Drugs

Vanda Sues FDA Over Pending Tradipitant NDA Decision

Vanda Pharmaceuticals has filed a lawsuit against FDA seeking an advisory committee meeting to assess the company’s pending NDA for tradipitant and its use in treating symptoms of gastroparesis in adults. Gastroparesis is a rare condition characterized by delayed gastric emptying that results in nausea, vomiting, bloating, fullness after meals, and abdominal pain.

The NDA was submitted 11/2023 and the user fee review action target date is 9/18. The unusual move by Vanda to sue FDA before it has formally acted on the NDA could suggest that the expected action by the agency is likely a complete response letter, which the company would expect based on feedback received during the review.

CDER Division of Gastroenterology (DG) is currently reviewing the NDA, according to Vanda, and the final decision is being made by Office of Immunology and Inflammation acting deputy director Kathleen Donohue. DG is a division within the Office of Immunology and Inflammation.

Vanda’s complaint says Donohue’s signatory authority for deciding on the NDA is invalid because she is not an officer of the U.S. under the Appointments Clause. It argues that such an appointment would need to be made by the president and confirmed by the Senate. “Because the power held by the signatory authority can be properly executed only by an officer, and because Dr. Donohue is not a properly appointed officer, the NDA proceeding is unlawful,” it contends. “FDA’s failure to comply with the Appointments Clause renders its review unconstitutional in violation of the Appointments Clause and the separation-of-powers principles recognized by the Supreme Court.”

The complaint asks the court to enjoin FDA from issuing a decision on Vanda’s NDA by Donohue or any other non-officer of the U.S. It also asks the court to order FDA to convene an advisory committee to make a recommendation on Vanda’s tradipitant NDA directly to FDA commissioner Robert Califf.

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