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The FDA Modernisation Act 2.0: What does it mean, and what will follow?

Published on January 20, 2023

In 2021, the European Medicines Agency (EMA)—responsible for the safety and monitoring of medicines in the EU—put in place measures to encourage and accelerate the development and adoption of non-animal methods in the testing and approval of new human drugs. For those of us who are working hard to achieve change in this field, it was a concrete sign that attitudes are, belatedly but encouragingly, changing.

A further, potentially highly significant sign came in the past few months, with the U.S. congress FDA Modernization Act 2.0 adoption, causing a stir globally by not requiring anymore animal testing for developing drugs. This is big step forward, considered as a triumph by animal alternative methods campaigners, after years of negotiation, petition, and proactive battle with the FDA to use scientifically satisfactory alternatives. It marks the beginning of the transition towards modern, animal-free toxicity testing process.

By relaxing the regulatory requirements for animal testing in the U.S., the law encourages scientists to make greater use of innovative and cutting-edge new approach methodologies (or NAMs) in their drug development strategies.

However, that won’t stop animal testing overnight. A pharmaceutical company that has always been testing and validating drug in animals and that has expertise on this field will not suddenly change its approach. Arguably, there needs to be a framework put in place to encourage, enable, and facilitate replacement, otherwise there is a danger that little, or nothing might change. Any change that does take place could take a long time.

Animal Free Research UK focuses on accelerating the acceptance of New Approach Methodoloies (NAMs), funding innovative animal free research projects, and bringing together research scientists, pharma and biotech and other stakeholders to facilitate the transition to human-relevant research via the Community of Practice, and scientific events like our Conference and Helpathon. Translational and human-relevant tools such as organ-on-chip and deep learning require particular attention in term of education, expertise, standardisation, and validation to be accepted and adopted by scientists and drug companies.

What happens in the U.S. hopefully will inspire change in the UK regulations. Last year, Animal Free Research UK put together recommendations for policymakers in the UK government to modernise biomedical research, and a briefing document for a parliamentary debate on how human-relevant innovations can transform patient’s lives and boost the UK’s economic growth.

The EU and the U.S. are at the tipping point of a great revolution in biomedical research and drug development, approaching the end of an era for animal testing. The UK has a choice to be part of the revolution and to maintain its position as a world leader in scientific innovations and medicine, or to be left behind by other countries that have greater vision and are embracing the change. Government, scientists, investors, and drug companies now need to rebuild their arsenal with NAMs that have the potential to lead the impending era of human-relevant, patient-centric research and drug discovery.

Read more about the FDA Modernisation Act 2.0 and NAMs:



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