In an effort to hurry along the FDA approval process for the artificial pancreas, members of the Juvenile Diabetes Research Foundation, government officials, health care professionals, and a large number of type 1 diabetics congregated in Washington, DC.
As the bodies of type 1 diabetics do not have the ability to produce insulin, they have to rely on outside regulators. Unfortunately, however, diabetics have been known to overdose on insulin by accident. In an effort to hurry along the FDA approval process for a new type 1 diabetes treatment, members of the Juvenile Diabetes Research Foundation (JDRF), government officials, health care professionals, and a large number of type 1 diabetics congregated in Washington, DC, on Wednesday.
The treatment is an artificial pancreas, a portable device designed to help control the blood sugar levels in type 1 diabetics through an insulin pump. Thus far, the FDA does not appear to be making the approval of the product a priority, and members of the diabetic community are becoming frustrated. Jeffrey Brewer, the president and CEO of the JDRF, has urged the FDA to expedite their review of the artificial pancreas. "Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves," Brewer said.
Brewer knows from personal experience handling his son’s diabetes how severe and real the threat of death by accidental insulin overdose can be. "My son almost died because he gave himself too much insulin,” he reported. “The insulin pump didn't have the right features to shut off insulin delivery." For his son and for the other three million Americans living with type 1 diabetes, Brewer urged the FDA to speed up the process of approving the artificial pancreas.
The goal of this gathering was to persuade the FDA to change policy and guidelines in order to make devices available on the market in less time; further, these changes would ideally allow for research into new products to help with insulin control.
Brewer stated, "FDA policies have delayed introductions of products such as the artificial pancreas to Americans by up to three years that are being safely used by people around the world with type 1 diabetes, and they prevent us from doing vital research in the US.”
In response to the congregation, the FDA reported that it looks forward to making the product available on the market, but the safety and efficiency of the device must be established first. Currently, the agency is putting together recommendations for approving the artificial pancreas for use in the US, but according to Brewer, the FDA’s draft guidelines only impede the process of approval and do not take into account the advice of experts. "[The FDA] just issued that guidance in June, but that product has been available in Europe for over three years,” vented Brewer.
Brewer and the numerous other advocates present at the gathering—including Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH)—urged the FDA to consider the close-to-unanimous opinions of experts who believe that the artificial pancreas will dramatically improve the lives of Americans suffering from type 1 diabetes.