WASHINGTON, D.C.—At a congressional briefing today, Vanda Pharmaceuticals, the Physicians Committee for Responsible Medicine, and the Humane Society of the United States urged Congress to task the U.S. Food and Drug Administration (FDA) with moving away from dog studies and other animal testing in the development of new medicines.
Although there are major problems with relying on dogs and other animals to predict human physiological response, every investigational medicine is tested extensively in animals at the nonclinical stage before human clinical trials. The animals killed most often from drug testing are dogs, mice, rats and monkeys. Innovative methods based on human biology are rapidly advancing to provide information that is more predictive of human safety and efficacy.
“There is momentum for change at FDA that Congress can build upon. Modern safety assessment of drugs intended for humans requires human-relevant testing methods that are based on human biology,” said Elizabeth Baker, Esq., pharmaceutical policy program director for the Physicians Committee. “Many of these tests exist now, and more are in development. A bold commitment from the FDA to move away from animal testing would spur innovation of more predictive methods and help the agency meet its goal of reducing animal testing as described with the agency’s Predictive Toxicology Roadmap”.
AJ Jones, Chief of Corporate Affairs and Communications Officer of Vanda Pharmaceuticals, a global biopharmaceutical company, described his company’s experience after the FDA required Vanda to test its drug tradipitant, a treatment for the stomach disorder gastroparesis, on dogs in a nine-month-long study. Vanda’s scientific analysis indicated the dog study would not be useful for decision-making, so Vanda asked FDA not to require the dog study, which would have taken place after Vanda had already begun testing the drug in humans. Instead, the FDA issued a clinical hold on further trials that began in December 2018. In February, Vanda filed a complaint against the FDA.
Kathleen Conlee, Vice President of Animal Research Issues for the Humane Society of the United States, also spoke about the ethical concerns of research and testing on dogs.
To speak with Ms. Baker, please contact Reina Pohl at 202-527-7326 or rpohl [at] pcrm.org.
Reina Pohl, MPH
Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in education and research.