In December 2022, Congress passed and President Biden signed into law the FDA Modernization Act 2.0. This was welcomed by animal activists the world over, as it addressed a long-followed rule that has meant the death and destruction of many animal species in the testing of drugs.
After the marketing of a product called Elixir Sulfanomide led to the deaths of more than 100 people, Congress enacted the original Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938. It required that all drugs be tested on animals before being tested on humans. After 85 years, advancements in clinical testing and trials necessitated the complete removal of the mandate from the act, updating it for modern times. Animal testing is now removed from the Act altogether.
So what does that mean? This revision to the Act means that clinical testing must be performed using what are referred to as New Approach Methodologies, aka New Alternative Methods, or NAMs. These modern capabilities eliminate the needless suffering of animals during testing that often does not result in the same outcomes as with humans. Specifically, the Act:
In Section 3209 of the FDA Modernization Act 2.0 entitled “Animal Testing Alternatives,” the bill amends the regulatory guidance at the FDA that requires animal testing for drugs and biosimilars. The bill amends the Federal Food, Drug, and Cosmetics Act (FFDCA) to:
- Substitute the term “nonclinical tests” for the current “preclinical tests” (including tests on animals),
- Substitute the term “animal” for “nonclinical tests” and,
- Add a new section defining “nonclinical tests” to include human-relevant testing methods such as cell-based assays, microphysiological systems (such as Organ-Chips), or bioprinted or computer models.1
In addition to the benefits of this update for animals, animal-free testing is also more accurate, cost-effective, faster, and more environmentally friendly3. For example, trials utilizing human skin cells grown via in-vitro methods have been shown to be more effective than traditional animal tests on rabbits, where results were shown to be incorrect 40 percent of the time. Testing using human skin cells also can provide results in as short a time period of minutes, whereby animal testing takes weeks or months. With the volume of new drug therapies being developed, this can obviously lead to products being available for human use much faster than with traditional animal-based testing methods. Finally, disposal of animals exposed to potential toxins as part of animal testing procedures represents an environmental concern, as those toxins could potentially make their way into the ground of water, destroying ecosystems and poisoning communities3.
The update of this Act represents a sea of change when it comes to how humans treat animals, as ethical concerns about the needless use and destruction of animals were a huge driver. Health organizations are applauding this move as a long-needed one that will help to improve human health overall2. Through the use of more accurate models instead of animals whose physiology differs from those of humans, consumers can have confidence in the drugs that they are taking, while reducing the biological waste that comes with the disposal of animals used for testing.
As animal lovers committed to making the treatment of animals more humane, HAP applauds this bi-artisan accomplishment that demonstrates what people who are passionate about an issue can achieve in making policy change.