Starting in February 2020, the US Food and Drug Administration (the "FDA") began using its Emergency Use Authorization ("EUA") powers under Section 564 of the Federal Food, Drug, and Cosmetic Act ("FD&C") to allow unapproved medical products or unapproved uses of approved products to detect and combat the spread of COVID-19. To date, the FDA has issued EUAs in the areas of in vitro diagnostics, personal protective equipment, "other medical devices," and therapeutics. A full, current listing of all EUAs is available online at the FDA's website.
The FDA is authorized to invoke its EUA authority once a declaration of emergency or material threat has issued by certain cabinet members, including the Secretary of Health and Human Services.1 In the case of COVID-19, the Secretary of Health and Human Services first made a declaration of a public health emergency on February 4, 2020, thus permitting the FDA to issue EUA.
In its first COVID-19-related declaration and EUA, the FDA addressed permitting in vitro diagnostics for detection or diagnosis of COVID-19. The agency implemented Guidance2 on diagnostic testing development for COVID-19 (the "In Vitro Testing Guidance") on February 29, 2020, updating the same on March 16, 2020. The In Vitro Testing Guidance provides both a policy for companies to submit a request for an EUA to the FDA3 and a policy covering tests developed by individual states where the state is responsible for the testing. For companies seeking an EUA from the FDA, the In Vitro Testing Guidance includes testing recommendations to validate the effectiveness of the testing, a notification procedure once validation is confirmed, and the availability of templates for requesting an EUA for a specific test or protocol.
The FDA also issued a declaration and EUA permitting emergency use of personal respiratory protective devices on March 2, 2020. The original EUA permitted the use of all approved disposable filtering facepiece respirators by healthcare workers as well as the use of such approved respirators past their shelf life. The FDA expanded the EUA throughout the month of March to cover all particulate-filtering air purifying respirators, the use of respirators that have been decontaminated, certain imported non-approved respirators, and certain respirator decontamination procedures.
On March 24, 2020, the FDA issued a declaration and EUA relating to medical devices and products that could be used as medical devices. Since issuance, this "other devices" EUA has been used to authorize a wider variety of ventilators, including modified machines and devices used for ventilation, along with related equipment. Safety, performance, and labeling criteria were also set out by the agency in the authorization letter.
The final category of COVID-19-related EUA involves therapeutics. On March 27, 2020, the FDA issued a declaration and EUA generally authorizing the emergency use of drugs and biological products. The following day, the FDA authorized the use of hydroxychloroquine sulfate and chloroquine phosphate products that had been donated to the Strategic National Stockpile for distribution to certain hospitalized COVID-19 patients. As part of the authorization, the FDA requires the provision of fact sheets for both health care providers and patients regarding the drug risks and potential interactions with other medications.
1. To make a declaration of an emergency, the Secretary of Health and Human Services must determine there is a public health emergency, or a potential for such an emergency, involving chemical, biological, radiological, or nuclear ("CBRN") agents or a disease or condition attributable to such agents that affects or may effect national security or health and security of US citizens living abroad. 21 U.S.C. § 360bbb-3(b)(1)(c). Other declarations that create the authority for the FDA to issue EUAs include (1) a determination by the Secretary of Homeland Security there is risk of attack with CBRN agents; (2) a determination by the Secretary of Defense of a military emergencies involving heightened risk of attack by CBRN agents or other life-threatening agents to US military forces; or (3) an identification of a material threat sufficient to affect national security or the health and security of US citizens abroad. Id. at § 360bbb-3(b)(1)(a)-(b), (d).
2. Guidances by the FDA represents the FDA's current thinking and do not establish any rights or responsibilities for any person. They are not binding on the FDA or the public and are intended to remain in effect only during the COVID-19 public health emergency declared by the Department of Health and Human Services and any renewals.
3. EUAs may take many forms. As with the FDA's recent in vitro diagnostics EUA, an EUA may require that companies who wish to be approved under the EUA submit individual applications. Other EUAs, such as those that expressly permit an otherwise unauthorized use of an approved product, will generally apply and an individual letter of authorization may be unnecessary. EUAs can also be used to change labeling, dosage, fact sheets, or other requirements, all of which are self-executing.
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