DeSantis Blasts FDA for Halting Drugs Ineffective on Omicron

Anthony Izaguirre, Associated Press

January 25, 2022

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

TALLAHASSEE, Fla. (AP) — Florida Gov. Ron DeSantis vowed Tuesday to fight a decision from federal health regulators to block two coronavirus antibody treatments after the drugs were found to be ineffective against the widespread omicron variant.

The Republican governor's comments come a day after the U.S. Food and Drug Administration moved to revoke emergency authorization for the antibody drugs from Regeneron and Eli Lilly. The drugs, which were purchased by the federal government and administered to millions of Americans, had become a centerpiece of DeSantis' coronavirus response as he resisted vaccine mandates and other safety measures.

The governor did not elaborate on how he plans to oppose to the decision from the FDA, which has sole authority over drug regulation in the U.S.

The FDA announcement was expected, as both drugmakers have said the treatments are less able to target omicron because of its mutations. In updated drug labeling released Monday, the FDA said omicron appears 1,000-fold less vulnerable to Regeneron's drug and nearly 3,000-fold less vulnerable to Lilly's drug.

DeSantis has risen to prominence within the Republican Party through his constant criticism of President Joe Biden and White House virus policy. The governor, who is running for reelection and considered to be eyeing a 2024 presidential run, has heavily promoted the monoclonal antibody treatments at infusion sites and during public appearances.

At a news conference Tuesday, DeSantis referenced anecdotal cases in which people were helped by the monoclonal antibody treatments and said it was "reckless" to block the drugs.

"People have a right to access these treatments, and to revoke it on this basis is just fundamentally wrong and we're going to fight back," DeSantis said at a news conference.

Asked about DeSantis' opposition to the FDA decision, White House press secretary Jen Psaki said, "Let's just take a step back here to realize how crazy this is."

"They are still advocating for treatments that don't work," she said of DeSantis.

A spokeswoman for the U.S. Department of Health and Human Services confirmed Tuesday that the U.S. government has halted shipments of the two antibodies. She added that the federal government continues to distribute a GlaxoSmithKline antibody and two antiviral pills that are effective against omicron. However, supplies of those drugs are limited.

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

Hours after the FDA announced its decision Monday, the Florida Department of Health said it would shutter all monoclonal antibody state sites until further notice. DeSantis, in a statement Monday night, warned of the repercussions to "Biden's medical authoritarianism."

The federal government in late December temporarily stopped distributing the drugs to states as omicron began to become the dominant coronavirus strain but resumed shipments after complaints from Republican governors, including DeSantis. The U.S. government has shipped enough doses of the two antibodies to treat more than 300,000 patients since early January.

The FDA says omicron is responsible for more than 99% of U.S. infections, making it "highly unlikely" that the antibodies would be effective for people seeking treatment. The drugs are not a substitute for vaccination and are generally reserved for people who are the most vulnerable, including seniors, transplant recipients and those with conditions like heart disease and diabetes.

AP Health Writer Matthew Perrone and AP writer Zeke Miller contributed to this report from Washington.

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