Saturday, 19 April 2025

FDA Moves To Replace Animal Testing

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The U.S. Food and Drug Administration (FDA) announced a plan to replace animal testing with “human-relevant methods.”

“The U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices,” the FDA stated in a press release.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said the agency would switch over to artificial intelligence.

RFK Jr. said AI is “much more precise in identifying the impacts of toxins in various products.”

WATCH:

Per FDA:

The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.

“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,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “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.”

From BioSpace:

This push is not new, William Blair analysts pointed out in a Thursday note to investors. In September 2022, for instance, Congress filed the FDA Modernization Act 2.0, which proposed a broader category of studies, dubbed “nonclinical tests,” which include animal testing but could also mean other biology-based approaches such as cell assays, bioprinted systems or computer models.

“That said, while the FDA Modernization Act 2.0 allowed for non-animal testing, the bill did not state any formal plans to refine, reduce, or completely replace animal testing over time,” William Blair added. Despite the new guidance—which the analysts anticipate the FDA to roll out “gradually over time”—the analysts expect drugmakers “will still want to do at least some animal testing.”

Meanwhile, Leerink analysts said “FDA’s announcement to phase out animal testing requirements is more public relations than a change in policy, in our view,” adding, “we expect minimal near-term impact on pharmaceutical preclinical testing.”

In its press announcement on Thursday, the FDA particularly pointed to “AI-based computational models of toxicity,” as an alternative that can be used in place of animal testing. “Software models could simulate how a monoclonal antibody distributes through the human body and reliably predict side effects based on this distribution as well as the drug’s molecular composition,” the regulator wrote.

Drug sponsors could also use what the FDA calls “human-based lab models,” including organ-on-a-chip systems, organoids and other models that can mimic human organs. The FDA will also use existing and real-world safety and efficacy data, including those from other countries, to better assess a drug.

The regulator did not give a detailed timeline for the elimination of its animal study requirements, but it did note that implementation of these new policies will begin “immediately.”


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