Friday, January 28, 2022

Experts question lack of clinical data to support FDA decision on monoclonal antibody treatments

The U.S. Food and Drug Administration used the results of laboratory experiments in its sudden and unexpected decision to revoke the emergency use authorizations for certain monoclonal antibody treatments for COVID-19, stating that data showed the treatments were ineffective against the Omicron variant.  

On Monday, the FDA announced that the Eli Lilly and the REGEN-COV treatments would no longer be made available to health care providers in areas where Omicron is the dominant COVID-19 variant, including states like Florida, where the treatments have been accessible for months. The decision was slammed by Florida Gov. Ron DeSantis (R), who has encouraged the use of monoclonal antibodies as an effective early treatment for those infected with coronavirus. In a statement responding to the announcement, DeSantis criticized the Biden administration for taking away the treatment option "without a shred of clinical data to support this action."

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