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Rep. Rosendale Introduces Islet Transplantation Bill

WASHINGTON, D.C. - Congressman Matt Rosendale (MT-02) introduced the Increase Support for Life-saving Endocrine Transplantation Act or ISLET Act to improve outdated regulation of islet transplants for patients with Type 1 Diabetes.

Islets are micro-organs found in the pancreas that secrete hormones like insulin, which those with Type 1 Diabetes cannot produce on their own. Islet transplantation is the process by which islets are taken from deceased donors and given to diabetes patients to help them produce insulin inside their own bodies. However, current regulations are limiting access to this cutting-edge procedure.

“Islet transplants have the potential to revolutionize care for those with Type 1 Diabetes, but existing regulations make it unnecessarily difficult to take advantage of this possibly life-altering procedure,” said Rep. Rosendale. “Our legislation will move islets to the proper regulatory framework, making transplants easier to access and more affordable. Patients and their doctors must have the latitude to find the most effective treatments.”

“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,” said Piotr Witkowski MD, Ph.D., Professor of Surgery, University of Chicago.

“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,” said Camillo Ricordi, Founding President and Treasurer of The Cure Alliance.

“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,” said Peter Stock, MD, Ph.D., Professor of Surgery, University of California, San Francisco.

Under current regulations, islets are recognized as drugs by the FDA, which requires each dose to be identical. But islets from deceased donors are by nature always different. The result is that islets do not meet the standard of care and are not broadly available to Americans with Type 1 Diabetes. The ISLET Act would update the definition of the word “organ” to include islets and require HRSA and OPTN to regulate islets as organs. This crucial legislation will allow Americans living with Type 1 Diabetes better access to this potentially life-altering procedure. Sen. Mike Lee introduced a companion bill in the Senate along with Sen. Ted Budd and Sen. Marsha Blackburn.

Read the full bill text here.