A federal court has dismissed Vanda Pharmaceuticals Inc.'s challenge against the Food and Drug Administration (FDA) regarding the approval process for its drug, tradipitant. This decision affects Vanda's ability to seek approval for its treatment of gastroparesis symptoms in adults and sets a precedent for how similar cases may be handled in the future.
The case, Vanda Pharmaceuticals Inc. v. Food and Drug Administration, was filed in the District Court for the District of Columbia under Civil Action No. 2024-2514. The ruling was issued by Judge Amit P. Mehta on July 17, 2026. The court's decision is significant as it clarifies the jurisdictional boundaries between district courts and appellate courts in reviewing FDA actions.
Background
Vanda Pharmaceuticals, a biopharmaceutical company, submitted a New Drug Application (NDA) to the FDA in September 2023 for its drug tradipitant, aimed at treating gastroparesis symptoms. In August 2024, the FDA designated Dr. Kathaleen Donohue as the signatory authority for this NDA, meaning she would decide whether to approve the drug or issue a complete response letter (CRL), allowing Vanda to provide more information before a final decision was made.
However, Vanda raised concerns about Dr. Donohue's authority, arguing that she was not properly appointed as an inferior officer under the Appointments Clause of the Constitution. This led Vanda to file a lawsuit seeking a preliminary injunction to stop Dr. Donohue's review of its NDA. The court denied this request, stating that Vanda had not demonstrated irreparable harm or a likelihood of success on the merits.
The Ruling
In the ruling, Judge Mehta explained that the court lacked jurisdiction to review the FDA's refusal of Vanda's NDA due to the Food, Drug, and Cosmetic Act. The Act states that orders refusing or withdrawing drug applications are directly reviewable by courts of appeals, not district courts. The judge noted, "Upon the filing of such petition, such court shall have exclusive jurisdiction to affirm or set aside such order."
As a result, the court granted the FDA's cross-motion to dismiss and denied Vanda's motion for summary judgment as moot. Judge Mehta emphasized that Vanda's challenge regarding the Appointments Clause could not be heard in the district court because it was tied to the FDA's final decision, which is unreviewable in this court.
Impact
This ruling has significant implications for Vanda Pharmaceuticals and other companies seeking FDA approval for new drugs. By affirming that district courts do not have jurisdiction over FDA decisions related to drug applications, the court has reinforced the structure of administrative law. This decision may discourage similar challenges in the future, as companies may find it difficult to contest FDA decisions in district courts.
Furthermore, the ruling sets a precedent regarding the Appointments Clause and the authority of FDA officials in the drug approval process. Vanda's arguments regarding the appointment of FDA officials will now be reviewed in the D.C. Circuit Court, where it has filed a separate petition challenging the FDA's refusal of its NDA.
What's Next
Vanda Pharmaceuticals can appeal this decision to the D.C. Circuit Court, where it has already filed a petition regarding the FDA's refusal of its NDA. The outcome of that appeal could further clarify the legal standards surrounding FDA appointments and the approval process for new drugs.