Posted by Dr Jarrod Bailey on 23rd July 2019
US drugs company challenges FDA request for dog tests
Is ‘Big Pharma’ standing up to regulators on animal testing?
The evidence against the human relevance of testing new drugs in animals is growing, and is at an unprecedented level. In part, this is thanks to work by Cruelty Free International, funded by our supporters, which has given rise to four important published papers in scientific journals since 2013.
Progress is being made. Privately, individuals within the pharmaceutical industry have, for some time, acknowledged the poor predictability of animal data for humans – but this is now acknowledged more publicly, and also at a corporate level. While not going as far as condemning the practice (most likely because they’ve been defending it for years), even regulators are now in on the act, showing their collective support for national and international initiatives to replace the use of animals in this field.
Yet, the pace of change remains slow. Animal studies continue to be the mainstay of drug testing in the absence of robust supporting evidence (and indeed, in the face of evidence against it), while arrays of many and varied alternative, humane, human-specific methods are required to ‘jump through hoops’ in rigorous, time-consuming validation processes that the animal methods have not had, and will never have, to face.
Amid the obstacles and challenges that we face in trying to force the pace of change to a level that ethics and science demand, amid a culture of habit, stubbornness and fear of change, a new, ground-breaking turn of events has given us great encouragement.
Vanda Pharmaceuticals, an international company founded in 2003 and with an annual revenue of $200m, recently stood up to the US drug regulatory agency, the Food and Drug Administration (FDA). The company is in the advanced stages of developing a new drug (in clinical human trials), and had submitted evidence of its safety, including the required animal data, to the FDA, when 150 people participating in their clinical trials were so impressed by its effects that they requested to stay on the drug for longer.
The FDA agreed to this extension, but only if the company conducted an additional 9-month study of the drug in dogs. Vanda challenged the FDA to provide a scientific justification for this requirement, especially given the amount of evidence that it had already provided. All the FDA could do was to point to non-binding guidance; no evidence was offered that the 9-month dog experiments were scientifically justifiable, and there is no specific legislation for them. See article in U.S. political newspaper/website ‘The Hill’, in which I was quoted.
Vanda felt such a sense of injustice that it brought a legal case (ongoing) against the FDA. This was an unprecedented step, and to our knowledge the first time a company has refused to take orders from the FDA, claiming those orders had no scientific basis.
We have spoken with representatives of Vanda to offer our help and support and the benefits of our scientific expertise.
We hope that this will not be the only time the industry defends itself against what we believe are unreasonable requests from regulators, which will result in the suffering and deaths of many animals, all with no benefit or protection for pharmaceutical consumers. The more the industry takes bold steps to ensure what they are required to do has scientific grounds, and the more the regulators feel they are obliged to justify their requirements, the quicker the paradigm shift from animal testing to more humane, more human-relevant drug testing will take place. And animals and humans alike—and the drug companies themselves—will benefit