During a hearing brought by three doctors over the Food and Drug Administration’s interference in their professional discretion to prescribe the drug Ivermectin as treatment for Covid-19, a government lawyer claimed that the FDA’s position was merely a “recommendation.”
“The cited statements were not directives. They were not mandatory. They were recommendations,” the government’s attorney Isaac Belfer argued. “They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
“They use informal language, that is true,” attorney Isaac Belfer told a Texas federal court in November, adding that, “it’s conversational but not mandatory.”
The FDA had directed physicians to “stop” prescribing the drug Ivermectin for Covid. On its webpage, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” it stated: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The FDA said in a second post: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
Physicians are claiming that the FDA interfered with their ability to prescribe Ivermectin as an “off-label” medication. Doctors have even been retaliated against for prescribing Ivermectin, as well as Hydroxychloroquine.
Ivermectin was first approved by the FDA in 1966. The drug is known to have anti-malarial properties and several medical researchers have attested to its usefulness in treating certain viral infections.
The three plaintiffs in the suit are Dr. Robert L. Apter, Dr. Mary Talley Bowden, and Dr. Paul E. Marik.
Jared Kelson, the doctors’ attorney, responded that the FDA’s argument “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.’”
The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he argued.
According to the lawsuit, Dr. Marik was even forced to resign because he wasn’t permitted to prescribe Ivermectin due to the FDA’s statements. Dr. Mary Bowden said that pharmacists had refused to fill Ivermectin prescriptions for her patients because it is not FDA approved for the treatment of COVID-19 and those off-label prescriptions in a manner categorically different from other off-label prescriptions.
Attorney Boyden Gray, a former legal adviser to the Reagan and Bush administrations, is heading the law firm that has taken the doctors’ case.
Gray told The Epoch Times that the FDA had “violated well-established law that allows doctors to prescribe an FDA-approved drug as an off-label treatment.”
“Congress recognized the importance of letting doctors be doctors and expressly prohibited the FDA from interfering with the practice of medicine,” Gray said.
“That is exactly what the FDA has done time and time again throughout this pandemic, assuming authority it doesn’t have and trying to insert itself in the medical decisions of Americans everywhere.”
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OPINION: This article contains commentary which reflects the author's opinion.