In a significant victory for doctors, the U.S. Food and Drug Administration (FDA) has agreed to remove social media posts and webpages that discourage the use of ivermectin for COVID-19 treatment. This decision comes as a result of a settlement reached between the FDA and doctors who sued the agency. The settlement, dated March 21, states that the FDA has already removed a webpage that advised against taking ivermectin for COVID-19 prevention or treatment.
The settlement also requires the FDA to remove another page titled “Why you should not use ivermectin to treat or prevent COVID-19” within 21 days. Currently, the page states that ivermectin has not been authorized or approved for COVID-19 and that available data do not support its effectiveness against the virus. However, some studies cited by the FDA's page actually show that ivermectin is effective against COVID-19. This discrepancy has been a point of contention between the FDA and doctors advocating for the use of ivermectin.
In addition to removing webpages, the FDA will delete multiple social media posts that criticized the use of ivermectin, including one that went viral and stated, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The doctors involved in the lawsuit have agreed to dismiss their claims in exchange for these actions by the FDA.
Dr. Mary Talley Bowden, one of the suing doctors, described the settlement as a landmark case that limits FDA overreach into the doctor-patient relationship. Dr. Paul Marik, another plaintiff and chief scientific officer of the FLCCC Alliance, expressed satisfaction with the outcome, stating that the FDA's language and posts about ivermectin interfered with the practice of medicine and potentially denied patients access to a lifesaving treatment.
The FDA maintains that it has not admitted any violation of law or wrongdoing and disagrees with the plaintiffs' claims. The agency asserts its authority to communicate with the public about the products it regulates and emphasizes that available clinical trial data do not demonstrate ivermectin's effectiveness against COVID-19. Ivermectin, approved by the FDA in 1996 for various conditions, including onchocerciasis, a tropical disease caused by a parasitic worm, is commonly prescribed off-label by doctors in the United States.
The lawsuit against the FDA was initially dismissed by U.S. District Judge Jeffrey Brown in 2022, who ruled that the FDA did not exceed its authority. However, an appeals court in 2023 ruled in favor of the doctors, highlighting that the FDA had no authority to recommend consumers to stop taking medicine. This ruling prompted the FDA to refuse any changes to its statements on ivermectin and seek a fresh dismissal of the suit.
The doctors who brought the case, Drs. Robert Apter, Bowden, and Marik, claimed that they faced repercussions after prescribing ivermectin to COVID-19 patients, with pharmacists refusing to fill prescriptions and insurance companies declining coverage. They argued that the FDA unlawfully interfered with their doctor-patient relationships and overstepped its authority under the Federal Food, Drug, and Cosmetic Act.
While government lawyers defended the FDA's actions, Judge Brown maintained that the FDA's powers were limited to medical devices. However, the appeals court disagreed, concluding that the FDA lacked the authority to provide medical advice and returning the case to the district court.
Overall, this settlement represents a victory for doctors advocating for the use of ivermectin in COVID-19 treatment. It sets an important precedent in limiting FDA overreach and highlights the significance of preserving the doctor-patient relationship. With ongoing debates surrounding COVID-19 treatments, this case underscores the importance of evidence-based medicine and the need for open dialogue between regulatory agencies, healthcare professionals, and patients.
