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# Vanda Criticizes FDA on Tradipitant Hearing Delay
- URL: https://www.fdaweb.com/vanda-criticizes-fda-on-tradipitant-hearing-delay/
- Published: 2025-04-23T12:00:00.000Z
- Updated: 2026-09-14T15:10:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159056

Vanda Pharmaceuticals says FDA is using recent staff cuts and a new commissioner as its “new scapegoat” to delay Vanda’s request for a hearing on the NDA approvability of tradipitant for gastroparesis. Earlier this year, FDA gave the company an opportunity for a hearing to contest an agency complete response letter issued 9/2024, which the company is now seeking ([see earlier story](https://www.fdaweb.com/vanda-can-seek-tradipitant-hearing-fda-notice/)). However, the agency this week told Vanda that the hearing will be delayed by at least six more months due to those recent changes at FDA.

In a [4/23 release](https://prnmedia.prnewswire.com/news-releases/fda-bureaucrats-unlawfully-delay-hearing-on-vanda-drug-and-falsely-blame-commissioner-makary-and-the-reductions-in-force-at-fda-302436404.html?ref=fdaweb.com), Vanda criticizes CDER’s ongoing delays and its recent excuses, claiming that “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.”

Vanda further states that 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.

”Vanda calls on Makary to “step in and restore adherence to the law at FDA; targeted RIFs are not to blame for FDA’s culture of delay and close-mindedness. Commissioner Makary and secretary Kennedy have been clear that ‘radical transparency and common sense’ should be the operating culture of the agency. We also urge attorney general Bondi to stop DoJ lawyers from defending unlawful agency actions.”