Washington, D.C. — The JDRF applauded leading clinical organizations specializing in diabetes care, who called on the Food and Drug Administration (FDA) to ensure that development of an artificial pancreas, the most revolutionary development in diabetes care since the discovery of insulin, is not delayed by unnecessary regulatory roadblocks.
In a letter sent to FDA Commissioner Margaret Hamburg and leading members of Congress, the American Association of Clinical Endocrinologists, American Association of Diabetes Educators, American Diabetes Association, and the Endocrine Society told the FDA that the final artificial pancreas guidance, due to be released by December 1, needs to avoid the shortcomings of the recently proposed guidance for Low Glucose Suspend System, an artificial pancreas (AP) precursor technology.
“Many of our organizations are concerned by guidance proposed by the FDA in June for Low Glucose Suspend systems, which created many unnecessary obstacles to the evaluation of those systems. We want to ensure that the artificial pancreas guidance avoids similar shortcomings that would be so detrimental to the well-being of millions of Americans,” the organizations wrote.
The organizations also noted in the letter that Commissioner Hamburg has “made advancing regulatory science at FDA a top priority” and urged the agency to “adopt recommendations from JDRF and leading clinical experts which would transform the care of people with type 1 diabetes in the United States and provide tangible evidence of your commitment for FDA to innovate and lead the world in bringing the most promising medical treatments to patients.”
The clinician organizations urged the FDA to issue guidance that will allow researchers, scientists and manufacturers to finally move forward with the next phase of outpatient clinical trials for the AP, a technology that researchers and patients believe has the potential to save lives, dramatically transform quality of life for people with type 1 diabetes and reduce preventable medical complications that impose huge costs on our health care system.
In the letter, the clinician organizations asked the FDA to ensure that the final AP guidance contains the following critical elements:
- A firm commitment to use continuous glucose monitor (CGM) data in evaluation of artificial pancreas systems
- Reasonable study progression
- Flexibility with respect to endpoints, patient population, and safety elements
- Policies to encourage system improvements
JDRF, the leading patient group for type 1 diabetes adults, children, and families applauded the letter.
“The FDA will soon release a guidance document which must be properly drafted or it could delay delivery of a highly promising medical technology that will improve or save the lives of millions of Americans living with type 1 diabetes,” said Jeffrey Brewer, President and CEO of JDRF. “This letter from leading clinical organizations reinforces how critical it is for the FDA to issue clear and reasonable AP guidance in December and echoes the concerns and consensus of the broader diabetes community. Failure to issue reasonable guidance will mean that patient access to this life-saving technology will be, at best, delayed, and at worst, prevented entirely.”
JDRF is the worldwide leader for research to cure type 1 diabetes (T1D). It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.
The mission of JDRF is to find a cure for diabetes and its complications through the support of research. T1D is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with T1D have to test their blood sugar and give themselves insulin injections multiple times or use a pump–each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with T1D, JDRF has awarded more than $1.5 billion to diabetes research, including $107 million last year. More than 80 percent of JDRF’s expenditures directly support research and research-related education. For more information, please visit www.jdrf.org.
Joana Casas, JDRF