Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

Regulatory NewsRegulatory News | 06 February 2019 |  By 

In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant.

The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinical study and a proposed 52-week open-label extension study for patients who completed Phase II of the tradipitant clinical study originally initiated in 2016, according to court filings.

“FDA issued a partial hold order to prevent Vanda continuing to study tradipitant in humans for longer than 12 weeks’ duration, even though a longer-term treatment for gastroparesis patients is urgently needed,” the company said in an open letter to FDA. With the decision to issue the hold, the position that the agency allegedly took requested that Vanda conduct an additional nine-month canine study.

The complaint further alleges that FDA Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Peter Stein, director of CDER’s Office of New Drugs “had conferred and that FDA would not reconsider its decision to impose the clinical hold.” FDA’s Medical Policy and Program Review Council “unanimously endorsed imposing” a non-binding recommendation to conduct an additional nine-month study, which was previously set forth in a guidance developed by the International Council on Harmonisation (ICH).

Vanda’s argument is centered on a lack of scientific or regulatory basis to insist on conducting the nine-month non-rodent study recommended in FDA’s 2010 addendum. It also banks on FDA’s alleged violation of the APA due to its reliance on the ICH guidelines in lieu of an official unreasonable risk determination.

“We won’t be able to comment on pending legal matters,” CDER told Focus in reaction to the complaint.

Still, the new open letter to FDA goes beyond the ask of Vanda’s complaint. It includes a call to action on boards of directors, executives and employees of pharmaceutical companies, animal advocacy groups, scientists and the general public to join Vanda in requesting that FDA conduct an analysis on the value of animal studies.

“FDA has relied on industry complacency for too long,” the company wrote. “Vanda refuses to sacrifice young beagles or other animals in a study that serves no scientific purpose.”


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