FDA Must Answer Vanda Request on Drug Denial, Court Rules

The FDA has until March 5 to provide an answer for Vanda Pharmaceuticals’ five-year quest to understand why the FDA denied the company’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) — filed in October 2018 — as a treatment for jet lag disorder, a federal judge has ruled.

Federal statute requires a hearing within 300 days after an application is filed, Judge Carl J. Nichols wrote in his opinion for the U.S. District Court for the District of Columbia. “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 a hearing.”

Vanda says the case “highlights the serious flaws in FDA regulations governing drug-approval processes and reinforces the FDA’s clear statutory obligations to render timely final decisions on drug applications,” the company wrote in a press statement. “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.”

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