

Reclassify Pancreatic Islets as Organs & Expand Access to Life-Changing Treatment for T1D
The Issue
Type 1 diabetes has shaped my family's life across multiple generations. In 2017 it again impacted our family with my son's diagnosis.
Every parent of a child with Type 1 diabetes dreams of the day their child doesn't have to count every carb, calculate every insulin dose, or wake up to alarms in the middle of the night.
I'm one of those parents.
Like millions of families, we've learned to live with Type 1 diabetes. We celebrate the advances in insulin pumps and continuous glucose monitors, but they don't cure the disease. They simply help manage it.
Today, there is another option for some people with Type 1 diabetes: transplanting insulin-producing islet cells from deceased organ donors. These transplants have helped people regain natural insulin production and, in recent cases, live without insulin injections.
So why aren't more people benefiting?
One major reason is that in the United States, pancreatic islets are regulated as drugs instead of organs. That outdated policy creates unnecessary barriers to research, clinical trials, and patient access.
There is growing bipartisan recognition that this should change. U.S. Senator Mike Lee, sponsor of the ISLET Act, has publicly supported reclassifying donated pancreatic islets as organs rather than drugs. The Congressional Diabetes Caucus sent a letter to the U.S. Food and Drug Administration noting Breakthrough T1D's HHS proposal and urging the agency to reconsider the regulatory pathway for deceased donor islets.
Importantly, reclassification isn't a cure for everyone living with Type 1 diabetes. Nearly 2 million Americans have T1D, and there simply are not enough donor pancreases to treat everyone.
But that's not a reason to do nothing.
Reclassification would allow thousands more people each year to benefit from islet transplantation and other emerging cell therapies. It could also remove unnecessary regulatory hurdles that slow clinical research and innovative trials, including therapies being developed by companies such as Eledon Pharmaceuticals.
Every medical breakthrough begins by helping some patients before it can help many more. Expanding access today will generate the experience, data, and innovation needed to improve these therapies for the future.
We are asking Robert F. Kennedy Jr. and the U.S. Food and Drug Administration to use their existing administrative authority to reclassify donated pancreatic islets as organs or establish an equivalent transplant-based regulatory pathway.
Congress shouldn't have to act before progress can be made. Existing administrative authority provides a path forward.
As a parent, I'm not asking for miracles.
I'm asking that outdated regulations stop standing in the way of medical progress.
If you believe more people should have the opportunity to benefit from life-changing islet cell therapies—and that promising research should move forward as quickly and safely as possible—please sign this petition.
Together, we can help move this forward.

195
The Issue
Type 1 diabetes has shaped my family's life across multiple generations. In 2017 it again impacted our family with my son's diagnosis.
Every parent of a child with Type 1 diabetes dreams of the day their child doesn't have to count every carb, calculate every insulin dose, or wake up to alarms in the middle of the night.
I'm one of those parents.
Like millions of families, we've learned to live with Type 1 diabetes. We celebrate the advances in insulin pumps and continuous glucose monitors, but they don't cure the disease. They simply help manage it.
Today, there is another option for some people with Type 1 diabetes: transplanting insulin-producing islet cells from deceased organ donors. These transplants have helped people regain natural insulin production and, in recent cases, live without insulin injections.
So why aren't more people benefiting?
One major reason is that in the United States, pancreatic islets are regulated as drugs instead of organs. That outdated policy creates unnecessary barriers to research, clinical trials, and patient access.
There is growing bipartisan recognition that this should change. U.S. Senator Mike Lee, sponsor of the ISLET Act, has publicly supported reclassifying donated pancreatic islets as organs rather than drugs. The Congressional Diabetes Caucus sent a letter to the U.S. Food and Drug Administration noting Breakthrough T1D's HHS proposal and urging the agency to reconsider the regulatory pathway for deceased donor islets.
Importantly, reclassification isn't a cure for everyone living with Type 1 diabetes. Nearly 2 million Americans have T1D, and there simply are not enough donor pancreases to treat everyone.
But that's not a reason to do nothing.
Reclassification would allow thousands more people each year to benefit from islet transplantation and other emerging cell therapies. It could also remove unnecessary regulatory hurdles that slow clinical research and innovative trials, including therapies being developed by companies such as Eledon Pharmaceuticals.
Every medical breakthrough begins by helping some patients before it can help many more. Expanding access today will generate the experience, data, and innovation needed to improve these therapies for the future.
We are asking Robert F. Kennedy Jr. and the U.S. Food and Drug Administration to use their existing administrative authority to reclassify donated pancreatic islets as organs or establish an equivalent transplant-based regulatory pathway.
Congress shouldn't have to act before progress can be made. Existing administrative authority provides a path forward.
As a parent, I'm not asking for miracles.
I'm asking that outdated regulations stop standing in the way of medical progress.
If you believe more people should have the opportunity to benefit from life-changing islet cell therapies—and that promising research should move forward as quickly and safely as possible—please sign this petition.
Together, we can help move this forward.

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Petition created on May 2, 2026