[Congressional Record (Bound Edition), Volume 157 (2011), Part 11]
[Extensions of Remarks]
[Page 16221]
[From the U.S. Government Publishing Office, www.gpo.gov]




               REGARDING THE NEED FOR ARTIFICIAL PANCREAS

                                 ______
                                 

                         HON. NICK J. RAHALL II

                            of west virginia

                    in the house of representatives

                      Wednesday, October 26, 2011

  Mr. RAHALL. Mr. Speaker, I rise today to call on the U.S. Food and 
Drug Administration to expedite its consideration of the artificial 
pancreas, a technology that will benefit those with type 1 diabetes.
  Recently, I was visited by Lori and Jay Happala; Gina Frye; and 
Margaret Hoover at my office in Beckley, West Virginia, as part of the 
Juvenile Diabetes Research Foundation's Promise to Remember Me 
campaign.
  These families and one of their children who is diagnosed with type 1 
shared with me personal stories about what life is like for sufferers 
of type 1 diabetes, and how continued research and breakthroughs in 
technology can help improve management of this disease.
  The Juvenile Diabetes Research Foundation and other clinical experts 
from organizations like the American Diabetes Association have 
indicated that an artificial pancreas has the potential to transform 
the lives of those with type 1 diabetes by automatically controlling 
blood glucose levels around the clock, enabling them to remain healthy 
until a cure is found. My constituents argue that this technology has 
the potential to help those with diabetes better manage their type 1 
diabetes in a more cost efficient manner, as well as help them to lead 
more fulfilling, active lives and reduce the risk of further health 
complications like kidney failure and heart disease.
  Before this technology can be made available, the FDA must approve 
next steps in the regulatory process to continue the development of 
artificial pancreas systems. Earlier this year, my colleagues and I 
wrote to the FDA, requesting a clear and reasonable regulatory pathway 
so that outpatient studies can proceed as soon as possible.
  Recently the FDA committed to publishing draft guidance for public 
comment by December 1. On behalf of the millions of Americans with 
diabetes, I urge the FDA to issue this draft guidance in a timely 
manner, so that artificial pancreas technologies can be tested in an 
outpatient setting and be made available to those who need as 
expeditiously as possible. Continued delays may slow innovation that 
has the potential to dramatically improve the lives of those with 
diabetes.