In a groundbreaking move, global drug developer Vanda Pharmaceuticals, Inc. has filed a lawsuit and taken a principled stance against the U.S. Food and Drug Administration (FDA) for its senseless demand that the company conduct an additional nine-month, large animal toxicity study in order to proceed with clinical trials for Vanda’s new drug, tradipitant.
The FDA’s decision means that dozens of animals, most likely dogs, will be put to death after enduring painful side effects from high levels of the drug.
While harsh and inhumane, the stipulation is also unnecessary. Vanda has already conducted numerous FDA-required animal tests, including three- and six-month trials with rats, mice and dogs at 300 times the human dosage amounts, and (according to the company) with no significant safety concerns.
It is highly unlikely that outcomes from an additional nine-month trial would deviate from previous results, but it is 100% certain that dozens of dogs will die a miserable death because of it.
CAARE emphatically supports Vanda’s lawsuit and has already reached out to the company letting them know we will back their position to the fullest extent.
We’re asking you to join us in supporting Vanda’s historic stance opposing the FDA’s senseless requirement for additional animal tests.
Fill out the form above to send your letter to FDA Commissioner Scott Gottlieb and Health and Human Services Secretary Alex Azar, letting them know you support Vanda’s efforts to waive these additional animal tests.
Vanda has released an open letter that unequivocally states its position, and urges all concerned individuals to get involved: “The FDA has relied on industry complacency for too long. Vanda refuses to sacrifice young beagles or other animals in a study that serves no scientific purpose. … Vanda is therefore standing up to the FDA and hopes that other scientists, drug companies, animal advocates, and the public will do the same.”
Evidence continues to mount that conducting animal experiments to predict human outcomes is as insufficient as it is unethical. Even the NIH fully acknowledges that human-relevant data derived from animal testing has a translational failure rate of over 90%. It’s time to stop requiring cruel and scientifically questionable animal tests.
Please send your letter today to support Vanda’s unprecedented action to oppose FDA’s senseless animal testing.
Citizens for Alternatives to Animal Research (CAARE), is a 501(c)(3) non-profit organization, established to highlight and promote research without animals.
Please donate to support CAARE’s mission to end animal suffering by disseminating information about the power and progress of research without animals.