U.S. FDA 2014 Ebola Outbreak in West Africa Fact Sheet

Fast Facts

• 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. Consumers who have seen these fraudulent products or false claims are encouraged to report them to the FDA.

Information from FDA

• August 20, 2014 – Responding to Ebola: The View From the FDA  – 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.
• 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)

Frequently Requested Links

• Ebola Hemorrhagic Fever information from CDC (includes information on the outbreak, symptoms, transmission, prevention, diagnosis, and treatment)
• HHS FAQ: Ebola Experimental Treatments and Vaccines (August 8, 2014)
• Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access, sometimes called “compassionate use”)
• About Emergency Use Authorization
• The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

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 theAssistant 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