Drugdu.com expert's response:

The U.S. Food and Drug Administration (FDA) plans to gradually terminate the requirement for animal testing of monoclonal antibodies, primarily based on the following aspects:

I. Technological Advancements Offer Alternative Approaches

Organoids and Organ-on-a-Chip Technology: These technologies can simulate the physiological functions of human organs, demonstrating high predictability in drug safety testing. For example, liver-on-a-chip models have achieved up to 87% accuracy in predicting drug-induced liver toxicity.

Artificial Intelligence and Computational Models: By simulating drug absorption, distribution, metabolism, and excretion (ADME) in the human body, AI models can more accurately predict drug efficacy and toxicity, reducing reliance on animal experiments.

Real-World Data: Leveraging existing real-world safety data from other countries to further validate drug performance in humans provides a more reliable basis for drug assessment.

II. Limitations of Animal Experiments

Species Differences: Animal models exhibit significant physiological and metabolic disparities from humans, making it difficult to extrapolate animal experiment results directly to humans. For instance, some drugs deemed safe in animals may cause severe side effects in humans.

Limited Predictive Power: Approximately 90% of drugs passing animal trials fail in clinical trials due to safety or efficacy issues, indicating that animal experiments are not a reliable safeguard for drug development.

Ethical Controversies: Animal experiments have sparked widespread ethical debates, with increasing public calls for reducing or replacing animal testing.

III. Enhancing Drug Development Efficiency

Accelerating Assessment Processes: New technologies enable faster and more accurate evaluation of drug safety and efficacy, shortening development timelines and reducing costs.

Reducing Ineffective Research: Early screening and predictive models can minimize the number of ineffective or high-risk drug candidates entering clinical trials, improving R&D success rates.

IV. Policy Support and Regulatory Updates

The FDA Modernization Act 2.0: This legislation eliminates the requirement for animal testing before human trials for new drugs, providing a legal foundation for the FDA’s new policy.

Regulatory Guideline Revisions: The FDA will update relevant guidelines to permit the use of data from alternative methods for drug assessment, supporting the adoption of non-animal testing approaches.

V. Global Trends and Industry Demands

International Regulatory Harmonization: Over 40 countries have enacted laws banning animal testing for cosmetics, aligning the FDA’s initiative with global trends and facilitating the unification of regulatory frameworks.

Industry Pressures: Soaring prices and scarcity of experimental animals (e.g., non-human primates) have imposed significant cost burdens on pharmaceutical companies, necessitating alternative solutions.

VI. Public Health and Animal Welfare

Improving Drug Safety: Human cell-based testing methods may better predict drug performance in real-world settings, mitigating safety issues arising from the limitations of animal experiments.

Reducing Animal Use: Terminating animal testing requirements will significantly curtail the use of experimental animals, aligning with animal welfare and ethical imperatives while enhancing public health safeguards.