The case names the FDA, the Department of Health and Human Services, HHS Secretary Xavier Becerra and FDA Commissioner Robert Califf as defendants.
The plaintiffs, Drs. Mary Talley Bowden, Robert L. Apter and Paul E. Marik, argued in the 37-page filing that the FDA acted beyond its authority by prohibiting the use of ivermectin to treat COVID-19 and the agency also “did not engage in reasoned decision making when it acted in a formal, conclusory, and unequivocal manner to prevent or otherwise interfere with the use of ivermectin to treat COVID-19.”
The doctors also accused the FDA of violating the Federal Food, Drug, and Cosmetic Act by “deliberately” interfering with the practice of medicine.
“Sadly, fighting the system has been a much bigger challenge than fighting the disease. Despite my excellent track record treating COVID patients, the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome,” Dr. Bowden commented on the filing in a press release from Boyden Gray & Associates, the law firm representing her and the other doctors.
“Pronouncements from the FDA against the use of ivermectin have been the basis for disciplinary actions against doctors, interfere with the doctor-patient relationship, and have had a severe chilling effect on the use of life-saving medication for a deadly disease,” plaintiff Apter noted.
Dr. Marik called the FDA’s comments on ivermectin “misleading” and said the agency has “raised unwarranted concern over a critical drug in preventing and treating COVID-19.”