FDA and Florida clash over federal restriction of monoclonal antibody treatments

On Monday, the Food and Drug Administration removed two monoclonal antibody therapies from the list of approved COVID-19 treatments, subsequently forcing treatment sites to close despite these locations being pivotol to Florida's COVID-19 response.

The FDA made this announcement Monday in a press release stating that the bamlanivimab-etesevimab cocktail and the REGEN-COV treatments were to be removed from the list of emergency use authorizations.

It continued by saying that these treatments should only be used “when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments” because “data show these treatments are highly unlikely to be active against the omicron variant.” The FDA did not elaborate or provide the data.

The FDA argued against the preventive treatments, stating that “treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

The Washington Post reported that Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research and author of Monday’s press release, said that these monoclonal antibody treatments are “highly unlikely to be active against the omicron variant” and that “these treatments are not authorized to be used at this time.”

The FDA press release states that “these [monoclonal antibody] treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”

However, the press release did not mention that the Omicron variant can circumvent COVID immunity gained through vaccination.

In an interview with the French outlet Le Monde, Ugur Sahin, the CEO of BioNTech, the co-developer of the Pfizer vaccine, confirmed this by saying, “We must be aware that even triple-vaccinated are likely to transmit the disease. ... It is obvious we are far from 95% effectiveness that we obtained against the initial virus.”

The FDA’s decision will force monoclonal antibody treatment facilities around the country to close their doors to those seeking treatment for COVID-19 other than the mRNA vaccine.

In Florida, monoclonal antibodies proved to be a vital lifeline in the state’s approach to combatting COVID-19. Officials from the state of Florida condemned the FDA’s decision, claiming it was made without any warning and determined through analyzing clinical data not made available to the public.

The Florida Department of Health issued a statement countering the FDA. In it, the state’s Department of Health lamented being forced to shut down state-run monoclonal antibody treatment sites, stating, “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical data.”