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IPFS News Link • Drugs and Medications

AAPS Establishes in Court Filing that the FDA Has No Authority to Interfere with Off-Label...

• by Edward Hendrie

I must give credit to Andrew L. Schlafly, who is the Counsel for the Association of American Physicians and Surgeons (AAPS). He wrote a powerful and to-the-point amicus curiae brief that was filed in Apter v. HHS, 3:22-cv-194 (JVB) (2022) in the U.S. District Court for the Southern District of Texas. In 12 pages he deconstructed the FDA's campaign against ivermectin and in the process revealed that the FDA emperor has no clothes. The AAPS brief states, in pertinent part:

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. 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. It has never been proper for the FDA to interfere with that essential part of the practice of medicine, and the FDA knows it. Yet it 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.

Defendant FDA lacks both the authority and the expertise to practice medicine, interfere with the practice of medicine, guide the practice of medicine, or advise about the practice of medicine. Federal law is clear about this, and common sense reinforces it. FDA employees are not practicing physicians, and are not treating patients. FDA employees, for the most part, are not even licensed physicians.


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