A U.S. federal court has determined that the Food and Drug Administration (FDA) under Democrat President Joe Biden’s leadership exceeded its jurisdiction by disseminating inaccurate information on social media concerning the use of ivermectin for COVID-19.
U.S. Circuit Judge Don Willett, who was appointed by former President Donald Trump, ruled against the FDA’s messaging that advised Americans to cease using ivermectin for treating Covid.
In 2021, the FDA initiated a social media campaign that ridiculed individuals using ivermectin as a Covid treatment. The FDA incorrectly asserted that ivermectin was a medication intended for horses and cautioned the American public against using it for managing coronavirus symptoms.
The FDA’s response came as people were resorting to self-medication with ivermectin due to reports suggesting its high efficacy in treating Covid. Subsequently, scientific studies have confirmed the drug’s remarkable effectiveness against the virus.
As was recently reported, a peer-reviewed study demonstrated that ivermectin can reduce COVID-19-related deaths by 74%.
Judge Willett stated in his ruling, “The FDA can provide information, but it has not identified any legal authority that allows it to advise consumers to ‘stop’ taking a medication.”
Throughout the COVID-19 pandemic, the FDA issued multiple statements discouraging the use of ivermectin for Covid. One particular social media post from August 2021 featured an image of a horse and provided a link to an FDA webpage on ivermectin.
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The page it linked to is titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
Three doctors have also previously filed a lawsuit against the FDA. They assert that the FDA lacks the authority to offer guidance to physicians regarding drug prescriptions.
It’s important to note that the FDA has approved ivermectin as an antiparasitic medication for use in both humans and animals. Contrary to the FDA’s erroneous assertions, ivermectin is not exclusively intended for horses and cows. It has a wide range of applications and is regularly prescribed to humans by healthcare professionals.
The FDA contends that it operated within its jurisdiction when disseminating the inaccurate information about ivermectin to the American public. Federal law generally provides government entities with immunity against legal actions. However, there are exceptions to this rule.
One such exception, referred to as “ultra vires,” arises when an official acts beyond their authorized scope. To challenge these actions, plaintiffs must demonstrate that the official was “acting ‘without any authority whatever,’ or without any ‘colorable basis for the exercise of authority,'” as outlined in a previous court ruling.
Both parties concur that the FDA has the authority to share data and facts. However, they disagree on whether the FDA can issue recommendations concerning medical matters, including treatments.
The FDA has argued that their statements do not constitute advice, asserting in one brief that they were “informational statements” that do not directly instruct consumers or others to take specific actions. Simultaneously, the FDA acknowledged that these statements “provided recommendations” and offered advice to consumers.
“Despite these concessions, FDA never points to any authority that allows it to issue recommendations or give medical advice,” Judge Willett wrote.
“Rather, FDA argues that some posts included a hyperlink that leads to the update.
“The update, in turn, directs consumers to “[t]alk to your health care provider.”
“But not all of the social media posts included such a link.
“And even for those posts that did include a link, the posts themselves offer advice, not mere information.”
The judge expressed concerns about the problematic nature of the FDA’s update, primarily its title, which reads, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” Although the update later acknowledges that individuals can take ivermectin when prescribed by a healthcare provider, the judge noted that the initial instruction’s imperative tone remains unchanged.
U.S. District Judge Jeffrey Brown had ruled against the doctors in 2022, finding that they had not established an exception to sovereign immunity, and there was no evidence that the FDA had exceeded its authority under the Federal Food, Drug, and Cosmetic Act.
However, the recent ruling contends that Judge Brown made an error in his second point. According to the new ruling, “Nothing in the Act’s plain text authorizes the FDA to provide medical advice or recommendations,” as stated by Judge Willett.
Judge Willett, who serves on the U.S. Court of Appeals for the Fifth Circuit, was appointed during the Trump administration. He was joined in the decision by U.S. Circuit Judges Edith Brown Clement and Jennifer Walker Elrod. Judges Clement and Elrod were appointed during President George W. Bush’s tenure.
The appeals court panel has sent the case back to Judge Brown to determine whether the doctors have legal standing.
The ruling comes following oral arguments presented before the panel. Dr. Robert Apter, one of the plaintiffs, celebrated the ruling as “a significant victory for doctors and patients.”
As of now, there has been no response from the Biden administration regarding this ruling.