FDA Releases Groundbreaking New Policy! Is It Time to Say Goodbye to Animal Testing in Drug
Development?

　　Recently, the U.S. Food and Drug Administration (FDA) launched a validation project for predicting drug-induced liver injury, aiming to incorporate non-animal methods—such as organ-on-a-chip, organoids, and AI modeling—into regulatory assessments through standardized experimental protocols and platform comparisons.

　　Prior to this, the FDA announced a landmark policy: starting with monoclonal antibody drugs as a pilot, it will gradually eliminate mandatory animal testing requirements in drug development.

　　These moves signal a shift in the century-old paradigm of drug safety evaluation, sparking significant attention within the industry.

　　Why replace animal testing with in vitro simulations? Will cutting-edge technologies replacing the gold standard of traditional drug evaluation lead to "using humans as guinea pigs"? Wenhui Daily interviewed Wang Mingwei, former director of the National Center for Drug Screening and chair professor of pharmacology at Fudan University’s School of Basic Medical Sciences. In his view, this transformation is not an overnight change but a gradual reform requiring coordinated support from data, standards, and ethics.

　　Old Standards Under Fire: Dual Challenges of Ethics and Efficacy

　　From mice to monkeys, the use of animal testing in biomedical research dates back to Aristotle’s era. In 1938, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act, mandating safety testing in animals for all new drugs before approval. Globally, over 115 million animals are estimated to be used in experiments annually.

　　However, this century-old evaluation system faces growing scrutiny. Ethically, animal welfare groups continue to pressure over concerns about animal suffering. Practically, animal data poorly predict outcomes for diseases like cancer, Alzheimer’s, and inflammatory disorders—over 90% of drugs deemed safe and effective in animals ultimately fail in human trials.

　　The FDA outlined a phased approach to phase out animal testing: within three years, primate toxicology testing cycles will shorten from six to three months; within three to five years, animal studies will become non-mandatory, permitted only when non-animal methods cannot address specific scientific questions. Long-term, monoclonal antibodies and other drugs may bypass traditional animal testing entirely, relying instead on a "human cell model + computational model" toolbox for safety validation.

　　Wang Mingwei emphasized that the FDA’s policy is not a blanket ban but a stepwise transition—first piloting with biologics like antibodies before expanding to traditional small-molecule drugs. Monoclonal antibodies, for instance, have lower intrinsic toxicity and wider safety margins, making them ideal candidates for setting new benchmarks.