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<p>In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov">EUAs</a>, now in the double digits, for in vitro diagnostic (IVD) products and personal protective equipment (PPE). Without providing a dissertation on FDA law, the 30,000-foot view is that generally, drugs and medical devices require preapproval before they may be marketed in the United States. The FDA is a consumer protection agency that ensures the safety and effectiveness of drugs and medical devices for specific uses. Ensuring safety and effectiveness takes time, on average 12 and seven years, respectively, for drugs and medical devices.<a href="#1">[1]</a> While this review is necessary and beneficial to public health, during a global crisis such as COVID-19, we as a nation must perform an expeditious risk-benefit analysis and get potentially lifesaving products into the hands of healthcare professionals and patients at a moment’s notice. The EUA pathway is estimated to provide a conduit in which applicants can collect all necessary information in just 85 hours.<a href="#2">[2]</a> This article will explain what an EUA is, the FDA’s authority to issue EUAs and how to pursue an EUA for stakeholders positioned to assist in fighting the war against COVID-19.</p>  <h5>FDA’s authority to issue EUAs</h5>  <p>Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act permits the FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product for certain emergency circumstances. The FDA may issue an EUA in response to emergencies involving chemical, biological, radiological and nuclear (CBRN) agents, including emerging infectious disease threats such as COVID-19.</p>  <p>Other measures similar to but separate and distinct from EUAs are found in other provisions of the FD&C Act. For example, Section 564A of the FD&C Act establishes streamlined mechanisms to facilitate preparedness and response activities involving certain FDA-approved medical countermeasures without the FDA issuing an EUA. Examples of streamlined activities include empowering the FDA to extend expiration dates of eligible products, permitting the FDA to waive current good manufacturing practice requirements, and allowing emergency dispensing of medical countermeasures during an actual emergency event without requiring an individual prescription for each patient if permitted by state law in the state where such dispensing occurs or if in accordance with an order issued by the FDA.<a href="#3">[3]</a></p>  <h5>What is an EUA?</h5>  <p>An EUA is essentially a temporary approval for a drug or medical device during an emergency. With an EUA, the FDA allows, in an emergency, use of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions. Two major steps are required for a product to receive an EUA.</p>  <p>First, the secretary of Health & Human Services (HHS) must make a declaration that circumstances exist justifying an EUA. This EUA declaration may be based on various factors. Before issuing an EUA declaration, the HHS secretary should consult with the assistant secretary for preparedness and response, the director of the National Institutes of Health, and the director of the Centers for Disease Control and Prevention.<a href="#4">[4]</a> In the current COVID-19 pandemic, HHS Secretary Alex Azar has made two declarations that circumstances exist justifying EUAs for 1) <a href="https://www.fda.gov/media/135010/download">IVD products</a> for the detection and/or diagnosis of COVID-19 and 2) <a href="https://www.fda.gov/media/135787/download">respiratory PPE</a>.</p>  <p>Second, once the EUA declaration is issued, the FDA may authorize the emergency use of an unapproved product or an unapproved use of an approved product. Four statutory criteria guide the FDA’s issuance of an EUA: 1) serious or life-threatening disease or condition, 2) evidence of effectiveness, 3) risk-benefit analysis, and 4) no alternative. For the FDA to authorize an EUA, the EUA declaration must reference a CBRN agent that can cause a serious or life-threatening disease or condition. The two EUA declarations made by Azar reference COVID-19, which is causing serious and life-threatening disease worldwide. Drugs or medical devices that may be considered for an EUA are those that “may be effective” to prevent, diagnose, or treat serious or life-threatening diseases or conditions that can be caused by a CBRN agent identified in the HHS secretary’s EUA declaration.<a href="#5">[5]</a> The “may be effective” standard is a lower bar than the standard used for traditional FDA approval and is based on a totality of scientific evidence available. The FDA also considers the risks and benefits of the drug or medical device. In doing so, the FDA weighs the known and potential benefits of the product when used to diagnose, prevent, or treat such disease or condition against the known and potential risks of the product, taking into consideration the material threat posed by the CBRN agent, here COVID-19. Lastly, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. After considering all four conditions, the FDA may statutorily issue an EUA.</p>  <h5>What products are eligible for an EUA?</h5>  <p>Both unapproved products and approved products intended for unapproved uses are eligible for EUAs. Potential EUA products include those that may be effective to prevent, mitigate, treat, or diagnose a disease or condition caused by a CBRN agent. In guidance, the FDA provides two examples of eligible products:<a href="#6">[6]</a></p>  <ul style="margin-left:40px"> 	<li>Use of an approved antibiotic as prophylaxis based on exposure to, or treatment of, a disease caused by a bacterium (or class of bacteria) that is not included in the indications and usage section of the approved labeling for the antibiotic.</li> 	<li>Substitution of a critical reagent of a cleared IVD product with another reagent that has not been cleared for use with the device.</li> </ul>  <p>Past EUAs granted for historical emergencies include diagnostic tests for Zika, mass dispensing of doxycycline for post-exposure prophylaxis involving anthrax, and diagnostic tests for Ebola. EUAs for the current COVID-19 emergency focus on IVD products and PPE. In addition to the EUAs already issued, in the upcoming weeks we may see further EUAs issued authorizing more products for diagnostic tests or PPE. It is likely that we could also see EUAs issued regarding ventilators and drug therapies to treat COVID-19.</p>  <h5>How does a firm apply for an EUA?</h5>  <p>Early engagement is critical to ensure quick response. In <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#footnote21">guidance</a>, the FDA lists the information recommended to be included in a request for an EUA. Specifically, for the two EUA declarations made by Azar in response to COVID-19, the FDA has issued templates for EUA submissions for IVD products for laboratories certified to perform high-complexity testing under clinical laboratory improvement amendments and test kit manufacturers. Templates are not available for manufacturers and strategic stockpilers of PPE. Working with professionals that have experience in obtaining EUAs is always recommended. Talk with our team to determine whether your product is eligible for an EUA and which FDA center to work with to expedite a temporary authorization to combat COVID-19.</p>  <p><em>Authorship Credit: Lee Rosebush, Lindsay Holmes and Marc Wagner</em></p>  <p><a id="1" name="1"></a>[1] Van Norman GA. Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs. JACC Basic Transl. Sci. 2016 Apr. 25;1(3):170-179.<br /> <a id="2" name="2"></a>[2] U.S. Food & Drug Admin., Emergency Use Authorization of Medical Products and Related Authorities Guidance for Industry and Other Stakeholders 43 (Jan. 2017).<br /> <a id="3" name="3"></a>[3] Id. at 4.<br /> <a id="4" name="4"></a>[4] FD&C Act § 564(c).<br /> <a id="5" name="5"></a>[5] FD&C Act § 564(c)(2).<br /> <a id="6" name="6"></a>[6] U.S. Food & Drug Admin. <em>supra</em> note 2 at 9.</p>




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Washington, D.C.

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Lee H. Rosebush

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Marc N. Wagner

COVID-19 Compliance

FDA Emergency Use Authorizations (EUAs): Cutting Regulatory Red Tape for COVID-19

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