The American Bar Association joins the fight to promote better science

By Paul Locke | February 22nd, 2024

The American Bar Association (ABA) is one of the largest voluntary professional associations in the world. With approximately 400,000 members, it serves the US legal community as a convener, opinion leader and educational center. In addition, it provides law school accreditation. The ABA is run by leaders elected from its membership, the majority of whom are lawyers. 

The ABA meets regularly to discuss and advance matters brought forward by its members that are important to the practice of law.  These matters are captured in resolutions, which are formal statements of principle setting out the ABA’s proposed position and calling for action.  At this year’s midyear meeting, the ABA adopted a resolution supporting the promotion, development and use of methods that seek to replace, reduce and refine animal models in biomedical research and testing.  In addition, the resolution also calls for the US Congress and US federal agencies to remove barriers to and create incentives for the application of non-animal models in regulatory testing and federally sponsored research. 

In passing this resolution, the ABA has recognized the importance that replacement alternatives are playing now and will play in the future.  Replacement alternatives are scientific methods that forgo the use animals in favor of human centered in vitro models.   As the ABA notes, it is imperative that the development and use of these human centric technologies be promoted and accelerated because these methods offer great potential for addressing many of the public health problems that society faces.

This ABA resolution is squarely in line with how science is evolving. Replacement alternatives are now making their way into biomedical science and public health, improving decision-making by providing important mechanistic information about the way human organs, cells and tissues are impacted by exogenous substances.  Here are three examples of how that evolution is progressing.

As a first example, the US Environmental Protection Agency (EPA) recently published a framework for its new chemicals program under the Toxic Substances Control Act (TSCA) for the identification of eye irritation and corrosion hazards that relies on testing methods that use human cells and tissues. This guidance moves away from using animal tests, such as the rabbit eye test, for these purposes.  The 2016 rewrite of TSCA contains provisions calling for EPA to use replacement alternatives when such methods were shown to be predictive and scientifically valid.

Activities at the Food and Drug Administration (FDA) provide a second example.  Last year, Congress passed, and the President signed, the FDA Modernization Act.  That law removed a requirement to test on animals during the drug approval process and replaced it with language that allows applicants to submit the best available science, including replacement alternatives.  FDA has established several programs to encourage the submission of data from alternatives across its programs. It published a predictive toxicology roadmap aimed largely at incorporating alternatives into its regulatory decision-making framework. 

A third example can be found at NIH. To improve the rate of success of new therapeutics, the National Center for Advancing Translational Sciences has awarded grants to support researchers’ efforts to build “organs-on-a-chip” to better inform clinical trial design for both common and rare diseases. These efforts should speed up drug delivery and lead to more cures and treatments. 

The ABA’s mission is to serve equally its members, the legal profession, and the public by defending liberty and delivering justice as the national representative of the legal profession.  This mission is implemented through four goals and this resolution supports at least three of them: serving members (Goal I), eliminating bias (Goal III), and holding the government accountable under law (Goal IV).  It reinforces Goal I because it is important that membership be aware of these cutting-edge technologies.  Legal challenges will arise that are associated with these replacement alternatives as their use increases.  Goal III comes into play because many of these new alternatives can be customized to address health issues that disproportionally impact populations that are now poorly served by current treatment methods or experience higher levels of pollution.  Finally, among the objectives of Goal IV is to hold governments accountable under law, which includes making sure that governmental decision-makers are using the most reliable scientific information in their work.    

I was fortunate to attend the ABA 2024 midyear meeting earlier this month and testify in support of this resolution.  As a scientist, attorney (and ABA member) and public health professional, it is clear to me that non-animal models are advancing rapidly.  ABA’s decision to promote the development and use of technologies that replace, reduce, and refine animal models adds an important advocate to the discussion.  To accelerate medical and public health progress, lawyers and scientists need to work together to promote reduction and refinement, and push for the replacement of animal models with in vitro human biological systems.  In tandem, the two can serve to guide progress in a more humane direction.

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.