A Turning Point: FDA and NIH Commit to Reducing Animal Testing

In opening remarks, FDA Commissioner Dr. Martin Makary emphasized the agency’s goal to replace animal testing, noting that the shift is not only about improving science and efficiency, but also about respecting and protecting animals.

Several presenters stressed the importance of leveraging internal FDA data, public datasets, and international studies to improve computational modeling and AI tools. Both Dr. Makary and Senior Advisor Dr. Tracy Beth Høeg highlighted the scientific, economic, and ethical advantages of replacing animal testing. They noted that modern science is increasingly centered on human biology to improve human health outcomes and reduce the use of animals in research and testing.

A recurring theme was the need for clear regulatory policies governing the use of nonanimal methods. Presenters stressed that publishing successful case studies can build confidence among sponsors and investors and accelerate adoption. In support of this, the  FDA announced it will begin publishing use cases of new approach methodologies (NAMs) and developing transparent policies that industry can rely on, including open regulatory pathways (FDA-NIH Workshop: Reducing Animal Testing - 07/07/2025 | FDA).

The FDA also committed to working internationally, recognizing that many companies operate globally. In partnership with the NIH, the agency will increase use of existing human clinical and nonclinical data to enhance predictive models for human safety.

Presentations from Dr. Høeg and Dr. Jacqueline Corrigan-Curay, acting director of the Center for Drug Evaluation and Research (CDER), highlighted the FDA’s progress and future directions to integrate nonanimal methods. Dr. Corrigan-Curay announced the formation of a CDER NAMs Coordinating Committee, which will streamline internal collaboration and support broader adoption of human-relevant methods. Dr. Høeg identified several immediate areas where the FDA can eliminate animal testing, including shellfish toxicity testing, rabies and leptospirosis vaccine testing, protein quality evaluation, pyrogen testing, and skin irritation testing.

In a major announcement from the NIH, Dr. Nicole Kleinstreuer revealed the agency will no longer seek research proposals that exclusively develop animal-based experiments. Moving forward, all NIH funding opportunities will include explicit consideration for nonanimal, human-specific methods—a policy change that removes a long-standing barrier to innovation.

The Physicians Committee commends the FDA and the NIH for their leadership and commitment to advancing modern, human-relevant scientific approaches. These changes represent a critical step toward reducing animal use while transforming biomedical research and safety testing. By prioritizing methods that are more ethical and better aligned with human biology, these efforts promise to deliver more accurate and effective outcomes for human health. This progress reflects years of advocacy by the Physicians Committee in support of human-relevant, nonanimal research.

The NIH and the FDA also signaled increased collaboration to utilize human data and develop in silico tools to replace animal use in Investigational New Drug (IND) applications, including through initiatives supported by the Advanced Research Projects Agency for Health (ARPA-H).

The Physicians Committee continues to support this transition through initiatives such as our December 2024 webinar for regulators on nonanimal protein quality testing and our NURA platform, which offers regulatory and pharmacopeia scientists targeted training on animal-free pyrogen testing. We also collaborate with international regulatory bodies, including the Organisation for Economic Co-operation and Development (OECD), to promote global adoption of nonanimal methods. Our contributions include support for OECD initiatives on respiratory sensitization and systemic toxicity, along with specialized training programs to aid regulatory uptake.

In our recent public comments on the FDA’s draft guidance for industry on the use of Generally Accepted Scientific Knowledge (GASK), we urged the agency to fully leverage existing human-relevant data to reduce unnecessary animal testing—a recommendation also echoed in the workshop by Dr. Haleh Saber, director of the Division of Hematology Oncology Toxicology (DHOT) at CDER.

The Physicians Committee strongly supports the publication of successful use cases of NAMs and the establishment of clear regulatory policies to guide their use. We also commend the NIH’s growing investments in infrastructure to support human-based science. The agency’s new funding policy, which prioritizes nonanimal approaches, represents a pivotal shift in federal research strategy—one that aligns closely with the reforms the Physicians Committee and its supporters have long championed.

We celebrate this progress and will continue to work alongside regulators, researchers, and policymakers to replace animal testing with science that truly serves human health.