FDA wins legal dispute with Vanda over partial clinical hold

The FDA has won a legal dispute with Vanda Pharmaceuticals over a partial clinical hold it imposed on tradipitant. Vanda took the FDA to court in the belief the agency's demand ran counter to scientific evidence but failed to convince the U.S. District Court for the District of Columbia.

The origins of Vanda’s dispute with the FDA date back to April 2018, when the drug developer filed a protocol amendment covering a 52-week open-label extension of a clinical trial testing neurokinin 1 antagonist tradipitantin patients with gastroparesis. After a back and forth between the agency and Vanda, the FDA placed a partial clinical hold on two studies the company planned to run. The FDA asked Vanda to run toxicity studies before giving tradipitantin to people for more than 12 weeks. 

Vanda hit back early last year with a lawsuit. The drug developer thinks the FDA’s request for chronic toxicity data in dogs, monkeys or miniature pigs is unjustified. 

Vanda publicly framed its lawsuit against the FDA as a stand against “unnecessary animal research.” Legally, the argument rested on claims that FDA failed to address substantial scientific evidence from Vanda and relied on a nonbinding guidance document as if it imposed regulatory requirements.

None of the arguments persuaded the court to side with Vanda, leading it to rule in favor of the FDA. However, Vanda is yet to admit defeat, stating instead that it will perform a “comprehensive review” before determining “the appropriate next steps.”

The case brought by Vanda is one of two recent lawsuits targeting the FDA’s handling of clinical holds. Months after Vanda began its case, Regenxbio took the FDA to court on the grounds that the agency hit it with a clinical hold “without notice or explanation” and then “rebuffed” its requests for details of the motivations for the regulatory action. The FDA has since lifted the clinical hold.