U.S. Senator Mike Lee (R-UT) has introduced the Increase Support for Life-saving Endocrine Transplantation (ISLET) Act, a bill aimed at changing how islet transplants are regulated in the United States. The legislation seeks to address what its sponsors describe as an outdated classification that treats islets—clusters of cells from the pancreas used in transplants for people with Type 1 diabetes—as drugs rather than organs.
Senator Lee said, “Americans living with diabetes have been kept from life-saving research by nonsensical red tape from the federal government. Other countries treat islet transplantation as standard care, but a miscategorization in our law regulates islet as drugs rather than organs. My ISLET ACT fixes this bureaucratic mess to bring America up to speed and make critical care available to those with Type 1 diabetes.”
The bill is co-sponsored by Senator Ted Budd (R-NC). He stated, “As the U.S. continues to lead the world in modern medicine, we should expand patient access to effective therapies rather than overregulating treatments. I am proud to introduce this important legislation alongside Senator Lee to place islets under a less strict regulatory framework to expand access to proven treatment methods for Type 1 Diabetes.”
Supporters of the bill include several organizations and medical professionals. Piotr Witkowski, M.D., Ph.D., Director of the Pancreatic Islet and Pancreas Transplantation Program at Islets for US Collaborative, said, “This long-awaited legislation brings hope to patients with Type 1 diabetes across the United States. It will make a life-saving procedure accessible for those in desperate need, while also enabling further progress in the field and advancing the pursuit of a cure for diabetes. I wholeheartedly support the Islet Act on behalf of the Islets for US Collaborative representing scientific and medical leaders in the field from leading US academic institutions.”
Camillo Ricordi, MD, FNAI of The Cure Alliance added, “It is with the highest level of enthusiasm that I endorse the ISLET Act. Finally, Americans with diabetes will be able to benefit from islet transplantation, a treatment that has already been approved, available and reimbursable around the world. We now have a chance to join the rest of the developed world, where islet transplants are regulated similarly to organ transplants, making the treatment available also in the U.S. while further contributing to advancing the field worldwide.”
The ISLET Act proposes several changes:
– It would update federal law so that human cadaveric islets are included under organ definitions within existing health statutes.
– It would authorize agencies such as HRSA and OPTN to regulate these transplants as organs.
– The Department of Health and Human Services (HHS) would be prohibited from regulating pancreatic islets as drugs or biological products.
– HHS would be required to update relevant regulations within one year if enacted.
– A report on implementation progress would be due within six months after enactment.
