FDA roadmap launched – a cause for hope?

The FDA’s ‘Roadmap to Reducing Animal Testing in Preclinical Safety Studies’ explains that they can, by partnering with other agencies:

‘accelerate the validation and adoption of these human-relevant methods, improving predictive accuracy while reducing animal use. This transition will enhance public health by streamlining drug development and ensuring safer therapies reach patients faster, while positioning FDA as a global leader in modern regulatory science and innovation.’

Animal Aid’s own roadmap urges the UK Government to take up our strategy and to be ambitious in their outlook to position the UK as a global scientific leader.

The FDA roadmap states something Animal Aid has said repeatedly over the years (we’ve removed their reference numbers for clarity):

The roadmap cites overwhelming public support too, similar to that we’ve found in the UK:

‘Public sentiment is also supportive of this transition with a recent survey finding that >85% of both Democratic and Republican-identifying adults felt that animal experiments should be phased out in favor of more modern methods.’

The roadmap admits that it is beginning with one class of medication monoclonal antibodies – mAb – and will then expand to similar ones and ‘eventually’ others. They do, however, outline the many issues with using animals in laboratories:

‘In addition to inherent biological differences, stress of laboratory life and use in research can impact immune function, inflammatory responses, metabolism, and disease susceptibility and progression. Moreover, some safety risks may go undetected in animals – a notable example is the mAb TGN1412, which caused a life-threatening cytokine release syndrome in human volunteers despite appearing safe in preclinical monkey studies. That tragedy highlighted the limitations of animal models for certain immune-activating mAbs and spurred efforts to develop in vitro assays to better predict human-specific responses’

Animal Aid reported on the TGN1412 tragedy over a decade ago.

The FDA roadmap describes several different ‘New approach methodologies’ which can be used, highlighting their benefits and the ‘innovative approaches’ which, when used in tandem, ‘might together cover the same ground as a traditional whole-animal study, but with greater accuracy and ethical acceptability’

Animal Aid’s roadmap has not tied itself to specific timelines, – we want an immediate end to all animal experiments, whilst the FDA aim to implement ‘reduced toxicity testing in animals at the FDA in the next 3 years’. They explain their ultimate goal is:

‘that no conventional animal testing will be required for mAb safety, and eventually all drugs/therapeutics – instead, a comprehensive integrated NAM toolbox (human cell models + computational models) will be the new standard.’

They outline specific steps, some of which appear in Animal Aid’s roadmap, such as targeting the development of ‘NAM technologies’ and also the importance of ‘Training, Communication, and Culture Change’. They also suggest proposing changes to international guidelines so that global regulations are aligned, that they will collaborate with other bodies to ‘accelerate progress by pooling expertise, data, and resources across government’. They also mention a ‘central database for validated NAMs’, a version of which should be available by the middle of this year.

We’re encouraged by their talk of ‘workshops and outreach’, ‘cross-agency training and expertise exchange’ and also of the FDA’s wish to engage with others besides government agencies, such as ‘industry, academic, and NGO stakeholders’. This is something which the UK government has pledged and we look forward to working with them to shape the UK roadmap, so it can be as ambitious and progressive as possible.

The FDA roadmap is not written exactly as we would like, (they are a government department and we are an animal rights group), but their headline recommendations and policy considerations, are encouraging as is their concluding sentiment:

‘By combining cutting-edge in vitro systems, advanced in silico modeling, and robust validation efforts – and by working collaboratively across government and industry – the FDA can ensure that drug development becomes more ethical, more efficient, and more predictive of human outcomes. Patients will benefit from safer and faster-to-market therapies, animals will be spared from testing, and the science of drug development will enter a new era aligned with 21st-century technology.’

As Animal Aid wait to see the UK governments own roadmap, we hope that they will be even more progressive than the FDA, in order to end animal suffering, facilitate better, more humane science in the UK and to position us as the global leader in non-animal NAMs and science which is fit for the 21^st Century!