Vanda Pharmaceuticals Accuses FDA of Unjustly Delaying Hearing for Its Drug Approval

Vanda Pharmaceuticals Inc. recently raised concerns regarding the FDA's alleged unlawful delays in holding a hearing for the approval of its drug, Tradipitant, intended for treating gastroparesis. On April 23, 2025, Vanda expressed dissatisfaction with the FDA's claims that a recent workforce reduction was a significant factor in delaying their hearing request by an additional six months. Instead of taking accountability for these delays, Vanda argues that the FDA has shifted blame onto the newly appointed Commissioner, Dr. Martin Makary.

In a federal court statement, the FDA suggested that the April 1 reductions in force are partly responsible for the extended timeline in making a recommendation about whether a hearing should be held. However, this assertion raised questions, particularly since Commissioner Makary emphasized that the cuts did not affect the scientists or reviewers essential for evaluating the hearing request. This explanation is viewed with skepticism, given that the Center for Drug Evaluation and Research (CDER) has previously requested similar extensions for other hearing requests.

The situation highlights a broader issue within the FDA regarding the treatment of hearing requests over the last decade. Vanda points out that the FDA has not approved a single hearing request on new drug applications in that timeframe. According to Vanda CEO Dr. Mihael Polymeropoulos, this pattern reflects an entrenched culture of delay within the FDA's decision-making processes.

In prior instances, federal judges have questioned the FDA's ability to comply with statutory requirements when faced with such delays. During a previous case involving Vanda, one judge even had to ask whether the HHS Secretary was complying with the law, to which a Department of Justice (DOJ) lawyer confirmed that they were not.

Vanda Pharmaceuticals is urging Commissioner Makary to intervene and promote adherence to legal standards at the FDA. They assert that targeted reductions in force are not to be blamed for the organization’s culture of postponement and lack of open-mindedness. Both Makary and Secretary Kennedy have previously recognized the need for “radical transparency and common sense” to guide the agency’s operations.

With significant emphasis placed on the necessity for reform, Vanda appeals to Attorney General Bondi to prevent DOJ representatives from defending actions that may be unlawful. Dr. Polymeropoulos reiterated Vanda's commitment to transparency and rational discourse, stating, "It is time for FDA and DOJ to stop fighting innovators like Vanda, to focus on fixing what is broken, and to listen to ideas on how to improve decision-making processes."

This public condemnation of the FDA's practices serves to illustrate the tension between pharmaceutical innovators and bureaucratic regulatory bodies. As Vanda pushes for more systematic and rational approaches to drug approval, the implications of these delays resonate within the broader healthcare sector, where timely access to new treatments can significantly impact patient lives.

As Vanda Pharmaceuticals continues to advocate for change within the FDA, the ongoing dialogue surrounding transparency and regulatory efficiency in drug approval will remain critical. The company stands at the forefront of pushing for an industry that respects both innovation and accountability. For more information on Vanda Pharmaceuticals, their therapies, and their advocacy work, visit Vanda's website or follow them on X @vandapharma.