sábado, 11 de octubre de 2014

Medical Countermeasures Initiative > 2014 Ebola Outbreak in West Africa

Medical Countermeasures Initiative > 2014 Ebola Outbreak in West Africa

2014 Ebola Outbreak in West Africa

Fast Facts

  • Transmission electron micrograph of an Ebola virus virion (Image: CDC/Cynthia Goldsmith)Ebola is the cause of a viral hemorrhagic fever disease.
  • Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.
  • Ebola does not pose a significant risk to the U.S. public.
  • Treatment: CDC recommends supportive therapy for patients as the primary treatment for Ebola. This includes balancing the patient’s fluids and electrolytes, maintaining their oxygen status and blood pressure and treating them for any complicating infections.
  • Investigational Products: While there are experimental Ebola vaccines and treatments under development, these investigational products are in the earliest stages of product development and have not yet been fully tested for safety or effectiveness. Small amounts of some of these experimental products have been manufactured for testing. Thus, very few courses of these experimental products are available for clinical use. The FDA hopes that these investigational products will one day serve to improve outcomes for Ebola patients. However, we expect that most, if not all, of the products in development will require administration in a carefully monitored healthcare setting, in addition to supportive care and rigorous infection control.
  • Fraudulent Products: Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. The FDA monitors for fraudulent products and false product claims related to the Ebola virus and takes appropriate action to protect consumers. There are no approved treatments for Ebola available for purchase on the Internet. Consumers are warned to beware unapproved products sold online and in retail stores claiming to prevent or treat the Ebola virus and other conditions, such as cancer, autism, Parkinson’s and heart disease. Consumers who have seen these fraudulent products or false claims are encouraged to report them to the FDA.

Information from FDA

  • September 24, 2014 – FDA has issued Warning Letters to three firms marketing products that claim to prevent, treat or cure infection by the Ebola virus: Natural Solutions FoundationYoung Living, and dōTERRA International LLC.  There are currently no FDA-approved vaccines or prescription or over-the-counter drugs to prevent or treat Ebola. Individuals and companies promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action.  

    Experimental Ebola vaccines and treatments are in the early stages of product development, have not yet been fully tested for safety or effectiveness, and the supply is very limited. There are no FDA-approved treatments for Ebola available for purchase on the Internet. A claim that a product prevents, treats, or cures a disease requires prior approval by FDA.
  • September 4, 2014 – The largest, most severe and most complex outbreak of Ebola virus disease in history is highlighting the absence of authorized medicines to treat or prevent this terrible disease affecting people in a number of countries in West Africa. In the face of this outbreak, medicines regulators worldwide have committed to enhanced cooperation with the World Health Organization (WHO) and between regulatory agencies to encourage submission of regulatory dossiers and evaluation of the submitted information on potential new medicines. The aim is to accelerate access to investigational treatments for patients most in need during the current outbreak. The enhanced cooperation also aims to ensure that in the future, public health authorities in countries affected by Ebola have safe and efficacious medicines at their disposal, and so strengthen their ability to respond effectively to outbreaks and to save lives. This pledge was made by members of an interim International Coalition of Medicines Regulatory Authorities (ICMRA). Read the full statement
  • August 25, 2014 – FDA and the World Health Organization Department of Essential Medicines and Health Products (WHO EMP) have signed an agreement (PDF, 550 KB)  to help facilitate communications between FDA and WHO EMP regarding an actual or potential public health crisis or public health emergency of international concern, such as the Ebola outbreak in West Africa. The agreement allows sharing of information that is non-public but important to address public health emergencies between the organizations. More information about FDA’s international arrangements
  • August 22, 2014  FDA Voice blog post: FDA works to mitigate the West Africa Ebola outbreak - The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. We at FDA are dedicated to helping end this outbreak as quickly as possible, and to help prevent future outbreaks like this. Read more
  • August 20, 2014 – Responding to Ebola: The View From the FDA disclaimer icon - As part of FDA's expert commentary and interview series, Medscape spoke with FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio, MD, about the issue of compassionate use and FDA efforts to respond to the Ebola outbreak.  
  • August 14, 2014 – FDA statement: FDA is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. 
    Español - La FDA advierte a los consumidores contra productos para el tratamiento del ébola fraudulentos
    Français - La FDA met en garde les consommateurs contre les produits frauduleux de traitement contre l’Ebola 
  • August 5, 2014 – FDA authorized the use of a diagnostic test developed by the U.S. Department of Defense (DoD) to detect the Ebola Zaire virus in laboratories designated by the DoD to help facilitate effective response to the ongoing Ebola outbreak in West Africa. The test is designed for use in individuals, including DoD personnel and responders, who may be at risk of infection as a result of the outbreak. Specifically, the test is intended for use in individuals with signs and symptoms of infection with Ebola Zaire virus, who are at risk for exposure to the virus or who may have been exposed to the virus. (See also: August 12, 2014 Federal Register notice from HHS: Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus and September 17, 2014 Federal Register notice: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus)


  • September 23, 2014  FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio participated in a symposium entitled The Ebola Crisis: Context, Systemic Challenges, Consequences.disclaimer icon Dr. Borio discussed FDA’s role in responding to the outbreak. The meeting was hosted by Georgetown University, Washington, D.C., and was open to the public.
  • September 17, 2014 – Testimony: FDA’s Dr. Luciana Borio spoke as part of a panel on Global Efforts to Fight Ebola (House Committee on Foreign Affairs, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations hearing)

Frequently Requested Links

FDA's Role

  • The FDA’s role during situations like this involves sharing information about medical products in development as well as communicating our assessment of product readiness and clarifying regulatory pathways for development.
  • The FDA works with U.S. government agencies that fund medical product development, international partners and companies to help speed the development of medical products that could potentially be used to mitigate the Ebola outbreak. For example, the FDA is involved in an inter-agency working group led by the Assistant Secretary for Preparedness and Response (ASPR) / Biomedical Advanced Research and Development Authority (BARDA) to facilitate and accelerate development of potential investigation treatments for Ebola.
  • The FDA also works directly with medical product sponsors to clarify regulatory and data requirements necessary to move products forward in development as quickly as possible. While the FDA cannot comment on the development of specific medical products, it’s important to note that every FDA regulatory decision is based on a risk-benefit assessment of scientific data that includes the context of use for the product and the patient population being studied.   
  • Under the FDA’s Emergency Use Authorization (EUA) mechanism, the agency can enable the use of an unapproved medical product, or the unapproved use of an approved medical product during emergencies, when, among other circumstances, there are no adequate, approved and available alternatives. An EUA is an important mechanism that allows broader access to available medical products.  
  • Under certain circumstances, the FDA can also enable access for individuals to investigational products through mechanisms outside of a clinical trial, such as through an emergency Investigational New Drug (EIND)application under the FDA’s Expanded Access program.  In order for an experimental treatment to be administered in the United States, a request must be submitted to and authorized by the FDA. The FDA stands ready to work with companies and investigators treating Ebola patients who are in dire need of treatment to enable access to an experimental product where appropriate.  
  • Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. The FDA monitors for fraudulent products and false product claims related to the Ebola virus and takes appropriate action to protect consumers. Related: August 14, 2014 statement

Contact FDA

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