WASHINGTON, Jan. 29,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today 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 (FDA) for unlawfully delaying a
hearing on the approvability of Vanda's supplemental new drug
application (sNDA) for HETLIOZ® to treat jet lag
disorder (Vanda Pharmaceuticals Inc. v. FDA, case no.
1:22-cv-2275-CJN).
The Federal Food, Drug, and Cosmetic Act (FDCA) 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® 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."
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.
References
- 21 U.S.C. § 355(c)(1)
- 21 U.S.C. § 355(c)(1)(B)
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on X @vandapharma.
About HETLIOZ®
For full U.S. Prescribing Information for HETLIOZ®,
including indication and Important Safety Information, visit
www.hetlioz.com.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.