Vanda Pharmaceuticals Escalates Dispute with FDA Over Gastroparesis Drug

Vanda Pharmaceuticals has intensified its conflict with the U.S. Food and Drug Administration (FDA) regarding the agency's handling of its gastroparesis drug candidate, tradipitant. The company has accused the FDA of deliberately delaying the approval process and avoiding accountability, marking a significant escalation in the ongoing dispute between the pharmaceutical firm and the regulatory body.

FDA Rejection and Vanda's Response

The controversy began in September 2024 when the FDA declined to approve tradipitant for the treatment of gastroparesis, a stomach condition characterized by delayed gastric emptying. Vanda criticized the FDA's decision, claiming that the agency "generally disregarded" the data presented and took issue with what it termed a "delayed" action.

In January 2025, Vanda escalated the matter by addressing former FDA Commissioner Robert Califf directly. The company partly blamed Califf for fostering a "culture of obfuscation and closemindedness" at the agency. Shortly after, the FDA provided an explanation for the rejection, stating that tradipitant "did not demonstrate a statistically significant" treatment effect, among other reasons.

Hearing Request and FDA's Timeline

Following the FDA's explanation, Vanda requested a hearing on the matter, expecting it to take place "no later than May 7." However, the FDA responded with a letter earlier this month, stating that it would be able to address Vanda's request "no later than September 12, 2025." The agency cited reasons for the extended timeline, including a "significant reduction in force" affecting officials assigned to review Vanda's request.

Vanda's Accusations and Call for Action

Vanda has strongly refuted the FDA's explanation for the delay. The company pointed out that the newly appointed FDA Commissioner Marty Makary had claimed that the staffing cuts did not involve scientists or reviewers. Vanda accused the FDA of using recent layoffs and the new commissioner as "a new scapegoat" to justify the delay.

In a statement released on Wednesday, Vanda slammed what it called "FDA bureaucrats" who are "committed" to delaying the hearing request. The company alleged that these officials are avoiding scrutiny of their decision-making by habitually denying hearings. Vanda further claimed that the FDA has denied every hearing request on new drug approvability for at least the past decade.

In light of these issues, Vanda is calling on Commissioner Makary to "step in and restore adherence to the law at FDA." The specific actions expected from Makary remain unclear, and BioSpace has reached out to Vanda for further comment on the matter.

As this dispute continues to unfold, it highlights the ongoing tensions between pharmaceutical companies and regulatory agencies in the drug approval process, particularly in cases where companies believe their data has been unfairly evaluated or the approval process has been unnecessarily prolonged.