Sponsors (7)
The bill seeks to expand and accelerate access to islet transplants and related research by removing certain regulatory classifications and enabling HHS funding, trading stronger FDA oversight and potential uniform safety protections for faster availability and increased federal support.
Patients with severe diabetes and transplant centers: increased access to transplantable human cadaveric islets because HHS may fund pancreas/islet procurement and transplantation through grants/contracts.
Scientists, researchers, and patients: clarifying that islets are not drugs/biologics/HCT/Ps and requiring HHS to update regulations and report improves regulatory clarity and administrative accountability.
Researchers and patients: reducing certain regulatory barriers may speed clinical research and the availability of islet transplants.
Patients and transplant centers: removing islets from drug/biologic/HCT/P definitions may weaken FDA oversight of safety and efficacy, increasing patient risk.
Patients and hospitals: faster availability under reduced oversight could produce uneven safety and quality standards across providers if implementing regulations are insufficient.
Taxpayers: expanding eligibility for HHS grants/contracts to support islet procurement and transplantation could increase federal spending or require reallocating existing funds.
Based on analysis of 2 sections of legislative text.
Adds human cadaveric islets to grant/contract eligibility and directs HHS to exclude them from drug/biologic/HCT/P classification and update regulations within one year.
Official title: To regulate human cadaveric islets for transplantation as organs.
Introduced March 19, 2026 by Ralph Norman · Last progress March 19, 2026
Adds human cadaveric islets to the list of items eligible for grants and contracts under existing public health transplantation authorities and directs HHS to update related regulations. The bill also specifies that human cadaveric islets should not be treated as drugs, biological products, or HCT/Ps under specified federal definitions, and requires HHS to revise implementing regulations within one year and report progress to Congress within six months.