DeSantis Blasts FDA For Halting Drugs Ineffective on Omicron
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.
January 26, 2022 at 09:55 AM
4 minute read
Florida Gov. Ron DeSantis pushed Tuesday for 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 pulled its emergency authorization for the antibody drugs from Regeneron and Eli Lilly.
DeSantis, who made the drugs a centerpiece of his virus response while resisting vaccine mandates and other safety measures, did not outline how he would fight the FDA decision and it is legally unclear how he would do so. His office did not immediately return an email seeking further clarification. The FDA has sole authority over drug regulation in the U.S.
The FDA announcement was expected, as both drugmakers have said for weeks that 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 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 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."
Federal officials said the FDA decision was supported by several independent studies, including a peer-reviewed paper published in the journal Nature last month. In that study, a consortium of European researchers tested the ability of several antibody drugs to neutralize a live sample of the virus, concluding that Lilly and Regeneron's antibodies "were inactive against omicron."
The American Medical Association, the nation's largest physician group, said it agreed with the FDA decision, issuing a statement that read: "Limiting the use of these treatments will help ensure patients receive the best available therapy."
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 DeSantis administration last week announced it was opening five new monoclonal antibody treatment sites, to "facilitate the distribution of lifesaving therapeutics."
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.
Perrone and AP writer Zeke Miller contributed to this report from Washington.
NOT FOR REPRINT
© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllThese Law Firm Leaders Are Optimistic About 2025, Citing Deal Pipeline, International Business
6 minute read'Serious Disruptions'?: Federal Courts Brace for Government Shutdown Threat
3 minute readGovernment Attorneys Are Flooding the Job Market, But Is There Room in Big Law?
4 minute readTrump, ABC News Settle Defamation Lawsuit Before Depositions
Trending Stories
- 1The Key Moves in the Reshuffling German Legal Market as 2025 Dawns
- 2Social Media Celebrities Clash in $100M Lawsuit
- 3Federal Judge Sets 2026 Admiralty Bench Trial in Baltimore Bridge Collapse Litigation
- 4Trump Media Accuses Purchaser Rep of Extortion, Harassment After Merger
- 5Judge Slashes $2M in Punitive Damages in Sober-Living Harassment Case
Who Got The Work
Michael G. Bongiorno, Andrew Scott Dulberg and Elizabeth E. Driscoll from Wilmer Cutler Pickering Hale and Dorr have stepped in to represent Symbotic Inc., an A.I.-enabled technology platform that focuses on increasing supply chain efficiency, and other defendants in a pending shareholder derivative lawsuit. The case, filed Oct. 2 in Massachusetts District Court by the Brown Law Firm on behalf of Stephen Austen, accuses certain officers and directors of misleading investors in regard to Symbotic's potential for margin growth by failing to disclose that the company was not equipped to timely deploy its systems or manage expenses through project delays. The case, assigned to U.S. District Judge Nathaniel M. Gorton, is 1:24-cv-12522, Austen v. Cohen et al.
Who Got The Work
Edmund Polubinski and Marie Killmond of Davis Polk & Wardwell have entered appearances for data platform software development company MongoDB and other defendants in a pending shareholder derivative lawsuit. The action, filed Oct. 7 in New York Southern District Court by the Brown Law Firm, accuses the company's directors and/or officers of falsely expressing confidence in the company’s restructuring of its sales incentive plan and downplaying the severity of decreases in its upfront commitments. The case is 1:24-cv-07594, Roy v. Ittycheria et al.
Who Got The Work
Amy O. Bruchs and Kurt F. Ellison of Michael Best & Friedrich have entered appearances for Epic Systems Corp. in a pending employment discrimination lawsuit. The suit was filed Sept. 7 in Wisconsin Western District Court by Levine Eisberner LLC and Siri & Glimstad on behalf of a project manager who claims that he was wrongfully terminated after applying for a religious exemption to the defendant's COVID-19 vaccine mandate. The case, assigned to U.S. Magistrate Judge Anita Marie Boor, is 3:24-cv-00630, Secker, Nathan v. Epic Systems Corporation.
Who Got The Work
David X. Sullivan, Thomas J. Finn and Gregory A. Hall from McCarter & English have entered appearances for Sunrun Installation Services in a pending civil rights lawsuit. The complaint was filed Sept. 4 in Connecticut District Court by attorney Robert M. Berke on behalf of former employee George Edward Steins, who was arrested and charged with employing an unregistered home improvement salesperson. The complaint alleges that had Sunrun informed the Connecticut Department of Consumer Protection that the plaintiff's employment had ended in 2017 and that he no longer held Sunrun's home improvement contractor license, he would not have been hit with charges, which were dismissed in May 2024. The case, assigned to U.S. District Judge Jeffrey A. Meyer, is 3:24-cv-01423, Steins v. Sunrun, Inc. et al.
Who Got The Work
Greenberg Traurig shareholder Joshua L. Raskin has entered an appearance for boohoo.com UK Ltd. in a pending patent infringement lawsuit. The suit, filed Sept. 3 in Texas Eastern District Court by Rozier Hardt McDonough on behalf of Alto Dynamics, asserts five patents related to an online shopping platform. The case, assigned to U.S. District Judge Rodney Gilstrap, is 2:24-cv-00719, Alto Dynamics, LLC v. boohoo.com UK Limited.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250