Vanda Pharmaceuticals is bringing a lawsuit against the FDA, saying the agency is forcing it to unnecessarily test a drug on dogs.
The FDA had placed a hold on Vanda’s clinical trials of tradipitant, which is being studied as a treatment for idiopathic and diabetic gastroparesis, saying that additional nonrodent animal testing of the drug needed to be done. But Vanda countered that there is already sufficient data to move the study into human trials and that additional animal testing of tradipitant would result in the “death of dozens of dogs,” because they’ll have to be euthanized once the trial is complete.
According to the Administrative Procedure Act of 1946, drugmakers can bypass this kind of animal testing if they provide equivalent data to what would be produced from testing on animals. The FDA, however, can make an assessment of the data — which in this case includes previous rodent and dog studies — and explain why it is not equivalent in order to mandate more animal testing. According to Vanda’s lawsuit, the FDA never provided an explanation that would warrant the additional nine months of testing on dogs.
If Vanda’s lawsuit fails, the company could be forced to conduct the nine-month dog study anyway. Those concerns made investors skittish and the company’s stock took a 20 percent plunge upon news of the lawsuit.
But the company appears to hope that public support for the case could boost its chances of winning. In an open letter to the FDA, the company called on pharma companies, animal rights groups, and the public to take a stand against unnecessary animal testing.
“Vanda refuses to sacrifice young beagles or other animals in a study that serves no scientific purpose,” the company stated.