ISLET Act

1/3
Status In Committee
Sponsor Mike Lee
Citation 118-S-2205
Actions 2
Introduced Jun 22nd, 2023
Cosponsors
3
Last Action Jun 22nd, 2023
Policy Area
Introduced Senate Jun 22
Senate
House
President
Enacted

Summary

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What this bill does

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Increase Support for Life-saving Endocrine Transplantation Act or the ISLET ActThis 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.

Actions

2
Senate
INTRODUCED
INTRODUCED
Jun 22, 2023
ON FLOOR
REFERRED TO COMMITTEE
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