118th Congress Health
H.R. 4304: ISLET Act
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.
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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 Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Don Bacon R-NEOriginal
- Marjorie Greene R-GAOriginal
- Stephanie Bice R-OK
- Christopher Smith R-NJ
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Other bills by Matthew Rosendale
History
- Introduced in the House by Matthew Rosendale.
Show the full action history (3 actions)
- Referred to the Subcommittee on Health.
- Introduced in House
- Referred to the House Committee on Energy and Commerce.