Most FDA COVID-19 EUAs ‘not supported by high-quality evidence’

Most of the emergency use authorizations the FDA issued related to COVID-19 were “not supported by high-quality evidence,” the authors of a cross-sectional study wrote in JAMA Internal Medicine.

Itay Moshkovits, MD, PhD, and Daniel Shepshelovich, MD, of the division of general medicine at Tel Aviv Sourasky Medical Center in Israel, gathered information regarding the FDA’s COVID-19–related EUAs from Jan. 1, 2020, to Jan. 22, 2021. The researchers obtained the EUA status as of Oct. 1 on 329 diagnostic tests, 54 medical devices and 10 drugs and vaccines related to COVID-19.

“Data were descriptively reported for the entire cohort and according to medical countermeasure type,” the researchers wrote. “Inferential statistics were not undertaken because of data heterogeneity and the low number of samples of several medical countermeasure types (eg, anti–COVID-19 drugs).”

According to Moshkovits and Shepshelovich, EUAs for 77% of the studied diagnostic products were supported by an assortment of assays that were previously authorized, while another 14% were supported by in vitro studies of an analytical nature. The researchers also reported that there was no supporting evidence indicated for 59% of the studied medical devices and, in instances where supporting evidence was available, 37% of the time it was laboratory data. In 70% of the EUAs for the studied drugs and vaccines, data from randomized clinical trials were used as support, and 80% of all the drugs and vaccines had not been previously approved by the FDA for other indications. In addition, EUAs for two of the drugs, seven of the medical devices and eight of the diagnostic tests were revoked by the FDA, and 59% of the time it was due to effectiveness or safety concerns. One drug and one vaccine received FDA approval.

“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,” Moshkovits and Shepshelovich wrote. The findings might help improve the FDA’s current EUA process, they added