WASHINGTON, Jan. 8, 2025
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
letter to FDA Commissioner highlights faulty gastroparesis NDA
review.
As previously reported, Vanda has sought approval from the U.S.
Food and Drug Administration (FDA) for tradipitant for the
treatment of patients with gastroparesis. FDA declined to approve
Vanda's New Drug Application (NDA) for tradipitant for the
treatment of symptoms of gastroparesis, providing Vanda with a
Complete Response Letter (CRL) on September
18, 2024.
Today, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's
NDA for tradipitant for the treatment of gastroparesis. The full
letter is shown below:
_____________________________________________________________________
Dear Dr. Califf:
We are writing to bring your attention to a
disturbing pattern of conduct at FDA that impairs the credibility
of the agency and harms the American public. In an interview last
year you stated that you would not overrule decisions made by civil
servants at the Agency except in certain cases of "corruption" or
"temporary insanity" of the decision
maker.1 Neither the public nor regulated entities
like Vanda are able to determine what instances of "corruption" or
"temporary insanity" would in your view merit overruling
lower-level FDA employee decisions. This opacity in decisionmaking
and oversight has allowed a culture of obfuscation and
closemindedness to fester at FDA. And your agency's review of our
application to market tradipitant is no exception.
Three months ago, Vanda received a complete
response letter (CRL), dated September 18,
2024, in response to the new drug application (NDA) Vanda
submitted on September 18, 2023, for
the use of tradipitant for the treatment of symptoms of
gastroparesis, a serious and debilitating gastrointestinal
disorder. We wrote to Dr. Nikolov expressing our surprise "by the
sheer disregard for the facts, evidence, and basic scientific
principles contained in the complete response"—a letter that could
not "possibly reflect a legitimate regulatory review" as it did not
"provide reasoned explanations or engage with the evidence we
presented on its merit—including voluminous evidence from
experts."
Three months later, Dr. Nikolov has not even
acknowledged that letter, let alone provided a response. This is
unacceptable, and stems from the seriously misguided nature of your
position that you will not overrule decisions made by civil
servants at the Agency except in extreme situations such as
"corruption" or "temporary insanity" of the decision maker. As a
political appointee and head of the agency, you are the only person
accountable to the American public—a public that needs to know that
the agency will follow the law and ensure courteous and civil
behavior by agency employees.
In addition, FDA has denied our request to
convene an Advisory Committee to consider our application for
tradipitant, a process by which experts and the public can voice
their opinion on our application. As you are no doubt aware, the
number of Advisory Committee meetings convened by the agency has
drastically declined over the last few years. See
Cheri Banks, The Future of Voting
for FDA Advisory Committees, Federation of American Scientists
(Sept. 9, 2024),
perma.cc/L8R3-2FJD (noting that in
2021, 6% of drug applications were referred to advisory committees,
down from 55% in 2010). You have stated separately that there
should be "less voting" by advisory committees, and that you don't
believe in "gladiator votes" because "votes don't matter."
These statements compound a sentiment that the agency avoids public
scrutiny of its decisions, which is dangerous both for public
health and agency credibility.
I understand that you may be leaving the agency
in the new administration, but I hope that you will consider this
letter, and I would welcome your thoughts in response. FDA's
policies, practices, and culture must be evaluated and corrected so
as to align with scientific evidence and the law.
Sincerely,
Mihael H.
Polymeropoulos, M.D.
Chief Executive Officer
Vanda Pharmaceuticals Inc.
1. MedPage Today,
Politics and Controversy in the FDA, YouTube (Apr. 11, 2023) (statement of Commissioner
Robert Califf, M.D.), available
at
https://www.youtube.com/watch?reload=9&app=desktop&v=zGrnzM51Jrs.
______________________________________________________________________
The text of the letter to Dr. Nikolov, referenced in the
second paragraph of the letter above, is available at:
https://assets.vandapharma.com/pdfs/vanda-letter-to-dr-nikolov.pdf
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.
Corporate Contact:
Kevin
Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
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SOURCE Vanda Pharmaceuticals Inc.
