Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies

Abstract

Preparing for and responding to public health emergencies involving medical countermeasures (MCMs) raise often complex legal challenges and questions among response stakeholders at the local, state, and federal levels. This includes concerns about emergency legal authorities, liability, emergency use of regulated medical products, and regulations that might enhance or hinder public health response goals. In this article, lawyers from the U.S. Department of Health and Human Services' (HHS) Office of the General Counsel (OGC), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) discuss federal legal tools that are critical to enhancing MCM legal preparedness for public health emergencies, with an emphasis on the legal mechanisms that can be used to facilitate the emergency use of countermeasures. Specifically, the authors describe the Public Readiness and Emergency Preparedness (PREP) Act and Emergency Use Authorization (EUA) authority, outlining the conditions under which these tools can be utilized and providing examples of how they have supported both pre-event (e.g., doxycycline mass dispensing preparedness for anthrax) and intra-event (e.g., 2009 H1N1 influenza pandemic response) activities.

An Assessment of State Board of Pharmacy Legal Documents for Public Health Emergency Preparedness

“…18,19 Although practical disaster-specific considerations (eg, record-keeping, medication disposal, refill dispensing, and emergency prescription drug order processing) for pharmacist volunteers depend on legal mechanisms within each state, 20 federal-level measures can be used to protect volunteers from liability. 20,21 For example, the Public Readiness and Emergency Preparedness (PREP) Act can be invoked by the US Secretary of Health and Human Services to provide immunity from problems arising from the use of medical countermeasures dispensed by pharmacists (and other authorized personnel). 20,21 The PREP Act also provides a regulatory mechanism to conduct basic, clinical, and administrative research on medical countermeasures.…”

“…20,21 For example, the Public Readiness and Emergency Preparedness (PREP) Act can be invoked by the US Secretary of Health and Human Services to provide immunity from problems arising from the use of medical countermeasures dispensed by pharmacists (and other authorized personnel). 20,21 The PREP Act also provides a regulatory mechanism to conduct basic, clinical, and administrative research on medical countermeasures. 21 Emergency Use Authorizations (EUA) are granted by the Food and Drug Administration (FDA) commissioner and provide for the emergency use of unapproved medical products and approved medical products for unapproved indications.…”

“…20,21 The PREP Act also provides a regulatory mechanism to conduct basic, clinical, and administrative research on medical countermeasures. 21 Emergency Use Authorizations (EUA) are granted by the Food and Drug Administration (FDA) commissioner and provide for the emergency use of unapproved medical products and approved medical products for unapproved indications. 21 Each EUA is associated with unique provisions governing its issuance and is effective until terminated by the FDA.…”

“…21 Emergency Use Authorizations (EUA) are granted by the Food and Drug Administration (FDA) commissioner and provide for the emergency use of unapproved medical products and approved medical products for unapproved indications. 21 Each EUA is associated with unique provisions governing its issuance and is effective until terminated by the FDA. 21 The Shelf Life Extension Program (SLEP) is a mechanism used in conjunction with an EUA to promote greater access to medical countermeasures during disasters.…”

“…21 Each EUA is associated with unique provisions governing its issuance and is effective until terminated by the FDA. 21 The Shelf Life Extension Program (SLEP) is a mechanism used in conjunction with an EUA to promote greater access to medical countermeasures during disasters. Once labels expire, medical countermeasures are tested for potency to determine their eligibility for extended shelf life.…”