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<\/a><\/p>\n(Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n WASHINGTON D.C.\u2013\u2013<\/strong>U.S. Food & Drug Administration commissioner Martin Makary on April 10, 2025 announced barely two weeks after taking office that the FDA is \u201creplacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, \u00a0human-relevant methods.\u201d<\/p>\n The Makary announcement came 50 years after non-animal-using monoclonal antibody testing methods were developed,\u00a0 becoming available in 1975.\u00a0 Makary at the time was only two years old.<\/p>\n The Makary announcement also came almost 28 years to the day after the American Anti-Vivisection Society in April 1997 petitioned all government agencies using monoclonal antibodies to adopt the non-animal approaches.\u00a0 Makary then was working on his master\u2019s degree in public health.<\/p>\n Charles Russell & Rex Burch.<\/strong><\/em><\/p>\n<\/div>\n Said Makary specifically in his April 10,\u00a0 2025 prepared statement,\u00a0 \u201cThe FDA\u2019s animal testing requirement will be reduced, \u00a0refined, \u00a0or potentially replaced using a range of approaches,\u00a0 including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting.\u201d<\/p>\n The Makary statement appeared to deliberately invoke the \u201cThree Rs\u201d pathway for eliminating animal testing outlined in 1959 by British scientists William Russell (1925-2006) and Rex Burch (1925-1996).<\/p>\n \u201cImplementation of the regimen will begin immediately for investigational new drug applications,\u201d\u00a0 Makary continued.<\/p>\n \u201cTo make determinations of efficacy, the agency will also begin use pre-existing, \u00a0real-world safety data from other countries, \u00a0with comparable regulatory standards, \u00a0where the drug has already been studied in humans.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n \u201cFor too long,\u201d\u00a0 Makary said,\u00a0 \u201cdrug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally.<\/p>\n \u201cThis initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use.<\/p>\n \u201cBy leveraging AI-based computational modeling, \u00a0human organ model-based lab testing, \u00a0and real-world human data, \u00a0we can get safer treatments to patients faster and more reliably,\u201d\u00a0 Makary promised, \u00a0\u201cwhile also reducing research and development costs and drug prices.\u201d<\/p>\n A six-paragraph addenda to Makary\u2019s statement outlined \u201ckey benefits of replacing animal testing in monoclonal antibody safety evaluation,\u201d\u00a0 explaining that \u201csoftware 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\u2019s molecular composition.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Also,\u00a0 \u201cThe FDA will promote the use of lab-grown human \u2018organoids\u2019 and organ-on-a-chip systems that mimic human organs \u2013 such as liver,\u00a0 heart,\u00a0 and immune organs \u2013 to test drug safety. These experiments can reveal toxic effects that could easily go undetected in animals,\u201d\u00a0 Makary said,\u00a0 \u201cproviding a more direct window into human responses.\u201d<\/p>\n In addition,\u00a0 Makary said,\u00a0 the FDA \u201cwill work to update its guidelines to allow consideration of data from these new methods. \u00a0Companies that submit strong safety data from non-animal tests may receive streamlined review, \u00a0as the need for certain animal studies is eliminated, \u00a0which would incentivize investment in modernized testing platforms.\u201d<\/p>\n Makary promised \u201cclose partnership with federal agencies such as the National Institutes of Health, the National Toxicology Program,\u00a0 and the Department of Veterans Affairs, \u00a0to accelerate the validation and adoption of these innovative methods through the Interagency Coordinating Committee on the Validation of Alternative Methods.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Further, \u00a0Makary said,\u00a0 \u201cOver 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. \u00a0Findings from an accompanying pilot study will inform broader policy changes and guidance updates expected to roll out in phases.\u201d<\/p>\n \u201cThis first action of commissioner Makary begins a new era for drug testing,\u201d\u00a0 enthused Physicians Committee for Responsible Medicine director of research policy Elizabeth Baker.<\/p>\n \u201cWhile I\u2019m always cautious about believing grand promises from federal agencies, \u00a0it was an incredible thrill to see those words uttered by a leader of the FDA,\u201d\u00a0 responded Center for a Humane Economy and Animal Wellness Action president Wayne Pacelle.<\/p>\n \u201cAt long last, \u00a0we may be at a pivot point where FDA is no longer obstructing the move away from animal testing,\u201d\u00a0 Pacelle said.<\/p>\n U.S. Senator Cory Booker (D-NJ).<\/strong><\/em><\/p>\n<\/div>\n Pacelle himself then pivoted to plug the FDA Modernization Act 3.0, \u00a0recently introduced into the House of Representatives as \u201da companion bill to the bipartisan Senate bill S.355,\u201d \u00a0co-authored by Senators Cory Booker,\u00a0 a Democrat from New Jersey,\u00a0 and Eric Schmitt, \u00a0a Republican from Missouri.<\/p>\n The FDA Modernization Act 3.0 would \u201crequire the FDA to publish a final rule to implement the FDA Modernization Act 2.0,\u201d\u00a0 passed in 2033 by the 117th Congress,\u00a0 requiring \u201cupdating regulations that allow for non-animal test methods.<\/p>\n \u201cA nearly identical bill passed the Senate by unanimous consent in December 2024, \u00a0but the House did not take up the measure before the end of the 118th Congress\u201d in January 2025,\u00a0 Pacelle noted.<\/p>\n \u201c<\/strong>The FDA Modernization Act 2.0,\u201d\u00a0 Pacelle argued, \u00a0\u201cwas, \u00a0without question, the most important policy change in the nation\u2019s history to address animal testing. \u00a0The bill eliminated an 84-year-old animal-testing mandate for every new drug in development.<\/p>\n \u201cThe FDA Modernization Act 2.0 did not ban animal testing,\u201d\u00a0 Pacelle acknowledged,\u00a0 \u201cbut it offered drug sponsors the option to use 21st-century alternatives such as cell-based assays, \u00a0organ chips, \u00a0computer modeling, \u00a0and bioprinting.\u201d<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Agreed Humane World for Animals president Kitty Block and Humane World for Animals Legislative Fund president Sara Amundson,\u00a0 in a joint blog focusing on animal use in Environmental Protection Agency testing,\u00a0 rather than on the Makary announcement pertaining to the FDA, \u00a0\u00a0\u201cOver the years, we\u2019ve seen a series of initiatives within the EPA and other federal agencies launch and then falter.<\/p>\n \u201cWith respect to the EPA,\u201d\u00a0 Block and Amundson explained,\u00a0 \u201cthe agency has traditionally relied on animal tests to assess the probable effects and toxicity thresholds for human exposure to chemicals and pesticides.<\/p>\n \u201cOur history with this issue goes back at least as far as the Clinton administration\u2019s proposal for a\u00a0High Production Volume Chemical Testing Program\u00a0to expand the number of animals used in tests. \u00a0We moved quickly to negotiate a firm commitment to the reduction and elimination of new testing, \u00a0and we helped to secure dedicated funding to support those goals at both the EPA and the National Institute of Environmental Health Sciences.<\/p>\n Mike Markarian left HSUS in 2018 to become a winemaker.<\/strong><\/em> \u201cWe led the campaign to reform the Toxic Substances Control Act,\u201d\u00a0 Block and Amundson claimed, \u00a0\u201cmaking it the first federal statute to call for an end to new animal testing.\u201d<\/p>\n Both Block and Amundson helped to lobby for the 2016 passage of the Toxic Substances Control Act reforms adopted in 2016,\u00a0 but Wayne Pacelle at the time headed both of their parallel organizations,\u00a0 then known respectively as the Humane Society of the U.S. and the subsidiary Humane Society Legislative Fund,\u00a0 titularly led by HSUS vice president Mike Markarian.<\/p>\n Block and Amundson also mentioned a 2024 \u201clegal petition to modernize FDA regulations \u202fand guidance governing testing for new drug approvals,\u201d\u00a0 paralleling the 1997 petition from the American Anti-Vivisection Society,\u00a0 which was immediately rejected by then-National Institutes of Health director Harold Varmus.<\/p>\n Henry Spira.\u00a0 (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n \u201cMost EPA-related testing involves private companies\u2019 submissions for registration of chemicals and pesticides,\u201d\u00a0 Block and Amundson continued.<\/p>\n \u201cFor that reason,\u00a0 we have also concentrated on accountability for corporations seeking regulatory approval. \u00a0We have pushed them to make their own strong commitments to reduce and eliminate animal tests.\u201d<\/p>\n This was the approach,\u00a0 highly controversial at the time,\u00a0 pioneered by Animal Rights International founder pioneer Henry Spira (1927-1998) in securing pledges from Avon and Revlon to quit animal testing in 1980,\u00a0 and from Procter & Gamble in 1984 to fund development of alternatives to animal testing. Procter & Gamble has now invested more than $480 million in fulfilling that pledge to Spira,\u00a0 developing more than two dozen non-animal testing methods now in use by companies all over the world.<\/p>\n \u201cWe have also worked directly with the scientific community worldwide to address the scientific challenge of moving away from animal use,\u201d\u00a0 Block and Amundson said,\u00a0 citing a \u201crecent collaboration with the EPA\u2019s Office of Pesticide Programs staff\u201d that \u201cresulted in a\u00a0published paper\u00a0showing that an\u00a0in silico<\/em>\u00a0[computer] model is a suitable replacement in most cases for an acute toxicity test in which rats are fed increasing doses of pesticides.\u201d<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n The American Anti-Vivisection Society petition to replace monoclonal antibodies extracted from animals was introduced in April 1997 by then-AAVS director of special projects David Cantor with an abortive media campaign titled \u201cAntibodies Without Animals.\u201d<\/p>\n Cantor explained that regulatory and procedural changes in monoclonal antibody production could save a million mouse lives a year, \u00a0largely through \u00a0adoption of an alternate production method that American Anti-Vivisection Society funding had helped to perfect.<\/p>\n The campaign drew favorable notice from the trade magazine Lab Animal<\/em>, \u00a0and from a variety of scientific, \u00a0technological, and legal journals, \u00a0but none from mainstream mass media.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Cantor left the American Anti-Vivisection Society after six months to found his own organization,\u00a0 Responsible Policies for Animals.<\/p>\n Then-American Anti-Vivisection Society executive director Tina Nelson,\u00a0 who headed AAVS from 1995 until her death in 2005,\u00a0 took over the campaign.<\/p>\n As Nelson\u2019s first priority,\u00a0 she issued a simplified description of what it was all about.<\/p>\n \u201cMonoclonal antibodies,\u201d\u00a0 Nelson explained, \u00a0\u201care used in essentially every field of human and veterinary research, \u00a0and in diagnosing and treating many cancers, \u00a0bacterial and viral infections, \u00a0and other ailments.<\/p>\n \u201cThey are especially useful because they attack specific antigens within the body, \u00a0where they are used to identify and\/or destroy foreign materials.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n \u201cUnfortunately, \u00a0many laboratories still use the outdated and painful ascites method of producing monoclonal antibodies. \u00a0When animals are used,\u201d Nelson described,\u00a0 \u201ctumor cells are injected into their abdominal fluid. \u00a0This causes ascites\u2013\u2013a painful swelling of the abdominal peritoneal cavity. \u00a0It is estimated that more than one million animals,\u201d \u00a0most or all of them mice, \u00a0\u201cundergo this torment each year in the U.S.<\/p>\n \u201cSince 1975,\u201d \u00a0Nelson explained, \u00a0\u201cscientists have known that monoclonal antibodies could be produced without the use of animals, but animal use proliferated in small-scale production.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n \u201cThe alternatives are so simple, \u00a0reliable, \u00a0and economical,\u201d\u00a0 Nelson said, \u00a0\u201cthat the Netherlands, \u00a0Germany, and Switzerland have banned the use of animals.<\/p>\n \u201cIn April 1997, \u00a0the European Centre for the Validation of Alternative Methods published its recommendation that the entire European Union prohibit animal monoclonal antibody production.\u201d<\/p>\n The U.S. lagged behind, \u00a0Nelson indicated, \u00a0as it still does,\u00a0 in part because Animal Welfare Act enforcement regulations exclude mice, \u00a0rats, \u00a0and birds from the definition of \u201canimal.\u201d<\/p>\nMakary finally does what the FDA,\u00a0 EPA,\u00a0 & National Institutes for Health were petitioned to do in 1997,\u00a0 50 years after key technology became available<\/em><\/span><\/h2>\n
<\/a><\/p>\n\u201cReduced,\u00a0 refined,\u00a0 or potentially replaced\u201d<\/h2>\n
<\/a><\/p>\n\u201cA paradigm shift in drug evaluation\u201d<\/h2>\n
<\/a><\/p>\n\u201cOrgan-on-a-chip systems\u201d<\/h2>\n
<\/a><\/p>\n\u201cNon-animal-based testing strategy\u201d<\/h2>\n
<\/a><\/p>\nFDA Modernization Act 3.0<\/h2>\n
<\/a><\/p>\n\u201cLaunch & then falter\u201d<\/h2>\n
<\/a><\/p>\n
(Facebook photo)<\/strong><\/em><\/p>\n<\/div>\nToxic Substances Control Act<\/h2>\n
<\/a><\/p>\nPrivate companies<\/h2>\n
<\/a><\/p>\nSaving mouse lives<\/h2>\n
<\/a><\/p>\nWhat are monoclonal antibodies?<\/h2>\n
<\/a><\/p>\nObsolete methods<\/h2>\n
<\/a><\/p>\nEurope was 28 years ahead of the U.S.<\/h2>\n