New Alternatives Hold Promise for Reducing Animal Tests

In a Policy Forum, Chad Nelson and colleagues highlight the efforts of the U.S. Food and Drug Administration (FDA) in advancing alternative methods to reduce animal testing for regulatory use. Animal studies have been crucial for advancing disease understanding, developing therapies, and assessing the safety and effectiveness of consumer products. However, reducing animal use and developing effective alternatives is an ongoing priority. Although advances in biology, engineering, and artificial intelligence offer new opportunities to improve product safety assessments, these technologies require extensive development to meet regulatory standards. According to Nelson et al., the FDA is working to advance alternative methods – new approach methodologies (NAMs) – that improve the safety, risk, and efficacy understanding of regulated products while reducing animal use. Here, the authors highlight these efforts. Over the years, the FDA has advanced NAMs, such as in vitro ocular irritation tests, which have replaced traditional rabbit testing. The FDA has also advanced the use of computational models to assess drug safety. Additionally, the agency has developed qualification programs to evaluate and validate these alternative methods for regulatory use, ensuring their effectiveness in making regulatory decisions. The FDA encourages innovation through programs like ISTAND, which supports new tools like organ-on-a-chip technologies. Nelson et al. argue that by collaborating with stakeholders, hosting workshops, and conducting its own research, the FDA continues to lead efforts in validating and adopting alternative methods that reduce reliance on animal testing.