In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.
Three physicians are suing the U.S. Food and Drug Administration (FDA) for launching what they allege is a “crusade” against ivermectin as a treatment for COVID-19 that “unlawfully interfered” with the doctors’ ability to practice medicine.
In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.
The suit, filed in the U.S. District Court, Southern District of Texas, Galveston Division, also names the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra and Robert Califf, acting FDA commissioner.
According to the complaint:
“The FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as ‘off-label’ use.
“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship.
“Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”
The plaintiffs said their lawsuit isn’t about whether ivermectin is an effective treatment for COVID-19. It’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.
In their complaint, they site an FDA publication, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” and tweets from the FDA — including one implying that ivermectin is intended only for animals — among examples of the FDA discouraging the use of ivermectin.
The plaintiffs also argued if the FDA is allowed to interfere with the practice of medicine now, using the pandemic as a cover, “this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”
“This lawsuit, brought by three eminently qualified physicians, is a welcome development,” said Mary Holland, Children’s Health Defense president and general counsel.
Holland told The Defender:
“These doctors rightfully assert that the FDA, assisted by corporate media, have unlawfully interfered in the doctor-patient relationship and the appropriate treatment for individual patients. Regulating the doctor-patient relationship is an area of well-established state, not federal, law.
“I hope these plaintiffs will enjoin the FDA from continuing to restrict access to ivermectin and from penalizing healthcare practitioners who use this licensed drug for their patients.”
The plaintiffs: well-respected in their field, high success rate treating COVID patients
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