharmacy or community distribution program. In order for Narcan Nasal Spray to transition into nonprescription status the FDA must find that the prescription requirement is no longer necessary for public health protection. To do so, the FDA must establish sufficient data to determine the drug can be used safely without the assistance of medical professionals.
The biggest obstacle for full FDA approval is the concerns raised about Narcan’s confusing packaging and instructions. These concerns were raised by participants in past studies by Emergent BioSolutions, the company whose Narcan nasal spray is up for approval. Although the company has pledged to revise the packaging and instructions to address the issues, it is possible the FDA could send the revised product back to the testing stage in order to meet the “sufficient data” standard. However, advocates are pushing for the FDA to quickly implement the advisory committee’s recommendation to align with the FDA’s Prescription Drug User Fee Act goal date of March 29, 2023.
Sources:
- https://www.americanbar.org/groups/health_law/section-news/2023/february/fda-advisory-committee-unanimously-votes-in-favor-of-switching-narcon-to-over-the-counter-status/
- https://www.fda.gov/media/165338/download
- https://www.pharmacytimes.com/view/fda-advisory-committees-recommend-naloxone-be-available-otc