Florida’s monoclonal antibody treatment sites shut down after FDA decision

TAMPA, Fla. (WFLA) — Those struggling with COVID-19 in Florida will have a harder time finding monoclonal antibody therapy.

The Florida Department of Health closed all its monoclonal antibody treatment sites Tuesday after the U.S. Food and Drug Administration decided to revoke the emergency authorization for monoclonal antibody treatments made by Regeneron and Eli Lilly.

More than 2,000 appointments were canceled, Gov. Ron DeSantis said in a statement.

According to the FDA, data showed the treatments were less effective against the the Omicron variant, which accounts for more than 99% of cases in the U.S.

“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. 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 in a statement.

DeSantis, a staunch supporter of the treatment, slammed the FDA for its abrupt decision.

“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,” DeSantis said. “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.”

Health experts said monoclonal antibodies are effective at decreasing hospitalization rates among those with COVID-19.

“I was heading for an ICU bed. There’s no doubt in my mind,” said Toma Dean, who received antibody therapy. “I received Regeneron and within about four to six hours, I knew I was going to make it.”

“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today,” the FDA explained.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration,” the Florida Department of Health said in a statement.

Health officials said the sites will remain closed until further notice. For more information about treatment options, reach out to your health care provider.