In a case brought before a federal judge in Texas, an attorney for the U.S. Food and Drug Administration (FDA) claimed that directives regarding ivermectin were merely recommendations.
Attorneys for the government have moved to dismiss the complaint, asserting plaintiffs lack standing because any injuries they suffered cannot be traced back to the FDA. The remarks by the attorney for the FDA were made during a hearing on the government’s motion to dismiss.
“The cited statements were not directives. They were not mandatory. They were recommendations,” argued Isaac Belfer, one of the FDA attorneys, before U.S. District Judge Jeffrey Brown.
The original complaint was brought before the U.S. District Court in Galveston by three doctors.
The doctors’ primary concern was that the FDA does not have the authority to ban or advise against particular medicines. Rather, “[t]hose decisions fall within the doctor-patient relationship” even if the drugs are used off-label.
The complaint cites multiple instances in which the FDA allegedly advised against using ivermectin to treat COVID-19.
One instance in which the FDA allegedly advised against using or prescribing ivermectin for COVID-19 was on an FDA webpage titled “FAQ: COVID-19 and Ivermectin Intended for Animals.”
The FDA also posted tweets that the doctors suggest constitute medical advice.
One of the tweets read, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” with a link to their webpage titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” The picture above the article depicts a horse with a veterinarian.
Belfer claimed to the court that these are merely “conversational but not mandatory” recommendations that use “informal language.”
“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,” continued Belfer.
The plaintiffs argued that the recommendations, informal as they may be, acted as a barrier to treating patients with COVID-19.
Dr. Robert Apter, a doctor of 40 years and one of the complainants, claimed that even though he found Ivermectin useful in treating COVID-19, pharmacists would refuse to fill prescriptions and cite the FDA’s guidelines.
Moreover, patients were dubious of the doctor’s Ivermectin prescriptions.
Dr. Mary Bowden, a doctor with 24 years of experience, had a patient who allegedly neglected to take the Ivermectin that Bowden had prescribed because of the FDA’s claims.
After other treatment options failed, the patient took the prescribed medication as directed. The complaint states that “[t]hese delays can be devastating because early treatment of COVID-19 is key.”
Brown expressed concern about the lack of qualifying statements in the social media posts made by the FDA.
All three doctors claim the FDA’s alleged recommendations caused them to face professional repercussions for prescribing Ivermectin or recommending it as a treatment option.
The third doctor in the suit, Dr. Paul Marik, was forced to resign from both of his positions at East Virginia Medical School and Sentara Norfolk General Hospital for promoting Ivermectin as a treatment option for patients.
In the suit, Marik observes that “it doesn’t matter whether FDA statements are technically binding on health professionals” because they are treated as such by pharmacists and hospitals.
The doctors also suggested that the FDA’s actions, if left unchecked, set a dangerous precedent against doctors acting in their patient’s best interest.
“This is not the first pandemic our country has faced, nor will it be the last. … If the FDA is not limited to its statutory lane, its unlawful actions will no doubt persist and repeat themselves.”
The complaint continued, “if the FDA is allowed to interfere with the practice of medicine now under cover of a pandemic, 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.”
Despite the complainant’s claims to the contrary, Belfer argued, “The [doctors], by their own admission, have continued to prescribe Ivermectin. So, they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority.”
Jared Kelson, an attorney representing the plaintiffs, disagreed.
“If the government is going to label Ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said.
“That is enough of a harm to get into court,” and survive the motion to dismiss, he said.
The actions of the FDA “clearly convey that this is not an acceptable way to treat these patients,” he argued.
Despite Brown’s assurances that he would rule quickly, no ruling has been issued by the court.