Scientists from Beth Israel Deaconess Medical Center found widespread use of ineffective COVID-19 treatments after FDA deauthorized their use.
Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections.
In early 2021, the U.S. Food & Drug Administration issued emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients.
However, these treatments were shown not to work against the omicron variant of COVID-19.
As a result of the monoclonal antibodies’ reduced efficacy against the variant, the FDA deauthorized their use in early January 2022.
In the study, the team assessed the use of these two monoclonal antibodies for patients with COVID-19 before and after FDA deauthorization.
The team found that though overall use of the two monoclonal antibodies declined gradually following deauthorization, a large number of doses were administered to patients well into 2022.
Altogether, over 158,000 doses of monoclonal antibodies were administered, providing little to no benefit to patients and potentially contributing millions of dollars in costs.
Whether the FDA will take regulatory action against those violating guidance remains unknown at this time.
The team says continued use of these treatments represents low-value care and may reflect conflicting state government guidance or a lack of hospital awareness of deauthorization.
Though the FDA clearly stated these treatments were no longer authorized for use, the FDA did not fully revoke their emergency use authorizations based on the possibility that they may work to treat future COVID-19 variants.
This could have led to confusion and misinterpretation.
The researchers hope that these findings will lead to greater attention and more diligent regulation by health care providers and government agencies to prohibit the use of unauthorized treatments.
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The research was published in JAMA Network Open and conducted by Timothy Anderson et al.
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