FDA to phase out animal testing requirement, adopt AI methods
Apr. 10, 2025 4:13 PM ETCharles River Laboratories International, Inc. (CRL) Stock, CERT Stock, RXRX Stock, SLP StockNOTV, BSGM, SDGR, ABCL, DNA, ABSIBy: Nilanjana Basu, SA News Editor77 Comments
(2min)
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The U.S. Food and Drug Administration said on Thursday that it will be phasing out the animal testing requirement for monoclonal antibody therapies and other drugs, replacing it with more ethical methods like AI computations and human-based models.
In a move to change drug testing methods and advance public health, the agency said that the current animal testing requirement will be taken over by novel approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting.
Contract research organizations Charles River Laboratories (NYSE:CRL) and Inotiv (NASDAQ:NOTV), where operations are exposed to preclinical animal-based research, quickly turned lower during regular trading after the announcement.
Meanwhile, AI-focused biotechs and health tech firms recorded sharp gains in the post-market trading. Notable gainers included Schrödinger (SDGR), Recursion Pharma (NASDAQ:RXRX), Absci (NASDAQ:ABSI), BioSig Technologies (BSGM), Ginkgo Bioworks (DNA), Simulations Plus (NASDAQ:SLP), Certara (NASDAQ:CERT) and AbCellera Biologics (ABCL).
"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," the FDA said in a statement.
To make determinations of efficacy, the agency said it will also begin using existing safety data from other countries with similar regulatory standards, where the drug has already been through human trials.
"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,” said FDA Commissioner Martin Makary.
The agency, over the coming year, will be launching a pilot program allowing some monoclonal antibody developers to use a primarily non-animal-based testing strategy, under FDA consultation.
Update 8.57 PM EST: Adds detailed stock reactions