By doing a single study to help establish a non-animal based model, officials with the FDA are aiming to replace much of the need to use dogs in future trials with new informatics tools.
The FDA has proposed a bioequivalence study that could lead to certain types of animal drug research being completed without the use of dogs. The proposed study is part of the agency’s overall efforts to help reduce reliance on animals in research conducted by both FDA scientists and drug manufacturers.
By doing a single study to help establish a non-animal based model, FDA officials are aiming to replace much of the need to use dogs in future trials with new informatics tools. “Our goal is to do 1 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,” said FDA Commissioner Scott Gottlieb, in a prepared statement.
If validated, the study could provide a new tool for animal drug developers to use in their own research for certain products. The study could also help drug developers generate data in support of applications submitted to the FDA, without relying on the use of animals.
“A critical element of the FDA’s mission is to help ensure that any products we approve are safe and effective for those who will ultimately use them. This is the approach we take for the approval of animal and human drugs,” said Dr. Gottlieb, in his statement.
Prior to approving an animal drug, the FDA requires data that show how a drug behaves in an animal’s body. One part of generating these data are bioequivalence studies, which compare pharmaceutical products, such as an original approved product versus a proposed generic version, to see if they are similar enough in safety and effectiveness.
“Specifically, the goal of the study we’re proposing today is to validate a research model for the comparison of blood levels of certain orally-administered canine drugs, in order to provide an alternative approach that animal drug developers can use to generate data needed to support the FDA’s approval of these types of drugs without the use of dogs during the research process,” Dr. Gottlieb said. “We’re accepting public comment on a white paper outlining this proposed study for the next 60 days.”
The FDA’s proposed study would compare the bioequivalence of tablets containing both locally and systemically acting antiparasitic drugs that are already widely used and well tolerated in dogs. In studying antiparasitic drugs that act locally within the gastrointestinal tract, researchers have historically gathered required data through terminal testing. The animals used in these studies were artificially infected with gastrointestinal parasites and euthanized at the conclusion of the study. This way, researchers could examine the animals’ GI tracts for parasites or parasite damage, evaluating whether the drug was effective.
According to Dr. Gottlieb, the goal of the FDA is to reduce or eliminate these types of research practices.
“In our study, no dogs would be euthanized. Instead, the proposed study would place dogs into 3 groups and, over the course of several months, they’ll receive a total of 3 pills. After each pill is administered, our researchers will draw a small amount of blood from the dogs at specified intervals to measure the concentration of the drugs in the blood and compare them against existing data for these products,” said Dr. Gottlieb, in his statement. “By using the data we generate from these blood tests to establish a clear benchmark for how these drugs are absorbed in the dogs’ blood, we expect to be able to use these data to develop informatics tools that can model the absorption of drugs in the future, rather than requiring the drugs to be tested on live dogs.”
According to the FDA, the research staff will work with the dogs to socialize and acclimate them to their environment for at least 2 months prior to the study’s start, preparing them to be calm for blood draws. The dogs being studied will receive regular veterinary care, including vaccinations, so that they remain happy, well socialized, and healthy. The FDA plans to offer the dogs for adoption as pets at the conclusion of the study.
“While we understand that in certain situations the use of animals in research is needed, we’re committed to exploring ways to help FDA scientists and product developers reduce reliance on this practice,” said Dr. Gottlieb, in the statement. “As we continue to advance new innovations for animals and people, we’re interested in learning about other new technologies that can reduce, replace and/or refine the need for animal testing.”
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials [news release]. Silver Spring, MD; November 16, 2018: FDA website. http://www.americanveterinarian.com//link/58. Accessed November 16, 2018.