Few medical products were authorized for 15 years after the first Emergency use authorization (EUA) for an anthrax vaccine was issued in February 2005. During the COVID-19 crisis, EUA was used extensively for rapid authorizations of medical products. In this study, we examined the COVID-19–related products authorized by the FDA and the quality of their supporting evidence, according to Researchers from Tel Aviv Sourasky Medical Center,
Of the 393 products that were granted EUAs for COVID-19–related purposes, 329 (84%) were diagnostic tests, followed by 54 medical devices (14%) and 10 drugs or vaccines (3%).The EUAs for diagnostic products were mostly supported by comparisons with various previously authorized assays (77%) and then by some analytical in vitro studies (14%).
Most COVID-19–related EUAs were issued for diagnostic products and supported either by comparisons to various previously authorized assays or by analytical, nonclinical data. Because these diagnostic products were not tested against criterion standard and no evaluation showed that the products correctly identified people with vs without COVID-19 infection, the true sensitivity and specificity as well as real-world frequency of false-positive and false-negative results can only be approximated.
Authorizations that were supported by such low-quality data are reasonable at the beginning of a pandemic, when diagnostic products are urgently required. In future public health emergencies, the FDA should consider raising the standard of evidence required for EUAs after several diagnostic products are marketed to ensure their accuracy.
Most medical devices were granted EUAs without any documented supporting data, and only a small number were supported by clinical data. Lack of evidence might bring to market devices that are potentially more harmful than beneficial. The rapid uptake of potentially beneficial technologies should be balanced against device-related safety problems.
The authorization of chloroquine/hydroxychloroquine use for COVID-19 infection was supported by low-quality retrospective data and was swiftly revoked by the FDA. Regulators should resist political pressure to authorize products that are not supported by high-quality clinical data. Doing so might prevent confusion and mistrust in the soundness of medical science and bolster the FDA’s reputation.
Most COVID-19–related EUAs are not supported by high-quality evidence. The findings from this study might inform regulators of the current status of EUAs and assist in guiding improvement efforts.