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ISLET Act

USA118th CongressS-2205| Senate 
| Updated: 6/22/2023
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (3)
Marsha Blackburn (Republican)Rand Paul (Republican)Ted Budd (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jun 22, 2023
Introduced in Senate
Jun 22, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 23, 2023

Latest Companion Bill Action

HR 118-4304
Referred to the Subcommittee on Health.
  • June 22, 2023
    Introduced in Senate


  • June 22, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 23, 2023

    Latest Companion Bill Action

    HR 118-4304
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-4304: ISLET Act
Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDigestive and metabolic diseasesOrgan and tissue donation and transplantation

ISLET Act

USA118th CongressS-2205| Senate 
| Updated: 6/22/2023
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 22, 2023
Introduced in Senate
Jun 22, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 23, 2023

Latest Companion Bill Action

HR 118-4304
Referred to the Subcommittee on Health.
  • June 22, 2023
    Introduced in Senate


  • June 22, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 23, 2023

    Latest Companion Bill Action

    HR 118-4304
    Referred to the Subcommittee on Health.
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (3)
Marsha Blackburn (Republican)Rand Paul (Republican)Ted Budd (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-4304: ISLET Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDigestive and metabolic diseasesOrgan and tissue donation and transplantation