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FDA Plans To Phase Out Animal Testing Requirements (axios.com) 43

Posted by msmash from the end-of-an-era dept.
The Food and Drug Administration says it would begin phasing out animal testing requirements for antibody therapies and other drugs and move toward AI-based models and other tools it deems "human-relevant." Axios: The FDA said it would launch a pilot program over the next year allowing select developers of monoclonal antibodies to use a primarily non-animal-based testing strategy. Commissioner Marty Makary in a statement said the shift would improve drug safety, lower research and development costs and address ethical concerns about animal experimentation.

FDA Plans To Phase Out Animal Testing Requirements More | Reply

FDA Plans To Phase Out Animal Testing Requirements

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  • Read in Morgan Freeman voice: "It did not improve the drug safety..."

    • Re: (Score:3)

      by SeaFox ( 739806 )

      It will make PETA happy, though. So that's something... e_e

      • I am sure that is high on the mind of the MAGArati. This serves as further proof that when you get to the extreme of both sides of the political spectrum ideologies tends to have a lot of overlap.

      • The EU is still going to require it, so if you want to sell there, and to other countries that copy/paste EU standards into their own laws, then you are still going to need to do animal testing.

      • PETA is fascist lite. A gateway drug to becoming a yoga mom. Indoctrination begins with free Ranger Rick magazines in grammar schools but they grow up so fast to be anti-science, alienated from nature, and suspicious of rural and indigenous people.

        At least Greenpeace has conceded that their antifur campaign led by Bridget Bardot to save baby seals was actually a bad idea that led to environmental damage and genocide of native peoples. Little late, but at least they apologized.

        PETA is a fundraiser
        • PETA is a fundraiser for ALF, a designated terrorist group, and yet dollars to donuts your local schools promote them to kids and your local animal shelters raise nearly as much money for them as they do selling Trank on the side.

          Citation needed.

        • Re: (Score:2)

          by kellin ( 28417 )

          PETA is a fundraiser for ALF, a designated terrorist group, and yet dollars to donuts your local schools promote them to kids and your local animal shelters raise nearly as much money for them as they do selling Trank on the side.

          What does Gordon Shumway have to do with PETA? They'd be against his eating of cats...

      • I can't take an informed position on how good the technology they're going to test with is, but I'll say this: PETA being happy is rarely a good sign.
    • Oh it definitely will, letting a stochastic parrot hallucinate that a drug is safe will be great!

    • As long as it doesn't reduce drug safety, it's a win. I'm skeptical of that though. We have some really good analogs among the animals we use for testing.

      • Almost all animal testing is done on mice and rats. Doing testing on human tissue makes a lot more sense, in most regards.

        • That's only true for those things for which mice are not great analogs. We use mice because they're cheap and easy usually, but sometimes we use them because the are the correct choice.

          Some studies should be done with pigs, some should be done with mice, some should be with other animals. Some should be done on humans. Follow the science instead of the politics.

  • Testing on mice has produced tens of thousands of results that don't fully translate to humans, things like organoids (cloned partial human organs) might be able to produce more accurate results anyway. Weird that the only section of the US government still seemingly half functional is run by the brain worm anti vax guy, shit maybe the US really should've have made him president.

    • Re: (Score:3, Interesting)

      by dfghjk ( 711126 )

      "...maybe the US really should've have made him president."

      Or maybe made the black woman president so that every section of the government would work.

      • Didn't matter. Both candidates operate on the same philosophy, the boat philosophy: bring out another trillion.

      • Re: (Score:3, Insightful)

        by ichthus ( 72442 )
        LOL. The same black woman who, when asked what she would do differently from the zombie that was in charge at the time said, "Not a thing comes to mind." [yahoo.com]?

      • People don't like the government, and don't want every part of it to work. That's why she lost.

        • People don't like the government, and don't want every part of it to work. That's why she lost.

          Yup they only care about the parts that affect them, ignoring the fact that different parts affect different people. The "to hell with compromise" and "I got mine" mentalities don't scale well to a government that's suppose to serve *all* the people as equally, fairly and universally as possible. (Sound like something this administration is trying to get rid of?)

    • Re: (Score:2)

      by dfghjk ( 711126 )

      "Testing on mice has produced tens of thousands of results that don't fully translate to humans..."
      Something no doubt scientists didn't know and are thankful for your insight. Fully translating to humans couldn't possibly be a consideration when they chose mice, right?

      "...things like organoids (cloned partial human organs) might be able to produce more accurate results anyway."
      All sorts of things "might be able", if only scientists would think of better ways. Again, they must be grateful for your insight.

    • Re:Plausibly fine (Score:5, Informative)

      by Gilgaron ( 575091 ) on Friday April 11, 2025 @07:39AM (#65297051)
      You catch things in animal models that you can't in vitro, they're very expensive and they wouldn't be used if they weren't necessary. This will just make it easier for slapdash snake oil to get FDA approval. The standout is mentioning AI... you can lessen reliance on animal models with multiplex in vitro and 'organ on a chip' type tests but AI is barely good enough to write code, it can't do complex protein interactions. AI isn't going to tell you that an unelucidated protein in the liver cross reacts your mAb, but dead mice will.

      • This will just make it easier for slapdash snake oil to get FDA approval.

        Snake oil? Please stop giving RFK Jr ideas for medicines - or condiments.

    • Re: (Score:3)

      by pesho ( 843750 )

      Testing on mice has produced tens of thousands of results that don't fully translate to humans, things like organoids (cloned partial human organs) might be able to produce more accurate results anyway. Weird that the only section of the US government still seemingly half functional is run by the brain worm anti vax guy, shit maybe the US really should've have made him president.

      Said like someone who truly has no clue about what they are talking.

      • 1. Organoids, which are definitely not "cloned partial human organs" may be useful for evaluating some of the effects of the drugs, but have little to offer in terms of evaluating safety and efficacy. For this you need to understand how a drug is absorbed throughout the organisms, how it is metabolized throughout the organisms, how it is excreted from the organism, and how toxic it is to different organs. A little thing called AdMeTox. Th
  • What really happens when you are deported. Nice out of the box thinking, RFK.

  • I'm sure it will work just as well for pharmaceutical companies.

    Fortunately, I'm old enough that it doesn't really matter what those idiots develop and approve for themselves.

  • oh, they're going to test on animals (Score:4, Interesting)

    by Thud457 ( 234763 ) on Friday April 11, 2025 @08:17AM (#65297113) Homepage Journal
    The animals in question now are just called "patients", "the public" or "customers".
    Another blow against oppressive regulation! /s

    • Re: (Score:2)

      by PPH ( 736903 )

      And yet, nobody is stopping Microsoft from testing its products on customers.

    • I bet i know who's getting paid to run the AI simulations! Likely more expensively than cheap lab rats too.

      They already do too much testing on humans without warning so now it'll increase. Netflix had a good series on medical devices skipping on testing with a loophole...

  • i hope this is an April Fool joke (Score:4, Informative)

    by RandCraw ( 1047302 ) on Friday April 11, 2025 @08:59AM (#65297235)

    i just retired from a pharma after 19 years. Animal testing is essential for safety assessment because off-target damage to tissues cannot be detected using any method other than entire animals since drug byproducts from digestion or absorption do not exist in the lab, in vitro or in silico. Measuring drug effects on the body requires exposure to ALL of an animal's tissues to see which will react. Drug efficacy too can't be measured usefully without full body animal and human studies.

    Whomever proposed this obviously did not talk to _anyone_ in the pharma industry. The strategy is completely and dangerously clueless. I'm sure Derek Lowe will very soon explain this better than I.

    Washington has gone insane.

    • Whomever proposed this most probably is under the false impression that today's "AI" are super-intelligent AGIs. Even if this was the case, it would still be questionable if animal testing could be even partially replaced. Unfortunately though, what we know as "AI" is actually LLM, a statistical machine than knows nothing that humans don't already know. It is utterly unsuitable for the kind of research work where experimentation needs to be performed. A current "AI" can be useful for vibe-suggesting new for

    • Re: (Score:2)

      by bobm ( 53783 )

      Fun read from Derek Lowe (not the baseball player)

      https://www.science.org/conten... [science.org]

    • What if animal lives are worth more than your desire to botox yourself?

    • "The failure rate for the translation of drugs from animal testing to human treatments remains at over 92%, where it has been for the past few decades." - https://pubmed.ncbi.nlm.nih.go... [nih.gov]

      I don't think you understand your industry very well.

      Go hurt animals on your own dime.

      • So? The failure rate of AI developed drugs translated to human patients might might 99.99%. No one knows. On its face, this could be a very dangerous policy, unless they've integrated additional animal testing into the phase out, going up head to head against AI developed medicine. Only once AI medicine proves efficacy at least to that of animal testing can we start looking to phase it out without causing real harm.

        • An AI can't simulate all the cell interactions and chemistry involved; you can't even simulate that outside of AI. This is not weather prediction; it's much more complex.

          You need a real world test on a real world biological system. Limiting it down to rats is extreme; humanized rates makes more sense. The all have narrow ranges of usefulness. Do protein folding in a simulator because it's way faster than in the real world. But I'd rather test rat poison on rats because some unknown might prove it's not as

  • Did I mention it's a bad idea?

  • AI taking more jobs! (Score:3)

    by databasecowgirl ( 5241735 ) on Friday April 11, 2025 @01:41PM (#65298109)
    First they came for the lab rats and I said nothing because I wasn't a lab rat...

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