FDA Modernization Act 2.0 PASSES, eliminating Federal Mandate for Animal Testing in New Drug development
12.23. 22 The US House of Representatives granted final passage of the FDA Modernization Act 2.0 today, hailed as a landmark piece of legislation promising a reduction in the number of dogs, primates and other animals subjected to safety and toxicity testing in the drug approval process.
The new legislation removes a nearly century-old mandate in the 1938 Federal Food, Drug, and Cosmetic Act that animals be used to test safety, efficacy and toxicity of new drugs and other products approved by FDA. There is also a provision to eliminate a similar mandate for biosimilars regulated by the U.S. Public Health Service. Congress also appropriated $5M in next year’s Federal budget to support a new FDA program aimed at developing and refining Novel Alternative Methods and the regulatory framework to support their adoption. Organ-chips, microphysiological systems, cell-based assays, computer modeling, and other human biology-based methods will all now be considered potentially acceptable methods.
To be clear, this legislation holds great promise for changing the tides on behalf of animals within in the biomedical research and pharmaceutical industries, and for improving human and animal health through better and more ethical research. Animal rights advocates have worked hard for decades to alleviate the suffering of animals in research and testing facilities, and their influence on public sentiment has helped drive this change. But the evolution and adoption of non-animal methods in the pharmaceutical and biomedical industries is not really being driven by ethics or animal rights activism—it is the evolution of non-animal models and technologies in recent years, and the favorable economic impact they purport to have on ‘the bottom line’ for drug companies that are really driving the change.
Costs of drug development are borne not just by the animals subjected to them, but also by the consumer who pays often exorbitant fees for the R&D when they come to market. More human-relevant models that improve predictability and reduce time length and overall costs of getting new drugs to market is good for business and consumers, but it is important to understand that these methods will be employed primarily as ‘complementary’ to animal models, not as replacements. When integrated ‘upstream’ of animal models as pre-screening tools, many animals could be spared from testing at this stage in the drug development process. But until these methods are fully accepted as alternatives to animal testing, animal models will remain a significant part of biomedical research and product testing, and dogs and other animals will continue to suffer.
A critical next step will be to ensure the regulatory agencies promulgate reasonable standards of acceptance of non-animal model results, and tech companies continue to improve their sophistication and predicative capacity, eventually rendering the use of dogs and other animals redundant and unnecessary. At the Aisling Center, we look forward to that day and are committed to supporting the transition at every step.
