Even in America most people don’t know about this lawsuit and finding updates requires lots of digging online. But it’s not too surprising when it’s about the FDA being sued for misleading the public about the off-label use of Ivermectin during the pandemic.
Not only is it Legal and a Long-Standing practice for doctors to prescribe medications off-label, it’s also a crucial element to their ability to treat patients. Without it, patients suffer.
The Association of American Physicians and Surgeons (AAPS) filed its motion and amicus brief with the federal district court in Galveston urging it to allow the lawsuit to proceed against the FDA for its misleading statements against ivermectin. In Apter v. HHS, a group of physicians sued to hold the Food and Drug Administration, a federal agency within the Department of Health & Human Services (HHS), accountable for its interference with physicians’ ability to treat Covid-19.
“Defendant FDA has improperly exploited misunderstandings about the legality and prevalence of off-label uses of medication, in order to mislead courts, state medical boards, and the public into thinking there is anything improper about off-label prescribing,” AAPS writes in its amicus brief to the court. “Not only is off-label prescribing fully proper, legal, and commonplace, but it is also absolutely necessary in order to give effective care to patients.”
Yet the FDA published multiple statements and sent letters to influential organizations to falsely disparage ivermectin, implying that it was not approved for treating Covid-19. Many, including courts and state medical boards, were misled by the FDA into thinking that its lack of approval for this treatment meant that ivermectin should not be used to treat Covid-19.
“It has never been proper for the FDA to interfere with that essential part of the practice of medicine, and the FDA knows it,” AAPS informed the court. The FDA “insisted and continues to insist on interfering with the prescription of this safe medication by physicians in treating Covid-19,” AAPS added.
AAPS General Counsel Andrew Schlafly pointed out to the court that the FDA “has engaged in a campaign of interference with the proper use by physicians of ivermectin, which has long been approved as fully safe for human use.” He alerted the court that once the FDA approves a medication as safe, then physicians have full authority to prescribe it to treat any illness, particularly a novel virus like Covid-19.
The Association of American Physicians and Surgeons (AAPS) is a national organization representing physicians in all specialties since 1943. Its motto is omnia pro aegroto (everything for the patient).