Court orders FDA to resolve Vanda’s jet lag hearing request by March 4

Vanda Pharmaceuticals announced that the United States District Court for the District of Columbia granted Vanda’s motion for summary judgment on its claim against the United States Food and Drug Administration for unlawfully delaying a hearing on the approvability of Vanda’s supplemental new drug application for HETLIOZ to treat jet lag disorder. Vanda submitted its sNDA in October 2018 for approval to market HETLIOZ to treat jet lag disorder. The FDA did not comply with the statute and did not timely approve or provide an opportunity for a hearing. Instead, the FDA issued a complete response letter in August 2019. Vanda said “The Court’s decision highlights the serious flaws in FDA regulations governing drug-approval processes, and it reinforces the FDA’s clear statutory obligations to render timely final decisions on drug applications. It appears from this case, and from the FDA’s standard policies, that FDA decisionmakers have implemented a policy of following the FDA’s own timelines, resulting in unlawful actions that are systemic. The FDA’s extraordinary delays impede medical innovation to the detriment of the many patients with unmet needs who lack effective therapeutics. The FDA’s delays force these patients to wait years longer than Congress envisioned for access to urgently needed pharmaceutical innovation.”