Why I'm Suing the FDA

Complaint filed 6/2/2022 in Texas Southern District Court

The Food and Drug Administration has politicized the practice of medicine during the pandemic, unlawfully foisting itself between doctors and patients on Covid-19 treatment decisions. I am taking legal action against the agency and fighting this injustice for myself, my patients, and my country. We must stand against the pernicious forces that are stifling medical debate and crushing dissent, or we risk losing our ability to make life-or-death decisions about our health.

As a licensed physician in Texas, I have had one mission since the pandemic began: help my patients. I offered access to testing when testing was hard to find. I provided treatment when other doctors told my patients to stay home. I kept over 3,900 patients out of the hospital and maintained a successful treatment rate of 99.97 percent.

I’ve relied on an array of medicines including ivermectin, an inexpensive drug the FDA approved for human use in 1996 but has since strenuously discouraged doctors from using to treat Covid-19. To be clear, the agency’s role is to approve the labeling for medications sold in America—period. It’s a gatekeeper, not a doctor. It has no accountability for patient outcomes and no authority to advise patients on what drug treatments to pursue. Yet it has repeatedly and unlawfully used its office to scare the public into thinking ivermectin is unsafe and unfit—even prohibited—for human consumption.

The agency maintains an official website headlined, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” This post was Tweeted from the verified “U.S. FDA”handle with the not-so-subtle caption reading, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The FDA also published a FAQ—again on its official website—reading “Should I take ivermectin to prevent or treat COVID-19?” with a decisive answer: “No.” The FDA then contacted numerous professional organizations directly, like the Federation of State Medical Boards and the National Association of Boards of Pharmacy, to enlist their help in ensuring compliance.

These relentless attacks on ivermectin have created hurdles I must overcome to treat my patients every day. Pharmacists won’t dispense it. Insurance companies won’t pay for it. Patients want reassurance that it’s safe—and I tell them it’s the safest medication I’ve ever prescribed.

Because I have a different point of view, no matter how well-informed, my medical license is at risk, my livelihood in jeopardy, and my ability to help my patients significantly impaired. Countless doctors across the country are in the same position, and several have joined me in taking legal action against the FDA to stop this injustice.

The issue in our case is not whether ivermectin is an effective treatment for Covid-19. Reasonable people can disagree on that point. The issue is whether the FDA can interfere with the free flow of information and assume the role of a doctor. We must have healthy debate about best methods to combat the disease, especially with cases spiking again—more than three times higher than this time a year ago. Covid-19 is not the first global pandemic, nor will it be the last. If the overreach of the FDA is not addressed now, its unlawful actions will no doubt continue, and doctors’ ability to practice medicine and help their patients will be restricted time and again.

You can bet that other government agencies are watching this episode and scheming to extend their regulatory authority. Imagine an Environmental Protection Agency that doesn’t just set minimum standards for automobile emissions, but also follows you to the car dealer and tells you which car to buy, aggressively shutting down any voices that disagree. The stakes are high, and such a precedent must be stopped in its tracks.

Science and medicine are always changing. So should our willingness to consider alternative strategies. Consider how our base of knowledge has changed since the start of the pandemic. In March 2020, the Surgeon General was urging Americans to “STOP BUYING MASKS,” describing them as “NOT effective in preventing general public from catching #Coronavirus,” but less than a year later President Biden was signing Executive Orders mandating masks as part of “science-based public health measures.” Similarly, Dr. Fauci once preached herd immunity, only to later abandon the idea.

I took an oath to practice medicine—“do no harm”—and the FDA is preventing me fulfilling that oath. That’s why I’m standing up to protect every doctor’s right to practice medicine without interference from politicized government agencies. Fighting the system should never be part of fighting the disease.

Mary Talley Bowden, M.D., is the Stanford-trained owner of BreatheMD, an independent, patient-focused Otolaryngology and Sleep Medicine practice in Texas. She is also a clinical advisor at the Front Line COVID-19 Critical Care Alliance.