New legislation has been introduced to allow pharmaceutical businesses to choose alternatives to testing on dogs.
A bipartisan committee of Congressional lawmakers is introducing legislation that would require the Food and Drug Administration (FDA) to permit pharmaceutical companies to avoid testing on dogs. The bill has been introduced amid criticism of the agency’s historic handling of testing requirements, which many believe to be too rigid and slow to change. The FDA has maintained its standards even though some pharmaceutical companies have indicated dog testing is not always necessary. Last year, the House Committee on Appropriations asked the FDA to come up with alternative testing criteria.
The Alternatives to Animals for Regulatory Fairness Act (AARF) acknowledged “the FDA will sometimes allow drug makers to use tests that do not involve animals to demonstrate the safety and effectiveness of a drug.” However, lawmakers noted the federal agency has not permitted companies to pursue other options. It also includes a finding from the National Institutes of Health that “30% of medicines have failed in human clinical trials because they are found to be toxic, despite promising preclinical studies in animal models.” This means, the use of dogs may not be warranted because the results aren’t always the same in humans.
“Testing human drugs on dogs and other animals is inhumane, inefficient, and inaccurate,” said Rep. Madeleine Dean (D-Pa.), one of three co-sponsors. “This legislation ensures that regulators allow drug makers to use the most cutting-edge, human-relevant technologies to test drugs whenever possible, rather than requiring them to rely on old-fashioned and cruel animal tests.”
In 2018, the FDA began to take steps to reduce the use of dog testing for veterinary medicine purposes, but animal advocates contend the process has been slow-going. An FDA spokesperson said, “While the FDA is committed to doing all that it can to reduce the reliance on animal-based studies, there are still many areas where animal research is necessary. Without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. We understand and share concerns that animals be involved in research only when there is no other way to fulfil an important public health objective. And, when these studies are necessary, the animals involved in research must be cared for under strict, humane guidelines.”
“Efforts to replace the use of animals with non-animal alternative are typically more effective, efficient and accurate and will only continue to improve over time in comparison to animal tests, which often give unreliable results, will always have limitations and be harmful to the animals,” Kathleen Conlee, vice president of animal research issues at the Humane Society, argued.
Matthew Bailey of the National Association for Biomedical Research, said such legislation is a bad idea, particularly given the current state of the world and the need for accurate medication trials. “There is language about drug safety and efficacy in the AARF bill that could set a dangerous precedent for deciding how biomedical research is conducted in the U.S,” he said, adding it could lead to drug and devices with undetected side effects that could prove fatal.
Bailey also believes “humans and animals share many similar genes, enabling researchers to study complex and essential organ functions to predict the safety and efficacy of drugs as well as medical devices. Non-animal research and testing methods cannot replicate the metabolism of a living organism as accurately as animal models.”
Jeff Brown, a science advisor at the People for the Ethical Treatment of Animals, said the testing approval process is so convoluted it is difficult to determine how the bill will fare. He explained, “You’ll be hard pressed to find a clear, central statement from the FDA on when or why it requires animal tests. The requirements themselves are scattered throughout scores of agency regulations and guidance documents. In practice, though, the impact of these regulations is clear: no drug has ever been approved by the FDA without required animal testing.”