WASHINGTON, March 28,
2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced a win in its jet lag FOIA
litigation against the FDA.
On March 27, 2023 a federal court
granted final judgment in favor of Vanda in its Freedom of
Information Act ("FOIA") case requesting records created by the
Food and Drug Administration ("FDA") during its review of Vanda's
application seeking approval of a new use for its drug,
Hetlioz® (tasimelteon). Vanda filed the lawsuit,
Vanda Pharmaceuticals, Inc., v. Food and Drug
Administration, case no. 1:22-cv-00938, in the United States District Court for the
District of Columbia in
April 2022 to compel the FDA to
produce, as required by FOIA, certain records relating to its
denial of Vanda's supplemental New Drug Application ("sNDA") for
HETLIOZ® in the treatment of jet lag disorder.
Vanda had repeatedly attempted to obtain these records from the
FDA pursuant to a FOIA request it submitted in December 2019, but the FDA had refused to
disclose those records, invoking the deliberative process exemption
under FOIA.
The court rejected the FDA's claim that it would suffer
"foreseeable harm" if it disclosed to Vanda its reviews relating to
Vanda's sNDA. In particular, the court held that in the context of
this case, contrary to the FDA's assertion, "[d]isclosure cannot
chill" the "deliberations" of agency staff.
Dr. Mihael H. Polymeropoulos,
Vanda's President, CEO and Chairman of the Board, said: "In order
to facilitate the development of promising new therapeutics for
unmet patient needs, it is crucial that the FDA work
collaboratively with drug innovators. The court's ruling today
constitutes an important step to ensure appropriate transparency at
the FDA, which is essential to scientific advancement in the
service of public health."
As part of its ruling, the federal court issued a final and
appealable order in Vanda's favor, which also denied the FDA's
cross-motion for summary judgment.
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 Twitter @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
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.