[Congressional Record (Bound Edition), Volume 157 (2011), Part 13]
[Extensions of Remarks]
[Page 18497]
[From the U.S. Government Publishing Office, www.gpo.gov]




 URGING FDA TO ACT PROMPTLY TO APPROVE ARTIFICIAL PANCREAS TECHNOLOGIES

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                            HON. DAN BURTON

                               of indiana

                    in the house of representatives

                      Wednesday, November 30, 2011

  Mr. BURTON of Indiana. Mr. Speaker, diabetes is a common, and 
growing, disease in Indiana. According to 2009 CDC data, approximately 
451,000 Hoosiers--9% of the state's population--had diagnosed diabetes. 
Adults who are overweight and not physically active are at risk for 
developing diabetes. Among adults with diabetes in Indiana, 88.1% are 
overweight and 42.5% reported physical inactivity.
  In addition to the human toll diabetes places on people in Indiana, 
the financial burden diabetes places on the health system in Indiana is 
staggering--in 2007, the direct and indirect cost of diabetes in 
Indiana was approximately $3.09 billion.
  Americans with diabetes, particularly young children with diabetes, 
desperately need better tools to manage their disease and thereby 
prevent many of its life-threatening and costly complications. Some of 
these breakthrough tools and technologies are already available.
  For example, Low-Glucose Suspend systems--devices that automatically 
suspend insulin delivery when blood sugar levels are dangerously low--
have been approved in more than 40 countries around the world. But not 
here in the United States.
  In fact, the FDA only this year--almost four years after these 
devices were approved for use in Europe, issued draft guidance on what 
studies manufacturers would need to conduct in order to win approval 
for Low-Glucose Suspend systems in the United States.
  To make matters worse, according to the Nation's leading clinical 
organizations specializing in diabetes care, the guidance proposed by 
FDA in June 2011 for Low-Glucose Suspend systems created many 
unnecessary obstacles to the evaluation of those systems.
  Thankfully, the FDA recently took an overdue step to clarify that 
ill-conceived guidance. However, there is significant concern within 
the diabetes community that forthcoming guidance--which the FDA has 
committed publicly to publishing by December 1st--on even more 
revolutionary technology--the artificial pancreas--will either be 
delayed or suffered from many of the same problems which plagued the 
FDA's Low-Glucose Suspend system guidance.
  The development of the artificial pancreas is critically important to 
many of my constituents, which is why I signed a broad, bipartisan 
letter in support of prompt and appropriate guidance on the artificial 
pancreas earlier this year. Any delay will slow an innovation that has 
the potential to dramatically improve the lives of those with diabetes.
  Mr. Speaker, on behalf of the thousands of Hoosiers, and millions of 
other Americans with diabetes, I urge the FDA to issue this draft 
guidance no later than December 1, if not sooner, so that artificial 
pancreas technologies can be tested in an outpatient setting and be 
made available to those who need it in the near future. This is 
literally a matter of life and death.
  I also would like to insert a copy of my letter to FDA Commissioner 
Hamburg in this subject in the Congressional Record.

                                     House of Representatives,

                                Washington, DC, November 29, 2011.
     Hon. Margaret Hamburg, M.D.,
     Commissioner, U.S. Food and Drug Administration, Silver 
         Springs, MD.
       Dear Commissioner Hamburg: I am writing to urge the Food 
     and Drug Administration (FDA) to expedite the development of 
     the artificial pancreas for the treatment of type 1 diabetes. 
     Specifically, I urge FDA to immediately issue clear and 
     unambiguous guidance so that outpatient artificial pancreas 
     studies can proceed as soon as possible.
       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. Americans 
     with diabetes, particularly young children with diabetes, 
     desperately need better tools to manage their disease and 
     thereby prevent many of its life-threatening and costly 
     complications.
       Some of these breakthrough tools and technologies are 
     already available in other parts of the world. Low-Glucose 
     Suspend systems--devices that automatically suspend insulin 
     delivery when blood sugar levels are dangerously low--have 
     been approved in more than 40 countries around the world but 
     not here in the United States. In fact, the FDA only this 
     year--almost four years after these devices were approved for 
     use in Europe, issued draft guidance on what studies 
     manufacturers would need to conduct in order to win approval 
     for Low-Glucose Suspend systems in the United States. To make 
     matters worse, according to the Nation's leading clinical 
     organizations specializing in diabetes care, the guidance 
     proposed by FDA in June 2011 for Low-Glucose Suspend systems 
     created many unnecessary obstacles to the evaluation of those 
     systems. For example, I understand that this guidance 
     requires multiple clinical trials (inpatient and outpatient) 
     involving a large number of subjects to show statistically 
     significant differences in preventing hypoglycemia. This is 
     an excessive hurdle when all that is required is data showing 
     safety and effectiveness (in other words equivalent glycemic 
     control) not that the Low-Glucose Suspend system is BETTER 
     than other techniques.
       Nighttime is a particularly dangerous time for individuals 
     with diabetes because their blood sugar level can drop while 
     they are sleeping, potentially leading to seizures, coma or 
     death. I have heard heart wrenching stories from parents 
     forced to wake their diabetic children in the middle of the 
     night to check their blood sugar levels and, if necessary, 
     administer insulin. Access to Low-Glucose Suspend systems, 
     and ultimately to artificial pancreas technology, is 
     desperately needed to help manage this disease and 
     effectiveness, would be unconscionable.
       We are at a critical point in the development of the 
     artificial pancreas. Timely approval of this technology will 
     help improve health outcomes for the millions of Americans 
     afflicted with type I diabetes; and potentially save hundreds 
     billions of dollars annually in health care costs. I urge 
     your timely consideration of this matter and respectfully 
     request a prompt response.
           Sincerely,
                                                       Dan Burton,
     Member of Congress.

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