Sponsors (5)
The bill would accelerate and expand access to cadaveric islet transplants and streamline regulatory pathways while increasing administrative clarity, but it does so by narrowing existing FDA product definitions—raising safety oversight, equity, and fiscal trade-offs.
Patients with severe diabetes would gain greater access to transplantable human cadaveric islets because HHS grant and contract authority would support pancreas/islet procurement and transplantation.
Clarifying that cadaveric islets are not drugs/biologics/HCT/Ps would reduce regulatory barriers and likely speed availability of islet transplants and related research.
Requires HHS to update regulations within one year and report in six months, improving regulatory clarity and administrative accountability for how islet transplantation is implemented.
Removing islets from drug/biologic/HCT/P definitions could weaken FDA oversight of safety and efficacy, potentially increasing health risks for transplant recipients.
Faster access enabled by reduced regulation could result in uneven standards or protections across providers if implementing regulations are insufficiently protective.
Expanding grant eligibility and supporting procurement/transplantation could increase federal spending or require reallocating HHS grant funds from other programs.
Based on analysis of 2 sections of legislative text.
Adds human cadaveric islets to the list of items eligible for federal grants/contracts and requires HHS to update regulations and report progress.
Introduced March 19, 2026 by Ralph Norman · Last progress March 19, 2026
Adds "human cadaveric islets" to the list of tissues and organs eligible for federal grants and contracts for transplantation and research, and instructs the Department of Health and Human Services to revise related regulations and report progress. It also clarifies that these islets are not to be regulated as drugs, biological products, or HCT/Ps under the referenced statutes and regulations.