FDA, NIH officials look to curb animal testing in drug development

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty Makary opened the meeting stating the agency is committed to exploring non-animal models and stressed that reducing animal testing is one of the agency’s biggest goals.

Makary said the topic “resonates with everybody,” and replacing animal testing with alternative models has can help expedite drug development, lower costs, and increase innovation.

“God did not make animals on planet Earth to abuse and torture, and so we have to respect animals, and this workshop is aimed at reducing animal testing in every way we can, while safeguarding the public with medications,” Makary added. Shortly after joining FDA, Makary announced a plan to “phase out” animal testing with new approach methodologies (NAMs), including computer simulation, artificial intelligence, lab-grown organoids, and organ-on-a-chip technologies. (RELATED: FDA seeks to reduce animal testing requirements for mAbs, other drugs, Regulatory Focus 11 April 2025)

Tracy Beth Høeg, senior advisor for clinical sciences in the Office of the Commissioner, noted that animal models are not reliable predictors of how drugs will work in humans. She pointed out that over 90% of drugs that pass animal testing ultimately fail to gain FDA approval due to concerns about safety or efficacy in humans.

Despite these disadvantages to using animal models, the adoption of alternative methods has been slow, said Jacqueline Corrigan-Curay, the acting director of the Center for Drug Evaluation and Research (CDER).

One issue is that the largest manufacturers default to including animal testing because it’s an established practice. Furthermore, there is a misunderstanding that new approach methodologies (NAMs) must be qualified or validated by the FDA.

Nonetheless, the agency is making efforts to encourage the use of NAMs for certain types of preclinical studies, said Corrigan-Curay. For example, FDA is encouraging the use of alternative methods for pyrogenicity testing and for skin irritation studies.

Corrigan-Curay recognized that while encouragement is important, it must be supported by established standards and best practices. She mentioned that the FDA is working on developing these standards and practices to ensure consistent applications and evaluations.

Haleh Saber, the division director of hematology, oncology, and toxicology at CDER, stated that “We are committed to reducing the use of animals in oncology drug development testing. We have successfully reduced animal testing, and new approaches are now being submitted on a voluntary basis.”

Saber mentioned that the FDA has permitted sponsors to forgo three-month toxicology studies if adequate justification is provided. These studies can be substituted with a weight-of-evidence approach.

During the workshop, an NIH official announced that it will no longer fund proposals that rely exclusively on animal testing for drug development. Instead, applicants are encouraged to incorporate NAMs to assess the safety and efficacy of new drug treatments.

“I am delighted to announce today that all new NIH funding opportunities moving forward should incorporate language on consideration of NAMs, said Nicole Kleinstreuer, acting NIH deputy director for program orientation of planning and strategic initiatives.

Kleinstreuer said that scientific studies using animal models have been entrenched in “decades and decades of historical use.” She said that “our task now is to build on NAMs and to go forward and to build on human-based methods.”

FDA

FDA, NIH officials look to curb animal testing in drug development

Related topics

Recommended content

Welcome to the new RAPS Digital Experience