Business
FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA
Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, April 23, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA) today announced that FDA bureaucrats have committed to delay Vanda's request for a hearing on the approvability of tradipitant for gastroparesis. Rather than take accountability, FDA bureaucrats identify a new scapegoat: newly appointed Commissioner, Dr. Martin Makary, and reductions in force.","length":408,"tagName":"p"},{"type":"image","alt":"Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.)","displaySize":"","headline":null,"caption":"Vanda Logo (PRNewsfoto/Vanda Pharmaceuticals Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":260,"url":"https://media.zenfs.com/en/prnewswire.com/743d2f4492e0b465012535111f8b6bc6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/t6bNuh3kAr03Rxr6Kla3dQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ1ODtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/743d2f4492e0b465012535111f8b6bc6","width":400,"height":260}},"href":"https://mma.prnewswire.com/media/2090054/VandaLogo_v1.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"FDA last night represented to a federal court that the April 1 reduction in force is partially to blame for the Center for Drug and Evaluation and Research's delay of at least 6 more months to provide its recommendation on whether the Commissioner should hold a hearing. But this cannot be true. Commissioner Makary said that any cuts were not to scientists or reviewers, the very individuals who supposedly need more time. This excuse is also suspect because CDER, in prior matters, has requested the same or longer delay to provide hearing recommendations: CDER took six months to submit a proposed order on the Hetlioz jet lag hearing request and likewise requested six months for the Hetlioz insomnia application.","length":726,"tagName":"p"},{"type":"text","content":"It is unfair for CDER and its lawyers to blame the recent reductions in force for their habitual institutional delays on hearing requests. These statements also conceal the extraordinary fact that FDA has denied every hearing request on new drug approvability for at least the past decade.","length":289,"tagName":"p"},{"type":"text","content":"FDA bureaucrats have created policies to avoid scrutiny of their decision-making by habitually denyin...