FDA Says Doctors Can Prescribe Ivermectin for COVID in Federal Court Lawsuit
Dr. Mary Talley Bowden fights to prescribe off-label medication for patients with COVID-19
Dr. Mary Talley Bowden has made an actual federal case out of the FDA telling people to stop taking ivermectin for COVID-19.
A year after filing a lawsuit, she sat in the Fifth Circuit Court of Appeals on Tuesday as the government defended its role in medical care. The judges sounded skeptical of the FDA’s defense that it never stopped doctors from prescribing the medication off-label for COVID.
This is the fourth part of the series on this case. Catch up and get the original sources: lawsuit filed (June 2022), federal district court hearing (Nov. 2022) and lawsuit dismissed and appealed (Dec. 2022.)
“When the FDA commanded the public not to take ivermectin— an incredibly safe medication used by over four billion people— my job treating COVID patients became incredibly more difficult,”
told me after the hearing in New Orleans.FDA on defense
Ivermectin is an off-label treatment for COVID. During the pandemic, the FDA posted on social media to “stop” taking it and put up a website telling people not to use it as treatment.
(The FDA may be scrubbing its website now. Details at the end only for paid subscribers.)
Under federal law, the FDA is not permitted to give medical advice. This was the point the judges pushed hardest when questioning the government lawyer.
The Justice Department’s lawyer, Ashley Cheung Honold, said the FDA was just giving a warning like opioids are dangerous. Honold said it was necessary after “consumers being hospitalized after self-medicating with Ivermectin intended for horses.”
Pressed by Elrod on what was allowed, Honold said that "FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.”
Pharmacies and insurance
Dr. Bowden said the FDA’s defense in the untelevised courtroom is not enough to end her lawsuit.
“We need the FDA to make an official announcement that clearly states doctors can prescribe and pharmacies can dispense ivermectin for whatever purpose they wish. That is how the law exists, and FDA is not above the law,” the doctor told me.
She said that without an official FDA statement, the public is still going to have difficulty accessing the drug.
“I continue to have to send prescriptions for ivermectin to special pharmacies that do not take insurance. Patients are paying hundreds of dollars for a very inexpensive medication because pharmacies like Walgreens and CVS are refusing to fill prescriptions for ivermectin.”
“Stop it”
Judge Elrod asked Honold about the tweet (below) and other social media posts that say, “You are not a horse. You are not a cow. Seriously, y'all. Stop it.”
“Is that a command? ‘Stop it,’” Elrod asked Honold multiple times but did not get a firm response.
Doctors’ authority
Bowden, Dr. Paul E. Marik and Dr. Robert L. Apter filed the lawsuit against the FDA in June 2022 for interfering with both their authority to prescribe an approved medication and the doctor-patient relationship.
“Nearly 40 percent of prescriptions in the United States are for off-label use,” the doctors’ lawyer, Jared Kelson of Boyden Gray and Associates, told the court.
“This is and always has been an integral aspect of the practice of medicine that is precisely why the FDA cannot interfere. In fact, Congress has expressly forbidden it.”
Bowden has prescribed ivermectin to many of her 5,500 COVID patients.
“I had to find pharmacies willing to dispense it, fight a hospital unwilling to use it, and reassure sick patients it was safe,” she said. “Countless other doctors faced the same roadblocks. The repercussions on patient care are immeasurable.”
Since Bowden has gone public about prescribing the controversial drug, she has been forced to defend her medical license and resign her privileges at Houston Methodist Hospital. Read her powerful Substack article on the impact of defending herself to the Texas Medical Board. None of the accusations against her are from her patients.
FDA accountability
The government’s position was that the court does not have a role to play in the FDA’s guidance on ivermectin. The judge asked Honold who or what would “correct” the FDA if it was giving out “false information.”
“The FDA is politically accountable, just like all other executive agencies,” replied the DOJ’s lawyer. “And the government has to be able to speak to its constituents by conveying information in this way.”
"But we don't elect the FDA,” the judge said. “So how would it be politically accountable?”
“The public can elect its government officials. And FDA, like other government agencies, have politically accountable heads of the agency who are held accountable by the political process,” said Honold. “It's not the role of the courts to fact-check the FDA’s scientific statements meant to further their mission to protect the public from dangerous uses of drugs.”
Legal battle ahead
While the judges delved into the merits of the case, the hearing will only determine whether the FDA can be sued. The case was dismissed by a lower court in December (my story here) because the government claimed it has sovereign immunity.
The doctors are arguing that the FDA is not immune because it acted outside its statutory authority.
All three judges- Elrod, Edith Brown Clement and Don Willett— were appointed by Republican presidents. You can listen to the 50-minute court audio here