Washington, D.C. — The Cure Coalition submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding its draft guidance for industry, “General Considerations for the Use of New Approach Methodologies in Drug Development” (Docket No. FDA-2025-D-6131). This guidance outlines how new lab methods are used in place of traditional animal studies to accelerate the safety testing of new medicines by drug companies.
As a coalition of families, patients, and health advocates, The Cure Coalition believes American families should never be forced to choose between innovation and safety, or between medical progress and ethical standards. Our comments urge the FDA to adopt a measured approach to implementing modern research tools, ensuring that patient safety, ethical research, and U.S. medical independence remain at the center of every decision.
Key highlights from the coalition’s comments include:
Patient Safety Must Remain the Non-Negotiable Standard
We support the FDA’s efforts to modernize drug development and reduce unnecessary animal use, but we maintain that new methods should only replace existing protocols when they have been rigorously proven to protect patients. While unvalidated “new approach methodologies” (NAMs) can provide supplemental information, they should not substitute for trusted safety tests until their performance is clearly demonstrated.
Unproven Tests Should Supplement, Not Replace, Proven Safety Tools
The draft guidance says a NAM “does not necessarily need to be validated” to be considered, which risks creating a false impression that unproven tools are interchangeable with established safety studies. We recommend that the FDA clearly require sponsors to flag all unvalidated methods, transparently explain the uncertainty they introduce, and demonstrate how they are being used alongside validated tests in a weight-of-evidence approach.
Not All Animal Studies Are the Same — and Some Remain Critical
Our comments explain that “animal testing” is not a single, uniform practice; different species and study designs answer distinct safety questions and possess vastly different track records in predicting human outcomes. We urge the FDA to compare NAMs to specific animal models and endpoints directly, ensuring that highly predictive studies are not prematurely discarded along with less reliable ones.
NAMs Are on a Spectrum of Readiness
Some NAMs — such as certain skin sensitization approaches — already possess strong validation and clear performance benchmarks, while others, including complex organ-on-a-chip systems, remain in the early stages of development. We recommend that the FDA adopt a tiered framework that applies stricter evidentiary standards to less mature methods, while providing a clearer pathway for well-validated tools.
Whole‑Body and Long‑Term Safety Risks Must Not Be Overlooked
Many serious problems, including reproductive and developmental harms, long-term organ damage, immune reactions, and central nervous system effects, often only emerge when the whole body is studied over time. We urge the FDA to acknowledge that current NAMs cannot yet replicate these system-level risks and to affirm that validated animal models remain the primary evidence source where no proven NAM alternative exists.
Stronger Safeguards for Vulnerable Patients
The draft fails to adequately address the heightened risk for children, pregnant individuals, older adults, and people with complex health conditions — the very area NAMs are least mature. We urge the FDA to apply higher scrutiny before allowing NAMs to replace traditional studies for these highly vulnerable populations and to maintain validated animal models as the default for developmental, reproductive, and pediatric safety until new tools are specifically validated for those uses.
Focus on the Whole Safety Package, Not Just Single Tests
Regulators approve a comprehensive nonclinical program, not isolated experiments. We recommend that the FDA give sponsors clearer direction on how to construct complete safety packages that combine NAMs, animal studies, and computational models into a cohesive narrative that provides adequate confidence to move into human trials.
Avoid Weakening U.S. Leadership and Exporting Risk Overseas
Our comments also highlight the profound global impact of these decisions. If U.S. safety standards shift faster than validated science supports, companies may move critical early-stage testing to countries with lower expectations, fragmenting safety data and weakening America’s research base. We urge the FDA to align the pace of NAM adoption with the maturity of the science so the United States can retain its position as the global leader in safe, ethical medical innovation.
We look forward to engaging in continued dialogue with the FDA, the scientific community, and fellow advocates to build a future where all American families can trust the safety and effectiveness of innovative medical tools anchored by U.S. gold-standard research.
About Cure Coalition
Cure Coalition advocates for responsible, evidence-based biomedical research that keeps our families safe and keeps trusted U.S. research approaches as the standard. As mothers, healthcare professionals, and concerned citizens, we’re committed to advancing treatments and cures through medicines Americans can count on. Learn more at curecoalition.org.