Sponsors (6)
The bill aims to expand and speed access to islet transplants and related research through funding and regulatory clarification, trading off increased patient access and administrative clarity against potential reductions in FDA oversight, uneven implementation risks, and modest federal costs.
Patients with severe diabetes could gain greater access to transplantable human cadaveric islets because HHS grants and contracts would support increased procurement and transplantation.
Patients and researchers could see faster availability of islet transplants and related research because the bill clarifies that islets are not drugs/biologics/HCT/Ps, reducing regulatory barriers.
Hospitals and researchers gain clearer regulatory expectations and more administrative accountability because HHS must update regulations within one year and report progress in six months.
Patients could face increased safety and efficacy risks if removing islets from drug/biologic/HCT/P definitions weakens FDA oversight of transplantation practices.
Faster access resulting from reduced regulation could produce uneven standards and variable protections across providers, potentially disadvantaging some patients.
Expanding grant eligibility and supporting procurement/transplant programs could increase federal spending or require reallocating existing HHS funds, affecting taxpayers and other programs.
Based on analysis of 2 sections of legislative text.
Adds human cadaveric islets to items eligible for federal grants/contracts and directs HHS to update regulations and report within set deadlines.
Adds human cadaveric islets to the list of items eligible for federal grants and contracts under the Public Health Service Act and clarifies that those islets are not to be regulated as drugs, biological products, or HCT/Ps. Requires HHS to revise related regulations within one year and to report to Congress on regulatory-update progress within six months of enactment.
Official title: To regulate human cadaveric islets for transplantation as organs.
Introduced March 19, 2026 by Ralph Norman · Last progress March 19, 2026