Today, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Health Resources and Services Administration (HRSA) published a request for information (RFI) seeking stakeholder input on the regulation of deceased donor islets (DDIs), including potential reclassification. We commend HHS for taking this critical first step. Reclassifying DDIs would make transplants more accessible to the community, especially those with complications like hypoglycemia unawareness. In March of this year, Breakthrough T1D submitted a proposal to HHS to reclassify DDIs and has since been engaging with administration officials on the proposed changes. We now encourage the type 1 diabetes (T1D) community to share their stories and input in response to this RFI.
“Broad cures for type 1 diabetes are in sight, but DDI transplants can be a cure for some people right now,” said Breakthrough T1D Chief Global Advocacy Officer Lynn Starr. “Removing barriers to DDI access is a win for the T1D community and our country. We applaud HHS, FDA, and HRSA for seeking input on ways to make deceased donor islets more readily available to those who qualify for them. As we detailed in our proposal, this change can bring swift relief to some while expanding research opportunities that will accelerate the development of scalable cures. We appreciate HHS’s responsiveness to our proposal, and we thank Senators Collins, Shaheen, and Lee, as well as Representatives DeGette and Bilirakis for their efforts to drive this change.”
DDI transplants are a proven therapy which can cure T1D. Currently, DDIs are classified as drugs, creating regulatory obstacles that make the islets largely inaccessible. While DDIs will not be suitable or available for everyone, reclassifying them as organs for the purpose of transplantation will make this treatment more accessible to people who qualify for it.
By issuing an RFI, HHS has shown their commitment to thoughtfully and effectively move the process forward. That is no small task, but it will mean much to the community and provide life-changing relief to those who qualify for transplants.