CRAWFORDVILLE, Fla. – Gov. Ron DeSantis went on the attack Tuesday morning following the Food and Drug Administration’s decision to revise the emergency use authorization for two monoclonal antibody treatments used in patients with COVID-19.
“Early this morning, thousands of Floridians woke up to news that their appointments to get treatment for COVID-19 infection were canceled by the Biden administration which revoked — outright revoked — authorization for two very popular monoclonal antibody treatments that the state of Florida really pioneered over the summer and that we’ve worked hard to make available to our residents who needed treatment,” DeSantis said.
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The governor has long championed the use of monoclonal antibody treatments in the state, particularly the treatment produced by Regeneron.
The FDA announced the decision to revise the authorizations Monday for REGEN-COV, commonly called Regeneron after the company that makes it, and bamlanivimab and etesevimab — a treatment taken together which is produced by Eli Lilly — for patients who have the omicron variant of COVID-19.
The authorizations now specifically limit the treatments’ usage to patients likely to have been infected by or exposed to a COVID variant other than omicron. However, the FDA said in its decision that the Centers for Disease Control and Prevention has estimated that more than 99% of COVID-19 cases accounted for in the U.S. are linked to the omicron variant.
“This (treatment) is something that they claim shouldn’t be used because we have omicron and what we would say in Florida is we have had people use it, and we’ve had good results,” DeSantis said. “It’s not 100% — we understand that — but you also don’t even know when someone goes in whether it’s omicron or still the delta. Yes, mostly in Florida it’s going to be omicron at this point, but it’s really a reckless decision to be able to take this option away from patients.”
The U.S. does not have a testing protocol that tells patients immediately if they have a specific variant of COVID-19. A sampling at certain wastewater treatment plants in Central Florida over the last week or so has found almost no trace of COVID-19 variants other than omicron.
“But even if with omicron it’s half as effective or even 25% as effective — that’s better than nothing for people,” DeSantis said. “As I’ve said anecdotally, we’ve had people that have had their symptoms resolved after doing it just in the last month of doing this. So this is wrong what they (the FDA) are doing.”
Studies in Germany found that the Regeneron and Eli Lilly treatments lost most of their effectiveness when exposed to the omicron variant, according to a December report from Reuters; however, antibody treatments from GlaxoSmithKline and Vir were shown to remain effective.
Regeneron itself noted last month that REGEN-COV had “diminished potency against omicron.”
Despite that, the governor promised to “fight back” against the decision.
When asked what that reprisal would look like, DeSantis was light on details.
“We’re gonna see,” he said. “I think, first of all, we are going to expose what this actually means for people. We have patients in Florida who have gotten these treatments over the last month and have had their symptoms resolved. I mean, we see that and again, you know, maybe you do a clinical trial and it’ll show it’s less effective than against delta — that may be the case — but we have patients who have benefited, that’s just a fact.”
When asked if there would be a lawsuit in the future to push back against the FDA’s decision, DeSantis responded, “I don’t know. We’re gonna look, we’re gonna see what we can do.”