ISLET Act

Bill: 118-s-2205
Sponsor: full_name: Sen. Lee, Mike [R-UT]
Introduced: 2023-06-22
Policy area: Health
Subjects: Administrative law and regulatory procedures

Congressional oversight

Department of Health and Human Services

Digestive and metabolic diseases

Organ and tissue donation and transplantation
Latest action: action_date: 2023-06-22
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-06-22
action_desc: Introduced in Senate
text: <p><strong>Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act</strong></p><p>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.)</p><p>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.</p><p>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.)</p><p>Specifically, the bill defines human cadaveric islets as organs and excludes them from definitions related to the regulation of drugs and biological products.</p>

tv_txt: II 118th CONGRESS 1st Session S. 2205 IN THE SENATE OF THE UNITED STATES June 22, 2023 Mr. Lee (for himself, Mr. Budd , and Mrs. Blackburn ) 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.

1. Short title This Act may be cited as the Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act . 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).