Fed Court Permits Doctor’s Lawsuit Alleging FDA Exceeded Its Authority with

The Food and Drug Administration went too far in its campaign to persuade Americans not to take the drug ivermectin as a treatment for COVID-19, a federal appeals court ruled Friday.

The decision did not make any judgments about the merits of the drug, but allowed three doctors suing the FDA to have their case heard, according to The Associated Press.

The doctors sued the FDA saying that the campaign, which included social media messages saying “You are not a horse,” went beyond the FDA’s authority.

Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik said they were harmed by the campaign. Bowden’s admitting privileges at a Texas hospital were revoked; Marik lost posts at a medical school and a hospital. The suit had been dismissed by a District court, but the doctors appealed. Their victory Friday sends the case back to a lower court.

All three concurred that their reputations had been harmed over this.

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

A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny. ONWARD! @RobertApter1 @drpaulmarik1 @emilymiller pic.twitter.com/lQTaxBzxn9

— Mary Talley Bowden MD (@MdBreathe) September 2, 2023

All three judges on the panel supported the ruling — Judge Don Willett, an appointee of former President Donald Trump who wrote the opinion,  Judge Jennifer Walker Elrod, who was appointed by former President George W. Bush,  and Judge Edith Brown Clement, also appointed by Bush.

“FDA is not a physician,” the ruling 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 … claims against the Agencies and the Officials,” the ruling said, referring to the Administrative Procedure Act.

“Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority,” the ruling said,

The ruling said the argument from the doctors was that: “(1) FDA cannot act without express statutory authority, (2) FDA does not have express authority to recommend against off-label uses of drugs approved for human use, (3) the Posts recommend against ivermectin, therefore ( 4) the Posts are beyond FDA’s authority”

Although the FDA said the APA gave it the power for its comments, the ruling disagreed.

“Nothing in the Act’s plain text authorizes FDA to issue medical advice or recommendations. FDA’s argument from the Act’s purpose statement thus leads nowhere. In sum, while FDA cites plenty of statutory authority allowing it to issue information, it never identifies even colorable authority allowing it to make medical recommendations (at least not without notice and comment),” the ruling said.

The FDA said its posts were information only, but the court said its messages “directed consumers to take specific actions in keeping with the generally applicable principle that FDA had settled on and announced” and added that “each of the Posts contains imperative elements that go beyond mere factual communication.”

The ruling said the enabling act that created the FDA “expressly shields the Doctors from certain kinds of FDA meddling.“

“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” Jared Kelson, the attorney for the doctors, said in a statement, according to The Hill.

Interesting

— Elon Musk (@elonmusk) September 3, 2023

“It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here,” Kelson said.