Insider reveals deeper meaning of NIH & FDA animal use policy changes

Insights into evolving considerations for Institutional Animal Care & Use Committee members

“How do we know that learning what happens to one animal tells us what will happen to another species,”  an ANIMALS 24-7 reader asked in response to recent coverage of animal use in biomedical research and testing,  “especially when the second species is the one we actually intend to understand?”

The question-asker,  ANIMALS 24-7 learned,  is an insider in the Institutional Animal Care & Use Committee at the question-asker’s place of employment,  who asked a great many more questions once we began discussing the first one.

An Institutional Animal Care & Use Committee is an oversight body required by the U.S. Animal Welfare Act at any entity using live vertebrate animals in biomedical research or testing.

The duty of the Institutional Animal Care & Use Committee is to evaluate and approve,  or reject,  any and all planned research activities involving live vertebrate animals before any work begins.

Confidentiality required

Under the Animal Welfare Act,  “all committee discussions,  meeting documents,  and protocol drafts must remain within official channels and cannot be shared or discussed outside of committee meetings,  the institution’s office of research,  or with outside faculty,”  let alone with news media.

For that reason,  the question-asker will not be identified in the following discussion of the Institutional Animal Care & Use Committee concerns brought up by three ANIMALS 24-7 articles in seven days.

ANIMALS 24-7 will,  however,  present the questions,  for the light they shed on what Institutional Animal Care & Use Committee members may be thinking about these days when reviewing a new experimental protocol.

What raised the questions?

Raising these questions were,  first of all,  our coverage of the two-week “March to Abolish Animal Testing” underway from Albany,  New York,  to the Marshall BioResources headquarters in North Rose, New York.

(See Can 15-miles-a-day march on the Erie Canal save Marshall Farms beagles?)

Coverage of the White Coat Waste report MAHA Betrayed followed,  exposing the failure of Robert F. Kennedy Jr.,  heading the U.S. Department of Health & Human Services under the Donald Trump administration,  to fulfill repeated promises to reduce dog and cat use in federally funded biomedical research.

            (See Dogs & cat use in labs is up under Trump/Kennedy, says White Coat Waste.)

Days after that,  the U.S. Food & Drug Administration belatedly moved to comply with the 2022 FDA Modernization Act 2.0,  ending the 84-year-old legal requirement that drugs had to be tested on animals before going to clinical trials on human subjects.

            (See FDA finally moves to comply with 2022 law ending animal testing mandate.)

“What counts as evidence that one method gives us better information than another?

“If we now have methods that study human cells,  human tissues,  organoids,  computational systems,  and other human-relevant models,”  the question-asker continued,  citing a list of non-animal methods mentioned by the FDA announcement,  “what should count as sufficient evidence that one method gives us better information than another?

“We are comparing methods.  New Approach Methodologies,”  called “NAMs” in the FDA announcement,  “merely bolster the biomedical research tool kits of biomedical researchers––a good thing,  but not enough to supplant vivisection,  even if the NAMS are extremely good.

“Not every animal experiment can simply be replaced tomorrow by a single NAM,”  the question-asker suggested,  “nor is every NAM automatically superior merely because it does not use animals.

“Another question that animal advocates ought to be asking”

“The question is what the method is supposed to tell us, and what evidence demonstrates that it actually tells us that.

“Animal advocates understandably tend to begin with the suffering of the animal,”  the question-asker supposed.

“But there is another question that animal advocates ought to be asking much more insistently:

“What knowledge are we buying with that animal’s suffering,  and how do we know that we are actually buying the knowledge we think we are buying?

“A key question that regulators are asking of Institutional Animal Care & Use Committees,”  the question-asker said,  is “Are we truly justifying the imposed ‘supreme sacrifices’ on all these unwilling sentient subjects with our research designs?

“Trying to get underneath the research design”

“I am not merely looking at the number of dogs and cats and asking,  ‘Why are they still experimenting on them?'”  the question-asker continued.

“I am trying to get underneath the research design:  What is the intended knowledge? What is the model?  What is the target?  What justifies the inference from one to the other?  And what would cause the investigators to change models?

“Animal research is not one method,”  the question-asker reminded.  “It is a family of research designs using animals for different purposes.”

Among those purposes,  the question-asker listed,  are:

• Basic biological research:  physiology,  neurobiology,  immunology,  development,  behavior,  genetics.
• Disease modeling:  attempting to reproduce aspects of a human disease in another species.
• Mechanistic research:  manipulating a biological pathway and observing consequences.
• Drug discovery and pharmacology:  studying absorption,  distribution,  metabolism, pharmacodynamics,  toxicity,  and therapeutic effects.
• Safety/toxicology testing:  looking for adverse effects before human exposure.
• Surgical/device research:  evaluating procedures,  implants,  or devices.
• Translational research:  attempting to move findings from an experimental model into human medicine.

“The animal is a model”

“The underlying methodological approach”  the question-asker explained,  “is usually to construct an experimentally manipulable model of a biological system,  manipulate it,  observe the resulting phenomena,  and then infer something about the target biological system,  often humans.

“An animal is not the human organism being studied,”  the question-asker emphasized.  “The animal is a model from which inferences about humans are made.

“The National Institutes of Health itself now explicitly says that model selection should be based on the particular scientific question,  human relevance,  translatability,  and context of use,  rather than simply on historical practice.”

New Approach Methodologies,  the question-asker explained,  are changing the techniques of experimental design,  but not comprehensively replacing either what researchers need to learn or every approach that might produce the information.

NIH & FDA policy changes

“As of September 2026,”  the question-asker detailed,  “the National Institutes of Health has stopped issuing new funding opportunities exclusively supporting animal models of human disease.

“The NIH has invested more than $150 million in Complement Animal Research In Experimentation,”  a program to speed the development,  standardization,  validation,  and use of human-based NAMs;  established the Office of Research Innovation, Validation, and Application (ORIVA);  funded a national standardized-organoid center;  and is explicitly encouraging investigators to select models according to scientific suitability rather than historical convention.

“FDA has likewise moved toward NAMs,  including a 2025 roadmap to reduce animal testing and 2026 draft guidance establishing considerations for validating NAMs in drug development,”  the question-asker reminded.

“Why does animal-model research persist?”

“So the actual question is ‘Why does an established animal-model research system persist even after alternatives have become scientifically and technologically credible?’

“There are several non-mutually-exclusive explanations,”  the question-asker suggested.

First,  “A liver-on-a-chip,  organoid,  cell culture,  computational model,  or other NAM can represent particular aspects of biology extraordinarily well without necessarily reproducing the entire interaction of brain plus immune system,  endocrine system,  circulation,  metabolism,  behavior,  microbiome,  development,  and whole-body pharmacokinetics.

“Some NAMs can combine several of these,”  the question-asker acknowledged.  “That is precisely why the current NIH strategy emphasizes combinations of models,  rather than assuming that every animal model can simply be replaced by one non-animal model.”

“Validation is itself a methodological problem.”

Second,  the question-asker explained,  “Validation is itself a methodological problem.  A new method must establish what exactly does this model predict,  under what circumstances,  and with what error rate?

“That requires reference data,  standardized protocols,  reproducibility studies,  defined contexts of use,  and comparison against outcomes that matter.

“FDA’s 2026 NAM guidance is essentially an institutional response to that problem,”  the question-asker said.

“The existing system has enormous institutional inertia,”  the question-asker mentioned,  raising the point that has probably most frustrated animal advocates confronting biomedical research use of animals over at least the past six decades.

“Animal facilities,  specialized personnel,  breeding colonies,  established protocols,  grant-review expertise,  historical datasets,  regulatory expectations,  published literature, and researcher training all constitute research infrastructure.

“Replacing the model means replacing the infrastructure”

“Replacing the model therefore isn’t merely substituting one laboratory instrument for another.  It means replacing the infrastructure of biomedical research and testing.

“Regulatory acceptance is a separate problem from scientific invention,”  the question-asker explained further.

“That is why validation and regulatory translation are now explicit components of federal NAM programs.  ORIVA was created partly to coordinate development,  evaluation,  and regulatory acceptance of new methods.

“If animal models have historically been used as the standard,”  the question-asker continued, “then a new model is often asked:  Does it reproduce what the animal model tells us?”

“But if the animal model itself is an imperfect predictor of human biology,  that can become circular,”  the question-asker observed.

“A better question is:  Does the new method predict the human phenomenon we actually care about?  The NIH is increasingly articulating exactly that shift in terms of human relevance and translational potential.”

“A mouse can be similar to a human in one respect and profoundly different in another.”

For example,  the question-asker offered,  “A mouse can be similar to a human in one respect and profoundly different in another.  And an animal model can be mechanistically informative while being predictively poor for a particular human outcome.

“That distinction is crucial.  The deeper problem is not ‘animal versus non-animal.’

“It is:  What warrants believing that observations generated under one set of biological conditions provide reliable knowledge about another biological system?

“That applies equally to NAMs.  An organoid is not automatically ‘the truth’ because it is human-derived.  An artificial intelligence model is not automatically ‘objective’ because it is computational.  A human cell culture is not automatically more informative for every question.”

“A much more demanding position”

Demanding to know whether the model for an experiment is appropriate for the intended context of use,  the question-asker said,  “is actually a much more demanding position than simply saying ‘Animals are bad’ or ‘NAMs are better.'”

Here,  the question-asker suggested,  “We need to distinguish the administration’s documented policy rationale from the criticism that its policies are inconsistent with its stated objective.

“The documented federal position in 2025–26 is not that animal models should simply continue unchanged.  Quite the contrary.

Contradictions from NIH?

“The NIH says human-based research is a Trump administration priority,  and NIH has committed substantial funding to NAM development. The FDA says it is moving away from animal testing as the default and toward human-relevant methods.

“At the same time,  the NIH explicitly says that animal models remain appropriate when scientifically justified, and its rules require researchers proposing animal experiments to explain why the goals cannot be accomplished with alternative models.

“So the administration’s apparent rationale is approximately:  Replace or reduce animal use where validated human-relevant alternatives can do the job,  but retain animal models where investigators determine that they remain scientifically appropriate,  including where NAMs cannot yet answer the particular question.

“That is materially different from ‘animal models are scientifically superior.’

Spending question raised by White Coat Waste

“But then there is the striking spending question raised by White Coat Waste’s September 10,  2026 report, MAHA Betrayed, which claims that the NIH committed more than $225 million in new funding, renewals, extensions, and other funding actions supporting dog and cat experiments between February 13, 2025, and September 8, 2026.

“White Coat Waste contrasts that with NIH’s $150 million investment in Complement Animal Research In Experimentation.

“How can an administration simultaneously promote a transition away from animal models and continue making substantial new discretionary investments in animal-model research?” questioned the question-asker.

“Possibilities should not be conflated”

“There are at least three different possibilities,  and they should not be conflated,”  the question-asker considered.

“Transition takes time.  Existing research programs,  facilities,  contracts,  and scientific questions cannot instantly disappear.

“Some animal models are being retained because federal agencies consider them scientifically necessary for particular questions.  NIH explicitly retains this position.”

Finally,  the question-asker observed,  “There may be a gap between stated policy direction and individual funding decisions.

“There is also an important complication:  ‘$225 million in animal research’ and ‘$150 million in NAM research” are not necessarily comparable measures of scientific activity.

“One is a set of funding actions for particular animal projects,  while the other is a strategic program for developing an entire alternative research infrastructure.

“Dollar-for-dollar comparison”

“Dollar-for-dollar comparison does not establish scientific equivalence.”

Asserted the question-asker,  “I think we have identified something deeper than an animal-welfare dispute.  The traditional justification is:  ‘We use animal models because they are established models.’

“But ‘established’ is a sociological property.

“Then:  ‘They are established because they have been used successfully.’

“But what counts as ‘success’?  If success means:  ‘The model generated publishable findings,’  that is one thing.  If it means:  ‘The model generated findings that reliably predicted human outcomes,’  that is much stronger.

“The danger isn’t uniquely animal research”

“And if the latter is the real objective,  then predictive validity for the target system should be the governing criterion.

“The danger isn’t uniquely animal research,”  the question-asker concluded,  though this is how most animal advocates,  especially anti-vivisectionists,  might perceive the issue.

“The danger,”  the question-asker said,  “is any research tradition in which the model becomes mistaken for the reality it was constructed to represent.

“And that is why New Approach Methodologies are interesting even apart from the ethical issue:  they force biomedical science to confront the question of what makes a model legitimately informative about the thing being modeled.”

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