PandemieGrippaleV1, Ncbi, Checkpoint, bibRecord, 001634

Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Identifieur interne : 001634 ( Ncbi/Checkpoint ); précédent : 001633; suivant : 001635

Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Auteurs : Brooke Courtney [États-Unis] ; Susan Sherman ; Matthew Penn

Source :

The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [ 1748-720X ] ; 2013.

RBID : pubmed:23590735

Descripteurs français

English descriptors

KwdEn :
- Consumer Product Safety (legislation & jurisprudence), Disaster Planning, Drug and Narcotic Control (legislation & jurisprudence), Humans, Investigational New Drug Application (legislation & jurisprudence), Liability, Legal, Mass Vaccination (legislation & jurisprudence), Off-Label Use (legislation & jurisprudence), Public Health (legislation & jurisprudence), United States.
MESH :
- geographic : United States.
- legislation & jurisprudence : Consumer Product Safety, Drug and Narcotic Control, Investigational New Drug Application, Mass Vaccination, Off-Label Use, Public Health.
- Disaster Planning, Humans, Liability, Legal.

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.

DOI: 10.1111/jlme.12033
PubMed: 23590735

Affiliations:

États-Unis

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pubmed:23590735

Le document en format XML

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<front><div type="abstract" xml:lang="en">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.</div>
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Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Federal legal preparedness tools for facilitating medical countermeasure use during public health emergencies.

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki