Biotech wants to reduce animal testing and FDA is now tasked with helping

While animal activists oppose animal testing on moral grounds, the biotech industry knows that alternative technology can provide more accurate and less expensive screening for experimental drugs.

“The ethical piece of this and the economic piece of this really do line up,” according to the Biotechnology Innovation Organization’s (BIO) Chief Advocacy Officer Nick Shipley.

As of December, the Food and Drug Administration (FDA) is trying to get the regulatory piece in line too. The FDA Modernization Act 2.0, passed as part of last year’s Omnibus spending act, allows drug makers to collect data on the efficacy and safety of new drugs using alternatives to animal testing, such as bioengineered organs or computer models. The industry has already been moving in this direction, and now, the FDA is encouraged to help them, according to Shipley.

“The agency, for reasons that are understandable, they want a very high level of comfort when it comes to safety and efficacy questions,” he explained. “But I do think that the inclusion of the FDA Modernization Act in the Omnibus bill sends a signal that Congress wants them to lean in more on this and catch up with the industry.”

Since the 1930s, the FDA has generally required animal tests to prove the safety of drugs and cosmetics before they are tested on people. In the last 10 years, animal activists helped put an end to the use of chimpanzees in biomedical research projects supported by the National Institutes of Health. But many other animals are still used in the lab. In 2019, scientists in the United States used from 12-24 million animals in research, according to Speaking of Research.

Technology offers alternatives

There are more than 100 alternatives to animal testing for chemical safety accepted by U.S. and international regulatory authorities, according to the Health and Human Services National Toxicology Program. Most of the methods used in drug development fit in a few broad categories, including:

•  Living tissue made with bioprinting or other means: Bioprinting is like the 3D printer technology used in “additive manufacturing,” but it involves a more complex process, using a nutrient-rich microgel for printing. Bioprinting, and other bioengineering techniques, can be used for producing two types of alternatives to animal testing: synthetic tissue, which acts like human tissue, or more complex replicas of human organs called organoids.
• Organs on chips: These are small devices, about the size of a thumb drive, that have thin channels lined with human cells. Drugs that need testing are pumped through these channels, in a manner that impersonates the way our body functions, and researchers can see how the human cells are impacted.
• Computer modeling: In some instances, computer models have been proven better at catching certain side effects than animal testing. One study found that “human computer models of heart cells are more accurate than animal experiments at predicting the drug-induced side effects for the heart in humans,” according to Scientific American.

Benefits of replacing animal testing

These non-animal methods can be necessary for certain types of testing, according to Rachael Anatol, BIO Senior Vice President for Science and Regulatory Affairs. “In some cases there is no animal model to evaluate a drug or biological product,” she said. Furthermore, these methods can offer greater efficiency.

“In terms of cost savings and time savings with the use of non-animal models, I certainly think there is a potential for both,” said Anatol.

Along with being more expensive, animal testing is getting more difficult, due to the scarcity of available animals, particularly the non-human primates that most closely resemble the human anatomy, according to Shipley.

“There is a literal shortage in nonhuman primates for research. And that just underscores the need to find more models, to find more options out there. And the companies want that. They are not wedded to the animal model,” Shipley said.

In 2013, China announced they would prioritize use of their research primates for domestic R&D, according to Shipley. Early in the COVID-19 pandemic, China completely suspended any exports of primates for testing, and they seem to be willing to maintain the prioritization of their domestic industry’s needs over exporting to the U.S., he said.

“We do rely on importation of research animals and that’s particularly true in the non-human primate class, when you get up to the bigger classes. So I do think from a global competitiveness standpoint, this is actually a pretty important thing,” he said.

A slow transition

FDA Modernization 2.0 will by no means bring about the end of animal testing. The FDA still has the right to require animal testing before approving a drug candidate, and they will continue to do so, Anatol said. The law should rather be seen as an impetus to reduce the practice, she explained.

“It’s going to take some time for the agency to feel comfortable with the use of these non-animal models,” and the industry will have to help the FDA feel comfortable, Anatol said. “I think manufacturers, and sponsors, and folks developing drugs and biological products, are going to have to show the agency really a proof of concept, that the non-animal models can be used in place of animal models.”

The FDA also needs to help the industry be more comfortable, Shipley said.

“What the companies need is for the agency to kind of showcase that they have confidence that they will accept non-animal models as part of the data package that they get,” he said.

New opportunities

Ultimately, all stakeholders want to move in this direction. “It’s a shared goal of the industry, and BIO, and also the regulatory agencies, to reduce and refine the use of animal models,” Anatol said. The result is a growing demand for non-animal tests.

“I see it as a way for maybe a new industry to crop up—now that there’s been some signal from Congress that they want FDA to use these non-animal models,” Anatol said. “It creates an environment where biotechnology companies can develop these non-animal models to be used for this testing.”

“There are a lot of companies out there that are already working on it,” said Shipley, noting that AI and machine learning also offer new possibilities to develop non-animal testing. “This is the type of innovation that we should be looking to incentivize and encourage. Because it’s going to take us to a better place.”

A world with less animal testing does sound like a “better place” for biotech, the FDA, animal rights activists—and animals too.