Astonishing April!
It all began on 10th April, when the US Food and Drug Administration (FDA) announced its intention to take ‘a groundbreaking step to advance public health’ by using ‘more effective, human-relevant methods’ to replace the use of animals in the development of monoclonal antibody therapies and other drugs.
Instead of using animals, the FDA will use a range of approaches, including AI-based computational modelling, human organ models and real-world human data. This, the agency says, will speed up and reduce the costs of drug development as well as improve drug safety. FDA Commissioner Martin Makary, who has only been in office since 25th March 2025, says the new approach ‘is a win-win for public health and ethics,’ noting that ‘Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.’
On the same day, the Washington Times reported that Lee Zeldin, the new administrator of the US Environmental Protection Agency, aims to reinstate a 2019 plan to ban animal testing at the agency. The plan, which committed to completely eliminating testing on mammals by 2035, had been dropped, but is now apparently going to be revived.
And then on 29th April came a wholly unexpected and groundbreaking development. Less than a month after taking office, Jay Bhattacharya, new Director of the US National Institutes of Health, announced a new initiative designed to usher in an era of innovation: the Office of Research Innovation, Validation, and Application (ORIVA), which will be dedicated to expanding human-based science and reducing animal use. ORIVA will increase funding and training in non-animal approaches and promote awareness of their translational value. As Bhattacharya put it: ‘By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted …’. The initiative aims to accelerate innovation and deliver life-changing treatments. How will they do this? Critically, NIH funding will be based on criteria that assess proposed methods for their appropriateness in answering the research question, context of use, translatability, and human relevance. Furthermore, those who review grant applications will receive training to prevent any possible bias towards animal studies and review boards will include experts in new methodologies. The NIH has also committed to publicly reporting on research spending annually to chart progress toward reducing funding for animal studies and increasing funding for human-based approaches. Finally, it will expand the infrastructure to make non-animal approaches more accessible to scientists.
Contrast this thoughtful, ambitious and inspiring announcement with the hugely disappointing conclusion of a UK parliamentary debate about the use of dogs in medical research, held on April 28th. More than 20 MPs contributed to this debate, each clearly articulating the scientific evidence in favour of a move away from using dogs in scientific research. Yet junior minister, Feryal Clark, appeared to have not been listening. Instead of responding to the evidence she trotted out a stale set of statements that UK citizens are now heartily tired of hearing: how the use of animals in the UK is ‘highly regulated’ and guided by the 3Rs; ‘alternatives’ are not yet sufficiently advanced; animal research has led to ‘life-changing discoveries’; if we banned animal testing in the UK it would move overseas. She also engaged in some considerable hyperbole and misinformation, claiming that forbidding the use of dogs in medical research would have ‘catastrophic effects’, making it impossible to meet international regulatory requirements for drug safety testing, preventing virtually all first-in-human trials, vastly reducing the number of clinical trials, bringing an end to much basic research and preventing insights that save lives. (A more realistic assessment of the use of dogs in medical research can be found here.)
This outdated and uninspiring approach does not bode well for the UK roadmap, promised by the end of the year. But the government will need to quickly up its game. As MP Steve Race noted in the UK debate, ‘If the US can move in that direction, it is imperative that the UK does so too.’ At least we now have a role model. As Thomas Hartung writes, ‘The coordinated actions of US regulatory agencies have demonstrated that decisive progress is possible when scientific evidence, ethical considerations, and regulatory willpower align.’
