On March 16, 2015, the Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for Corgenix Inc.’s ReEBOV Antigen Rapid Test for the presumptive detection of Ebola viruses. This test is the eighth in vitro diagnostic authorized by FDA for emergency use for the detection of the Ebola virus. These ongoing authorizations underscore the critical need for additional effective tools to address Ebola. Further, although the outbreak was declared a year ago, the Administration’s willingness to partner with the life sciences industry has not diminished. Companies with interest, expertise and potentially viable proposals across the continuum of need should engage.
Of note, in parallel with work in diagnostics, efforts continue in both the public and private sectors to develop vaccines and treatments for the Ebola virus as well. Multiple products are in development and several vaccines are in phase I clinical trials in affected countries. FDA’s Vaccines and Related Biological Products Advisory Committee will meet on May 12, 2015 “to discuss the development and licensure of Ebola vaccines.”1
The initial EUA for the ReEBOV Antigen Rapid Test was issued on February 24, 2015.2 The seven previous authorizations were for real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assays developed in both the public sector (the Centers for Disease Control & Prevention (CDC) and the U.S. Department of Defense) and by private companies. Although the ReEBOV Antigen Rapid Test is less sensitive than authorized rRT-PCR tests, it can produce results in as little as 15 to 25 minutes and is intended for use in circumstances when use of a rapid test is more appropriate than using an authorized Ebola virus nucleic acid test.
Under the EUA provision of the Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 360bbb-3), FDA may authorize the introduction into interstate commerce of a drug, device or biological device without regard to ordinary pre-market approval or notification requirements, if certain conditions are satisfied. First, the Secretary of Health and Human Services (HHS) must declare that emergency authorization is justified on one of four enumerated bases, including “the identification of a material threat pursuant to section 319F-2 of the Public Health Service Act [42 U.S.C. 247d-6b] sufficient to affect national security or the health and security of United States citizens living abroad.” If this condition is satisfied, FDA may issue an EUA for a product as long as four additional threat-specific and product-specific criteria are met. In the case of Ebola, the Secretary of HHS declared that circumstances existed justifying the authorization of emergency use of in vitro diagnostics for detection of the Ebola virus on August 4, 2012. The HHS declaration can be found here. Based on Secretary of Homeland Security Michael Chertoff’s prior determination on September 22, 2006, the Ebola virus presents a material threat sufficient to affect national security.
According to the CDC, the 2014 West Africa Ebola outbreak has, to date, resulted in nearly 25,000 total cases and over 10,000 deaths. There have been four confirmed cases, one resulting in death, in the United States.3