Regulatory Approval of CBRN Medical Countermeasures: Current Scenario and Way Ahead

Abstract

This review is focused on chemical, biological, radiological and nuclear (CBRN) medical countermeasures (MCMs) regulations in the United States between 2014 and 2024. Primary agencies involved in this process include the Food and Drug Administration (FDA), National Institutes of Health, Department of Homeland Security, and Centers for Disease Control and Prevention. Upon emergency declaration by the Secretary of Health and Human Services Emergency Use Authorization (EUA) goes into effect. Current regulation encompasses section 564 of Federal Food, Drug, and Cosmetic Act of 1938) governing EUA and authorizes the FDA to permit the use of unapproved medical products or unapproved uses of approved medical products to diagnose, prevent, or treat serious or life-threatening conditions caused by CBRN threat agents when no adequate, approved, and available alternatives exist. The regulation also includes Animal Rule, which allows pharmaceuticals or biologics licensing based on animal studies when conducting human efficacy studies is unethical. While expedited pathways exist for CBRN EUA, balancing speed and safety considerations is crucial. Priority Review Vouchers can be issued by the FDA to manufacturers for developing medical products during public health emergencies. While these policies and practices have worked well enough, there is room for improvement in the current regulatory framework regarding ongoing innovations, anticipated changes in regulatory policies, and global collaboration efforts. In this article, we discuss various regulatory challenges, including ethical and safety issues to be considered during the approval of MCMs for CBRN threats. Overcoming these challenges necessitates safety and efficacy demonstration of MCMs, maintaining public trust, and striking a balance between speed and safety considerations.