If you've noticed the family pet has been a little more lighthearted this year, they might have heard the news before you: the U.S. Food and Drug Administration (FDA) is not requiring all new human medicines to be tested in animals!
This new legislation, passed by unanimous consent in the Senate (Sept 2022) and signed by President Joe Biden (Dec 2022), is a significant shift away from a 1938 stipulation that potential drugs be tested for safety and efficacy first in animals. Instead, clearing drugs for human trials can now come in the form of nonanimal methods like computer modeling, organ chip technology, organoids, and other emerging technologies.
While animal welfare organizations like the Center for a Humane Economy and Animal Wellness Action are hailing this new legislation as a major win, pro-research groups are playing down the law, emphasizing these new rules will not change the drug approval process overnight. While true, the FDA still retains the discretion to require animal tests, – a brighter future for animals is on the horizon.
"We support alternative methods that are backed by science and provide the necessary data showing whether products are safe and effective," Namandjé Bumpus, the FDA's chief scientist, says. Bumpus favors moving away from animal testing when other approaches are readily available. To further that sentiment, the FDA received $5 million this year to launch an agency-wide program to study nonanimal alternatives and ways to reduce and refine animal testing. Though there have been significant improvements in alternative testing methods, it is going to take years before technology fills in all of the gaps and makes animal testing obsolete.
But, as it happens with new legislation and government agencies, the animal testing waters are still murky. While the new law — officially called the FDA Modernization Act 2.0 and part of a massive package of spending legislation, clears the way for drugs to proceed to human trials without animal testing, it doesn't prohibit animals to be part of the process anymore. Ongoing animal research will still be regulated by the Laboratory Welfare Act, which was passed in 1966 and relies on what some would consider outdated inhumane standards. So, as the family dog leans in for some ear scratches tonight, let's just not mention that part.