RxLegal: Emergency Use Authorizations

Abstract

Emergency use authorizations (EUAs) are a mechanism to allow for the availability and use of medical products during a public health emergency. During the COVID-19 pandemic, hundreds of products have been authorized for use under an EUA. This has led to legal issues—most prominently, the legality of vaccine mandates. Language within the statute that created the EUA pathway has been subject to varying interpretations that could refuse or allow the implementation of EUA vaccine mandates and suits have been filed against organizations that have established vaccine mandates as a term of continued employment.

The Food and Drug Administration (FDA) defines an Emergency Use Authorization (EUA) as a “mechanism to facilitate the availability and use of medical countermeasures during public health emergencies.” ¹ The concept of an EUA surfaced after the events of September 11th and subsequent anthrax mail attacks, with Congressional passage of the Project Bioshield Act of 2004. ² This Act allows the FDA to authorize the emergency use of unapproved medical products, or unapproved uses of approved medical products, against a threat to public health and safety when certain statutory criteria are met.^1,2 These statutory criteria include that a serious or life-threatening disease or condition exists; that the medical product “may be effective” to prevent, diagnose, or treat the disease or condition; that the benefits of the product outweigh the potential risks; and that there are no adequate, approved, and available alternative products. ³ Prior to the COVID-19 pandemic, few medical products were authorized for use under an EUA. However, during this crisis, EUA has been used extensively for rapid authorizations of vaccines, monoclonal antibodies, oral antivirals, tests, and other equipment. ⁴

The widespread use of the EUA process during the pandemic, instead of conventional FDA approval, has caused confusion amongst the public and healthcare providers as well as legal concerns. A prominent legal issue has been the legality of mandates for vaccines initially authorized under an EUA. When the EUA pathway was created, language was included in the statute stating that individuals offered a medical product authorized under an EUA must be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” ⁵ This wording has been subject to varying interpretations with some individuals concluding that mandates are prohibited since each individual must have an option to “accept or refuse” the EUA medical product. While others state that the wording as a whole may be interpreted to mean that even though an individual may refuse an EUA medical product, refusal can result in “consequences.” A broad definition of the term “consequences” could potentially allow for the implementation of vaccine mandates by public and private entities.

Of the various legal cases regarding the legality of EUA vaccine mandates, Bridges versus Houston Methodist Hospital is among the most well-known. In this case, 117 employees sued Houston Methodist over its COVID-19 vaccine requirement in Federal District Court. ⁶ The plaintiffs argued that the hospital was unlawfully forcing its employees to receive an “experimental and dangerous” COVID-19 vaccine and that no one can be mandated to receive “unapproved” medicines in emergencies (at the time of the lawsuit, the FDA had not fully approved any of the vaccines). ⁷ However, U.S. District Judge Lynn Hughes dismissed these arguments and ruled for Houston Methodist. In the ruling, Judge Hughes noted that federal law “authorized the Secretary of Health and Human Services to introduce into interstate commerce medical products intended for use in an emergency” and that the argument that the EUA COVID-19 vaccines are experimental and dangerous is both false and irrelevant. Judge Hughes also noted that under Texas law, an employee is only protected from termination for refusing to commit an illegal act and that receipt of a EUA COVID-19 vaccination is not an illegal act. The plaintiffs in the case appealed this decision; however, the U.S. Fifth Circuit Court of Appeals affirmed the dismissal of the case by the lower court. ⁸

Since the Pfizer-BioNTech and Moderna COVID-19 vaccines are now fully FDA approved, legal challenges to vaccine mandates based on the EUA “accept or refuse” provision are more than likely moot at this juncture. However, the legal issues surrounding EUA of medical products should be considered by healthcare providers and organizations if future public health emergencies require prompt availability without full FDA approval, given the lessons learned from the ongoing COVID-19 pandemic.