FDA Modernization Act 2.0: A step in the right direction

Animal testing

By DDW Editor Reece Armstrong

A lot has already been said about the US Food and Drug Administration’s (FDA) Modernization Act 2.0 and for good reason.

The decision by the Biden administration to end the federal requirement for drugs under development to be tested on animals represents a significant step forward for the life sciences sectors. The legislation means that drug developers will now have further options to investigate the safety and efficacy of their products under investigation.

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now
all be regarded as suitable alternatives to animal testing in the early phases of drug development.

Animal testing, whilst serving an important purpose for drug development has long been regarded as a contentious issue by both animal rights activists and scientists themselves.

The ethical quandaries are obvious. Moving away from animal studies is no doubt the right thing to do from a moralist’s standpoint but it is further compounded by the challenges drug developers have faced when using these models.

The limitations of animal studies are widely documented. Whilst mouse models have been standard use in clinical trials due to the animal’s genetic and physiological similarities, the issue of translatability remains. Animal models can be great indicators to assess how a drug will perform in vivo, in a particular species, but the human body is complex.

A paper published in the American Journal of Translational Research explains the issue well. “In many cases, mouse models serve to replicate specific processes or sets of processes within a disease but not the whole spectrum of physiological changes that occur in humans in the disease setting,” the authors write1.

It’s an important point and one which supports the latest move by the FDA away from animal models. Technologies such as digital twins, organoids and microphysiological systems can potentially better replicate how the human body might react to a therapy and detail the intricate systems at work within a disease. Of course animal models will still be used and in many cases will represent an important step in a drug’s potential journey to market. But, importantly, the FDA’s legislation means that now, drug developers will have more options to investigate their therapies.

This is essential. The collation of data on tools investigating safety and efficacy will bolster their use in clinical settings and encourage more developers to explore all of the options that might increase their chances of bringing that all important therapy to market.

Animal models will still be used across drug discovery and development. As mentioned earlier, they can serve as a great indicator to how a drug will perform in vivo and that offers researchers essential early references to whether their drug is safe and effective. And whereas technologies such as AI might have limited data, animal models have a wealth of historical data that teams can draw on for their experiments.

So, the FDA’s latest legislation represents a step in the right direction for the industry, offering researchers more options in the early stages of drug development.

In the cases where animal models are still used – and these will be vast – teams should strive to follow the rules of the 3Rs: Replace, Reduce, and Refine.

The first rule will be bolstered by the Modernization Act 2.0 in that where appropriate, teams should consider the use of non-animal experiments in their studies. And bearing in mind the reduction and refinement of animal models used throughout experiments will improve the welfare of any animals used.

These points, coupled with the Modernization Act 2.0 will better the industry and increase options for developers looking to bring important and innovative therapies to market.


  1. Mak IW, Evaniew N, Ghert M. Lost in translation: animal models and clinical trials in cancer treatment. Am J Transl Res. 2014 Jan 15;6(2):114-8. PMID: 24489990; PMCID: PMC3902221.

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