Court orders FDA to resolve Vanda Pharmaceuticals’ hearing request on HETLIOZ

The company states: “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(R) to treat jet lag disorder. The Federal Food, Drug, and Cosmetic Act requires the FDA to either approve a new drug application or provide an opportunity for a hearing within 180 days after submission of the application.1 Vanda submitted its sNDA in October 2018 for approval to market HETLIOZ(R) 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. Following multiple attempts to informally resolve the complete response letter, Vanda requested an opportunity for a hearing in July 2022, and the FDA provided Vanda a private notice of an opportunity for a hearing. After doing so, the FDA was required under the FDCA to commence the hearing within 120 days2, but the FDA failed to meet this legal obligation. To remedy the FDA’s extraordinary delays, Vanda filed its lawsuit in September 2022. On January 26, 2024, a federal judge ruled that the FDA “has violated the statute” and ordered the FDA to either finally resolve Vanda’s sNDA or commence a hearing on the sNDA on or before March 5, 2024. As the Court explained, “the statute requires that a hearing shall commence within 300 days after an application is filed. Vanda’s application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for hearing.”