Biologics

Expand Some Islet Cell Transplantation Access: Senators

Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME), co-chairs of the Senate Diabetes Caucus, are calling on FDA to improve access to deceased donor islet cell transplantation for certain individuals with Type 1 diabetes (T1D). In a letter to FDA acting commissioner Kyle Diamantas, the senators say that while recent scientific and clinical efforts have brought the medical field closer to potentially curative therapies for certain eligible patients, some existing regulatory classifications continue to limit patient access to islet cell transplantation, which they say holds promise as a treatment option that is both safe and effective for some individuals.

“We ask FDA to reconsider the regulatory pathway for transplantation of deceased donor islet cells and regulate them as organs rather than biologics,” Shaheen and Collins write. “With appropriate quality and safety controls in place, a targeted regulatory modernization could better align oversight with the biological nature of these cells, expand access for eligible patients, and preserve rigorous standards for safety and accountability.”

The senators say they recognize that deceased donor islet cell transplantation is not indicated for the majority of individuals with T1D but it can be life-changing for people with particularly severe and uncontrolled T1D.

“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 letter says. “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. While it is critical to oversee manufactured cell therapies and any deceased donor islet products that undergo further modification through the biological products pathway, targeted and sensible reforms to current regulations and practices could improve short-term access to deceased donor islet cells for the subset of individuals with T1D for whom transplantation is indicated.”

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