Court to FDA: Stop Playing Doctor

The Food and Drug Administration regulates pharmaceuticals, but it has no business playing doctor and giving you medical advice. That’s the message of a Sept. 1 ruling from the Fifth U.S. Circuit Court of Appeals, which strikes a blow against the public-health excesses of the Covid-19 pandemic and in support of the physician-patient relationship.

The decision reversed a district court’s dismissal of an action by three physicians who alleged the FDA overstepped its authority by issuing medical advice. That lawsuit will now proceed.

The physician-plaintiffs had prescribed the human version of the antiparasitic drug ivermectin to Covid-19 patients. The doctors claimed that six FDA informational releases—which the court dubbed the “posts”—interfered with physicians’ “ability to exercise professional medical judgment in practicing medicine” by advising Covid-19 patients not to use ivermectin.

The physicians also alleged the posts resulted in harms to their reputations. One was referred to state medical boards for prescribing ivermectin, and the referrals included copies of the FDA’s posts. Another lost her hospital admitting privileges. The third lost medical school and hospital positions.

The physicians argued that the FDA posts were ultra vires—beyond the agency’s legal power or authority—under the Administrative Procedure Act and the Food, Drug and Cosmetic Act. The appellate court agreed: “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine” and that nothing in the law’s plain text “authorizes FDA to issue medical advice or recommendations.”

The physicians claimed the right to prescribe an approved drug off-label—for a use different than that approved and labeled by the FDA. Off-label use accounts for about a fifth of all prescriptions. Existing medications are often repurposed because their safety profiles are already established. Repurposing was common early in the pandemic when no treatments or vaccines were available.

Initially, doctors had good reasons to think ivermectin might work. Several laboratory studies showed its antiviral activity against a range of viruses, including SARS-CoV-2. Studies in humans followed. Most showed no benefits, and many of the positive ones had a high risk of bias or were fraudulent.

The FDA didn’t claim authority to issue advice. Instead, it denied that its posts contained advice. Judge for yourself: An FDA “consumer update” was titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” A website post read “Q: Should I take ivermectin to prevent or treat COVID-19. A: No.” Three social-media posts suggested ivermectin was only a livestock medication and directed patients to “Stop it with the #ivermectin.” The agency tweeted: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

The FDA claims broad authority to protect public health, much as other agencies did during the pandemic to justify everything from eviction moratoriums to vaccine mandates. Courts have repeatedly struck down such far-reaching assertions of authority unless statutes specifically authorized them.

Read the full article on the Wall Street Journal.