In a landmark ruling on September 1, a federal court stated that the U.S. Food and Drug Administration (FDA) abused its authority under federal law when it advised Americans to “stop” using the drug Ivermectin as a treatment for COVID-19.
Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter had filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) over the agencies’ unlawful attempts to block the use of Ivermectin in treating COVID-19.
The plaintiffs contested the FDA’s portrayal of Ivermectin as dangerous for human consumption. They noted that the FDA had approved Ivermectin for human use since 1996 for a variety of diseases. But in 2021, the FDA tweeted, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
In 2022, the agency pressed the attack further, tweeting, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.″ Both posts were linked to FDA’s website with the title, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
On Friday, September 1, U.S. Circuit Judge Don Willett stated in his written ruling, “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
According to the court’s decision, the three physicians can now pursue legal action, arguing that the FDA’s campaign went beyond the scope of the agency’s jurisdiction as defined by federal legislation.
“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for a panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.”
In the ruling, Judge Willett wrote, “Left unmentioned in most of that messaging: Ivermectin also comes in a human version. And while the human version of Ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.”
He added, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”
There have now been 99 Ivermectin COVID-19 controlled studies that show a 62% improvement in COVID patients.
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