Global Liver Institute Leads Efforts in Urging FDA to Recognize Patient-Defined Progress in Drug Development
(Washington, D.C. June 24, 2025) – At the Global Liver Institute, we believe that it all starts with a patient because only they define what progress means to their lives. By elevating their lived experiences, we ensure that science, policy, and care move in the direction that matters most: toward earlier answers, more options, and a better standard of care.
Today, alongside fellow patient advocacy groups, we submitted patient experience insights to the FDA under the 21st Century Cures Act. Our message is clear: therapies that can prevent disease progression before transplant becomes the only option are urgently needed. From early diagnosis to stabilizing treatments, patients’ voices highlight what truly matters: fewer hospitalizations, more active days with family, and hope for the future.
We urge the FDA to recognize that halting or slowing damage—not just curing it—is a meaningful and lifesaving outcome. These lived experiences call for earlier access to treatments, shorter clinical trials, and greater regulatory flexibility to realize the patient-centered vision the Cures Act was designed to fulfill.
Together, our voices are stronger. We call for deeper collaboration with the FDA to ensure these perspectives are not only heard but acted upon. A unified voice not only reinforces the urgency of our message but also demonstrates the strength and solidarity of the rare liver and lung disease community. Help us share this message across all of our channels and read our joint statement below.
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI holds Platinum Transparency with Candid/GuideStar, is a member of the National Health Council, and serves as a Healthy People 2030 Champion. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube or visit www.globalliver.org.