Vanda Pharmaceuticals Battles FDA Over Gastroparesis Drug Hearing Delays
核心洞察
Vanda Pharmaceuticals has accused FDA officials of unlawfully delaying a hearing on its gastroparesis (搜索) drug tradipitant, claiming the agency is using recent staff reductions as a false excuse for a six-month postponement.
The company alleges FDA bureaucrats have systematically avoided scrutiny by denying all new drug approvability hearing requests for at least a decade, calling for Commissioner Makary to intervene.
The dispute centers on tradipitant for gastroparesis (搜索), which the FDA rejected in September 2024, claiming the drug failed to demonstrate statistically significant treatment effects.
Vanda Pharmaceuticals has escalated its conflict with the U.S. Food and Drug Administration (FDA), accusing agency officials of deliberately delaying a hearing on the approvability of its gastroparesis (搜索) drug candidate tradipitant. In a strongly worded statement released on April 23, the company claimed FDA bureaucrats are unlawfully postponing the hearing while falsely blaming newly appointed Commissioner Dr. Martin Makary (搜索) and recent staff reductions.
According to Vanda, the FDA informed a federal court that the April 1 reduction in force was partially responsible for the Center for Drug Evaluation and Research (搜索)'s (CDER) decision to delay its recommendation on whether to hold a hearing by at least six more months. Vanda disputes this explanation, noting that Commissioner Makary had previously stated that staffing cuts did not affect scientists or reviewers – the personnel who would be involved in processing the hearing request.
"It is unfair for CDER and its lawyers to blame the recent reductions in force for their habitual institutional delays on hearing requests," Vanda stated. The company pointed out that CDER has requested similar or longer delays in previous matters, taking six months to submit proposed orders on hearing requests for other Vanda products.
The Tradipitant Controversy
The dispute centers on tradipitant, Vanda's drug candidate for gastroparesis (搜索), a stomach condition characterized by delayed gastric emptying that can lead to malnutrition and other complications. The FDA declined to approve tradipitant in September 2024, stating the drug "did not demonstrate a statistically significant treatment effect."
Vanda has consistently challenged the FDA's decision, claiming the agency "generally disregarded" the clinical data. In January 2025, the company escalated its concerns to then-FDA Commissioner Robert Califf, criticizing what it described as a "culture of obfuscation and closemindedness" at the agency.
After the FDA provided an explanation for the rejection and offered Vanda the opportunity for a hearing, the company requested a hearing date "no later than May 7." However, the FDA responded that it would not be able to address the request until September 12, 2025, citing staffing reductions as a factor.
Allegations of Systemic Issues
Vanda's criticism extends beyond this specific case, with the company alleging systematic problems in the FDA's handling of hearing requests. "FDA bureaucrats have created policies to avoid scrutiny of their decision-making by habitually denying hearings," the company stated, claiming the agency "has denied every hearing request on new drug approvability for at least the past decade."
Dr. Mihael Polymeropoulos (搜索), Vanda's President, CEO and Chairman of the Board, called for change: "Vanda has fought for 'transparency and common sense' for years because rational innovation can only thrive in a democracy and not in a bureaucracy. It is time for FDA and DOJ to stop fighting innovators like Vanda, focus on what is broken and listen to ideas of how it can be fixed."
Legal Implications
The company's statement also references previous legal confrontations with the FDA. Vanda noted that when questioned by a federal judge about delays in resolving a prior hearing request, a Department of Justice lawyer acknowledged that the Health and Human Services Secretary was "not complying with the statute."
Vanda is now urging Commissioner Makary to "step in and restore adherence to the law at FDA" and calling on Attorney General Bondi to "stop DOJ lawyers from defending unlawful Agency actions."
FDA's New Leadership
The dispute comes at a sensitive time for the FDA, with Dr. Makary recently appointed as Commissioner. Vanda referenced Makary and Secretary Kennedy's stated commitment to "radical transparency and common sense" as the desired operating culture for the agency.
The outcome of this conflict could have implications not only for Vanda's gastroparesis (搜索) treatment but potentially for how the FDA handles hearing requests and regulatory decisions under its new leadership. For patients with gastroparesis, who currently have limited treatment options, the resolution of this dispute could impact when or if a new therapeutic option becomes available.