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# Court Won’t End Vanda Clinical Hold
- URL: https://www.fdaweb.com/court-wont-end-vanda-clinical-hold/
- Published: 2019-03-20T12:00:00.000Z
- Updated: 2026-09-15T01:14:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143651

The DC federal court has granted an FDA motion for a voluntary remand of Vanda Pharmaceuticals’ suit challenging the agency requirement to perform nine-month large animal studies of its tradipitant before beginning studies in humans. (Tradipitant is a potential treatment for several human conditions including gastroparesis). The court declined the company’s request that it vacate the clinical hold on its 52-week human study while the case is remanded so FDA can reevaluate its position.

Attorney **Sara Koblitz** (Hyman, Phelps and McNamara) [writes](http://www.fdalawblog.net/2019/03/a-doggone-shame-for-vanda-dc-district-court-grants-fdas-remand-motion-on-dog-study-ind-clinical-hold-challenge/?ref=fdaweb.com) in her firm’s *FDA Law Blog* that FDA sought the voluntary remand to “address certain procedural issues Vanda noted in its complaint, including the allegations about the agency’s response to scientific arguments submitted by Vanda and the treatment of a guidance document as a binding rule.”

Vanda’s suit [says](https://www.fdaweb.com/vanda-lawsuit-against-fda-over-animal-study-requirement/) that agency recommendations in guidance documents “are not legally binding on either FDA or drug developers. If a company submits information to FDA to show that further study in humans would be safe based on different information, FDA is supposed to evaluate the company’s proposal and make a case-specific, science-based determination as to whether it agrees.” Instead, the company says, FDA treated a non-binding recommendation as a non-negotiable requirement.

Koblitz says that since the company has been fighting with FDA on the issue since 5/2018, “it’s interesting that it took litigation to compel FDA to address Vanda’s procedural and scientific complaints with any sort of gravity…. The agency fully admits that it did not comply with its own requirements, and it is now asking for the opportunity to do so only after Vanda filed a lawsuit. Even if FDA is just going to ‘put lipstick on a pig’ here and redraft its clinical hold letter to include a reasoned explanation, all reasonable parties should agree that it shouldn’t take litigation to pry such an explanation from FDA.”