This article about ivermectin and a recent lawsuit against the FDA was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law San Francisco, who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively about vaccination’s social and legal policies in law journals. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines. This parent-led organization supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.
On 21 March 2024, the FDA and the plaintiffs in a case that was previously Apter but now carries anti-vaccine doctor’s, Mary Talley Bowden, name filed a joint stipulation of dismissal – in essence, a settlement agreeing to dismiss the case as long as defendants fill certain conditions. The conditions were that the FDA would remove its consumer update on ivermectin and the social media posts calling out the use of veterinary ivermectin to treat COVID-19. The stipulation is already being misrepresented on social media as evidence that the FDA was wrong on COVID-19 and ivermectin, which is one reason – though not the only one – I think the FDA was wrong to agree to it.
The case
I addressed this case, Apter v. Department of Health and Human Services, before in a lengthy post. Three doctors who faced consequences for prescribing Ivermectin for COVID-19, against the evidence, were unhappy that the FDA criticized people for using veterinary ivermectin and that the FDA recommended against using ivermectin.
Presumably, the doctors were prescribing human ivermectin, but they still were unhappy that the FDA did not support their practice, and saw the FDA’s recommendation as part of the reason they faced consequences for their action (and maybe as affecting their sale of their prescription services). They sued, claiming that the FDA was not allowed to make the statement. A district judge dismissed the lawsuit, and the Fifth Circuit, in a decision that arguably ignored the law on this issue, sent the lawsuit back for a fuller hearing.
The case was now before the district judge.
The stipulation — FDA and ivermectin
As mentioned, on 12 March 2024, the parties filed a joint stipulation to “dismissal with prejudice of all claims in the above-captioned case because the parties have reached a settlement.” The settlement was that “In exchange for Plaintiffs’ agreement to dismiss all claims in this case, Defendants agree to, within 21 calendar days:
- Retire FDA’s Consumer Update entitled, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, originally posted on 5 March 2021, and revised on 7 September 2021 (ECF No. 12, Ex. 1), while retaining the right to post a revised Consumer Update.
- Delete and not republish (1) FDA’s Twitter, LinkedIn, and Facebook posts from August 21, 2021 (ECF No. 12, Exs. 4, 5), that read, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”; (2) FDA’s Instagram post from August 21, 2021 (ECF No. 12, Ex. 6), that reads, “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”; (3) FDA’s Twitter post from April 26, 2022 (ECF No. 12, Ex. 7), that reads, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”; and (4) all other social media posts on FDA accounts that link to Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (ECF No. 12, Ex. 1).
FDA has already retired the Frequently Asked Questions (ECF No. 12, Exs. 2, 3) at issue in this case.”
In other words, FDA agreed to remove and archive the materials on ivermectin, for dismissal. Why? Well, the source I found on this seems problematic, but has a quote from the FDA:
An FDA spokesperson told The Epoch Times in an email that the agency “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”
FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said. “FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”
In other words, the FDA decided that litigating things long past is not a good use of its time. I think this is a mistake by the FDA; not necessarily not continuing the district litigation, but not appealing the Fifth Circuit’s flawed and bad decision.
The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it. I understand why it’s not looking to continue to fight over things long done, and expect it will put up a new consumer advisory that will repeat that Ivermectin is not clinically supported as a treatment for COVID-19. But it would have been worth fighting to clarify that it had this authority to make recommendations. This is not the first bad decision from the Fifth Circuit the Supreme Court would have been called upon to fix, and the justices have fixed some other mistakes of that circuit.
Anti-vaccine misrepresentation and why it’s wrong
Several anti-vaccine activists misrepresented the decision already. In a tweet, Dr. Mary Talley Bodwen – a promoter of ivermectin for COVID-19, anti-vaccine misinformation, and other bad information – said:
Breaking: FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history. This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship…
This tweet is mostly misleading, though I agree with one point. The FDA has not “lost its war” on ivermectin. While it agreed to remove certain social media posts (though there are screenshots and these things are forever), it reserves the right – and should – repost about ivermectin.
The stipulation itself also sets no precedent. Settlements do not set precedents.
But Dr. Bowden has a point that the Fifth Circuit’s bad decision – which the FDA did not appeal – can be used in other cases to combat the FDA’s recommendations about other products, which is why I think not appealing it was a mistake.
Once that decision was made, deciding not to litigate 2-4-year-old social media posts kind of makes sense, even though it can be misused by promoters of fake treatments like Dr. Bowden to claim a win – it’s simply that the government has a lot of battles going on.
Anti-vaccine activist Jessica Rose, known for misrepresenting VAERS reports and participating in retracted or bad anti-vaccine studies, wrote a very incorrect tweet. She said:
So if the FDA were lying about IVME to the point we’re [sic] they’ve been ordered to remove their lies from social media, one must ask: What else were they lying about?
This is misleading (probably from ignorance; Dr. Rose likely does not understand the legal errors she made). First, there is no indication the FDA was even wrong on Ivermectin, let alone lying. There is no court decision saying that, there is no good basis to argue it. Second, the FDA was not ordered to remove anything. It offered, as a settlement to avoid bothering with a case that it – wrongly, in my view – considered too small to be worth more effort.
Conclusion on FDA and ivermectin
I think the FDA made an error in not appealing the Fifth Circuit’s initial bad decision. This stipulation – which agrees to remove the social media posts on ivermectin and the current consumer information, though leaves open the ability to publish more on ivermectin and COVID-19 – followed. It’s sad to see the FDA give even this limited win to doctors seeking to avoid criticism for selling fake COVID-19 treatments (and apparently, seeing a call not to use veterinary ivermectin in humans as a personal criticism – which may raise questions as to what they prescribe). But the government has to set its litigation priorities and decided this was not one.
That is all this FDA decision on ivermectin means.
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!
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