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By: Chad Landmon and Drew Hillier, Axinn, Veltrop & Harkrider LLP
This article provides guidance on Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs). This article offers an overview of the legal and regulatory framework for EUAs, provides practical tips for obtaining an EUA, introduces considerations for importing and exporting under an EUA, and highlights certain recent EUAs, including some relating to the coronavirus disease (COVID-19).
In an emergency, and when there are no adequate, approved, and available alternatives, Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act),1 authorizes the FDA Commissioner to allow unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions. These medical products, also known as medical countermeasures, include drugs, biologics, and devices (including in vitro diagnostics and personal protective equipment).
FDA’s authority to allow EUAs was created through multiple amendments to the FD&C Act, including the Project Bioshield Act of 2004,2 the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016,3 and Pub. L. 115-92, 131 Stat. 2023 (Dec. 12, 2017).
In 2017, FDA finalized its guidance Emergency Use Authorization of Medical Products and Related Authorities (2017 Guidance).4 The 2017 Guidance replaces two prior guidance texts: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009).
In February 2020, FDA issued its guidance Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency (COVID-19 Guidance).5
As explained in the 2017 Guidance, obtaining an EUA involves:
Before an EUA can issue, pursuant to FD&C Act § 564(b)(1),6 the Secretary of the U.S. Department of Health and Human Services (HHS) must declare that at least one of four circumstances exists. The four circumstances are:
Criteria for Issuance
After the HHS Secretary makes an EUA declaration, FDA can authorize unapproved products or unapproved uses of approved products, subject to the criteria discussed below. Even if there has been an EUA declaration, for an EUA to issue, four criteria must be met:
Pre-EUA Activities and Submissions
Before applying for an EUA designation, a product sponsor should contact FDA. This will allow the sponsor to coordinate with FDA on appropriate clinical trials and the proper form for supplying data prior to a formal submission.
Submission of an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) is not required for potential EUA products. Sponsors submitting data, however, as part of pre-EUA activities should follow FDA recommendations for submitting pre-IND, IND, and device pre-submissions, as well as the recommendations in 2017 Guidance § III.C.
Early discussions with FDA allow sponsors to address the factors that FDA takes into account in prioritizing EUA requests.15 These factors include:
Requests for an EUA
Many formal requests are made by a government sponsor (e.g., an executive branch agency), although industry sponsors are free to make formal requests. Obtaining a government sponsor or supporter can be a key component in the attention given by FDA to a request. The actual authorization is a letter to the sponsor that includes a description of the product, its uses, contraindication, criteria for issuance, the scope of authorization, waiver of any requirements, and any conditions. The letter will also be issued with certain materials, for example, instructions for use and fact sheets.
2017 Guidance § III.D.2.a recommends that the following information be included in any request for an EUA:
A formal request to issue an EUA should generally not be submitted until there has been an EUA declaration. If required and if FDA has adequate information, FDA can issue an EUA within hours or days of a request. To facilitate a fast approval, sponsors should provide as much information to FDA as possible as part of its Pre-EUA Activities and Submissions.
Waivers and Conditions of Authorization
FDA may waive certain requirements or impose conditions for an unapproved product or unapproved use.
FDA will waive requirements on a case by case basis.18 These waivers can include:
FDA will impose conditions similar to conditions for approved products and uses. The following is a non-exhaustive list:
An EUA generally remains in effect for the duration of the related EUA declaration. The effective date will be specified in the EUA. FDA will periodically review EUAs and may revoke an EUA for a number of reasons, including the following:
Keep the following in mind for EUA submissions:
In addition to other submission requirements outlined in the 2017 Guidance, a message highlighting the urgency and including the cover letter and submission should be sent to EUA.OCET@fda.hhs.gov, as well as the appropriate center, and any other contacts familiar with the submission.
Given the fact that FDA’s resources will likely be relatively taxed during the health emergency, contacting the agency both early and often is recommended throughout the process.
Contact information for each center can be found in the 2017 Guidance.
A medical product authorized for emergency use under an EUA may be legally imported and exported under FD&C Act § 801.22 According to 2017 Guidance § VIII, the EUA letter of authorization is the appropriate documentation or certification to show that the product may be imported or exported.
The HHS Secretary determined on February 4, 2020 that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus, SARSCoV-2, that causes the disease COVID-19. On March 4, 2020, the HHS Secretary also declared that there was justification to authorize emergency use of personal respiratory protective devices during the COVID-19 outbreak.
In the early stages of the coronavirus outbreak, FDA issued letters of EUA on February 4, February 29, and March 4, 2020 to allow for emergency uses of diagnostic panels and protective devices. FDA has issued a specific guidance for diagnostic tests that have not received EUA. The policy sets recommended limits of detection, standards for clinical evaluation in the absence of known positive samples, and reporting suggestions, among other things.
FDA has also provided a template for a COVID-19 EUA requests. The template, which practitioners should consult before preparing a request, is available on FDA’s website.23
Keep in mind that FDA’s website24 contains historical letters of authorization, fact sheets, and instructions for use.
Practitioners should consult FDA’s website for the latest developments.
Entorovirus D68 (EV-D68)
In contrast to the response for COVID-19, the HHS Secretary issued a determination on Enterovirus D68 on February 6, 2015, but it was not until May 12, 2015 that FDA issued a letter of EUA. The slower time to issuance can be explained by the significantly lower scale of the Enterovirus D68 outbreak compared to SARS-CoV-2.
FDA issued its EUA determination on tests for detection of Zika Virus and/or diagnosis of Zika infections on February 26, 2016, the same day that it issued an EUA letter for the CDC’s Zika immunoglobulin M Antibody Capture Enzyme-Linked Immunosorbent Assay. Additional EUA letters issued in March, April, May, June, July, September, November, and December 2016, as well as August and September 2017.
As is frequently the case for emergency conditions lasting several years, the authorizations were amended multiple times.
Practitioners can review FDA’s template for Zika-related EUA submissions by contacting FDA at CDRH-ZIKA-Templates@fda.hhs.gov.
Examples of healthcare provider25 and patient26 fact sheets, as well instructions of use27 are available on FDA’s website.
Chad Landmon chairs Axinn’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, 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.
To find this article in Lexis Practice Advisor, follow this research path:
RESEARCH PATH: Life Sciences > FDA Approval Process > Practice Notes
For a discussion of the FDA drug approval process, see
> FDA REGULATION OF PHARMACEUTICALS
For an overview of the FDA regulatory requirements applicable for products that are classified as medical devices, see
> FDA REGULATION OF MEDICAL DEVICES
For practical guidance on the coronavirus in a number of practice areas, see
> CORONAVIRUS (COVID-19) RESOURCE KIT
RESEARCH PATH: Life Sciences > Corporate Transactions > Practice Notes
1. 21 U.S.C.S. § 301 et seq. 2. Pub. L. 108-276, 118 Stat. 835 (July 21, 2004). 3. Pub. L. 114-255, 130 Stat. 1033 (Dec. 13, 2016). 4. https://www.fda.gov/media/97321/download. 5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior. 6. 21 U.S.C.S. § 360bbb-3(b)(1). 7. FD&C Act § 564(b)(1)(A); 21 U.S.C. S. § 360bbb-3(b)(1)(A). 8. FD&C Act § 564(b)(1)(B); 21 U.S.C.S. § 360bbb-3(b)(1)(B). 9. FD&C Act § 564(b)(1)(C), as amended by the PAHPRA; 21 U.S.C.S. § 360bbb-3(b)(1)(C). 10. FD&C Act § 564(b)(1)(D); 21 U.S.C.S. § 360bbb-3(b)(1)(D). 11. 2017 Guidance § III.B.1.a. 12. 2017 Guidance § III.B.1.b. 13. 2017 Guidance § III.B.1.c. 14. 2017 Guidance § III.B.1.d. 15. 2017 Guidance §§ III.C and III.D.4.a. 16. 2017 Guidance § III.D.2.b. 17. https://www.fda.gov/media/134922/download. 18. See FD&C Act § 564(e)(3); 21 U.S.C. S. § 360bbb-3(e)(3). 19. For an example of a healthcare provider fact sheet for the novel coronavirus, see https://www.fda.gov/media/134920/download. 20. See 21 C.F.R. pt. 50; 2017 Guidance § III.E.1.b. 21. For an example of a patient fact sheet for the novel coronavirus, see https://www.fda.gov/media/134921/download. 22. 21 U.S.C.S. § 381. 23. https://www.fda.gov/media/135900/download. 24. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 25. https://www.fda.gov/media/96355/download. 26. https://www.fda.gov/media/120190/download. 27. https://www.fda.gov/media/96373/download.