[Congressional Record (Bound Edition), Volume 150 (2004), Part 15]
[House]
[Pages 20804-20805]
[From the U.S. Government Publishing Office, www.gpo.gov]




           PANCREATIC ISLET CELL TRANSPLANTATION ACT OF 2004

  Mr. BARTON of Texas. Mr. Speaker, I move to suspend the rules and 
pass the bill (H.R. 3858) to amend the Public Health Service Act to 
increase the supply of pancreatic islet cells for research, and to 
provide for better coordination of Federal efforts and information on 
islet cell transplantation.
  The Clerk read as follows:

                               H.R. 3858

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Pancreatic Islet Cell 
     Transplantation Act of 2004''.

     SEC. 2. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

       Section 371 of the Public Health Service Act (42 U.S.C. 
     273) is amended by adding at the end the following:
       ``(c) Pancreata procured by an organ procurement 
     organization and used for islet cell transplantation or 
     research shall be counted for purposes of certification or 
     recertification under subsection (b).''.

     SEC. 3. ANNUAL ASSESSMENT ON PANCREATIC ISLET CELL 
                   TRANSPLANTATION.

       Section 429 of the Public Health Service Act (42 U.S.C. 
     285c-3) is amended by adding at the end the following:
       ``(d) In each annual report prepared by the Diabetes 
     Mellitus Interagency Coordinating Committee pursuant to 
     subsection (c), the Committee shall include an assessment of 
     the Federal activities and programs related to pancreatic 
     islet cell transplantation. Such assessment shall, at a 
     minimum, address the following:
       ``(1) The adequacy of Federal funding for taking advantage 
     of scientific opportunities relating to pancreatic islet cell 
     transplantation.
       ``(2) Current policies and regulations affecting the supply 
     of pancreata for islet cell transplantation.
       ``(3) The effect of xenotransplantation on advancing 
     pancreatic islet cell transplantation.
       ``(4) The effect of United Network for Organ Sharing 
     policies regarding pancreas retrieval and islet cell 
     transplantation.
       ``(5) The existing mechanisms to collect and coordinate 
     outcomes data from existing islet cell transplantation 
     trials.
       ``(6) Implementation of multiagency clinical investigations 
     of pancreatic islet cell transplantation.
       ``(7) Recommendations for such legislation and 
     administrative actions as the Committee considers appropriate 
     to increase the supply of pancreata available for islet cell 
     transplantation.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Texas (Mr. Barton) and the gentlewoman from Colorado (Ms. DeGette) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Texas (Mr. Barton).


                             General Leave

  Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks on this legislation and to include extraneous material on 
the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise in strongest possible support of H.R. 3858, the 
Pancreatic Islet Cell Transplantation Act of 2004, introduced by the 
gentleman from Washington (Mr. Nethercutt).
  The Pancreatic Islet Cell Transplantation Act is short and simple. It 
requires the pancreata donated for the purposes of islet cell 
transplantation or research be counted for purposes of certification or 
recertification of organ procurement organizations. Islet cell 
transplantation is a procedure where islet cells are removed from a 
donor pancreas and transferred into another person. Once implanted, the 
beta cells in these islets begin to make and release insulin. H.R. 3858 
will help to increase the number of pancreatic and other organ 
donations, expanding the capabilities of pancreatic islet cell 
research.
  My family is very active in raising the awareness of diabetes. My 
father, Larry Barton, died of complications from diabetes, and my wife, 
Terry Barton, is executive director of the Tarrant County Chapter of 
the American Diabetes Association. So I know personally how excited 
people are about islet cell transplantation. It may help people with 
certain type 1 diabetes live without daily injections of insulin, which 
is very exciting. It is my hope that this legislation will help to 
speed this research forward.
  Mr. Speaker, I cannot urge in any stronger possible terms that all 
Members support this legislation.
  Mr. Speaker, I reserve the balance of my time.
  Ms. DeGETTE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, today this body can greatly improve the lives of more 
than 1 million Americans who are affected by juvenile diabetes. The 
Pancreatic Islet Cell Transplantation Act addresses a significant 
problem by reducing the nonscientific barriers standing in the way of 
this promising treatment.
  Pancreatic islet cell transplantation is a procedure that infuses new 
insulin-producing cells into an individual with juvenile diabetes. This 
procedure has now been performed in over 300 people in this country. 
The results are nothing short of miraculous. A majority of those islet 
cell transplantation recipients no longer need to inject themselves 
with insulin.
  For a person with juvenile diabetes this change is life altering. It 
means no more needles and no more worry. It means the question of what 
to eat no longer requires calculation or cause for alarm. For those 
patients islet cell transplantation means freedom, and ultimately islet 
cell transplantation will be a cure for type 1 diabetes.
  As we know too well, Mr. Speaker, living with diabetes is 
challenging. Insulin is not a cure. It is only a means of managing the 
disease, and it is more complicated by the difficulties of monitoring 
glucose levels. Very serious complications like blindness and kidney 
disease are not uncommon. In fact, a staggering number of patients with 
juvenile, or type 1, diabetes suffer from some type of complication. 
Every year 82,000 individuals lose their foot or leg to diabetes. Heart 
disease is the leading cause of diabetes-related deaths. And diabetes 
is the leading cause of new blindness in people 20 to 74 years old.
  This bill, which I was proud to introduce with the gentleman from 
Washington (Mr. Nethercutt), who, unfortunately, cannot be here with us 
today, takes us one step closer to preventing these devastating 
complications. H.R. 3858 will help increase the supply of pancreata for 
islet cell transplantation and better coordinate Federal Government 
efforts and information. These are narrow, yet essential, improvements 
to our health care system that may not only change the lives of people

[[Page 20805]]

with juvenile diabetes but also will reduce costs in our health care 
system.
  The total annual cost of diabetes in 2002 was estimated to be $132 
billion. Of that, $23 billion was due to the cost care for 
complications of diabetes. This is exactly why we need to use new 
procedures like islet cell transplantation to improve lives and reduce 
the cost of health care in the United States.
  We are at a time of extraordinary opportunity in the field of 
juvenile diabetes research, and pancreatic islet cell transplantation 
is just one of the new procedures that gives us great hope. The 
gentleman from Washington (Mr. Nethercutt) and I have been the co-
chairs of the Congressional Diabetes Caucus for many years now, and we 
are pleased to say it is still the largest caucus in Congress. We have 
seen the technologies improve, and we have worked to improve the 
coordination and Federal support for diabetes programs. The Pancreatic 
Islet Cell Transplantation Act continues that work.
  Like so many of my colleagues, I support improved scientifically 
based efforts that will improve patients' lives and even eradicate this 
disease. Since the science in this area is developing at a rapid pace, 
additional efforts are needed to ensure that Federal policies and 
regulatory actions support the momentum.
  I want to add my thanks to the gentleman from Texas (Chairman Barton) 
and for the gentleman from Michigan (Mr. Dingell) as well as the 
Committee on Energy and Commerce staff on both sides of the aisle for 
their hard work and diligence on this and all of the health bills being 
considered today.

                              {time}  1430

  Their leadership provides exactly the kind of bipartisan cooperation 
that we need to address significant issues like improving our health 
care system, that Congress faces today.
  I also want to thank the volunteers of the Juvenile Diabetes Research 
Foundation and the American Diabetes Association. These two 
organizations have been tireless, and they are to be commended.
  Finally, Mr. Speaker, I would like to thank you for all of your hard 
work in this area over the years.
  Pancreatic islet cell transplantation is an incredible innovation in 
medicine. I urge all of my colleagues to support this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, let me in summary again commend the gentlewoman from 
Colorado (Ms. DeGette), the gentleman from Michigan (Mr. Dingell) and 
all the folks on the minority side that worked with us on this. I want 
to thank again the gentleman from Washington (Mr. Nethercutt) for his 
work.
  This bill is going to pass on suspension, which shows how 
noncontroversial and bipartisan this particular issue is. But this is a 
bill that is worthy of considerable celebration because if you have a 
family member that has diabetes and you have to watch and sometimes 
help them get their insulin injections, the ability to get an islet 
cell transplant revolutionizes their life. It is just amazing.
  Our problem is that there just are not enough organ donations to make 
it possible to do this for many people. Hopefully, this legislation 
will make it possible to get more donations and, over time, perhaps 
even do the research that can result in being able to replicate the 
islet cells so that every diabetic in the country that wants one of 
these transplants can get that.
  So I cannot say in stronger terms how happy I am to bring this to the 
floor, and I would urge unanimous adoption of the bill.
  Mr. NETHERCUTT. Mr. Speaker, I rise in strong support of the 
Pancreatic Islet Cell Transplantation Act and urge my colleagues to 
pass this bill
  As the parent of a daughter with Type 1, or juvenile diabetes, I can 
tell you that it is a terrible disease. People with diabetes must 
contend with daily insulin injections and blood tests to monitor 
glucose levels. Hanging above this constant management is the 
threatening cloud of complications, such as kidney failure, blindness 
or amputation that this disease so often brings.
  The legislation that we consider today reflects an extraordinary 
opportunity in the field of juvenile diabetes research. Pancreatic 
islet transplantation has been hailed as the most important advance in 
diabetes research since the discovery of insulin in 1921. The 
procedure, which involves transplanting insulin-producing cells into an 
individual with juvenile diabetes, has been performed on over 300 
individuals, and the majority of them no longer need to take insulin to 
stay alive. While significant research remains to be done to expand 
this procedure to all who suffer with juvenile diabetes, its promise is 
incredibly exciting for families like mine.
  My bill seeks to remove some of the non-scientific barriers currently 
before the scientists racing to perfect this procedure. A shortage of 
donor pancreata is one of the major obstacles to higher transplant 
rates. In 2001, approximately 1,800 pancreata were donated and only 500 
were available for islet cell transplantation and research. At the same 
time, more than one million people suffer from juvenile diabetes. 
Current Federal regulations do not credit organ procurement 
organizations (OPOs) for harvesting pancreases for islet cell 
transplantation toward their certification or recertification. The 
Pancreatic Islet Cell Transplantation Act alters these regulations to 
credit OPOs for pancreata used for islet cell transplantation or 
research.
  This legislation provides help for an extremely promising procedure, 
that in turn offers a great deal of hope to the millions of Americans 
with juvenile diabetes. It gives me great pride to have introduced this 
bill, and I urge my colleagues to support this legislation.
  Ms. DeGETTE. Mr. Speaker, I yield back the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield back the balance of my 
time.
  The SPEAKER pro tempore (Mr. Fossella). The question is on the motion 
offered by the gentleman from Texas (Mr. Barton) that the House suspend 
the rules and pass the bill, H.R. 3858.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

                          ____________________