In a groundbreaking announcement today, the U.S. Food and Drug Administration (FDA) revealed plans to begin phasing out its longstanding requirement for animal testing in the development of monoclonal antibody therapies and other drugs — replacing it with modern, human-relevant testing methods.
This is a big step forward towards the future we’ve been fighting for!
So, what’s changing? Under this new plan, the FDA will:
- Encourage drug developers to use cutting-edge, non-animal methods — like lab-grown human organoids and organ-on-a-chip technology — to test for safety and effectiveness;
- Accept AI-powered computer modeling to predict how drugs will behave in the human body — helping to eliminate animal tests; and
- Allow real-world human data to replace some animal studies, when that data already shows a drug’s safety in people.
This shift starts immediately, with new guidance for companies submitting Investigational New Drug (IND) applications to the FDA.
For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation.
— Dr. Martin Makary, FDA Commissioner
The FDA’s new plan is a win on many fronts:
→ For animals: Fewer animals will suffer and die in drug development labs.
→ For patients: Human-relevant science means safer, more effective treatments can reach people faster.
→ For everyone: Cutting out animal tests could help lower drug development costs — and eventually, drug prices.
So, is this the beginning of the end for animal testing?
This isn’t the final chapter — yet. The FDA’s new approach applies (for now) primarily to monoclonal antibodies and select other drugs. But make no mistake: this is a seismic shift in how drugs are evaluated in the U.S.
It’s a clear signal that the future of medicine does not depend on the exploitation of animals.
At Rise for Animals, we’ve always known that animal experiments are unethical as well as failed models for human health. Today’s FDA announcement proves that the science and its regulatory landscape is finally catching up.
We’ll be watching closely to make sure these changes move forward swiftly, transparently, and with accountability.
Because everyone — human and non-human — deserves nothing less.
Let’s keep up the momentum! Take action now to end wasteful, taxpayer-funded animal research. The Safeguard Pets, Animals, and Research Ethics (SPARE) Act is a bill that aims to end federally funded animal research. Urge your U.S. elected officials to support the SPARE Act now.