Abstract

The Food and Drug Administration (FDA) recently held a meeting to explore new paradigms for drug availability under the regulatory rubric of novel conditions of nonprescription drug use.  Subsequent to this meeting, FDA held a workshop on naloxone for prevention of death from opioid overdose. This represented the first publicly discussed switch candidate for novel conditions of nonprescription drug use. The workshop was in the form of an open pre-IND meeting to raise awareness about what considerations would be essential to address if a company were to pursue this switch candidate. Using the methodology previously reported in creating the published list of ‘Considerations for Rx-to-OTC Switch’, a critical synthesis of the FDA recommendations at the naloxone workshop was undertaken to determine if this Switch Considerations List should be refined. Overall, FDA reviewers used the same considerations for expanding nonprescription access to naloxone that have been used for first-in-class Rx-to-OTC switches in the past. However, because of the unique nature of naloxone as a possible intranasal antidote for opioid overdose and the emphasis on certain of the Switch Considerations, several recommendations are made to refine the list, including: addition of a Human Factors Section, renaming the list as ‘Considerations for Rx-to-Nonprescription Switch’; and adding a section on Regulatory Considerations, among others. Compiling and maintaining an up-to-date list of Switch Considerations is important, as it synthesizes the historical and current perspective to help companies predict FDA requirements, may be helpful to train new industry and government personnel, and provides a framework for persons without a regulatory science background to understand FDA switch decision making.