FDA Modernization Act 2.0 – An Important Step in the Right Direction, but Much Work Remains

By Rebecca Critser | August 17, 2023

In December 2022, Congress passed the FDA Modernization Act 2.0 and President Biden signed it into law as part of the Omnibus bill. This new law has implications for the future use of alternatives to animal models in science and research. The Act changes statutory language of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) so that animal testing is no longer required at the pre-clinical stage before regulatory approval. Previously, the statute required “the submission … of preclinical tests (including tests on animals) … to justify the proposed clinical testing.” This was interpreted as a requirement to perform animal testing prior to proceeding to tests on humans.

The law has been changed so that several “nonclinical” options are available, including “(1) Cell-based assay[,] (2) Organ chips and microphysiological systems[,] (3) Computer modeling[,] (4) Other nonhuman or human biology-based test methods, such as bioprinting[, and] (5) Animal tests.”

This is a major step forward for the use of alternatives in drug development because it eliminates the need to test in animals.  While animal tests are still permissible, there is now a menu of options available that do not use non-human animals.   

The new law thus opens the door to increased use of alternative methods.  But very few alternative methods are off-the-shelf ready to be used in research or pre-clinical settings. Rather, alternative methods are still being developed and validated. Validation or qualification presents a high hurdle for alternative methods. While animal models were primarily adopted without validation, they have become the standard. Consequently, questions remain around how to best validate alternative methods. Ultimately, the goal is to identify validation methods that ensure the results accurately inform the user about the safety and/or efficacy of the drug product. These questions are still being worked out by industry, academia, and the FDA.

 While the statutory language has been amended, much work remains to be done before widespread replacement of animal tests will occur.  The scientific and policy communities should come together to write a roadmap to take advantage of the opportunities that the FDA Modernization Act creates.  In addition, training on non-animal alternatives is needed for regulators and others so that the transition to non-animal models can be facilitated.

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