Introduction

Section 2811(d) of the Public Health Service (PHS) Act (42 U.S. Code § 300hh–10) directs the Administration for Strategic Preparedness and Response (ASPR) to develop a "coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats." This plan is developed in consultation with the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and is submitted to Congress biennially.

The PHEMCE was established by the U.S. Department of Health and Human Services (HHS) in 2006 and codified by Congress in 2019 to advance the country's MCM preparedness against CBRN and emerging infectious disease threats. MCMs include both pharmaceutical interventions (e.g., vaccines, antimicrobials, antidotes, antitoxins, or other therapies such as those that may target the host) and non-pharmaceutical interventions (e.g., medical devices – including diagnostics, life support products, personal protective equipment, decontamination systems, and clinical decision-making support tools), as well as other needed medical products that may be used to detect or assess, prevent, mitigate, or treat the adverse health effects of a public health emergency caused by a naturally occurring, accidental, or deliberate threat.