Phibro Animal Health Corporation's lawsuit challenging the FDA's decision to withdraw carbadox, an antimicrobial drug for food-producing pigs, was dismissed by the District Court. The lawsuit, filed on January 5, 2024, alleged that the FDA's orders violated the Administrative Procedure Act. The FDA had proposed to withdraw approval for carbadox after revoking the related regulatory method in November 2023.
The court determined that Phibro's claims were not "ripe for judicial review" because the FDA had not yet denied Phibro's request for a hearing on the proposed withdrawal of the carbadox New Animal Drug Applications (NADAs). Phibro can continue to market carbadox until the NADA is actually withdrawn, meaning enforcement and actual liability are not imminent.
The District Court also noted that Congress granted exclusive jurisdiction over appeals concerning the refusal or withdrawal of drug application approvals to federal courts of appeals, not district courts. This jurisdictional point further supported the court's decision to dismiss the case, indicating that any future challenge would need to be pursued in a higher court.
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