In diagnostics alone, FDA has worked with over 300 test developers interested in submitting EUAs, resulting in more than 30 EUAs. This unprecedented activity by FDA is likely to continue as the nation struggles to diagnose and treat those impacted by COVID-19. Companies who are developing treatments, diagnostics, personal protective equipment, and other medical products directed to the COVID-19 crisis should be mindful of FDA’s EUA process and consider obtaining an EUA when appropriate.
Summary of EUA Process
Multiple legislative changes over the last decade to the Federal Food, Drug, and Cosmetic Act (FD&C Act) have granted the FDA Commissioner the ability to issue EUAs to authorize the marketing of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions. Before FDA can issue an EUA, however, an emergency declaration must first be made by the HHS Secretary, finding that one of our circumstances exist:
1. a domestic emergency involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (CBRN) agent;
2. a military emergency with a heightened risk of an attack with a CBRN agent on U.S. military forces;
3. a public health emergency affecting or with the significant potential to affect national security or the health and security of U.S. citizens living abroad, that involves a CBRN agent or related disease or condition; or
4. a material threat sufficient to affect national security or the health and security of U.S. citizens living abroad.
Following the emergency declaration by the HHS Secretary, companies can request an EUA from FDA. According to FDA’s guidance on Emergency Use Authorization of Medical Products and Related Authorities (2017 Guidance), the following information should be included in an EUA request:
• Description of product and its intended use
• Description of the product’s FDA approval status
• The need for the product, including whether there are adequate, approved, and available alternatives
• Available safety and efficacy information, including, for example, any controlled clinical trials, in vitro testing, and/or clinical experience
• A discussion of risks and benefits, including: (a) measures taken to mitigate risk or optimize benefit; (b) limitations, uncertainty, and data gaps; (c) contraindications; and (d) actual and potential threats posed by CBRN agents that may be relevant.
• Information on chemistry, manufacturing and controls, and the sites of manufacture, including the current good manufacturing practices (CGMP) status of those sites
• Information on the quantity of product on-hand and surge manufacturing capabilities
• Information comparable to an FDA-approved package insert or instructions for use; drafts of Fact Sheets for health care professionals and recipients of the product; and a discussion of the feasibility of providing this information in an emergency
• Information to support an extension of a label’s expiration date, if sought –and–
• Any right of reference to rely upon data submitted by others
Given that FDA’s resources are taxed in responding to the emergency, companies seeking an EUA should reach out to FDA before filing a request to ensure that the proper information is being submitted and that any special issues identified by FDA can be resolved. If required by the emergency and if FDA has adequate information, FDA can issue an EUA within hours or days of a request.
FDA’s Aggressive COVID-19 EUA Activity
FDA has been aggressively reviewing and approving EUAs as it tackles the COVID-19 health emergency. The first COVID-related EUA was issued on February 4, 2020 for the Center for Disease Control and Prevention’s (CDC) Real-Time Reverse Transcriptase Diagnostic Panel. Since that time, FDA has issued approximately 35 additional EUAs to test kit manufacturers and commercial laboratories for various in vitro diagnostic products. On March 31, 2020, FDA announced that it would provide authorization for certified high-complexity labs to use molecular-based laboratory tests that had been developed by the lab seeking authorization.
Approximately 15 laboratories have been granted a letter including them under the March 31 EUA. FDA’s EUAs have also extended to personal protective equipment, including three EUAs for respirators and one EUA for face shields. Other EUAs include: four EUAS for reprocessing medical devices that provide decontamination or sterilization; one EUA for ventilation equipment; two EUAs for extracorporeal blood purification devices; one EUA for a therapeutic product, chloroquine, and three EUAs for other medical devices such as pumps and diaphragm pacing therapy systems.
Given the unprecedented nature of the coronavirus pandemic and its impact on our nation, including shortages of critical supplies and diagnostics, the life sciences industry has been actively ramping up production and pursuing EUAs like never before. In coordinating such efforts with FDA, needed products have been rushed into our healthcare system to stem the tide of COVID-19. Only time will tell how effective these efforts will be.
Chad Landmon chairs Axinn, Veltrop & Harkrider LLP’s Intellectual Property and Food and Drug Administration Practice Groups and focuses his practice on patent litigation and counseling and food and drug law, with an emphasis on pharmaceuticals, biologics, medical devices, and human tissue products. He maintains a particular focus on patent trial work and FDA litigation, having served as a first chair trial lawyer on multiple cases and having litigated over 50 cases during the past 10 years alone, many of which have included products with billions of dollars in annual sales.
Drew Hillier is an attorney at Axinn, Veltrop & Harkrider LLP. His experience includes representing manufacturers of pharmaceutical, biologic, and medical-device products in patent litigation, as well as related commercial and regulatory matters. Drew graduated first in his class from the University of Connecticut School of Law, where he was editor-in-chief of the law review. He clerked for U.S. District Judge Michael P. Shea in the District of Connecticut.