On August 21, 2021, the Food and Drug Administration’s official account published eight words a federal appeals court would later pick apart at length: “You are not a horse. You are not a cow.” The post told Americans to “stop it” with ivermectin, a drug the same agency had approved for human use decades earlier and whose discoverers had won a Nobel Prize for it.

THE ARC
2021FDA runs the horse-dewormer campaign2023Fifth Circuit revives the doctors' suit2024FDA settles and deletes the posts
The campaign ran for years before the agency abandoned it in a settlement rather than defend it. Source: Apter v. HHS docket; FDA settlement, 2024

Three doctors sued to make the agency take the posts down. By the time the FDA finally did, in March 2024, the fight had already cost them far more than the posts ever cost the FDA. Mary Talley Bowden had lost her privileges at Houston Methodist and drawn a reprimand from the Texas Medical Board. Paul Marik had resigned his chair at Eastern Virginia Medical School. Robert Apter had been referred to two state medical boards. The agency deleted eight words and conceded nothing. The doctors kept the records. The record was the punishment, and a settlement does not expunge it.

FROM THE DOCUMENT
You are not a horse. You are not a cow.
The agency's own words, later deleted as a term of settlement. Source: FDA post, August 21, 2021

The FDA erased those posts not because it changed its scientific mind, but because the case had turned against it. After the Fifth Circuit let the doctors’ suit proceed, the agency agreed to take the material down as a term of settlement. That sequence, the confident public campaign followed by the quiet retreat, is the record behind Joseph Varon’s essay this week for the Brownstone Institute, Saving Lives Should Not Require Permission. Varon, a Houston critical care physician who now presides over the Independent Medical Alliance, asks when saving a life started to feel like breaking a rule. The documents answer with more precision than the essay does, and they cut harder.

The doctors who paid first

The lawsuit is Apter v. Department of Health and Human Services, and its three plaintiffs were not activists. Apter is an emergency physician. Marik was then chair of pulmonary and critical care medicine at Eastern Virginia Medical School. Bowden is a Houston ear, nose and throat specialist. Each prescribed ivermectin off-label for COVID-19, a lawful act, and each paid a different professional price for it.

The prices are in the record. Houston Methodist suspended Bowden’s privileges in November 2021; she resigned rather than accept the terms, and the Texas Medical Board later reprimanded her for treating a patient at a Fort Worth hospital where she lacked privileges. Marik resigned his EVMS post effective December 31, 2021, in the middle of a losing fight to force Sentara Norfolk General to let him administer the drug, after his school directed him to pull his treatment protocol from its servers. Apter was referred to the medical boards of Arizona and Washington. The consequences were not identical, and that difference matters. No single scientific body was disciplining quacks here. Several institutions moved in the same direction, at the same time, against doctors who had prescribed a human drug to human patients.

What the FDA’s own authority actually says

Here is the part the agency understood and much of the public did not. The FDA regulates how manufacturers label and market drugs. It does not license or supervise the practice of medicine, and off-label prescribing, the use of an approved drug for an unapproved purpose, is lawful and routine. The Texas boards said so in plain terms. In a joint statement dated September 3, 2021, the Texas Medical Board and the Texas State Board of Pharmacy wrote that “drugs are permitted to be prescribed off-label” and that it is “the professional judgement of each physician to write their prescriptions.” The same board that reprimanded Bowden had already conceded the principle she was practicing.

That is why the campaign was legally exposed. When the doctors sued, a unanimous Fifth Circuit panel in 2023 let the case proceed and wrote a line the agency has never publicly reckoned with: “FDA is not a physician. It has authority to inform, announce, and apprise, but not to endorse, denounce, or advise.” The federal food and drug law the agency enforces bars construing the statute to interfere with a practitioner’s authority to prescribe. Read the Food and Drug Law Institute’s own analysis of the ruling and the catch surfaces: that non-interference clause names devices explicitly, leaving the drug question one Congress never squarely answered. The agency wandered into that gap and told the country its doctors were treating patients like livestock.


What the record establishes, and what it does not

Precision matters here, because the loudest tellings of this story overstate it in both directions. The Fifth Circuit did not rule that the FDA broke the law. It reversed a dismissal and held that the doctors were entitled to make their case; as fact-checkers correctly noted, no court ever entered a final judgment on the merits. What the record does establish is narrower and, for the agency, worse. Rather than defend those eight words in front of a judge, the FDA settled and erased them. Its stated reason was that it “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

Weigh that explanation against the incentives. An agency confident that its messaging was lawful and correct has little reason to delete it to dodge a trial; the cheaper course is to litigate, win, and let the posts stand as vindication. The FDA chose the opposite. It kept the reputational benefit of two years of “horse dewormer” coverage and gave up the posts only once the surrender cost it nothing it could not spare. The doctors could not settle their way back into the hospitals they had left.

Varon writes from inside this pattern, and his affiliations belong on the table. The Independent Medical Alliance is the successor to the FLCCC Alliance, the group that built the off-label COVID protocols at the center of these fights, and Brownstone is a reliably anti-lockdown publisher. None of that is hidden, and none of it answers his central claim, because the claim is not really contestable. Varon treated COVID patients with off-label ivermectin by the thousand, which he was legally entitled to do, during a period when a federal agency told the public that doing so made a doctor a danger.

Who has not acted

The posts are gone. The lawsuit is closed. What remains open is everything that would actually close the gap. The record here names no one at the FDA as responsible for a communications campaign the agency was unwilling to defend under oath. The medical boards that referred and reprimanded these physicians have left those findings where they stand; a reprimand does not lift because the agency that helped set the tone deleted its tweets. And Congress has not touched the statutory ambiguity the Fifth Circuit flagged, the open question of whether the FDA may lean on the practice of medicine through advisory posts it calls mere information. Until it does, the next agency that decides a lawful prescription is a public relations problem will reach for the same tool, and the next set of doctors will learn what Bowden, Marik, and Apter did: the deleted post was never the cost. The record was, and no one has moved to expunge it.

Sources

  1. United States Court of Appeals for the Fifth Circuit – Apter v. HHS, No. 22-40802 (opinion)
  2. Justia – Apter v. Dept. of Health & Human Services, No. 22-40802 (5th Cir. 2023)
  3. Food and Drug Law Institute – analysis of Apter v. HHS and 21 U.S.C. § 396
  4. Texas Medical Board and Texas State Board of Pharmacy – joint statement on off-label COVID-19 prescribing (Sept. 3, 2021)
  5. Bloomberg Law – Texas doctors force FDA to remove COVID-19 posts in settlement
  6. CNN – FDA settles lawsuit over ivermectin content that doctors said harmed their practice (Mar. 27, 2024)
  7. Courthouse News – Fifth Circuit sides with ivermectin-prescribing doctors against the FDA
  8. Science Feedback – No court ruled the FDA broke the law with its ivermectin advisory
  9. Houston Chronicle – Bowden says Houston Methodist “vilified” her over ivermectin views
  10. Houston Chronicle – Texas Medical Board reprimands Bowden over treatment of a COVID-19 patient
  11. WTKR – Marik resigns from EVMS amid legal battle with Sentara over ivermectin
  12. Brownstone Institute – Joseph Varon, Saving Lives Should Not Require Permission
  13. Newsweek – Varon says he used ivermectin on thousands of COVID patients despite FDA warnings