Science - Encouraged and Supported by Law - will Pave the Way to Non-Animal Testing

Almost one year ago (June 18, 2021) Gary E. Marchant, Regents’ Professor and faculty director of the Center for Law, Science & Innovation at the Sandra Day O’Connor College of Law at Arizona State University published a nice column in Bloomberg Law, in which he stated that law - not science - impedes the shift to non animal safety testing.

In his column Prof. Marchant nicely summarized the paradigm shift away from animal testing which is being propelled by the convergence of ethical, economic, and scientific pressures. 

Animal rights proponents have long opposed animal testing, and this ethical campaign is strengthening with growing antipathy to animal tests by young consumers and scientists. Economics provides a second rationale for considering alternatives to animal testing, as housing, feeding, and exposing animals under carefully controlled conditions is increasingly expensive. But probably most remarkably is the role that science is playing in pushing for non-animal alternatives. While it has been known for a long time that animal tests have limitations and that their predictive value is sometimes low, there was no scientifically credible alternative. But this has changed over the last couple of years. A variety of new testing approaches have recently been developed. These include a variety of human cell in vitro systems, artificial organoids, “lab on a chip” technology, other high throughput screening methods, and computational or in silico tools in which machine intelligence conducts the analysis virtually.

Prof. Marchant then pointed to the important fact that despite all these encouraging developments the replacement of animal tests with non-animal methods always faced one significant hurdle, and that is to overcome the legal barriers to use of non-animal alternatives. U.S. regulatory agencies operate in highly legalized environments, and are required to follow the procedure and substance specified by law. Both statutes enacted by Congress that give agencies their regulatory authority, and the regulations adopted by agencies to implement those statutes, are binding “law” under U.S. administrative law. An agency that deviates from the procedural or substantive dictates of applicable statutes and regulations is likely to have its regulatory decisions overturned by reviewing courts. Animal testing was mandated and, as a consequence, agencies such as the FDA have embedded animal testing requirements into their regulations, which have the force of law. Unless these existing regulations are resolved, regulators cannot mandate or even approve non-animal testing for product safety, and manufacturers will not have confidence that their non-animal testing will stand up to regulatory or judicial scrutiny.

This situation will now come to an end, because with overwhelming bipartisan support, last week Wednesday night, the U.S. House of representatives passed the Food and Drug Amendments of 2022, H.R. 7667, which includes „Section 701: Animal Testing Alternatives.“ The section identifies other drug-testing means that manufacturers could employ to prove the safety and efficacy of their products, including cell-based assays; organ chips and microphysiological systems; computer modeling; and other nonhuman or human biology-based test methods. Animal testing would remain as an alternative, according to the legislation, which will now passed on to the U.S. Senate.

This could be The Big Change or to say it with Prof. Marchant by adding a last chapter to his previous column: „Science, encouraged and supported by law, will pave the way to non-animal testing“. It`s about time.