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# FDA Urges High Court Rejection of Vanda Petition
- URL: https://www.fdaweb.com/fda-urges-high-court-rejection-of-vanda-petition/
- Published: 2025-10-16T12:00:00.000Z
- Updated: 2026-09-14T15:24:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160057

FDA has [filed a response](https://www.supremecourt.gov/DocketPDF/24/24-1187/379737/20251015163428860%5F24-1187%20--%20Vanda%20Pharmaceuticals%20Inc.%20v.%20FDA.pdf?ref=fdaweb.com) urging the Supreme Court to reject Vanda Pharmaceuticals’ petition challenging the agency’s decision to deny fast-track status for its experimental drug tradipitant for gastroparesis. Vanda had argued that FDA improperly evaluated its application, claiming the drug itself — not the broader development program — should determine eligibility for fast-track designation. The company also contended that the lower courts misinterpreted the statutory criteria and applied an outdated form of judicial deference to the agency.

In its reply, filed 10/15 by the U.S Solicitor General, FDA defended a Washington, DC Court of Appeals’ ruling, which upheld the agency’s denial. The agency emphasized that fast-track status requires a drug to demonstrate the “potential” to address an unmet medical need, an inherently prospective standard. FDA noted that tradipitant’s development plan and outstanding clinical concerns were therefore relevant to determining potential, particularly given that the drug’s partial clinical hold limited the agency’s ability to evaluate long-term safety and efficacy.

The agency also highlighted that Vanda’s studies contained methodological issues, including non-significant results and confounding variables, which made the data difficult to interpret. It contended that earlier court opinions found Vanda had failed to show that tradipitant could meet the long-term treatment needs of patients with gastroparesis, for which short-term therapies already exist.

FDA’s response also argued that the case does not present a broader legal question warranting Supreme Court review. It pointed out that Vanda’s challenge is one of the first ever to contest a fast-track denial, and subsequent developments — including FDA declining to approve Vanda’s new-drug application in its current form — make fast-track status largely irrelevant to the company at this stage.

“Absent additional studies to resolve outstanding safety concerns, Vanda could not demonstrate tradipitant’s potential to address unmet medical needs,” FDA wrote. The agency concluded that the petition for certiorari should be denied, noting that there is no ongoing practical benefit to fast-track designation for Vanda at this point.