Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug

Vanda Pharmaceuticals Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request due to a partial clinical hold on the drug, citing the lack of long-term animal studies to assess its toxicological effects13.

Court Decision:
The United States Court of Appeals for the District of Columbia Circuit affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs13.

Legal Background:
The FDA process for drug approval generally takes approximately ten months and requires manufacturers to submit an Investigational New Drug Application (IND) before filing a marketing application. The FDA must confirm that a new drug is safe and effective before it can be marketed in the United States3.

Vanda's Arguments:
Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law, contending that the FDA erred in considering the clinical hold as a factor and improperly defined the unmet medical need at issue to constitute long-term treatment only13.

FDA's Position:
The FDA maintained that the denial of fast track review was justified due to the clinical hold, which prevents long-term clinical studies until long-term animal studies are completed to assess the drug's toxicological effects13.

Impact:
The court's decision underscores the importance of thorough safety assessments in the drug approval process, emphasizing that the FDA's consideration of clinical holds and development plans is critical in determining fast track eligibility13.

Sources:

1. https://law.justia.com/cases/federal/appellate-courts/cadc/23-5200/23-5200-2024-12-17.html

3. https://media.cadc.uscourts.gov/opinions/docs/2024/12/23-5200-2089874.pdf