ISLET Act

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. 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

1. 22 June 2023

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 22 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

3. 22 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 23 June 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 22 June 2023 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 22 June 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 22 June 2023

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 22 June 2023

  Open at official source

Sponsors

• Matthew Rosendale · R · Sponsor
• Don Bacon · R · Sponsor
• Marjorie Greene · R · Sponsor
• Stephanie Bice · R · Cosponsor
• Christopher Smith · R · Cosponsor
• · hsif00 · Standing

Related records

• related to → ISLET Act