[Congressional Record (Bound Edition), Volume 157 (2011), Part 11]
[Extensions of Remarks]
[Page 16215]
[From the U.S. Government Publishing Office, www.gpo.gov]




     EXPRESSING SUPPORT FOR FDA'S APPROVAL OF ARTIFICIAL PANCREAS 
                              TECHNOLOGIES

                                 ______
                                 

                            HON. JOHN KLINE

                              of minnesota

                    in the house of representatives

                      Wednesday, October 26, 2011

  Mr. KLINE. Mr. Speaker, I offer the following statement urging the 
U.S. Food and Drug Administration to move forward in the approval 
process of artificial pancreas technologies and issue draft guidance no 
later than December 1, 2011.
  Diabetes is a common, serious, and costly disease that poses a major 
public health problem. Diabetes affects more than 25 million adults and 
children in the United States or 8.3 percent of the population. One out 
of every three Americans born in the year 2000 is predicted to develop 
some form of diabetes during his or her lifetime. One third of every 
Medicare dollar is spent on individuals with diabetes, and estimates 
show diabetes costs the U.S. economy $174 billion annually. In my home 
state alone, approximately 243,000 Minnesotans have been diagnosed with 
diabetes.
  The statistics about diabetes and its consequences for Americans are 
staggering. But they are not nearly as compelling as hearing firsthand 
from a child with type I diabetes what he or she goes through to keep 
their glucose levels stable. Recently, I met with the Theis, Strader, 
Melhus, and Nash families, who came to my office as part of an effort 
organized by the Juvenile Diabetes Research Foundation. They shared 
with me what it's like to live with the disease and what medical tools 
are available to better manage it.
  One such medical advancement is the artificial pancreas. This 
technology has the potential to dramatically improve the health and 
quality of life of those who have diabetes. As shown in a landmark 
study in February 2010, a first generation artificial pancreas system 
can improve diabetes control and even lower the risk of blood glucose 
emergencies. Specifically, it will combine two external devices--an 
insulin pump and a continuous glucose monitor (CGM)--which will 
stabilize glucose levels by automatically providing the correct amount 
of insulin at the appropriate time.
  Before this technology can be made available to people with diabetes, 
the U.S. Food and Drug Administration must approve next steps in the 
regulatory process. Earlier this year, I sent a letter to FDA's 
Commissioner Margaret Hamburg, urging her to quickly provide clear and 
reasonable guidance so outpatient artificial pancreas studies can 
proceed as soon as possible. I urge the FDA to issue this draft 
guidance no later than December 1, if not sooner, to enable artificial 
pancreas technologies to be tested in an outpatient setting and be made 
available to those who need it.

                          ____________________