Senators Collins, Shaheen Urge FDA to Expand Access to Islet Cell Transplantation for Individuals with Type 1 Diabetes

WASHINGTON, D.C. - U.S. Senators Susan Collins and Jeanne Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus and lead sponsors of the bipartisan INSULIN Act, are urging Acting Commissioner of the Food and Drug Administration (FDA) Kyle Diamantas to improve access to donor islet cell transplantation for certain individuals living with Type 1 Diabetes.

For many patients, donor islet cell transplantation can be life changing. Yet, despite rigorous scientific research showing the efficacy of the procedure and FDA approval of a donor islet product in 2023, patient access remains extremely limited, suggesting the current regulation is stifling availability for those who could most benefit.

"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)," Senators Collins and Shaheen wrote. "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."

"Patient access to deceased donor islet cell transplantation has remained extremely limited, despite FDA approval of a deceased donor islet cell product in 2023," they continued. "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."

"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," Senators Collins and Shaheen concluded.

Click here to read the complete text of the letter.

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As co-chairs of the Senate Diabetes Caucus, Senators Collins and Shaheen have led efforts in the Senate to advance legislation that will lower the cost of insulin, invest in treatment and early detection, and prioritize diabetes research. They recently led the introduction of the bipartisan INSULIN Act to cap the monthly out-of-pocket cost of insulin at $35 per month for Americans with private insurance and create a pilot program for uninsured patients. The bipartisan proposal enjoys wide and growing support in Congress, with 26 senators now backing the bill.

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