Nonprescription Naloxone: Update and Implications

While the Food and Drug Administration (FDA) has long prioritized availability of naloxone products, the agency has significantly ramped up its efforts to increase naloxone access in recent years. The first half of this session will focus on FDA’s actions and activities, ranging from engaging stakeholders through public meetings to facilitating development of nonprescription naloxone products. Other efforts, such as engagement with federal partners and an exploratory analysis describing some of the current distribution channels of naloxone in the United States, have been helpful in contextualizing the impact of prescription status on access to naloxone and potential unintended access issues.

FDA approval of nonprescription naloxone will have numerous implications on consumers and policymakers, some of which are not fully known at this time. One such question is whether consumers will be able to rely upon third-party payment options, such as Medicaid or private health insurance, when purchasing nonprescription naloxone. Additionally, uncertainties exist about the interplay between nonprescription naloxone and currently-in-force state laws covering standing orders, co-prescription requirements, and layperson administration. The second half of this session will involve a discussion about all these issues, as well as the potential for future state legislation aimed at them.