U.S. Rep. Ralph Norman has introduced the House companion to Senate legislation aimed at removing federal regulations that limit access to islet transplantation for Americans with type 1 diabetes.
Based on a release from U.S. Rep. Ralph Norman (SC-05).
WASHINGTON — U.S. Rep. Ralph Norman, R-S.C., introduced the House companion to the Increase Support for Life-saving Endocrine Transplantation (ISLET) Act on March 19, according to the Office of Congressman Ralph Norman. The bill mirrors legislation introduced in the Senate by Sen. Mike Lee, R-Utah, and Sen. Ted Budd, R-N.C.
The ISLET Act would correct what the office described as a longstanding federal misclassification that treats pancreatic islets as drugs rather than organs, a designation the office said has created regulatory barriers to a treatment already widely available in other developed countries.
According to the Office of Congressman Ralph Norman, the legislation would update the Public Health Service Act to classify human cadaveric islets as organs, prohibit the U.S. Department of Health and Human Services from regulating pancreatic islets as drugs under the Food, Drug, and Cosmetic Act, and prevent islets from being regulated as biological products or cellular/tissue-based products. The bill would also require HHS to update federal regulations within one year and report to Congress within six months on implementation progress.
“Americans living with type 1 diabetes deserve access to critical treatments that can improve and even save their lives,” Norman said. “Right now, outdated federal rules are standing in the way of a procedure that is safely performed around the world. America should lead the world in medical innovation, not lag behind because of outdated bureaucracy.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.”
Lee said the bill would fix what he called a bureaucratic mistake in federal law. “Other countries treat islet transplantation as standard care, but a miscategorization in our law regulates islets as drugs rather than organs,” Lee said. “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.”
Budd said he was proud to co-lead the Senate legislation alongside Lee. “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,” Budd said.
According to the Office of Congressman Ralph Norman, the legislation has received support from the Islets for US Collaborative, The Cure Alliance and the Diabetes Research Institute Foundation.
