I strongly support Vanda Pharmaceuticals’ refusal to conduct an FDA-mandated, nine-month, non-rodent toxicity study in order to proceed with clinical trials for its drug tradipitant. Vanda has already conducted abundant, FDA-required animal tests, including three- and six-month toxicity trials with both rodents and dogs at 300 times the intended human dosage. The company has reported no clinically significant safety issues. Evidence indicates that it is highly unlikely an additional nine-month toxicity study on animals will yield any pertinent information.

This study will do no more than result in the needless suffering and death of dozens of young dogs. There is no scientifically justified purpose for killing these animals. In fact, by adhering to this requirement, the FDA is breaking with its own guidelines regarding case-specific evaluation of whether additional preclinical animal tests are even necessary at this stage.

I urge you to uphold Commissioner Gottlieb's recent commitment to eliminate the use of dogs in certain trials. He unequivocally stated, "[that it] is part of the FDA’s overall efforts to help reduce reliance on animals used for research conducted by the agency’s scientists, as well as research conducted by industry.”

The senseless killing of animals is unethical and unjustified. Please waive the additional animal testing requirement placed on Vanda for tradipitant, as well as eliminate the overall FDA requirements for excessive animal testing.