Ebola Response Updates from FDA
FDA is working to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring the Ebola epidemic in West Africa under control as quickly as possible. View the latest updates from FDA here.
April 9, 2015 – LuSys Laboratories, Inc. has recalled its Ebola Virus One-Step Test Kits to stop and prevent further use of these devices. These test kits have not been cleared, approved or authorized by the FDA for diagnostic purposes.
March 23, 2015 – FDA authorized emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus (also see Emergency Use Authorization below)
March 19, 2015 – Turning the Tide on Ebola: A first-hand account from Liberia, from one of FDA's U.S. Public Health Service officers
- 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.
- FDA Ebola task force: FDA has an Ebola Task Force with wide representation from across FDA to coordinate our many activities. We are actively working with federal colleagues, the medical and scientific community, industry, and international organizations and regulators to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring the epidemic under control as quickly as possible.
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.
- FDA has an Ebola Task Force with wide representation from across FDA to coordinate our many activities. We are actively working with federal colleagues, the medical and scientific community, industry, and international organizations and regulators to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring the epidemic under control as quickly as possible.
- At least 12 FDA employees are being deployed to West Africa as part of the Public Health Service’s team to help with medical care. Read a first-hand account from Liberia, from one of FDA's Public Health Service officers.
- 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.
- The FDA has been actively using orphan designation and other drug development programs to encourage the development of treatments for Ebola. This designation, coupled with other FDA programs used to expedite product development, review and approval, provides incentives to encourage companies to invest and develop treatments for rare diseases like Ebola, with the ultimate goal of getting safe and effective products to U.S. patients as quickly as possible. The FDA has granted orphan designation to products being developed to treat Ebola virus infection. Details about these products can be found in FDA's database of orphan designations and approvals.
FDA has been collaborating very closely with the European Medicines Agency (EMA) on orphan designation over many years. Developers of Ebola medicines are encouraged to submit applications for orphan designation to FDA and EMA in parallel to help speed the development process for these products globally. Both agencies will be sharing information on the applications received and their assessment to facilitate an understanding of data requirements for the relevant applications. About FDA orphan designation, and how to apply
- 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 (also see the Fraudulent Products section below)
Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola
- 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. For those in limited supply, there are efforts underway to increase production so safety and efficacy can be properly assessed in clinical trials.
- 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.
How FDA is working to expedite development and availability of products
- FDA Ebola response efforts include providing scientific and regulatory advice to commercial developers and U.S. government agencies that support medical product development, including the National Institutes of Health (NIH), the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). The advice that FDA is providing is helping to accelerate product development programs.
- FDA medical product reviewers have been working tirelessly with sponsors to clarify regulatory requirements, provide input on manufacturing and pre-clinical and clinical trial designs, and expedite the regulatory review of data as it is received. FDA has been in contact with dozens of drug, vaccine, device, and diagnostic test developers, and we remain in contact with more than 20 sponsors that have possible products in pipeline.
- We have also been collaborating with the World Health Organization and other international regulatory counterparts—including the European Medicines Agency, Health Canada, and others—to exchange information about investigational products for Ebola in support of international response efforts.
- As FDA continues to work to expedite medical product development, we strongly support the establishment of clinical trials, which is the most efficient way to show whether these new products actually work. In the meantime, we also will continue to enable access to investigational products when they are available and requested by clinicians, using expanded access mechanisms, also known as “compassionate use,” which allow access to such products outside of clinical trials when we assess that the expected benefits outweigh the potential risks for the patient.
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.
- 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. A claim that a product prevents, treats, or cures a disease requires prior approval by FDA.
- 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.
Fraudulent Product Updates and Warning Letters
- November 19, 2014 – FDA has issued Warning Letters to three additional firms marketing products that claim to prevent, treat or cure infection by the Ebola virus: Ebola-C Inc., Bodyhealth.com LLC and LifeSilver. 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. These letters were issued jointly with the Federal Trade Commission. FDA previously issued Ebola-related Warning Letters to three companies on September 24, 2014.
- 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 Foundation, Young Living, and doÌ„TERRA 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.
- 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
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by certain threat agents when there are no adequate, approved, and available alternatives. More about EUAs
Ebola Virus EUA Information by Date
March 23, 2015 – FDA authorized emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus. The test should be performed in CLIA moderate and high complexity laboratories, or similarly qualified non-U.S. laboratories, by personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems. Additional technical information
March 16, 2015 – In response to Corgenix Inc.’s request to amend this EUA, FDA reissued the February 24, 2015 EUA in its entirety with the Corgenix Inc. requested amendments incorporated. The amendments allow, in addition to Corgenix Inc., distributors that are authorized by Corgenix Inc. to distribute the ReEBOV™ Antigen Rapid Test with certain conditions applicable to such authorized distributor(s). The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments. Additional technical information
March 2, 2015 – In response to CDC’s request, FDA reissued the two October 10, 2014 CDC EUAs in their entirety. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments (updated attachments). The amendments also allow the future use of “other authorized instruments,” of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA. Additional technical information
March 2, 2015 – In response to BioFire Defense, LLC’s request, FDA reissued (PDF, 326 KB) the October 25, 2014 FilmArray NGDS BT-E Assay EUA in its entirety. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use (PDF, 740 KB) and Fact Sheet for Healthcare Providers (PDF, 40 KB) have also been updated to incorporate this amendment. The amendments also allow the future use of “other specimen types” when requested by BioFire Defense and concurred with by FDA. Additional technical information
February 24, 2015 – (see note above about update on March 16, 2015) FDA granted an Emergency Use Authorization (EUA) for Corgenix’s ReEBOVTM Antigen Rapid Test. This is the first rapid assay to detect Zaire Ebola virus authorized for use during the current Ebola epidemic in West Africa. Note: Documents related to the February 24, 2015 EUA are now archived.
December 23, 2014 – FDA issued an EUA to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The test runs only on specified instruments used by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories. Additional technical information
- November 26, 2014 – In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued (PDF, 263 KB) the November 10, 2014 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The Instructions for Use (PDF, 634 KB) and Fact Sheet for Health Care Providers (PDF, 81 KB) have also been updated to incorporate these amendments. Additional technical information, Federal Register notice
- November 10, 2014 – (see note above about update on November 26, 2014) FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. The test, which does not distinguish between different Ebola virus species or strains, detects Ebola viruses in plasma from individuals with signs and symptoms of Ebola virus infection, in conjunction with epidemiological risk factors. Under this authorization, the test must be conducted on specified instruments by CLIA high complexity laboratories. This EUA provides another commercial Ebola diagnostic (in addition to the October 25, 2014 EUA for the BioFire Defense FilmArray Biothreat-E test). Note: Documents related to the November 10, 2014 EUA are now archived.
- October 25, 2014 – (see note above about update on March 2, 2015) FDA authorized emergency use of two BioFire Defense diagnostic tests to detect the Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection, or who are at risk for exposure, or may have been exposed (in conjunction with epidemiological risk factors). The BioFire Defense FilmArray NGDS BT-E Assay is for use by laboratories designated by the Department of Defense (DoD). The BioFire Defense FilmArray Biothreat-E test is for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests. The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab. Note: Documents issued on October 25, 2014 associated with the NGDS BT-E Assay are now archived. Additional technical information, Federal Register notice
- October 10, 2014 – (see note above about update on March 2, 2015) FDA authorized emergency use of two Centers for Disease Control and Prevention (CDC) diagnostic tests to detect the Ebola Zaire virus in individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay can test for the virus in whole blood, serum, and plasma specimens, and can also be used with urine specimens when tested in conjunction with whole blood, serum, or plasma from the same patient. Use of these tests is limited to qualified laboratories designated by the CDC. Note: Documents issued on October 10, 2014 are now archived. Additional technical information, Federal Register notice
- October 10, 2014 – Upon request from the U.S. Department of Defense (DoD), FDA has reissued the August 5, 2014 Emergency Use Authorization (EUA) for use of a DoD diagnostic test to detect the Ebola Zaire virus. The test is designed for use in individuals, including DoD personnel, who may be at risk of infection as a result of the outbreak. The reissued EUA replaces the August 5, 2014 EUA. The EUA has been amended to expand the types of specimens that can be tested to include whole blood and plasma, in addition to blood or plasma that has been treated to make the sample non-infectious. The August 5 letter of authorization, fact sheets, and instructions for use have all been reissued to reflect this amendment. Additional technical information
- August 5, 2014 – (see note above about update on October 10, 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)
June 14-18, 2015 – DIA 2015 51st Annual Meeting (Washington, DC) - FDA's Dr. Luciana Borio will discuss FDA's point of view in the forum New Pandemics: Lessons Learned from the Ebola Experience
May 12, 2015 – The FDA Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss the development and licensure of Ebola vaccines (Silver Spring, MD and webcast) (Federal Register notice)
April 25, 2015 – At the Association of Clinical Research Professionals 2015 Global Conference & Exhibition (Salt Lake City, UT), FDA's Dr. Luciana Borio will participate in a panel: Ebola and Other Emerging Pathogens - A New Challenge for Research and Healthcare
March 5, 2015 – Harvard Medical School forum - Rethinking the Response to Emerging Microbes: Vaccines and Therapeutics in the Ebola Era (Boston, MA) - Philip Krause, MD, Deputy Director of the Office of Vaccines Research and Review in FDA's Center for Biologics Evaluation and Research, participated in a panel on scientific and regulatory issues limiting development of Ebola vaccines and therapeutics - #EbolaForumHMS
February 5-6, 2015 – Presidential Commission for the Study of Bioethical Issues public meeting (Washington, DC and webcast) - The Commission discussed the ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic. FDA's Dr. Luciana Borio presented as part of a panel "Ethical Issues Associated with Research in the Context of a Public Health Emergency" - agenda - webcast recording (Federal Register notice)
- January 27, 2015 – Update on Ebola clinical trial research - transcript from a January 22, 2015 HHS media briefing on the status of clinical trials for Ebola vaccines and therapeutics from HHS officials including NIAID/NIH, CDC, BARDA and FDA
- December 12, 2104 – Public Workshop: Immunology of Protection from Ebola Virus Infection (Rockville, MD and webcast) - The purpose of this workshop is to discuss important aspects of Ebola virus and vaccine immunology in order to inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola. Webcast recording now available (7 hours, 32 minutes)
- December 3, 2014 – Dr. Edward Cox and Dr. Luciana Borio discussed Drug Development in a Time of Ebola at the Forbes Healthcare Summit (New York, NY) - view a video of the discussion (13 minutes)
- November 19, 2014 – Testimony: FDA's Dr. Luciana Borio spoke as part of a panel on Examining Medical Product Development in the Wake of the Ebola Epidemic (House Committee on Energy and Commerce, Subcommittee on Health hearing)
- November 5, 2014 - Director of Antimicrobial Products Dr. Edward Cox and Assistant Commissioner for Counterterrorism Policy Dr. Luciana Borio participated in a media briefing on Ebola at the American Society of Tropical Medicine and Hygiene Annual Meeting. View the full list of speakers (PDF, 269 KB), and listen to the recording (1 hour, 14 minutes).
- October 16, 2014 – Testimony: FDA’s Dr. Luciana Borio spoke as part of a panel on Examining the U.S. Public Health Response to the Ebola Outbreak (House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations hearing)
- 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. 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)
- 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
- Information for Healthcare Workers from CDC (includes information on U.S. healthcare settings, diagnosis/testing, and protecting healthcare workers)
- Ebola Outbreak Information Resources, from the National Library of Medicine, Disaster Information Management Research Center, including multi-language resources
You may also call 1-888-INFO-FDA / (1-888-463-6332)
Report a fraudulent Ebola product
Includes options for phone and online reporting
Press: contact the Office of Media Affairs
Email firstname.lastname@example.org or call 301-796-4540
Clinicians: Emergency Investigational New Drug (EIND) Applications for antiviral products
Instructions for physicians. You may also call 301-796-1500 regarding EINDs.
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