Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act
This bill removes pancreatic islets that are donated from human cadavers from regulation as a drug or biological product by the Food and Drug Administration (FDA). (Islets are groups of cells, including those that make insulin, in the pancreas, and islet transplantation is an experimental treatment for certain conditions, such as type 1 diabetes.)
Current FDA guidance treats pancreatic islets as a biological product, which makes them subject to the biological license application process and related standards for manufacturing practices, safety, identity, purity, and potency.
The bill, instead, treats human cadaveric islets as organs, which makes them subject to the regulatory framework that governs the allocation, safety, and efficacy of organ donation and transplantation. That framework, developed by the Health Resources and Services Administration, is carried out by contract through the Organ Procurement and Transplantation Network. (The network is a public-private partnership that links the professionals involved in the U.S. donation and transplantation system.)
Specifically, the bill defines human cadaveric islets as organs and excludes them from definitions related to the regulation of drugs and biological products.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4304 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 4304
To regulate human cadaveric islets for transplantation as organs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 22, 2023
Mr. Rosendale (for himself, Mr. Bacon, and Ms. Greene of Georgia)
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).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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