Lawsuit over FDA’s swine drug cancer concerns dismissed as ‘unripe’

Published 12:45 pm Wednesday, November 6, 2024

The U.S. government’s potential withdrawal of a veterinary drug due to cancer concerns isn’t yet “ripe” for a court challenge, according to a federal judge.

U.S. District Judge John Bates in Washington, D.C., has dismissed a lawsuit  the Phibro animal health company filed earlier this year against the U.S. Food and Drug Administration.

The complaint argued that FDA’s determinations regarding the cancer-causing potential of carbadox, an antimicrobial used to treat swine illnesses, were “arbitrary and capricious” in violation of federal laws.

Veterinary drugs with the potential to cause cancer in humans or animals cannot win the FDA’s regulatory approval unless they meet certain conditions, such as a lack of pharmaceutical residue in the meat of slaughtered livestock.

Carbadox has repeatedly been granted approval over the past half-century, but more than a decade ago, the FDA began asking for more data about potential health risks and reconsidering its earlier findings.

Last year, the agency revoked the “regulatory method” that had concluded no cancer-causing residues remain in swine three days after they’re treated with carbadox, though the drug can still be sold.

Phibro objected to the FDA’s decision through an administrative process and a federal lawsuit, arguing it’s inconsistent with the evidence and has deprived the company of due process rights, among other allegations.

However, the judge has now thrown out that complaint because Phibro still has a hearing request pending before the FDA and the matter is “entitled to further agency review,” which means there’s no “agency denial” to challenge in federal court.

“This circumstance favors judicial restraint,” the judge said.

Though Phibro claims the agency has “tarnished the company’s reputation and undermined the goodwill built up in the carbadox brand,” it hasn’t demonstrated sufficient hardship to justify the lawsuit, he said.

The company is still allowed to market the drug, and the FDA’s determinations don’t require it to “adjust conduct immediately,” as enforcement proceedings and penalties are only possible once carbadox itself is formally prohibited, the ruling said.

The FDA hasn’t recommended “people make changes in their food choices” during the regulatory process, and a letter from several lawmakers that criticized the agency’s actions didn’t damage the drug’s reputation, the judge said.

“Nothing in the letter supports Phibro’s unsubstantiated claim of reputational harm,” he said.

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