FDA-NIH Workshop: Reducing Animal Testing
A cultural shift
Much has been written about Nicole Kleinstreuer’s announcement in the joint workshop between the FDA and the National Institutes for Health (NIH), namely that all new NIH funding opportunities will henceforth incorporate language encouraging consideration of NAMs and that proposals exclusively for animal models will no longer be funded.
This is wonderful news, but there were even more things to cheer in this workshop, held on July 7th, on the topic of reducing animal testing. For one, Kleinstreuer, who is Acting Deputy Director for Program Coordination, Planning, and Strategic Initiatives at NIH, noted that the first priority of the NIH is to improve population health, but this could not be done using outdated animal-based models. The NIH is investing in NAMs, she said, so that the best science possible is employed to improve public health protection. Second, she spoke inspiringly about the importance of creating long-lasting transformation: ‘We’re not just investing in NAMs’, she said, ‘we’re creating the policy, infrastructure, and partnerships that make that sustainable adoption possible. So, we’re not just shutting down animal labs overnight, we are actually developing long term solutions that ensure there are no new animal labs that open up in their place.’ Third, she noted that NAMs are not ‘side projects’, but ‘foundational’, so that NIH funded research becomes rooted in human relevance. And fourth, referring to plans announced earlier in the year to provide training for reviewers and regulators, she emphasised, ‘These are not just administrative tasks, they are cultural shifts.’ All in all, she described a systems-based approach to transition, focusing on phasing out animal use as well as phasing in NAMs, to ensure lasting cultural, as well as scientific, transformation of the NIH into an institution that prioritises human biology-based research.
And Kleinstreuer was not the only one. I never thought I would hear such enthusiasm about ending animal experiments from an FDA Commissioner, but Commissioner Makary was on fire. He noted that one of his main goals – one of the first he acted on within weeks of gaining office – is to reduce animal testing and said he was struck by how much consensus there was on the topic. Speaking of reducing animal use he said: ‘For one it can help deliver cures and meaningful treatments faster, to the public. Number two it can reduce R&D costs and potentially even translate into lower drug prices, which is an important agenda item for this administration. It can also encourage more innovation. It reduces the capital requirements for new drug development, and finally it’s more humane and more ethical for animals. God did not make animals on planet Earth for us to abuse and torture. And so we have to respect animals and this workshop is aimed at reducing animal testing in every way we can, while safeguarding the public with medications.’
To hear such words issuing from the FDA and NIH is remarkable and signals a clear cultural shift within the US. Imagine similar statements from the UK’s Medicines and Healthcare products Regulatory Agency, or from the UK’s Medical Research Council or Biotechnology and Biological Sciences Research Council. We can only hope that our government is aware of and emboldened by these awe-inspiring developments as it moves forward with its strategy to reduce the use of animals in scientific research.
Watch the inspirational workshop here: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-nih-workshop-reducing-animal-testing-07072025
