Diabetes Caucus Bipartisan Letter to FDA on Artificial Pancreas Guidance
Dear Hamburg:
We are writing to express our strong interest in the development of the artificial pancreas, which is at a critical point in the regulatory process at your agency. Your continued leadership is essential. This technological development has the potential to dramatically improve the health and quality of life for those who have diabetes. Building on that leadership and recognition of the potential innovation. we encourage your agency to quickly take into account guidance put forth by leading experts in the field regarding the artificial pancreas so that this promising technology may be made available to those with type 1 diabetes in the near future.
As you are well aware, diabetes is a burdensome, dangerous, and debilitating disease. Nearly 26 million Americans have diabetes, and one in three American children born today will develop the disease. Diabetes is the leading cause of kidney failure and adult-onset blindness. Moreover, diabetes increases the risk of heart attack deaths by two to four times, and causes more than 80,000 amputations each year. People with diabetes are also at risk for seizures, comas, and sudden death. One third of every Medicare dollar is spent on people with diabetes and estimates show that diabetes costs the U.S economy $174 billion annually. Simply put, people with diabetes desperately need better tools to manage their disease and prevent its live-threatening and costly complications.