This article is more than 5 years old. Information may no longer be current.
FDA seeks to remove dogs from some clinical trials
Click Here to Manage Email Alerts
The FDA outlined details of a study today that it said might allow animal drug developers to conduct certain types of research without the use of dogs.
“The aim is this: by doing a single study to help establish a non-animal-based model, we can potentially replace much of the need to use dogs in future trials with new informatics tools,” FDA Commissioner Scott Gottlieb, MD, said in a release. “In short, our goal is to do one single study involving a small number of dogs — where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial — to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.”
The study announced today will compare the bioequivalence of tablets containing both locally and systemically acting antiparasitic drugs that are already widely used and well-accepted in dogs. Sometimes this research involves antiparasitic drugs that act locally within the animal’s gastrointestinal tract, necessitating the animal be artificially infected with gastrointestinal parasites and euthanized at the study’s end, according to the statement.
“The goal of the model we’re aiming to develop is to reduce or eliminate these research practices. In our study, no dogs would be euthanized,” Gottlieb said.
The FDA will accept public comment on the study for the next 60 days. Instructions on doing so can be found at: https://www.fda.gov/downloads/AnimalVeterinary/ScienceResearch/ToolsResources/UCM626050.pdf