Bill Summary
The "Increase Support for Life-saving Endocrine Transplantation Act" (ISLET Act) is a legislative proposal aimed at regulating human cadaveric islets for transplantation. The Act amends the Public Health Service Act to explicitly include human cadaveric islets alongside pancreas transplants. It clarifies that human cadaveric islets do not fall under the definitions of drugs, biological products, or human cells and tissues as defined in existing laws, thereby establishing a distinct regulatory category for them.
Furthermore, the Act mandates the Secretary of Health and Human Services to update relevant regulations to implement these changes within one year of enactment. Additionally, the Secretary is required to report to Congress on the progress of these regulatory updates within six months. The overall goal of the ISLET Act is to enhance the regulatory framework surrounding islet transplantation, potentially improving access and outcomes for patients needing such life-saving procedures.
Possible Impacts
Here are three examples of how the "Increase Support for Life-saving Endocrine Transplantation Act" (the "ISLET Act") could affect people:
1. **Increased Availability of Islet Transplantation**: By regulating human cadaveric islets as transplantable organs, the ISLET Act could lead to increased research and development in islet transplantation techniques. This may result in more transplant centers being established, greater availability of islet transplants for patients with diabetes, and improved outcomes for those in need of these life-saving procedures. Patients may experience better management of their diabetes, reduced dependence on insulin, and an overall enhancement in their quality of life.
2. **Enhanced Regulatory Oversight**: The act mandates the Secretary of Health and Human Services to update existing regulations related to human cadaveric islets. This could ensure that safety and efficacy standards are clearly defined and followed, creating a more secure and regulated environment for both donors and recipients. Individuals considering islet transplantation may feel more confident in the process, knowing that rigorous standards are in place, thereby potentially increasing public trust in transplantation practices.
3. **Impact on Organ Donation Programs**: By explicitly including human cadaveric islets in the regulatory framework for organ transplantation, the ISLET Act may encourage more people to consider becoming organ donors. As awareness of the potential benefits of islet transplants grows, it could lead to a boost in organ donation rates, thereby providing more opportunities for patients in need. This could help address the organ shortage crisis and save more lives, as more individuals could benefit from receiving islet transplants.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8018 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 8018
To regulate human cadaveric islets for transplantation as organs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 19, 2026
Mr. Norman (for himself and Mr. Bacon) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To regulate human cadaveric islets for transplantation as organs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Increase Support for Life-saving
Endocrine Transplantation Act'' or the ``ISLET Act''.
SEC. 2. REGULATION OF HUMAN CADAVERIC ISLET TRANSPLANTS.
(a) In General.--Section 374(d)(2) of the Public Health Service Act
(42 U.S.C. 274b(d)(2)) is amended by striking ``pancreas,'' and
inserting ``and pancreas, human cadaveric islets,''.
(b) Clarification.--Notwithstanding any other provision of law,
none of the following terms includes human cadaveric islets:
(1) The term ``drug'', as defined in section 201(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).
(2) The term ``biological product'', as defined in section
351(i) of the Public Health Service Act (42 U.S.C. 262(i)).
(3) The term ``human cells, tissues, or cellular or tissue-
based products (HCT/Ps)'', as defined in section 1271.3 of
title 21, Code of Federal Regulations (or any successor
regulations).
(c) Regulations.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall update regulations promulgated under parts F, G, and H of
title III of the Public Health Service Act (42 U.S.C. 262 et
seq., 264 et seq., 273 et seq.) and the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), and such other
regulations as the Secretary determines appropriate, to carry
out the amendment made by subsection (a).
(2) Report.--Not later than 6 months after the date of
enactment of this Act, the Secretary shall report to Congress
on the progress made in updating regulations as required under
paragraph (1).
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