Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review

Core Message - Vanda Pharmaceuticals Inc has issued a letter to FDA Commissioner Robert M Califf MD highlighting concerns over the FDA's review process for its New Drug Application (NDA) for tradipitant a treatment for gastroparesis [1][2][3] FDA Review Process - Vanda submitted an NDA for tradipitant for the treatment of gastroparesis on September 18 2023 and received a Complete Response Letter (CRL) from the FDA on September 18 2024 [2][4] - The CRL was criticized by Vanda for lacking reasoned explanations and failing to engage with the evidence presented including voluminous evidence from experts [4] - Vanda expressed surprise at the disregard for facts evidence and basic scientific principles in the CRL which they argue does not reflect a legitimate regulatory review [4] FDA Advisory Committees - FDA denied Vanda's request to convene an Advisory Committee to consider the tradipitant application [5] - The number of Advisory Committee meetings convened by the FDA has drastically declined from 55% of drug applications in 2010 to 6% in 2021 [5] - FDA Commissioner Robert Califf has stated a preference for less voting by advisory committees and expressed skepticism about the value of votes which Vanda argues contributes to a lack of public scrutiny of FDA decisions [5] Communication and Accountability - Vanda wrote to Dr Nikolov expressing concerns about the CRL but received no acknowledgment or response three months later [4] - Vanda criticizes the FDA's opacity in decision-making and oversight which they argue fosters a culture of obfuscation and close-mindedness [3][4] - Vanda emphasizes the need for FDA policies practices and culture to align with scientific evidence and the law [6] Company Background - Vanda Pharmaceuticals Inc is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs [9]