New law clarifies alternatives to animal testing for safety, efficacy of drugs

Expert says animal research remains integral to medical advancements

Newly passed legislation clarifies that pharmaceutical companies can use alternative testing methods other than animals for nonclinical tests or studies before drugs go to human trials.

On Dec. 29, 2022, President Biden signed the FDA Modernization Act 2.0 as part of a larger spending package. The new law makes clear that the definition of a nonclinical test or study under the Food, Drug, and Cosmetic Act includes adjunct and complementary testing methods.

The FDA Modernization Act 2.0 does not change the regulatory process for drugs, medical devices, and treatments prior to reaching clinical trials in humans, and it does not eliminate animal testing.

Transgenic mouse on the gloved hand of a scientist in a modern laboratory
AVMA policy states that animals have an important role in research, testing, and education for continued improvement of animal and human health.

Rather, this bill clarifies that data from the use of certain alternatives to animal testing, including cell-based assays, bioprinted models, organs-on-a-chip, and computer models, can be used to submit an application for a new drug to the Food and Drug Administration.

“People don’t realize there are a lot of early compound screenings that don’t use animal models,” said Dr. B. Taylor Bennett, a laboratory animal veterinarian who is a management consultant in the area of program evaluation and regulatory compliance and serves as the senior scientific adviser for the National Association for Biomedical Research. He listed alternative models such as tissue cultures and artificial intelligence as examples.

“The science and technology and the speed at which it’s advancing these days is really mind-boggling,” Dr. Bennett said.

The FDA states that many procedures intended to reduce animal tests are still in various stages of development. The federal budget also included $5 million for a new FDA program aimed at reducing animal testing by helping to develop new product testing methods.

Dr. Bennett explained that the number of animals that are used today in testing is much less than years ago because of new techniques that improve their use and thus improve the data.

Laboratory veterinarians, he said, have had a significant impact in refining how animals are managed in a laboratory setting. For example, there are new techniques and treatments to minimize animal distress, such as the use of long-acting analgesics.

“The laboratory animal veterinarian has more control over the welfare of the animals they oversee than any other component of veterinary medicine because the law mandates that they do,” Dr. Bennett said. “Students see they can have a huge impact on animal welfare by going into laboratory veterinary medicine.”

While the number of animals used has been reduced, Dr. Bennett said, “These alternative techniques are nowhere near being able to totally replace animal research.”

According to the NABR website, “Animal testing followed by human clinical trials currently remains the best way to examine complex physiological, neuroanatomical, reproductive, developmental and cognitive effects of drugs to determine if they are safe and effective for market approval.”

NABR recognizes the purpose of alternative testing methods, but states, “Not conducting animal tests, when necessary, would likely subject humans and other animals to unreasonable risks.”

AVMA policy states that animals have an important role in research, testing, and education for continued improvement of animal and human health, including the discovery and development of safe and efficacious drugs, vaccines, biologicals, and medical devices that benefit animals and humans.

As for a future where animal testing isn’t needed, Dr. Bennett has his doubts.

“I don’t see it ever totally going away,” he said. “Every time we answer one question in research, it poses another question because we have to learn more.”