What Is the Islet Cell Act? A Guide to Proposed Changes in Transplant Regulation

Pancreatic islets are insulin-producing cells from a donor's pancreas. When transplanted into a person with Type 1 diabetes, these cells can help regulate blood sugar, and in some cases, may reduce or eliminate the need for insulin injections.

Today, the FDA regulates donated islets as biological products—similar to how it oversees medications. This means they must meet strict standards for manufacturing safety, purity, identity, and potency before they can be used in transplants. Some supporters of regulatory change argue this approach has unintended consequences.

In June 2023, the FDA granted a private company exclusive distribution rights for islet transplants under the brand name Lantidra. Some in the diabetes community and among lawmakers have raised concerns that treating a human-derived transplant as a conventional drug may create challenges: fewer competitors, higher costs, and potentially reduced access for patients who might benefit.

The strict drug-like approval process, while designed to ensure safety, can affect how quickly islet transplants become available and limit how many reach patients who need them.

The Islet Cell Act, first introduced in June 2023 and reintroduced in Congress in November 2025, proposes a different approach. The bill would reclassify pancreatic islets as organs rather than drugs, shifting regulatory oversight from the FDA to the Health Resources and Services Administration (HRSA)—the same system that manages other organ transplants like hearts and kidneys.

Under this framework, islet transplants would follow organ transplant rules instead of pharmaceutical approval rules. Proponents believe this change could simplify the pathway to transplant, reduce regulatory barriers, and potentially increase patient access.

Islet transplantation research continues to advance. Recent trials have reported that some recipients have achieved insulin independence—meaning they no longer require insulin injections to manage their blood sugar. These outcomes show the real potential of the procedure and have renewed focus on making it more widely available.

The Islet Cell Act remains under consideration in Congress. Its passage would represent a significant shift in how this treatment is regulated and distributed in the United States.

Source: YouTube community video. Evidence type: Community video — lay discussion, not peer-reviewed research. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.