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J Law Med Ethics. 2013 Mar;41 Suppl 1:22-7. doi: 10.1111/jlme.12033.
Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies.
Courtney B, Sherman S, Penn M.
Source
Regulatory Counsel in the Office of Counterterrorism and Emerging Threats, Office of the Commissioner, U.S. Food and Drug Administration. Senior Attorney in the Office of the General Counsel, U.S. Department of Health and Human Services. Director of the Public Health Law Program in the Office for State, Tribal, Local, and Territorial Support, U.S. Centers for Disease Control and Prevention.
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.
? 2013 American Society of Law, Medicine & Ethics, Inc.
PMID:
23590735
[PubMed - in process]
Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies.
Courtney B, Sherman S, Penn M.
Source
Regulatory Counsel in the Office of Counterterrorism and Emerging Threats, Office of the Commissioner, U.S. Food and Drug Administration. Senior Attorney in the Office of the General Counsel, U.S. Department of Health and Human Services. Director of the Public Health Law Program in the Office for State, Tribal, Local, and Territorial Support, U.S. Centers for Disease Control and Prevention.
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.
? 2013 American Society of Law, Medicine & Ethics, Inc.
PMID:
23590735
[PubMed - in process]
