FDA publishes new plan to phase out animal testing in medical research

Last month, the U.S. Food and Drug Administration (FDA) published its roadmap to replace the use of animal testing in preclinical safety studies with human-specific technologies, such as organ-on-chip, complex cell culture methods and Artificial Intelligence (AI). This roadmap, which has been welcomed by the Centre for Human Specific Research, represents a huge step forward to progressing to a world where animals and humans lead healthy, happy lives, free from suffering.

The FDA will initially begin with a focus on monoclonal antibodies (mAbs), which are molecules produced in a laboratory to mimic the antibodies produced naturally by the immune system, as a first step and then the FDA will expand their focus to investigate the wider landscape of replacing the use of animals in medical research. The FDA has been crystal clear that their ultimate aim in the coming years is to make “animal studies the exception rather than the norm for pre-clinical safety/toxicity testing”.  As highlighted by the Centre for Human Specific Research, drug discovery and development has become an increasingly costly and inefficient process. In 2023, the top 20 biopharma companies collectively poured $145.5 billion into research and development. With a drug failure rate of 92% during human clinical trials, the cost of bringing a single drug to market is reported to cost over $2 billion. Human-specific technologies have “enormous cost saving potential” as they are not burdened by the eye-watering costs associated with research and development in drug discovery.

Why monoclonal antibodies? 

Currently, the FDA requires mAbs to be tested and monitored in animals for up to 6 months, with typical mAb development programs using around 144 non-human primates (NHPs). In recent years, associated costs have skyrocketed up to $50,000 per NHP, making this requirement inexorably expensive and further adding to the huge budgets already involved with drug discovery. However, this process is flawed due to inherent differences in biology between humans and animals, particularly in the immune system, which can lead to inaccurate and potentially dangerous outcomes.

Under the current process, safety risks can go undetected in animals – a key example is the clinical trial of the mAb TGN1412 – which initially appeared ‘safe’ in preclinical animal testing, but resulted in six human volunteers in a clinical trial being rushed into intensive care with multiorgan failure.

Adoption of human-specific technologies 

Essential to achieving a phase out of animal testing in medical research by 2035 is an acceleration of the validation and acceptance of human-specific technologies by regulators and industry. To help achieve this, the FDA will encourage ‘sponsors’ (companies wanting to bring drugs to market) to submit non-animal data in parallel with animal data to build up a bank of knowledge for regulators. This will not only help regulators to become more familiar with data from human-specific technologies but will also allow regulators to identify pilot cases – which could lead to incentives for companies wanting to use human-specific technologies (such as quicker regulatory approvals and fee waivers). The FDA will also now consider human drug toxicity data from other countries where a compound has already received approval, this is an important step which will save repeating animal experiments.

As part of the roadmap, the FDA has announced that it will be providing training workshops for drug assessors on interpreting human-specific technologies (organ-on-chip data and understanding AI model outputs). This will build expertise amongst regulators when they are reviewing submissions using human-specific technologies. The FDA will also create a culture which celebrates successful cases where a human-specific method provided a key insight or decision-enabling information, and it will create clear channels of communication to encourage more ‘sponsors’ to adopt human-specific technologies.

The National Institutes of Health (NIH) in the United Stated has also announced that it will be adopting a new initiative to expand innovative, human-specific science. The NIH has stated that it will set up the Office of Research Innovation, Validation, and Application (ORIVA), which will coordinated efforts to develop, validate and scale the use of human-specific methods and serve as a hub for interagency coordination and regulatory translation for public health protection. ORIVA will expand funding and training in human-specific technologies and awareness of their value in translational success.

Conclusion 

The FDA roadmap represents a significant gear change in attitudes towards the phase out of animal testing in medical research. By supporting the development and validation of the next-generation of human-specific techniques, benchmarking results against human data and encouraging companies to adopt these methods, millions of animals each year will be saved from enduring medical experiments and patients will benefit from safer, quicker and much more effective medicines.

If Britain does not act and adopt a plan to phase out animal testing over the next decade, we risk being overtaken by much bolder action on the global stage. The implementation of Herbie’s Law would consign animal testing to the history books and produce quicker and better medicines for us all.