On September 1, a federal court in the United States issued a ruling stating that the U.S. Food and Drug Administration (FDA) likely exceeded its authority when it advised Americans to “stop” using ivermectin as a treatment for COVID-19. U.S. Circuit Judge Don Willett, who authored the ruling, asserted that while the FDA has the authority to provide information to consumers, it lacks the power to recommend that consumers “stop” taking a particular medication.
The FDA’s involvement in the issue stems from its role in regulating drugs under the Federal Food, Drug, and Cosmetic Act as reported by The Epoch Times on Saturday September 2, 2023.
Throughout the COVID-19 pandemic, the FDA had issued several statements cautioning against the use of ivermectin for treating or preventing COVID-19.
These warnings often featured social media posts with messages such as “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” along with links to an FDA webpage titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
In response to the FDA’s statements, three doctors filed a lawsuit against the FDA, arguing that the agency had overstepped its bounds by providing advice to medical professionals on which drugs to prescribe.
Ivermectin, they noted, is approved by the FDA as an antiparasitic drug for both human and animal use.
Under federal law, government officials generally enjoy immunity from legal actions, but there are exceptions. One such exception is “ultra vires,” which occurs when an official acts beyond their legal authority.
To challenge such actions, plaintiffs must demonstrate that the official acted “without any authority whatever” or lacked a “colorable basis for the exercise of authority.”
The crux of the legal dispute revolved around whether the FDA could issue recommendations on medical matters like treatments.
The FDA contended that its statements were merely “informational” and did not “direct” consumers to take or avoid any specific actions, while still acknowledging that they provided recommendations and advice.
However, U.S. Circuit Judge Don Willett found that the FDA failed to point to any authority allowing it to issue recommendations or provide medical advice.
He argued that the FDA’s posts on social media offered advice rather than mere information, and he scrutinized the problematic title of the linked FDA webpage, which stated, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” despite later mentioning that people could take ivermectin if prescribed by a healthcare provider.
In 2022, U.S. District Judge Jeffrey Brown had ruled against the doctors, stating that they had not proven an exception to sovereign immunity, and that there was no evidence that the FDA acted beyond its authority granted by the Federal Food, Drug, and Cosmetic Act.
However, Judge Willett’s new ruling countered this, asserting that the Act’s plain text did not authorize the FDA to issue medical advice or recommendations.
The appeals court panel, consisting of Judges Willett, Clement, and Elrod, remanded the case back to Judge Brown to determine whether the doctors had legal standing.
The ruling was met with enthusiasm by one of the plaintiffs, Dr. Robert Apter, who called it “a big win for doctors and for patients.”
As of now, there has been no official response from the U.S. government regarding this ruling, and the legal battle over the FDA’s authority in matters of medical advice and recommendations continues.
by: _lewi