Vanda Escalates Vendetta Against FDA, Blasts Bureaucrats for Delaying Stomach Drug

Title

Vanda Pharmaceuticals Intensifies Criticism of FDA Over Delays and Rejection of Gastroparesis Drug

Keywords

Vanda Pharmaceuticals
FDA
gastroparesis drug
tradipitant
regulatory dispute
drug approval
agency transparency
bureaucratic delays
public health
FDA criticism

Key Facts

Vanda Pharmaceuticals has escalated its confrontation with the US Food and Drug Administration (FDA) following the agency’s rejection of its investigational gastroparesis drug, tradipitant, in September 20243 5.
The company’s CEO, Mihael Polymeropoulos, penned a strongly-worded letter to FDA Commissioner Robert Califf in January 2025, accusing the agency of a “disturbing pattern of conduct” and a “culture of obfuscation and closemindedness” that harms public health and undermines the FDA’s credibility5.
Vanda criticized the FDA for allegedly disregarding the clinical evidence submitted and for issuing the rejection after the mandated review deadline of 180 days4 5.
The company argued that their late-stage trial did not meet its endpoint due to confounding factors, but claimed that the drug was effective when these factors were accounted for5.
The dispute is not limited to the gastroparesis drug; Vanda is also engaged in litigation with the FDA over off-label promotion rules, and recently lost a confidentiality complaint regarding the agency’s interactions with generic drug developers1 2 4.
Vanda has publicly accused the FDA of lack of transparency and failure to provide clear oversight, quoting Commissioner Califf’s statements on agency decision-making and questioning the criteria for overruling staff decisions5.
The ongoing conflict highlights growing industry concerns over regulatory consistency, transparency, and the speed of drug approvals that can impact both public access to therapies and company interests4 5.

“This opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA,” — Mihael Polymeropoulos, Vanda CEO5.