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WASHINGTON — Today, Congressman Norman (R-SC) introduced the House companion to Senator Mike Lee (R-UT) and Senator Ted Budd’s (R-NC) Increase Support for Life-saving Endocrine Transplantation (ISLET) Act, legislation aimed at removing outdated federal regulations that currently prevent many Americans with type 1 diabetes from accessing life-saving islet transplantation.

The ISLET Act corrects a longstanding federal misclassification that treats pancreatic islets as drugs rather than organs. This bureaucratic designation has created unnecessary regulatory barriers to patient access to a treatment already widely available in other developed countries.

“Americans living with type 1 diabetes deserve access to critical treatments that can improve and even save their lives,” said Congressman Norman. “Right now, outdated federal rules are standing in the way of a procedure that is safely performed around the world. America should lead the world in medical innovation, not lag behind because of outdated bureaucracy. The ISLET Act cuts through red tape, enabling doctors to provide a procedure already used safely around the world and to continue advancing treatments that could one day cure diabetes.”

The ISLET Act would:

• Update the Public Health Service Act to classify human cadaveric islets as organs,
• Prohibit HHS from regulating pancreatic islets as drugs under the Food, Drug, and Cosmetic Act,
• Prevent islets from being regulated as biological products or cellular/tissue-based products,
• Require HHS to update federal regulations within one year, and
• Direct HHS to report to Congress within six months on implementation progress.

By aligning U.S. policy with international standards, the legislation would provide access to life-saving treatment options for Americans living with diabetes, while simultaneously supporting continued and needed innovation in transplant medicine.

The legislation mirrors the Senate version introduced by Senator Mike Lee (R-UT) and Senator Ted Budd (R-NC), and has received support from organizations including the 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 islets as drugs rather than organs. The ISLET Act fixes this bureaucratic mess to bring America up to speed and make critical care available to those with type 1 diabetes. Thank you to Congressman Norman for his work to bring this crucial bill to the House.”

“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 co-lead this important legislation in the Senate alongside Senator Lee, and I am grateful for Rep. Norman’s leadership in the House to place islets under a less strict regulatory framework to expand access to proven treatment methods for type 1 diabetes.”

Read the bill text HERE.