The US Food and Drug Administration is required to resolve Vanda Pharmaceuticals’ jet lag hearing request by March 5.

The United States District Court for the District of Columbia granted Vanda Pharmaceuticals’ motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for unlawfully delaying a hearing on the approvability of Vanda’s supplemental new drug application (sNDA) for Hetlioz 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. 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, indicating the agency determined it would not approve the application in its present form, in August 2019. In the response letter, the FDA stated that measures demonstrating improved sleep were of unclear clinical significance.

According to documents filed in the US District Court for the District of Columbia, after “unsuccessful informal attempts” to change the agency’s view, Vanda requested 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 Federal Food, Drug, and Cosmetic Act to commence the hearing within 120 days, but this legal obligation wasn’t met.

Vanda filed its lawsuit in September 2022. 

On Jan 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. 

According to documents filed in the US District Court for the District of Columbia, “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.”

“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,” according to a release from Vanda. “It appears from this case, and from the FDA’s standard policies, that FDA decision-makers 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.”

Hetlioz is currently FDA-approved to treat non-24-hour sleep-wake disorder and sleep disturbances in Smith-Magenis Syndrome.

Photo 180701217 © Andrey Prilutskiy | Dreamstime.com