FDA Science Board Report Promotes Changes to Integrate Nonanimal Test Methods

NAMs replace traditional animal tests that measure the toxicity of chemicals by exposing animals to them, often at the maximum tolerated doses. With NAMs, the products that the FDA regulates can be assessed more accurately and efficiently, advancing the agency’s mission to protect public health. The report’s recommendations align closely with the Physicians Committee’s longstanding advocacy for replacing animal experiments with modern, human-based methods. We’ve urged the FDA’s Commissioner to expedite the report’s implementation and pledged our expertise and support to the success of this agency-wide initiative.

With the Physicians Committee’s participation, the FDA already promotes NAMs through programs like Innovative Science and Technology Approaches for New Drugs – or ISTAND – at the Center for Drug Evaluation and Research, which is currently evaluating an organ-on-a-chip to assess the risk of drug-induced liver injury. However, organizational barriers can limit the broader adoption of NAMs that address specific information needs at the FDA’s product centers. That’s why the report’s key recommendation is the creation of a high-level NAMs office to serve as a center for common knowledge, strategy, advocacy, and funding. We agree that this centralized approach, under dedicated leadership, is needed not only to coordinate the efforts of the FDA’s ongoing programs, but to drive the integration of NAMs agency wide. With other stakeholders, we look forward to contributing to plans and activities that set timelines and identify deliverables to advance its objectives, similar to the Environmental Protection Agency’s NAMs Work Plan.

The Physicians Committee was especially pleased to see that the report identifies tracking the use of both animals and NAMs as one of those objectives. As we have repeatedly shown, collecting detailed information on how animals are currently used identifies opportunities for reduction and establishes a baseline to measure progress, while tracking how NAMs are already used promotes their uptake by new product applicants. Limited to publicly available information, our work suggests that additional opportunities would be identified by systematically analyzing the many product submissions available to the FDA. The report also recommends maintaining a database of NAMs that have already been adopted along with new methods emerging from research and development programs like the National Institutes of Health’s Compliment Animal Research in Experimentation. While other regulatory agencies and stakeholders like the Physicians Committee maintain lists of NAMs, the availability of a comprehensive database would alleviate the uncertainty faced by applicants over whether NAMs will be accepted to support authorizing their products.

The next step is for the FDA’s full Science Board to review the report and offer its recommendations. At every opportunity, the Physicians Committee will continue to participate in this important initiative’s development and implementation. We will also continue to encourage and support updated regulations and guidance to industry that communicates the FDA’s willingness to consider NAMs in its decision-making and encourages their submission by sponsors to support authorization of regulated products.