A D.C. federal judge said Vanda Pharmaceuticals must press its Appointments Clause fight over FDA's refusal of its tradipitant application in the court of appeals, not district court.
What happened
A D.C. federal judge dismissed Vanda Pharmaceuticals Inc.'s district court challenge over who at the U.S. Food and Drug Administration could act on its tradipitant new drug application, ruling that the case belongs in the D.C. Circuit now that Vanda has petitioned for review of the agency's final refusal order.
U.S. District Judge Amit P. Mehta granted FDA's cross-motion to dismiss, denied the agency's summary judgment motion as moot and denied Vanda's summary judgment motion. The court said Vanda may once have had a district court forum, but not after the later agency action and appellate petition changed the case's posture. As the opinion put it, "Though this court arguably had jurisdiction to resolve the parties’ dispute at first, it no longer does."
The case began after Vanda submitted an NDA in September 2023 seeking approval of tradipitant to treat gastroparesis symptoms in adults. Vanda objected when FDA named Dr. Kathaleen Donohue as the signatory authority for the application, arguing that she lacked authority to make a binding agency decision because she had not been properly appointed as an inferior officer under the Appointments Clause.
FDA later identified Dr. Nikolay Nikolov as an alternative or additional signatory authority, and the court previously denied Vanda preliminary injunctive relief. FDA then issued a complete response letter signed by Dr. Donohue and Dr. Nikolov declining to approve the NDA, followed by a final order refusing a hearing and rejecting Vanda's arguments about who had authority to sign off on the agency's decision.
That final refusal order moved the fight to the court of appeals, Judge Mehta said. Under the Food, Drug, and Cosmetic Act, FDA orders refusing or withdrawing approval of a drug application are directly reviewable in the courts of appeals, and the filing of a petition gives that court exclusive jurisdiction to affirm or set aside the order.
The district court also rejected Vanda's effort to keep its Appointments Clause challenge separate from the final refusal order. Judge Mehta reasoned that FDA's earlier complete response letter merged into the agency's final action, meaning the same appointment-authority arguments now belong in the D.C. Circuit petition where Vanda has already raised them.
Because the ruling rested on statutory jurisdiction, the court did not reach FDA's mootness argument. The practical result is that Vanda's challenge to FDA appointment authority over the tradipitant decision continues, if at all, in the D.C. Circuit review proceeding rather than in parallel district court litigation.