The U.S. Food and Drug Administration (FDA) on Monday night severely restricted the use and dispersing of monoclonal antibody treatments for COVID-19, claiming that they are ineffective against the Omicron strain of the virus. Governor Ron DeSantis has pushed for the use of monoclonal treatments, recently committing to opening new treatment stations statewide.
“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” the FDA said in a statement. “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”
The FDA said the monoclonal treatments produced by Eli Lilly and Regeneron should only be used in patients that have been infected with or exposed to a variant that is susceptible to the treatments, including Delta. DeSantis, who referred to the move as reckless and sudden, pointed out that the Delta variant is still present in Florida, also making the claim that there is anecdotal evidence of monoclonal antibodies lessening the symptoms brought on by an Omicron variant.
“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” said DeSantis. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”
DeSantis, during a press conference on Tuesday morning, pledged to provide evidence of Floridian cases of effective treatment, claiming that the revoking of authorization was based on a single, non-peer-reviewed article without conducting a clinical trial.
“As a result of this abrupt and clinically unsupported action, the appointments for more than 2,000 Floridians to receive this treatment were canceled on January 25, 2022, alone. This decision was made solely by Biden’s Food and Drug Administration (FDA) without advance warning to states or health providers and without clinical data to support the decision,” continued the governor. “The deliberate decision by the Biden Administration to make this announcement effective immediately, through a press release, actively prevents states and health care providers from making real-time operational decisions that save lives.”
The FDA states that Omicron accounts for over 99 percent of all new COVID-19 cases in the nation and that it is highly unlikely that Delta is prevalent enough to necessitate the use of monoclonal treatments.
DeSantis in December pushed for the state to privately acquire its own stock of Ely Lily and Regeneron in spite of the federal government’s then-pause in shipping treatments to the state.
“We were concerned about what was happening with the taking back of monoclonal antibody supplies. The government stopped sending both Regeneron and the Eli Lilly monoclonal, and that was based on some preliminary study saying that it may not be as effective against Omicron,” said DeSantis. “But of course, Omicron isn’t the only variant out there, and it’s something that we actually have seen applied to Omicron patients and seeing that their symptoms were resolved. It’s not clear that this is something that won’t be a benefit. It may not be as effective as it was against Delta, but we want it to be something available to patients.”