Heard of the FDA Modernization Act? It’s already got quite a reputation.
After its passage in the final days of 2022, PETA immediately deemed the federal legislation “groundbreaking,” calling it “a radical shift in the way drugs and treatments are developed.” Another animal rights group predicted the act would usher in “better treatments to patients, and drive down drug prices.”
Sounds pretty exciting. So what is it?
Simply put, the act authorizes the FDA to allow non-animal methods when safety testing new medications and therapies being considered for possible use in the United States. And while the FDA already had a tremendous amount of discretion in this area, the legislative language related to these decisions has now been expanded and updated.
As for the lofty claims made by groups opposed to all animal studies, the actual science tells a very different story. That’s because we still have a long way to go before we can entirely remove animals from the drug development process.
Don’t get me wrong, tremendous strides have been made in creating alternatives, including computer models, organs-on-a-chip, and organoids, which are tissues derived from stem cells to mimic individual organs. These technologies help reduce the number of animals studied. However, we mustn’t forget they are based entirely on the knowledge we have gathered to date. Human-made scientific models are only as good as the data behind them. And when it comes to the incredibly complex functions of health and countless diseases, we have so much to learn.
Because of these scientific realities, many experts believe there may always be a need to study animals, at least in some form. Animal activists frequently remind us that mice are not humans. But we also need to recognize that computer models, organoids and organs-on-a-chip aren’t either.
Furthermore, we cannot forget several points in the drug and therapy development process — not just in the safety testing phase — where animals play a critical role. Animals are frequently involved in basic science, an entire stage of the research process that reveals the building blocks of life. For instance, these studies unearth how cells communicate with one another. It explains how our bodies regulate breathing, heart rate and even our body weight, all of which are critical functions required for continued life and good health. Most important, basic research helps identify new treatment avenues we never knew about.
Animal research also allows us to test promising therapeutic approaches in complete living systems long before human-based research is feasible. It would be highly unethical to “test out” new surgical approaches for the first time in patients. Another example is the development of the new mRNA platform, which was employed in the safe and highly effective COVID-19 vaccines we have today. The creation of this new vaccine platform featured several major hurdles, largely overcome via animal research, including a series of pivotal proof-of-concept studies in rodents in the 1990s.
Of course, we all want to see a reduction in the need for animal studies. But given the incredible complexities of human health, the many similarities between species and the fact that non-animal alternatives are still in their infancy, it’s unrealistic and unethical to suggest that several vital steps in the research process can be immediately eliminated.
When reducing the need for animal research, we need to let science, data and safety lead the way. After all, we are talking about fighting disease, which is often quite literally a matter of life and death.
