FDA takes first step toward ending animal testing as part of ‘3.0 modernization'
The U.S. Food and Drug Administration (FDA) announced it will be phasing out animal testing for some new drugs, in favor of “more effective, human-relevant methods.”
In a press release, the agency said the shift begins with monoclonal antibody therapies, where soon new drug applications will no longer require testing on animals to demonstrate safety. Instead, the FDA plans to adopt “new approach methodologies,” including “AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting.”
Typically, once a drug is successfully tested on animals, safety tests are then conducted on humans. However, the FDA now believes this decades-old process has become too expensive—and with the evolution of technology, it may not be the best way to ensure a drug is safe.
“The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development costs, and ultimately, drug prices,” the agency said.
The change is made possible by a 2022 bipartisan law, the FDA Modernization Act 2.0, which paved the way for human-based lab models and advanced computer simulations that can be used in place of animal testing.
The act removed the requirement that animal studies be conducted for drug approval, under the discretion of the FDA. Per the now-changing rules, no new drug was spared from the requirement, including pharmaceuticals that are prescribed internationally for use by humans.
In the future, companies seeking approval for a drug used overseas can provide data on efficacy and safety, in lieu of redoing all animal and human safety trials.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” FDA Commissioner Martin A. Makary, MD, said in the news release. “By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
Upgrade to 3.0 in progress
The move has been praised by animal rights and provider groups alike, with Animal Wellness Action and the Physicians Committee for Responsible Medicine both releasing statements praising the decision and endorsing the FDA Modernization Act 3.0, a proposed bill that would solidify the policy shift on animal testing, opening up all new drug applications to alternatives.
“At long last, we may be at a pivot point where FDA is no longer obstructing the move away from animal testing,” Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy, said in a statement. “With today’s comments, Commissioner Makary is suggesting that the FDA will become a catalyst for the transition to 21st-century science grounded in human biology.”
The FDA said it will begin immediately testing and validating alternatives to animal models, working closely with the National Institutes of Health, the National Toxicology Program and the Department of Veterans Affairs. However, monoclonal antibody therapies can take advantage of the flexibility in the near future, when a pilot program is expected to begin.
Other drug types will be able to follow, once the FDA puts in place a permanent framework for using lab simulations and AI for safety testing.
"Over the coming year, the FDA aims to launch a pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy, under close FDA consultation," the agency added. "Findings from an accompanying pilot study will inform broader policy changes and guidance updates expected to roll out in phases."
The full announcement is available here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.