WASHINGTON – U.S. Senator Mike Lee (R-UT) introduced legislation today to cut nonsensical bureaucratic red tape preventing life-saving islet transplants for diabetic Americans. The Increase Support for Life-saving Endocrine Transplantation (ISLET) Act corrects a miscategorization of islets as drugs rather than organs – cutting through unnecessary regulations keeping critical surgeries out of reach. The legislation is sponsored by U.S. Senator Ted Budd (R-NC) and endorsed by Islets for US Collaborative, The Cure Alliance, and the Diabetes Research Institute Foundation.

“Americans living with diabetes have been kept from life-saving research by nonsensical red tape from the federal government,” said Senator Mike Lee. “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.”

“As the U.S. continues to lead the world in modern medicine, we should expand patient access to effective therapies rather than overregulating treatments,” said Senator Ted Budd. “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,” 

“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 of behalf of the Islets for US Collaborative representing scientific and medical leaders in the field from the leading US academic institutions.” – Piotr Witkowski, M.D. Ph.D, Director, Pancreatic Islet and Pancreas Transplantation Program, Islets for US Collaborative

“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.” – Camillo Ricordi, MD, FNAI, The Cure Alliance

The ISLET Act:

• Updates the current definition of organ in the Public Health Service Act (PHSA) to include “human cadaveric islets.” This would authorize HRSA and OPTN to regulate islets as organs. 
• Prohibits HHS from regulating pancreatic islets as drugs under the Food Drug & Cosmetic Act (FDCA).
• Prohibits HHS from regulating pancreatic islets as biological products or Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) under the Public Health Service Act (PHSA).
• Requires the Secretary of HHS to update all regulations within a year of enactment to reflect the previously mentioned changes.
• Requires the Secretary of HHS to submit a report to Congress on its progress within 6 months of the date of enactment.