FDA’s ‘tweet-sized doses’ of ivermectin advice can be challenged in lawsuit, 5th Circuit says

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Health Law FDA's 'tweet-sized doses' of ivermectin advice can be challenged in lawsuit, 5th Circuit says

By Debra Cassens Weiss

September 5, 2023, 11:09 am CDT

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The 5th U.S. Circuit Court of Appeals at New Orleans has said the U.S. Food and Drug Administration is not protected by sovereign immunity in a lawsuit alleging a violation of the Administrative Procedure Act. Image from Shutterstock.

Doctors who prescribed the human version of a drug called ivermectin to thousands of their COVID-19 patients can sue the U.S. Food and Drug Administration, a federal appeals court has ruled.

The 5th U.S. Circuit Court of Appeals at New Orleans said the FDA is not protected by sovereign immunity in the lawsuit alleging a violation of the Administrative Procedure Act.

The Associated Press and Courthouse News Service are among the publications with coverage of the Sept. 1 decision.

The doctors had alleged that the FDA’s social media posts on ivermectin interfered with their ability to exercise professional medical judgment, harmed their reputations and led to professional consequences. The suit claimed that the posts were outside the FDA’s legal authority.

At issue is whether the FDA went too far when it recommended against the parasitic medication on social media, rather than simply informing consumers. The 5th Circuit, in an opinion by Judge Don R. Willett, sided with the doctors.

Willett was on former President Donald Trump’s short list of possible U.S. Supreme Court nominees.

The “FDA is not a physician,” the 5th Circuit said. “It has authority to inform, announce and apprise—but not to endorse, denounce or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.

“Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”

The social media posts included an image of a horse and said:

• “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
• “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”
• “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

The case is Apter v. Department of Health & Human Services.

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