Vanda Pharmaceuticals is taking legal action against the U.S. Food and Drug Administration (FDA) after the government agency blocked the company from continuing studies of a new drug when it declined to adhere to the FDA’s “illegally imposed” requirement to test it on dogs.
The Washington-based company is developing the drug, tradipitant, as a treatment for a variety of ailments including gastroparesis. Following a short clinical trial on 150 human volunteers in 2018, Vanda Pharmaceuticals requested permission from the FDA to prolong the study to over three months.
However, the FDA refused, demanding that Vanda Pharmaceuticals carry out non-rodent animal toxicity studies for a nine-month period before tradipitant could be studied further in humans, and placed a partial clinical hold on the drug’s research.
“The FDA explicitly told us — based on a guidance, which is a recommendation, not binding — that in order to expose patients to more than three months [of] treatment, certain studies have to be done,” said Vanda Pharmaceuticals CEO Mihael Polymeropoulos, speaking to The Hill. “We’ve done most of them except one: a dog study where you treat dogs for nine months. Then you sacrifice the dogs and you look at their organs.”
In a press release, the drug company said that the FDA’s requirement for “unnecessary and unethical animal studies,” which usually involves beagles, would lead to the needless destruction of dozens of dogs.
“We believe that there is no scientific justification for the requirement that tradipitant be tested in a nine-month dog study, given its currently understood safety profile in both animals and humans, and further, that these studies should not be a routine requirement for all sponsors,” explains Polymeropoulos.
“The FDA is ignoring a large body of published scientific evidence which concludes that these chronic dog studies do not offer any additional useful information. That policy is based on old, outdated science and requires the killing of too many dogs without any scientifically justified purpose. Yet, companies have been reticent to stand up to the FDA and demand that it change its policy. Vanda is unwilling to accept the status quo.”
Help stop the cruelty. Sign Lady Freethinker’s petition urging the FDA to abolish nine-month, non-rodent toxicity studies that result in the needless and painful deaths of innocent animals.
Sign: Stop the US Government from Forcing Cruel Drug Tests on Dogs
VANDA SHOULD BE THE EXAMPLE THIS WORLD FOLLOWS. MAY THE FDA BURN TO THE GROUND, NOW.
YES i agree Skynet—Burn the FDA to the ground. Thank you Vanda for being heartful and kind. God Bless You.
FDA is backwards to allow innocent animals to suffer. Hurting animals is making things safer for people. Drugs are not the answer. Prevention and natural help which doesn’t hurt may help in a fantastic way.
Any chemical that is foreign to the brain/body and is not food may hurt people’s mitochondria/liver/kidneys. They don’t need to test it on dogs/animals. They know it is not healthy. . Drugs are not helping America…may hurt and not help and have many side effects. Just because they get money for research doesn’t mean they should abuse animals to spend the money. Natural help doesn’t hurt people and is fantastic and may help people thrive. Allowing Conventional medicine hurt people/animals is sad! They try to hurt natural help which is awesome!
Good for Vanda. Stand up to them.
Stop,all Testing on all Animals it is so cruel
Please consider the suffering of these beautiful animals, man’s best friend and find other ways of doing these experiments…
Be a pioneer for animal free experiments!
I This is not right
Justice for the victims of these horrific companies!
STOP cruelty!
Thank you, Vanda, for standing up to the FDA! It’s time for this craziness that involves torturing and then killing animals to stop. The FDA needs to get into the 21st century and actually read the scientific literature that shows they don’t need to do these horrible animal studies.
It’s time to put a stop to all animal testing of drugs. Heartless and unnecessary cruelty.
WOW!! Very happy to hear big pharma trying to do the right thing and suing the FDA…this is the best news I’ve heard all year!!
Please Help stop Animal Cruelty Everywhere it is Unacceptable
Change your policies FDA. It is not necessary to test on animals. Change or become obsolete.
Please bann testing on dogs and all animals.
Please do not allow these cruel and painful tests to be done on dogs or any other animals. There is no benefit from these “unnecessary and unethical animal studies,” which usually involves beagles, would lead to the needless destruction of dozens of dogs.” Please have compassion for them. They want to live and play. Animals are not here for us to do whatever we want regardless of how it causes them to be miserable and suffer.
Well done Vanda, stepping up and showing other pharm companies what should, or in this case, shouldn’t be done. More pharm. companies- and cosmetic companies, etc…- need to step up and put an end to their needless and cruel animal testing. Cover Girl- extremely huge co.- just became Leaping Bunny logo cruelty-free, which is very hard to receive this approval. If a company that size can do, and a pharm co. like Vanda is willing to sue the FDA for morality, then other companies can do it too. Time for all to step up and BAN ALL ANIMAL TESTING!
Cruelty needs to STOP!
This FDA people are Criminals. LAB EXPERIMENTS ON ANIMALS ARE ABSOLUTELY “NOT” NECESSARY. This FDA money hungry, thugs are wasting the Tax Payers money for Bogus animal experiments forcing the Pharmaceutical corporations to torture/murder these innocent sentient beings.
Scientists & Governments around the world agree that experiments done on Animals, for the sake of finding HUMAN cures for human diseases is a pure waste of money & time.They have proven that Animal testing has never been applicable to human.
These researches are wasteful, silly & irrelevant. IT ONLY DOES TO CREATE MORE FAKE JOBS TO THE SO CALLED RESEARCHERS & GRAB THE TAX PAYERS MONEY.
Poor innocent animals are confined into small cages, repeatedly subjected to immense pains & sufferings by injecting various meds into their tiny bodies, , blood collecting, cutting their limbs while still conscious, piercing their skulls & inserting metallic objects etc etc. in those laboratories in the name of finding cures are a HELL ON EARTH FOR THE DEFENSELESS CREATURES. THOSE PEOPLE MUST BE PUNISHED FOR THE SUCH CRUELTY THEY DO ON TO HELPLESS GOD’S CREATIONS. PLEASE STOP THIS BARBARIC & BOGUS EXPERIMENTS ON ANIMALS.
There is no need to test on animals – PERIOD.
The FDA is a sham and a mismanaged department to begin with. It is staffed by a bunch of archaic idiots. I can‘t believe a pharmaceutical company is suing the jerks because of the requirements by the FDA to experiment first on animals. I have to say that I am very proud of Vanda Pharmaceuticals and I hope they win and perhaps other companies will follow.
Well done Vanda Pharmaceuticals. What a great example to other pharmaceutical companies.I’m sure that all the other animal tests that Vanda has performed are as useless as this dog study, but at least Vanda is showing that it has some sense of morality and courage.
The FDA is a joke and doesn’t do one thing properly. Thank G- d one drug company has the guts to do the right thing.
Please stop this 😢😢
Ban all testing and experimentally on all animals, and these dogs and cats.
Since I can’t say anything that will not offend you, all I can say is HOW CRUEL AND TOTALLY WRONG THIS IS!
We need to stop this practice if it is not working.
Thank you Vanda Pharmaceuticals for taking action to sue the FDA for demanding you use animal testing. Thank you for not wanting to and holding steadfast on that! WE the people MUST be the voice, the saving grace for animals who have no voice, are innocent, helpless, with no choices & no ways to help themselves. We MUST be their SAVING GRACE!
Why dont they test on humans? Never understand this, how can the results from a test on animals be the same as on humans??
If the tests has been done o humans, and the outcome has the benefits outweighing the risks, why would the FDA enforce an outdated practice instead of other widespread innovations that are more reliable and are already in place.
Some people are truly sadistic
Let them test it on their own employees!!
Dogs are not experiments!
Animals used in research MUST be adopted out to loving people- this is HEARTBREAKING- reputable institutions do NOT use Animals for ANY kind of research whatsoever—pay a visit to PCRM.org- STOP w/ needless, depraved & unconscionable suffering & abuse- get some rationality, sanity, morality & compassion- IMMEDIATELY transfer out animals- where they can lead happy lives— pay a visit to PCRM.org
Well done Vanda.
STOP using innocent gentle creatures as objects!!! This is just plain CRUEL cruel cruel!!!I. I get the impression some so -called humans enjoy causing pain to other living creatures!! STOP
Tests with animals for “human health”????? There are other methods, that save the life of millions of innocent, helpless animals. But they are more expensive than alternative methods. For these “scientists” animals are cheap “material”- not more. They intern them, torment them, abuse them and at last kill them. Barbarians! These tests is a way to get money or reputation! Shame on you, collegues all over the world. You once swore an oath to save and protect life! YOU destroy life! You are living zombies!
Testing on animals has to end, it is nothing but sadistic and cruel.
Vivisection of other species has never been a scientific method for revealing test results for people, but it has grown into it’s own profitable industry, much of it’s profits stolen from taxpayers:
VIVISECTION OR SCIENCE: A CHOICE TO MAKE
http://www.pnc.com.au/~cafmr/online/research/croce1.html