‘Reckless’: Monoclonal antibody treatment sites close following FDA decision to remove emergency use

Monoclonal antibody treatment sites will be closed until further notice following the Food and Drug Administration’s abrupt decision to remove its emergency use authorization for two monoclonal antibodies, the Florida Department of Health said late Monday.


State officials said the FDA “without any advanced notice” revised emergency use for bamlanivimab/etesevimab and REGEN-COV. The revised emergency use does not allow providers to administer the treatments within the United States.

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As a result, all antibody monoclonal state sites will be closed until further notice, canceling the appointments for more than 2,000 Floridians who were scheduled to receive the treatment on Tuesday.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the Florida Department of Health said in a news release. “To date, such clinical evidence has not been provided by the FDA.”

Jennifer Brumale, who received monoclonal antibody therapy last week after catching COVID-19 for the third time, said she’s not happy with the decision.

“It’s kind of infuriating to me that they would take something away from people that could potentially save lives,” said Brumale.

Brumale said she’s glad she was able to access the treatment.

“By the next day, I wouldn’t say it was 100% better, but definitely fever gone, walking around,” she said.

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In a statement, Gov. Ron DeSantis demanded the Biden administration to reverse “its sudden and reckless 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.”

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Adam Poulisse, WFTV.com

Adam Poulisse joined WFTV in November 2019.

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