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Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review.\n\n \n \n \n \n \n \n\n \nAs 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.\nToday, 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:\n_____________________________________________________________________\nDear Dr. Califf:\nWe 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.\nThree 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.\"\nThree months later, Dr. Nikolov has not ...