| Literature DB >> 35565599 |
Isobel Hutchinson1, Carla Owen1, Jarrod Bailey1.
Abstract
In the context of widespread public and political concern around the use of animals in research, we sought to examine the scientific, ethical and economic arguments around the replacement of animals with New Approach Methodologies (NAMs) and to situate this within a regulatory context. We also analyzed the extent to which animal replacement aligns with British public and policymakers' priorities and explored global progress towards this outcome. The global context is especially relevant given the international nature of regulatory guidance on the safety testing of new medicines. We used a range of evidence to analyze this area, including scientific papers; expert economic analysis; public opinion polls and the Hansard of the UK Parliament. We found evidence indicating that replacing animals with NAMs would benefit animal welfare, public health and the economy. The majority of the British public is in favor of efforts to replace animals and focusing on this area would help to support the British Government's current policy priorities. We believe that this evidence underlines the need for strong action from policymakers to accelerate the transition from animal experiments to NAMs. The specific measure we suggest is to introduce a new ministerial position to coordinate and accelerate the replacement of animals with NAMs.Entities:
Keywords: New Approach Methodologies (NAMs); alternative methods; animal replacement; animal research; animal testing
Year: 2022 PMID: 35565599 PMCID: PMC9100373 DOI: 10.3390/ani12091173
Source DB: PubMed Journal: Animals (Basel) ISSN: 2076-2615 Impact factor: 3.231
Relevant publications by the FDA.
| Year | Publication | Significance |
|---|---|---|
| 2011 | Advancing Regulatory Science at FDA [ | Identifies the need to modernize toxicology as one of eight priority areas. Includes commitment to develop tools that better predict patient responses, and to using computational methods. However, also commits to developing new ‘animal models’. |
| 2017 | FDA’s Predictive Toxicology Roadmap [ | Sets out a series of steps to promote the development of NAMs and integrate these into regulatory assessments. These include training and improved communication with drug developers. |
| 2021 | Advancing New Alternative Methodologies at FDA [ | Developed by the Alternative Methods Working Group, reports on progress in NAM development and integration across the FDA. |