Dear FDA Matters readers: This column is the second in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. The first (here) was on the Advanced Research Projects Agency-Health (ARPA-H). Another spotlight column is in process, and more will follow.
If you are aware of a cause or an organization that you feel could benefit from a spotlight column, please reach out to me.
Thanks,
Steven
Early in my career, the leading animal rights advocate in the House of Representatives was also an equally passionate advocate for spinal cord injury research, which requires research on animals. I don’t remember him ever acknowledging the tension between his two positions.
Today’s guest is Naomi Charalambakis, Ph.D., the Director of Communications and Science Policy at Americans for Medical Progress (AMP) (www.amprogress.org). The organization lives in the middle of that tension.
AMP educates the public, including policymakers, about the role and value of animals in medical research. It also supports continued efforts to develop alternatives that can complement and, where appropriate, reduce our reliance upon animals.
AMP’s key message: this is not an “either/or” choice. Scientific progress depends on a “both/and” approach that integrates new technologies alongside animal research to generate robust, decision-ready data.
Steven: What is AMP and why is it needed?
Naomi: Americans for Medical Progress (AMP) was founded more than 30 years ago to ensure that the public, including policymakers, understands the essential role animals play in advancing medicine. Many of the treatments we rely on today—from vaccines and cancer therapies to surgical techniques and medical devices—were developed through carefully regulated research involving animals. AMP also supports continued efforts to develop alternatives that can complement and, where appropriate, reduce our reliance upon animals.
Steven: Can you explain why AMP’s job has become more complex in recent years?
Naomi: The most obvious answer is that groups with anti-animal research agendas have become more involved in the policy and political process. We have needed to become more sophisticated ourselves to meet the challenge.
Also, declining public appreciation of medical progress plays a role. When we were chatting, you mentioned that you were going to reference “spinal cord injury” in your introduction. Nerve regeneration used to be somewhere between science fiction and pure fantasy, but it will be a reality in the near future. This is in part due to the important role that animal research has played in advancing treatments for spinal cord injuries.
Part of AMP’s job is to help the public appreciate the medical miracle involved; the profound accomplishment it represents; the life-changing impact it will have on countless people’s lives….and the vital role played by research using animals.
Steven: What is meant by the 3Rs of animal research—Replacement, Reduction, and Refinement?
Naomi: The 3Rs—Replacement, Reduction, and Refinement—are guiding principles that shape how animal research is conducted worldwide and are embedded in the U.S. oversight frameworks.
- Replacement refers to using non-animal methods whenever scientifically appropriate, including cell-based systems, computer modeling, and other emerging technologies.
- Reduction focuses on designing studies that use the smallest number of animals necessary to generate reliable data.
- Refinement involves improving housing, care, and experimental techniques to minimize discomfort and enhance animal welfare.
These principles are embedded in federal regulations, veterinary standards, accreditation programs, and institutional oversight committees. The 3Rs framework encourages innovation while recognizing that complex biological questions sometimes still require whole-organism models.
Steven: What are NAM’s and how do they relate to the 3 R’s?
Naomi: New Approach Methodologies (NAMs) is an overarching term for any analytic framework that can be used to replace or reduce animal studies with equally valid and relevant data.
One challenge is the lack of a harmonized definition for NAMs. Without a consistent definition, it becomes difficult for regulators, sponsors, and stakeholders to interpret how these methods should be applied and integrated into decision-making.
Steven: What are some of the specific issues with FDA and the use of animals in medical product development?
Naomi: FDA plays a critical role in translating scientific discoveries into approved medical products. Animal studies often provide key information about safety, dosing, and biological effects before therapies move into human trials.
A key challenge is ensuring that evolving policies keep pace with innovation and without undermining evidentiary standards. Recent FDA draft guidance suggests that a NAM “may not need to be fully validated” for regulatory consideration. While flexibility can support innovation, it raises questions about a premature reliance on methods that may not yet be robust or may not yield reproducible results under specific conditions.
Striking the right balance—encouraging new technologies while maintaining rigorous, fit-for-purpose standards—is essential to ensuring safe and effective medical products.
Steven: What are your thoughts on the Administration’s efforts to reduce and replace the use of animals in biomedical research?
Naomi: AMP strongly supports efforts to advance new scientific tools that may reduce or potentially replace animal studies in certain areas. Scientific innovation is essential, and researchers have been developing alternative methods for decades.
For regulators like the FDA, ensuring that new medicines are both safe and effective requires multiple lines of evidence, including animal models. Notably, many biological processes—such as immune responses, neurological function, and complex drug interactions—cannot yet be fully replicated using current technologies. Eliminating animal research entirely before alternatives are fully validated would pose significant risks to medical progress and patient safety.
Steven: What can interested individuals and organizations do to advocate for appropriate and continued use of animals in research?
Naomi: One of the most important steps is staying engaged in the conversation. Policymakers often hear from vocal critics of animal research, but less frequently from the scientists, veterinarians, patients, and research professionals who understand its value. Speak up. And speak up frequently.
Advocates can play an important role in helping the public connect the dots between basic research and medical progress. Too often, breakthroughs are celebrated without recognition of the research—often involving animals—that made them possible. Highlighting real-world examples and patient stories can make that connection clearer, more relatable, and more meaningful.
Steven: Any final thoughts?
Naomi: AMP supports innovation in the use of animals in research while emphasizing that scientific progress requires a thoughtful, evidence-based approach. Our role increasingly involves helping policymakers, regulators, and the public understand how animal research, advanced technologies, and regulatory science fit together to improve human and animal health.
