WASHINGTON, D.C. — The Cure Coalition today urged caution around the U.S. Food and Drug Administration’s (FDA) new draft guidance, “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products,” warning that the shift of cancer drug development further from proven safety models could put American families at stark and growing risk from inadequately tested treatments.
While the Coalition shares the goal of faster, more humane drug development, it cautioned that good intentions cannot substitute for proven science. The coalition believes pushing critical research overseas to countries like China or rushing development and approval of unproven methods could leave American patients, including children, as the first real test of a treatment’s safety.
“We all want faster cures and less reliance on animal testing, but you cannot regulate away the science,” said Cara Kingan, Executive Director of Cure Coalition. “Every time we step away from proven safety models like animal research before alternatives are ready, the work meant to protect patients simply moves overseas. In countries like China, with less rigorous research standards and animal care, Americans lose oversight, and animals lose ethical treatment. Neither is acceptable.”
The draft guidance recommends that, for certain well-defined classes of cancer therapies, including PD-(L)1 antibodies, CD3 bispecific T-cell engagers, and some antibody-drug conjugates, sponsors may replace longer animal studies with a weight-of-evidence risk assessment, a single-species study, or rodent-only studies. The Coalition’s concern is less about this single proposal than the trajectory it accelerates: a steady move away from the validated models that have protected patients for decades.
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.