Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies
Identifieur interne : 001568 ( Main/Exploration ); précédent : 001567; suivant : 001569Federal Legal Preparedness Tools for Facilitating Medical Countermeasure Use during Public Health Emergencies
Auteurs : Brooke Courtney ; Susan Sherman ; Matthew PennSource :
- The Journal of Law, Medicine & Ethics [ 1073-1105 ] ; 2013-03.
Descripteurs français
- KwdFr :
- Contrôle des médicaments et des stupéfiants (législation et jurisprudence), Humains, Planification des mesures d'urgence en cas de catastrophe, Présentation de nouveau médicament de recherche (législation et jurisprudence), Responsabilité légale, Santé publique (législation et jurisprudence), Sécurité des produits de consommation (législation et jurisprudence), Utilisation hors indication (législation et jurisprudence), Vaccination de masse (législation et jurisprudence), États-Unis d'Amérique.
- MESH :
- législation et jurisprudence : Contrôle des médicaments et des stupéfiants, Présentation de nouveau médicament de recherche, Santé publique, Sécurité des produits de consommation, Utilisation hors indication, Vaccination de masse.
- Humains, Planification des mesures d'urgence en cas de catastrophe, Responsabilité légale, États-Unis d'Amérique.
- Wicri :
- geographic : États-Unis.
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.
- Teeft :
- Actual anthrax emergency, Additional information, Anthrax, Antiviral drugs, Authorization, Cbrn, Cbrn agent, Cbrn agents, Certain products, Countermeasure, Countermeasures injury compensation program, Critical challenges spring, Diagnostic devices, Disaster Planning, District court, Domestic emergency, Doxycycline, Drug administration, Emergency preparedness, Euas, Federal food, General counsel, Health emergency, Homeland security, Household members, Human services, Humans, Influenza, Influenza pandemic, Inhalational anthrax, Investigational, Investigational drugs, Investigational products, January, Legal authorities, Legal preparedness, Legal preparedness tools, Liability claim, Liability immunity, Liability protections, Liability, Legal, Material threat, Mcms, Medical countermeasures, Medical products, Medicine ethics courtney, Military emergency, National security, Novel health threats, Oral formulations, Pandemic, Pandemic influenza vaccines amendment, Practical approaches, Prep, Preparedness, Preparedness reauthorization, Private sector, Protection devices, Public health, Public health emergencies, Public health emergency, Public health response goals, Public readiness, Response concerns, Services administration, Several areas, States citizens, Subject matter jurisdiction, Such challenges, Susan sherman, Vaccine.
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.
Url:
DOI: 10.1111/jlme.12033
Affiliations:
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Le document en format XML
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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></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Courtney, Brooke" sort="Courtney, Brooke" uniqKey="Courtney B" first="Brooke" last="Courtney">Brooke Courtney</name><name sortKey="Penn, Matthew" sort="Penn, Matthew" uniqKey="Penn M" first="Matthew" last="Penn">Matthew Penn</name><name sortKey="Sherman, Susan" sort="Sherman, Susan" uniqKey="Sherman S" first="Susan" last="Sherman">Susan Sherman</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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