Emergency Use Authorization for COVID-19 Polymerase Chain Reaction Kits: A Confusing Continuation Open Access

To the Editor.—The US Food and Drug Administration (FDA) plays an essential role in protecting the American public by ensuring that medical products and devices are upheld to rigorous standards before they enter the market. During the COVID-19 pandemic, the FDA’s Emergency Use Authorization (EUA) mechanism facilitated the rapid deployment of diagnostic kits that were urgently needed at the time. Nevertheless, it is very perplexing that the FDA is currently allowing the coexistence of COVID-19 diagnostic kits under EUA and fully approved tests. Indeed, of the 29 molecular diagnostic COVID-19 tests granted traditional marketing authorization by the FDA, 16 (55.2%) still coexist with authorized EUA tests from the same company.

The primary purpose of an EUA should be to provide temporary access to medical products and devices in extraordinary circumstances when one cannot wait for a full approval without endangering the public. Once a product gains full FDA approval, the rationale for maintaining competing EUA products is significantly reduced, as full approval means that tests that meet the highest standards for safety, efficacy, and reliability are now available.

Complicating this issue further is the current difference in approved use for the EUA kits versus the fully approved kits. EUA COVID-19 polymerase chain reaction kits were approved for testing of both symptomatic and asymptomatic patients, whereas fully approved kits are now restricted to testing of symptomatic patients only. This limitation for fully approved kits likely reflects concerns over the potential for higher false-positive rates associated with testing asymptomatic populations when the background prevalence of disease is low—a well-documented challenge.¹  Allowing EUA kits to be used for asymptomatic patients will result in far more false-positive results than true positives, and will contribute to public confusion, inaccurate data collection, financial losses, and misallocation of resources.

From a regulatory perspective, continuing to market EUA products after full approval of equivalent tests is inconsistent with the intended temporary nature of emergency use. The FDA should cancel EUAs for diagnostic tests once full approval has been granted, aligning market offerings with established safety and performance benchmarks.

The COVID-19 pandemic highlighted the importance of regulatory agility, but consistency in public health messaging is equally critical and the coexistence of EUA and fully approved tests might raise suspicion about the integrity of the regulatory process. Sunsetting EUAs when full approval is achieved would reinforce the public’s trust in the FDA’s regulatory framework and avoid the abovementioned consequences associated with the testing of asymptomatic patients.