Vanda Pharmaceutical files suit over FDA order regarding studies for tradipitant

By Bree Gonzales | Feb 20, 2019

WASHINGTON (Legal Newsline) – A pharmaceutical company has filed a suit against the Food and Drug Administration to challenge the agency's imposition of a hold prohibiting it from continuing a human study of a drug to treat a gastrointestinal disease.

Vanda Pharmaceuticals Inc. filed a complaint on Feb. 5 in the U.S. District Court for the District of Columbia against Food and Drug Administration, Commissioner of Food and Drugs Scott Gottlieb M.D., and Secretary of Health and Human Services Alex M. Azar II citing the Administrative Procedure Act.

According to the complaint, the plaintiff in-licensed tradipitant in 2012 and has been studying its efficacy and safety for gastroparesis, a chronic digestive disorder. It alleges initial studies have shown "no safety signal of concern for humans."

"Despite this evidence of tradipitant’s safety, as well as evidence regarding the ineffectualness of conducting additional non-rodent animal toxicity studies of tradipitant, FDA reflexively imposed an order to cease studies in humans past 90 days until Vanda had completed further chronic toxicity studies in dogs, which would require sacrificing the dogs, without any specific scientific justification. In so doing, FDA violated the Administrative Procedure Act," the suit states.

The plaintiff seeks an order for the court set aside the FDA’s clinical hold on its proposed 12-month clinical studies of tradipitant; declare that the FDA may not impose a clinical hold on it without making an unreasonable risk determination regarding the proposed clinical trials or relying upon a duly enacted regulation. It is represented by Douglas Hallward-Driemeier, Beth Weinman and Gregory H. Levine of Ropes & Gray LLP in Washington, D.C.

U.S. District Court for the District of Columbia case number 1:19-cv-00301-JDB 

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