America's FDA Forced to Settle 'Groundless' Lawsuit Over Its Ivermectin Warnings
Published on April 01, 2024 at 01:25AM
As a department of America's federal Health agency, the Food and Drug Administration is responsible for public health rules, including prescription medicines. And the FDA "has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19," they confirmed to CNN this week. "The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19." But there was also a lawsuit. In "one of its more popular pandemic-era social media campaigns," the agency tweeted out "You are not a horse. You are not a cow. Seriously, y'all. Stop it." The post attracted nearly 106,000 likes — and over 46,000 reposts, and was followed by another post on Instagram. "Stop it with the #ivermectin. It's not authorized for treating #COVID." Los Angeles Times business columnist Michael Hiltzik writes that the posts triggered a "groundless" lawsuit: It was those latter two lines that exercised three physicians who had been prescribing ivermectin for patients. They sued the FDA in 2022, asserting that its advisory illegally interfered with the practice of medicine — specifically with their ability to continue prescribing the drug. A federal judge in Texas threw out their case, but the 5th Circuit Court of Appeals — the source of a series of chuckleheaded antigovernment rulings in recent years — reinstated it last year, returning it to the original judge for reconsideration. Now the FDA has settled the case by agreeing to delete the horse post and two similar posts from its accounts on the social media platforms X, LinkedIn and Facebook. The agency also agreed to retire a consumer advisory titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19." In defending its decision, the FDA said it "has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old." That sounds reasonable enough, but it's a major blunder. It leaves on the books the 5th Circuit's adverse ruling, in which a panel of three judges found that the FDA's advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right... That's a misinterpretation of the law and the FDA's actions, according to Dorit Rubinstein Reiss of UC College of the Law in San Francisco. "The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it," she observed after the settlement. "A survey by Boston University and the University of Michigan estimated that Medicare and private insurers had wasted $130 million on ivermectin prescriptions for COVID in 2021 alone."
Published on April 01, 2024 at 01:25AM
As a department of America's federal Health agency, the Food and Drug Administration is responsible for public health rules, including prescription medicines. And the FDA "has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19," they confirmed to CNN this week. "The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19." But there was also a lawsuit. In "one of its more popular pandemic-era social media campaigns," the agency tweeted out "You are not a horse. You are not a cow. Seriously, y'all. Stop it." The post attracted nearly 106,000 likes — and over 46,000 reposts, and was followed by another post on Instagram. "Stop it with the #ivermectin. It's not authorized for treating #COVID." Los Angeles Times business columnist Michael Hiltzik writes that the posts triggered a "groundless" lawsuit: It was those latter two lines that exercised three physicians who had been prescribing ivermectin for patients. They sued the FDA in 2022, asserting that its advisory illegally interfered with the practice of medicine — specifically with their ability to continue prescribing the drug. A federal judge in Texas threw out their case, but the 5th Circuit Court of Appeals — the source of a series of chuckleheaded antigovernment rulings in recent years — reinstated it last year, returning it to the original judge for reconsideration. Now the FDA has settled the case by agreeing to delete the horse post and two similar posts from its accounts on the social media platforms X, LinkedIn and Facebook. The agency also agreed to retire a consumer advisory titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19." In defending its decision, the FDA said it "has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old." That sounds reasonable enough, but it's a major blunder. It leaves on the books the 5th Circuit's adverse ruling, in which a panel of three judges found that the FDA's advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right... That's a misinterpretation of the law and the FDA's actions, according to Dorit Rubinstein Reiss of UC College of the Law in San Francisco. "The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it," she observed after the settlement. "A survey by Boston University and the University of Michigan estimated that Medicare and private insurers had wasted $130 million on ivermectin prescriptions for COVID in 2021 alone."
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