In Monumental Declaration, NIH Follows FDA and Says Agency Will Turn Away from Animal Testing

Those of us who care about animals will long remember April 2025 as the month when everything began to turn around on the long-standing moral and scientific problems with animal testing and research.

Earlier this week, on April 29, the director of the National Institutes of Health announced the agency’s bold plan to favor human-based research technologies over animal use in intramural research, NIH-funded extramural studies, and basic sciences.

Mind you, this is the largest grant-making agency in the world, last year delivering grants of $46 billion to academic researchers throughout the nation, mostly for animal tests.

And just more than two weeks prior to that, the director of the FDA announced a plan to phase out the use of animals in drug testing.

These are responses by the largest and most important public health agencies in the world to the “Modernize Testing” campaign of the Center for a Humane Economy and Animal Wellness Action.

For the last four years, we’ve been battling to change the ways of the FDA and the NIH, mainly by pushing Congress to change the statutes that guide the agencies’ work in this space.

We knew that if we changed the FDA, it would have a spillover effect at the NIH, whose intramural research and grant-making also focus on understanding the molecular basis of diseases for drug development.

We had hoped for change after we moved heaven and earth to pass the FDA Modernization Act 2.0 (FDAMA 2.0) in Congress in December 2022, with unanimous votes in both chambers.

While the change in the law was monumental, we knew we then had to bring the principles of that law to life within the major federal agencies driving animal testing within the $1.35 trillion pharmaceutical sector and within academic institutions funded by the NIH across the nation and even the world.

But after Congress passed the FDA Modernization Act 2.0, Biden’s FDA stonewalled. And that’s when we worked with our allies in Congress to introduce the FDA Modernization Act 3.0 — to push the act to implement the law with vigor.

But then something remarkable happened with a change in leadership at the FDA. Confirmed on April 1, Dr. Marty Makary made it his first official public-facing announcement to phase-out animal testing and to promise a dramatic reboot of our drug development processes.

Then in rapid-fire actions, EPA Administrator Lee Zeldin affirmed an earlier commitment to phase out animal tests for chemicals within a decade. And then just two days ago came the consequential announcement from NIH Director Dr. Jay Bhattacharya that he was not only on board with these new strategies but ready to take the lead at one of the largest health research agencies in the world.

For decades, our biomedical research system has relied heavily on animal models. With this initiative, NIH is ushering in a new era of innovation,” wrote Dr. Bhattacharya in the NIH press release. “By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted — from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”

Millions of Animals, Millions of People to Benefit from New Agency Directives

I want you to understand what this means.

It means that, perhaps in a few years, we’ll stop using millions of animals a year in invasive, painful, and often lethal tests. That includes more than 100,000 primates a year and half that number again of beagles. It means that the work at the seven regional primate centers may wither. And it means that the private dog breeding labs — more akin to factory farms for dogs — will also lose markets for the dogs they breed to be hurt.

Taking a wider lens and looking at the effects of these declarations for public health, here’s what it means:

• The FDA Roadmap and NIH initiative will expand the use of innovative 21^st-century human-based science to reduce animal testing.
  
  
• The agencies are making it a national priority to reduce and replace animal testing and research to use billions in tax dollars more efficiently.
  
  
• This new focus on human-based biology will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments, in a critical leap forward for science, public trust, and patient care.

And it means that other analogue agencies to the FDA and the NIH throughout the world will shift their focus to human-relevant, human-biology-based testing methods.

The impetus for all of this was the FDA Modernization Act 2.0, which we can already judge as the most important policy change in the nation’s history to address animal testing. The bill eliminated an 84-year-old animal-testing mandate for every new drug in development, whether a drug for cancer, pain, Alzheimer’s, or any other affliction of the human body.

An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, driving up costs for drugs, harming millions of animals, and delivering too few tangible results for patients in life and death circumstances.

Over 7,000 rare diseases affect between 25-35 million Americans — and 95% of those diseases have no cure. By shedding the animal testing, drug developers can invest in treatments and cures for thousands of these maladies without breaking the bank.

The innovative 21^st-century methods outlined in FDAMA 2.0 are among the most promising frontiers in understanding rare diseases: organ chips for Barth Syndrome, 3D models (organoids) of the midbrain for NGLY1 deficiency (a rare neurological disease), and artificial intelligence in developing treatments for Fragile-X syndrome.

Importantly, 21^st-century technologies — referred to as New Approach Methodologies — are the only relevant models in the growing therapeutic areas known as biologics, where therapies (e.g., immunotherapy, cell-therapy) are by design very human-specific. The use of animals in this category of drug development is acutely misleading and scientifically unjustified.

A New Era in Science and Public Health Dawns

Commissioner Makary captured it so well in his statement: “For patients, it means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.” (emphasis in the original)

Thank you for sticking with us in this fight. It may turn out to be one of the great gains for our cause this century.