FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read Part I of our series and Part II of our series. Please also visit our COVID-19 resource page for additional thought leadership and information to guide your business as this outbreak unfolds.
The U.S. Secretary of Health and Human Services declared the novel 2019 coronavirus a U.S. public health emergency on Friday, January 31, 2020 and this determination was formalized pursuant to pursuant to section 564(b)(1)(C) of the Food Drug and Cosmetic Act on February 4, 2020. CDC developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified and, in the U.S., certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. On Monday, February 3, 2020, CDC submitted an Emergency Use Authorization (EUA) package to FDA in order to expedite use of the CDC diagnostic panel in the United States.
The EUA process enables FDA to consider and authorize the use of unapproved but potentially life-saving medical or diagnostic products during a public health emergency. FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a declared public health emergency, such as currently in effect in the U.S. relating to COVID-19. On February 4, 2020, FDA granted the EUA request to the CDC, permitting use of the CDC test kit in labs certified to perform high complexity tests. FDA simultaneously developed an EUA review template for tests to detect the virus, which outlines the data requirements for a Pre-EUA package available to developers upon request. This revised template for these EUA submissions is available now on FDA’s website. FDA reports it has shared its EUA review template with more than 50 developers who have expressed interest in developing diagnostics for this virus.
On February 25, 2020, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the United States. The new policy authorizes certain laboratories to develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their EUA requests—allowing the immediate use of these tests and not requiring the laboratory to await FDA approval of the EUA. This emphasizes FDA’s public health role in the rapid detection of COVID-19 to assist in controlling community spread of the virus. Only laboratories certified under the Clinical Laboratory Improvement Amendments to perform high complexity tests can take advantage of this unprecedented policy, and only after appropriate analytical validity testing is completed and documented by the laboratory. The new policy requires a laboratory taking advantage of this process to notify FDA of such usage and submit a complete EUA request to FDA within 15 days of the use of the test to detect COVID-19.
Then, on February 29, 2020, FDA completed its review and authorized the EUA of Wadsworth Center, New York State Department of Public Health’s “New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel,” which is indicated for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic locations where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation). Testing is limited to the Wadsworth Center and certain authorized state and city laboratories. A Fact Sheet for Health Care Professionals details the use and limits of the test. Only one day after receiving the EUA approval, New York’s Wadsworth Center identified New York’s first case of COVID-19 using its FDA EUA authorized RT-PCR Diagnostic Panel.
FDA is also drawing on its vast public health expertise in providing regulatory advice, guidance and technical assistance to sponsors. Although media reports indicate a number of drug and vaccine firms are working toward medical products to address COVID-19, there are no FDA-approved vaccines or therapeutics to prevent or treat COVID-19. The National Institutes of Health began a randomized controlled trial for the treatment of COVID-19 patients. While sponsors are usually expected to allow 30 days between submission and initiation of an initial Investigational New Drug (IND) protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible.