Shaheen, Collins Urge FDA To Expand Access to Islet Cell Transplantation to Better Address Health Needs of Millions with Type 1 Diabetes

(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), Co-Chairs of the Senate Diabetes Caucus and leaders of the bipartisan INSULIN Act to cap monthly insulin costs at $35 a month, are urging Acting Commissioner of the Food and Drug Administration (FDA) Kyle Diamantas to improve access to deceased donor islet cell transplantation for certain individuals living with Type 1 Diabetes. For many, deceased donor islet cell transplantation can be life changing. Yet, despite rigorous scientific research showing the efficacy of deceased donor islet transplantation and FDA approval of a deceased donor islet product in 2023, patient access remains extremely limited, suggesting the current regulation is stifling availability for those who could most benefit. The Senators wrote, in part: “With the goal of better addressing the health needs of people with diabetes, we write to request that the Food and Drug Administration (FDA) take administrative action to improve access to deceased donor islet cell transplantation for certain individuals living with Type 1 diabetes (T1D). Recent scientific and clinical efforts have brought the medical field closer to potentially curative therapies for certain eligible patients. Some existing regulatory classifications, however, continue to limit patient access to islet cell transplantation, which holds promise as a treatment option that is both safe and effective for some individuals.” They continued: “Patient access to deceased donor islet cell transplantation has remained extremely limited, despite FDA approval of a deceased donor islet cell product in 2023. The lack of access suggests the current regulatory pathway is not functioning in a way that supports broad, practical availability of this therapy for the patients most likely to benefit.” The Senators concluded: “Approximately 1.6 million Americans are living with T1D, and many could benefit from increased access to deceased donor islet cell transplantation. We appreciate your attention to this issue and your leadership in advancing policies that improve outcomes for people living with chronic diseases. We would welcome your partnership on developing a pathway as swiftly as possible that provides effective oversight, expands access for eligible patients, and supports continued innovation in the search for cures and better treatments for T1D.” A copy of the full letter can be read HERE. Throughout her decades-long career in the Senate, Shaheen has long-championed improving access to medication and treatment for those with diabetes. As Co-Chairs of the Senate Diabetes Caucus, Senators Shaheen and Collins lead the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act to cap the monthly out-of-pocket cost of insulin at $35 for Americans on private and employer-sponsored insurance and create a pilot program to provide insulin at the same cost to Americans without insurance. With 13 Republican cosponsors, the INSULIN Act has the broad, bipartisan support needed to pass on the Senate floor. ###