H.R. 4304 · 118th Congress
ISLET Act
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
RosendaleSponsor4 cosponsors · 4 R
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act
What it does: CRS summary · Introduced in House · Jun 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: ISLET Act
Also known as: Increase Support for Life-saving Endocrine Transplantation Act
Latest action (Jun 23, 2023): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 22, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.