FDA’s ‘Not a Horse’ Covid-19 Twitter Posts Are Agency Actions

“Tweet-sized doses of personalized medical advice are beyond” the Food and Drug Administration’s statutory authority, the Fifth Circuit ruled as to the agency’s social media posts that discouraged using ivermectin to treat Covid-19.

A lower court must decide whether the case from three ivermectin-prescribing doctors has “any other jurisdictional” or standing issues that would prevent it from moving forward so remand was appropriate, the appeals court also said.

“Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19,” the FDA told its audience on X, formerly known as Twitter, as part of a viral engagement strategy that some staffers described as “the most popular post we’ve ever had on” the social media platform. Some posts admonished the public for taking the drug as if they were horses or cows. The posts, alongside links to its website with further instructions, were part of the agency’s attempt to counter misinformation around Covid-19 and vaccines designed to treat it.

The doctors alleged that the posts, cited in media reports and judicial opinions, interfered with their medical practices and harmed their reputation. Collectively, they say, pharmacies have refused to fill their ivermectin prescriptions, hospitals have revoked their titles and privileges, and people have referred the doctors to medical boards. But the US District Court for the Southern District of Texas dismissed the suit, saying while the posts were perhaps imprudent, the FDA was entitled to sovereign immunity.

However, where an agency takes an action within its zone of interests, final or not, that is plainly not permitted under its enabling statutes, Judge Don R. Willett wrote Sept. 1 that sovereign immunity is waived, and that the FDA’s posts are thus unprotected.

The FDA argued that the posts were informational statements, not advice or rules that directed consumers to do a specific thing. The US Court of Appeals for the Fifth Circuit concluded that the posts themselves don’t bind the FDA to a legal position, so they don’t represent final agency actions that the doctors can challenge only under the Administrative Procedure Act.

But “virtually every statement an agency may make” could be a non-substantive rule under the APA, Willett wrote, and because the FDA posts recommended people not use ivermectin to treat Covid-19, they are non-final agency actions that would support a non-statutory ultra vires claim against the agency.

The court declined to rule on the doctors’ ultra vires claims, or whether the doctors had Article III standing.

Judges Edith Brown Clement and Jennifer Walker Elrod joined in the opinion.

Boyden Gray PLLC represented the doctors.

The case is Apter v. HHS, 5th Cir., No. 22-40802, 9/1/23.