JACKSONVILLE, Fla. —
What you need to know:
- The U.S. Food and Drug Administration on Monday cut Florida’s weekly allotment of monoclonal antibody treatment.
- In a press conference Tuesday, DeSantis said the Biden administration withdrew the treatments without evidence.
- DeSantis’ criticism came after the FDA said Regeneron and Eli Lilly’s monoclonals are not effective against the Omicron variant, which is responsible for the vast majority of infections in the U.S.
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Governor Ron DeSantis said the state will fight back against the FDA’s decision to revoke authorization for two popular monoclonal antibody treatments for COVID-19.
In Jacksonville and across the state, Floridians seeking the treatments were greeted with closed signs on the doors of treatment centers.
Harry Hall, who is visiting from Oregon received a monoclonal antibody treatment Saturday.
He said he felt better by Monday, but now his wife is unable to receive treatment.
“We set up an appointment for today and we came all the way up here and now we just find out that this closed down. Biden shut it down,” said Hall.
The FDA decision affects Regeneron and Eli Lilly’s monoclonal antibody treatments, both heavily used in Florida.
As a result, the Florida Department of Health shut down all state-run sites.
RELATED: FDA orders monoclonal antibody treatments to stop
“Mind you the number of the people that seek this treatment is overwhelmingly people that have been vaccinated, but yet they’re still infected and many of them are high risk,” said DeSantis at a press conference Tuesday.
DeSantis was quick to criticize the decision, which he called ‘reckless’.
“Now they are relying on revoking this and pulling the rug out from under people on a single non-peer-reviewed, non-clinical study that was actually done by a consultant for a rival company to the other two monoclonal antibody treatments,” said DeSantis.
The FDA release doesn’t link to any specific studies or findings justifying the decision.
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“Data show these treatments are highly unlikely to be active against the omicron variant,” states the release.
The DeSantis administration contends the FDA is relying on this preprint study released in mid-December, but even that study states it remains to be determined how its findings translate to clinical protection.
“But even if with omicron it’s half as effective or even 25 percent as effective, that’s better than nothing for people and as I’ve said, anecdotally we’ve had people that have had their symptoms resolved,” said DeSantis.
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We did reach out to the FDA via email in hopes of getting some clarity on the new data the agency says justifies its decision to pull the anti-body treatments, but we did not receive a response.
The FDA noted in its release there are other treatment options available, including anti-viral medications and at least one monoclonal antibody treatment that has been shown to be effective against omicron.
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