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To regulate human cadaveric islets for transplantation as organs.
Summary
The ISLET Act regulates human cadaveric islets for transplantation by adding them to the list of organs covered under federal organ transplant law. The bill clarifies that human cadaveric islets are not to be classified as drugs, biological products, or tissue-based products under existing federal definitions. The Secretary of Health and Human Services must update relevant regulations within one year to implement these changes and must report to Congress on regulatory progress within six months.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Lee, Mike [R-UT] (R-UT)
3 cosponsors
- Sen. Budd, Ted [R-NC] (R-NC)
- Sen. McCormick, David [R-PA] (R-PA)
- Sen. Tuberville, Tommy [R-AL] (R-AL)
Actions (2)
- Nov 5, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Nov 5, 2025 Introduced in Senate
Similar bills (6)
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Full text
IN THE SENATE OF THE UNITED STATES
November 5, 2025
Mr. Lee (for himself and Mr. Budd) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
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). <all>
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