Wednesday, September 28, 2022

Florida Gov. Ron DeSantis Slams the Food and Drug Administration for Stopping Drugs That Don’t Work on Omicron

TALLAHASSEE, Florida (AP) — Florida Gov. Ron DeSantis on Tuesday urged coronavirus patients to continue receiving antibody treatments deemed ineffective against the omicron variant, vowing to fight White House health regulators in his latest feud with President Joe Biden.

The Republican governor’s comments came a day after the U.S. Food and Drug Administration withdrew its emergency authorization for antibody drugs from Regeneron and Eli Lilly.

DeSantis, who has made drugs the centerpiece of his response to the virus while resisting vaccination demands and other safety measures, has not said how he will fight the FDA’s decision, and it is legally unclear how he will do so. His office did not immediately respond to an email asking for further clarification. The FDA has exclusive authority to regulate drugs in the United States.

The FDA’s announcement was expected as both drug makers have been stating for weeks that the treatment is less able to target omicron due to its mutations. In a drug labeling update released Monday, the FDA said Omicron appears to be 1,000 times less vulnerable to Regeneron and nearly 3,000 times less vulnerable to Lilly.

DeSantis rose to prominence in the Republican Party for his constant criticism of Biden and the White House’s virus policy. The governor, who is running for re-election and is believed to be considering running for president in 2024, is actively promoting monoclonal antibody treatment.

At a press conference on Tuesday, DeSantis cited isolated cases of people being treated with monoclonal antibodies and said it was “reckless” to block the drugs.

“People have a right to have access to these therapies and it is simply fundamentally wrong to revoke it on that basis, and we are going to fight back,” DeSantis said at a press conference.

Asked about DeSantis’ objection to the FDA’s decision, White House Press Secretary Jen Psaki said, “Let’s just take a step back to see how crazy this is.”

“They’re still advocating treatments that don’t work,” she said of DeSantis.

A spokeswoman for the US Department of Health and Human Services confirmed on Tuesday that the US government had suspended shipments of two antibodies. She added that the federal government continues to distribute the GlaxoSmithKline antibody and two antiviral pills effective against omicrons. However, supplies of these drugs are limited.

“The administration is focused on making sure that if an American gets sick with COVID-19, they get treatment that actually works,” Kirsten Allen of HHS said in a statement.

Hours after the FDA announced its decision on Monday, the Florida Department of Health said it would close all state-owned monoclonal antibody sites until further notice. DeSantis, in a statement Monday night, warned of the consequences of “Biden’s medical authoritarianism.”

Federal officials said the FDA’s decision was supported by several independent studies, including a peer-reviewed article published in the journal Nature last month. In this study, a consortium of European researchers tested the ability of several antibody-based preparations to neutralize a live sample of the virus and concluded that Lilly’s and Regeneron’s antibodies “were inactive against omicrons.”

The American Medical Association, the nation’s largest group of physicians, said it agreed with the FDA’s decision, issuing a statement saying, “Restricting the use of these treatments will help ensure patients receive the best therapy available.”

The federal government temporarily halted state drug distribution in late December as omicron began to become the dominant strain of the coronavirus, but resumed supplies following complaints from Republican governors, including DeSantis. Since early January, the US government has sent enough doses of the two antibodies to treat more than 300,000 patients.

The DeSantis administration last week announced the opening of five new monoclonal antibody treatment centers to “facilitate the distribution of life-saving therapeutics.”

The FDA says omicron is responsible for more than 99% of U.S. infections, making it “highly unlikely” that the antibodies will be effective in people seeking treatment. These drugs are not a substitute for vaccination and are generally reserved for the most vulnerable people, including the elderly, transplant recipients, and people with conditions such as heart disease and diabetes.

Perrone and AP correspondent Zeke Miller contributed to this report from Washington.

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Nation World News Desk
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