WASHINGTON - Sens. Mike Lee (R-UT), Ted Budd (R-NC), and Marsha Blackburn (R-TN) introduced a bill aimed at empowering patients and improving the outdated regulation of islet transplantation, a cutting-edge treatment for individuals with Type 1 Diabetes. Rep. Matt Rosendale (R-MT) introduced a companion bill in the House of Representatives. Focused on patient-centered care, this effort would move islets to a more appropriate regulatory framework.

Islets, vital micro-organs in the pancreas responsible for insulin production, are essential for individuals' well-being. However, those with Type 1 Diabetes face a daily struggle as their islets fail to function properly, necessitating insulin injections. Islet transplantation presents a transformative solution by utilizing islets from deceased donors to restore natural insulin production, potentially liberating patients from constant insulin administration.

Unfortunately, the current regulatory framework classifies islets as drugs, hindering progress and limiting access to this life-changing procedure. While other nations recognize islets as organs, establishing islet transplantation as the standard of care, the United States lags behind with outdated regulations.

Of the bill, Sen Lee said, “This bill holds tremendous potential for those living with this chronic condition, offering the possibility of reducing or eliminating the need for injected insulin. By redefining islets as organs rather than drugs, we aim to align the regulatory framework with the scientific advancements in the field. This will promote innovation, enhance patient access to islet transplantation, and potentially improve outcomes and quality of life for individuals with Type 1 Diabetes. It is time for Congress to act and address the regulatory mismatch that currently hinders progress in islet transplantation. By granting regulatory authority to the appropriate agencies and prohibiting the classification of islets as drugs, we can unlock the full potential of this life-changing procedure.”

Of the bill, Piotr Witkowski MD, Ph.D., Professor of Surgery, University of Chicago, said,  “The ISLET Act is extremely important for our patients with type 1 diabetes and is long overdue. It will allow us to treat the most vulnerable patients with a life-threatening form of diabetes and develop novel therapies to cure the disease. If passed, Americans, like diabetic patients in other countries, will finally have open access to islet transplantation procedures and the chance to experience a new life, one without insulin, constant blood sugar swings, and fear of sudden death. The ISLET Act is the result of several years of joint efforts of leaders and experts in the field of transplantation and diabetes from top academic instruction in the US calling for years for this regulatory update.”

Of the bill, Camillo Ricordi, Founding President and Treasurer of The Cure Alliance said, “On behalf of the entire board of The Cure Alliance, it is with the highest degree of enthusiasm that we support, without any reservation, this initiative that may allow for US patients with diabetes to benefit from islet transplantation, like it is already happening in most of the rest of the world.”

Of the bill, Peter Stock, MD, PhD, Professor of Surgery, University of California, San Francisco said, “I strongly support the Increase Support for Life-saving Endocrine Transplantation (ISLET) Act. If enacted, this bill will put the US on par with the rest of the world, and facilitate research and clinical application of islet transplantation for the treatment of diabetes mellitus.”

Of the bill, Whitney Rimmer, an ISLET transplant recipient, said, "The Increase Support for Life-saving Endocrine Transplantation (ISLET) Act would be an answered prayer for so many with diabetes. I know, because I was a brittle type 1 diabetic for 32 years and recently received an islet cell transplant that has allowed me to be insulin independent. This has allowed me to really live again, not just survive, and to be present for my children, family and friends."