[Congressional Record Volume 161, Number 183 (Wednesday, December 16, 2015)]
[House]
[Pages H9333-H9335]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




     STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and concur in the 
Senate amendment to the bill (H.R. 2820) to reauthorize the Stem Cell 
Therapeutic and Research Act of 2005, and for other purposes.
  The Clerk read the title of the bill.
  The text of the Senate amendment is as follows:
  Senate amendment:

       Strike out all after the enacting clause and insert:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Stem Cell Therapeutic and 
     Research Reauthorization Act of 2015''.

     SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 
                   TRANSPLANTATION PROGRAM.

       (a) In General.--Section 379(d)(2)(B) of the Public Health 
     Service Act (42 U.S.C. 274k(d)(2)(B)) is amended--
       (1) by striking ``remote collection'' and inserting 
     ``collection''; and
       (2) by inserting ``including remote collection,'' after 
     ``cord blood units,''.
       (b) Authorization of Appropriations.--Section 379B of the 
     Public Health Service Act (42 U.S.C. 274m) is amended--
       (1) by striking ``$30,000,000 for each of fiscal years 2011 
     through 2014 and''; and
       (2) by inserting ``and $30,000,000 for each of fiscal years 
     2016 through 2020'' before the period at the end.
       (c) Secretary Review on State of Science.--The Secretary of 
     Health and Human Services, in consultation with the Director 
     of the National Institutes of Health, the Commissioner of the 
     Food and Drug Administration, and the Administrator of the 
     Health Resources and Services Administration, including the 
     Advisory Council on Blood Stem Cell Transplantation 
     established under section 379(a) of the Public Health Service 
     Act (42 U.S.C. 274k(a)), and other stakeholders, where 
     appropriate given relevant expertise, shall conduct a review 
     of the state of the science of using adult stem cells and 
     birthing tissues to develop new types of therapies for 
     patients, for the purpose of considering the potential 
     inclusion of such new types of therapies in the C.W. Bill 
     Young Cell Transplantation Program (established under such 
     section 379) in addition to the continuation of ongoing 
     activities. Not later than June 30, 2019, the Secretary shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives recommendations on 
     the appropriateness of such new types of therapies for 
     inclusion in the C.W. Bill Young Cell Transplantation 
     Program.

     SEC. 3. CORD BLOOD INVENTORY.

       Section 2 of the Stem Cell Therapeutic and Research Act of 
     2005 (42 U.S.C. 274k note) is amended--
       (1) in subsection (a), by striking ``one-time'';
       (2) by striking subsection (c);
       (3) by redesignating subsections (d) through (h) as 
     subsections (c) through (g), respectively;
       (4) in subsection (d) (as so redesignated)--
       (A) in paragraph (1), by striking ``paragraphs (2) and 
     (3)'' and inserting ``paragraphs (2), (3), and (4)'';
       (B) in paragraph (2)(B), by striking ``subsection (d)'' and 
     inserting ``subsection (c)''; and
       (C) by adding at the end the following:
       ``(4) Consideration of best science.--The Secretary shall 
     take into consideration the best scientific information 
     available in order to maximize the number of cord blood units 
     available for transplant when entering into contracts under 
     this section, or when extending a period of funding under 
     such a contract under paragraph (2).
       ``(5) Consideration of banked units of cord blood.--In 
     extending contracts pursuant to paragraph (3), and 
     determining new allocation amounts for the next contract 
     period or contract extension for such cord blood bank, the 
     Secretary shall take into account the number of cord blood 
     units banked in the National Cord Blood Inventory by a cord 
     blood bank during the previous contract period, in addition 
     to consideration of the ability of such cord blood bank to 
     increase the collection and maintenance of additional, 
     genetically diverse cord blood units.'';
       (5) in subsection (f) (as so redesignated)--
       (A) by striking paragraph (4); and
       (B) by redesignating paragraphs (5) and (6) as paragraphs 
     (4) and (5), respectively; and
       (6) in subsection (g) (as so redesignated)--
       (A) in paragraph (1)--
       (i) by striking ``$23,000,000 for each of fiscal years 2011 
     through 2014 and''; and
       (ii) by inserting ``and $23,000,000 for each of fiscal 
     years 2016 through 2020'' before the period at the end; and
       (B) by striking paragraph (2).

     SEC. 4. DETERMINATION ON THE DEFINITION OF HUMAN ORGAN.

       Not later than one year after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall issue 
     determinations with respect to the inclusion of peripheral 
     blood stem cells and umbilical cord blood in the definition 
     of human organ.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Pitts) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Pennsylvania.

                              {time}  0915


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 2820, the Stem Cell 
Therapeutic and Research Reauthorization Act, introduced by my 
colleagues, Representative Chris Smith of New Jersey and Representative 
Doris Matsui of California.
  This bill is another example of the Energy and Commerce Committee's 
ongoing effort to work together in a bipartisan manner to strengthen 
public health and solve problems in our Nation's healthcare system.
  H.R. 2820 reauthorizes the National Cord Blood Inventory program and 
the C.W. Bill Young Cell Transplantation Program through fiscal year 
2020,

[[Page H9334]]

which provides Federal support for cord blood donation and research 
essential to increasing patient access to transplants.
  The National Cord Blood Inventory, the NCBI, is a program to collect, 
store, and distribute umbilical cord blood to those in need of a cord 
blood stem cell transplant. These cord blood units must meet specific 
criteria, and are available through the C.W. Bill Young Cell 
Transplantation Program to treat patients who need a transplant.
  The blood-forming cells from cord blood have unique qualities that 
help some patients who would otherwise be unable to have a potentially 
lifesaving transplant. NCBI is the largest and most diverse marrow 
registry in the world.
  The C.W. Bill Young Cell Transplantation Program provides support to 
patients who undergo a transplant and helps match donors to patients 
who are in need of an unrelated marrow donor. Seventy percent of all 
patients who need a transplant don't have a match donor in their 
family, and this program gives them somewhere to turn.
  I support H.R. 2820. I urge my colleagues to support this important 
piece of legislation.
  I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  H.R. 2820, the Stem Cell Therapeutic and Research Reauthorization 
Act, would continue the highly successfully Be The Match Registry for 
bone marrow and umbilical cord blood transplantation.
  This program provides hope to people in need of lifesaving 
transplants. Each year about 20,000 patients receive blood marrow 
transplants. Seventy percent of those patients do not find a match 
within their family and instead rely on the Be The Match Registry to 
find a non-relative bone marrow donor.
  That is why continued Federal support for the Be The Match Registry 
and its nearly 12.5 million registered bone marrow donors and 
collection of more than 209,000 cord blood units is so important.
  I am glad that we have come together on a bipartisan basis in our 
committee and in the House and the Senate to support this lifesaving 
program.
  I want to thank Congresswoman Matsui for her leadership in this area. 
I urge my colleagues to vote ``yes'' to concur with Senate H.R. 2820.
  I reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  I would like to reiterate the important work that the National Marrow 
Donor Program does for patients. Be The Match, operated by the National 
Marrow Donor Program, has facilitated more than 68,000 marrow and cord 
blood transplants, which is an average of more than 520 transplants a 
month. They conducted their first transplant as the National Marrow 
Donor Program in 1987.
  They also continue to lead the way in developing new cellular 
therapies, in advancing services to speed the transplant process, and 
improving treatments for post-transplant complications. Be The Match 
invests in dedicated researchers whose countless hours in the lab and 
caring for patients have helped more patients than ever before to 
receive a transplant.
  Beyond establishing the registry, investment in medical research over 
the years has been essential in helping find the answers that save the 
lives of more patients.
  In 1990, the Nobel Prize in Medicine was awarded to Dr. E. Donnall 
Thomas for discoveries in cellular transplantation.
  In 1994, the first peripheral blood stem cell collected for use in 
unrelated transplants occurred.
  In 1998, the cord blood program was launched.
  In 2001, the NMDP Repository was built, one of the world's largest 
tissue sample storage facilities used for medical research.
  In 2004, Be The Match and the NMDP partnered with the Medical College 
of Wisconsin to create the Center for International Blood and Marrow 
Transplant Research.
  The great work and discovery continues. I urge bipartisan support for 
H.R. 2820 and support for discovery and cures for patients.
  I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I continue to reserve the 
balance of my time.
  Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Carter).
  Mr. CARTER of Georgia. Mr. Speaker, I rise today in support of H.R. 
2820, the Stem Cell Therapeutic and Research Reauthorization Act of 
2015.
  This bill reauthorizes the National Cord Blood Inventory program and 
the C.W. Bill Young Cell Transplantation Program, two programs that 
save lives every day through bone marrow transplants and blood 
infusions.
  This bill is very similar to legislation that the Georgia General 
Assembly passed in 2007, establishing the newborn umbilical cord blood 
bank. I voted for that legislation in the Georgia General Assembly, and 
I will vote in favor of this legislation.
  For some patients who have leukemia, lymphoma, sickle cell anemia, or 
a life-threatening blood cancer, help from programs like the National 
Cord Blood Inventory program and the C.W. Bill Young Cell 
Transplantation Program, may be their last hope at living longer, 
healthier lives. That is why H.R. 2820 is so important.
  This bill reauthorizes these two programs through 2020, and continues 
to provide lifesaving techniques and research to many who fight for 
their lives every day.
  This bill originally passed the House on September 8 by voice vote. I 
encourage my colleagues to support it again.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield back the balance of my 
time.
  Mr. PITTS. Mr. Speaker, I yield such time as he may consume to the 
gentleman from New Jersey (Mr. Smith), the prime sponsor of this 
legislation.
  (Mr. SMITH of New Jersey asked and was given permission to revise and 
extend his remarks.)
  Mr. SMITH of New Jersey. Mr. Speaker, I want to thank, first of all, 
our distinguished chairman, Chairman Pitts, for his extraordinary work 
on this legislation.
  I also want to thank Mr. Gene Green of Texas, Mr. Pallone, and, of 
course, Chairman Upton for his strong support of this reauthorization.
  In the Senate, we have had a tremendous team of Orrin Hatch, Jack 
Reed, Richard Burr, and Al Franken, who again worked in a very 
bipartisan way to ensure that this life-affirming, lifesaving 
legislation not only made it through the Senate, but was beefed up, 
made stronger.
  People talk about the lack of bipartisanship. I do believe this is 
one of those bills where we have all come together to try to say--
whether it be bone marrow or adult stem cells in the form of cord 
blood--that it be made available to as many people as possible in the 
most usable and efficacious way.
  Mr. Speaker, just let me say--and we know this and I will try not to 
be too redundant because I think the chairman has explained it--the 
bill under consideration by the House today does reauthorize through 
2020 two critically important and complementary programs, the C.W. Bill 
Young Cell Transplantation Program and the National Cord Blood 
Inventory.
  It is especially appropriate during this time of gift-giving to 
reauthorize these life-giving programs. Americans willing to give the 
gift of life to others are at the heart of the success of this program.
  In reauthorizing it, we are grateful for the adult donors willing to 
provide bone marrow or peripheral blood stem cells as well as mothers 
who donate their child's cord blood through public cord blood banks.
  Under the National Cord Blood Inventory program, Mr. Speaker, 
contracts are awarded to cord blood banks to collect cord blood units 
donated after mothers give birth.
  Around 4 million births occur in the United States every year. God, 
in his grace and love, has left a gift that then gives life and helps 
to cure diseases, including leukemia and other devastating blood-
related diseases, left after that birth.
  Again, cord blood and the placenta itself is teeming with stem cells 
that are, again, highly efficacious in curing and mitigating disease.
  Americans have access to more than 12 million adult volunteer donors 
and 209,000 cord blood units through Be The Match. The program's Bone 
Marrow and Cord Blood Coordinating Centers

[[Page H9335]]

make information about bone marrow and cord blood transplants available 
to donors and patients. The Office of Patient Advocacy helps support 
patients and families dealing with a life-threatening diagnosis. The 
Stem Cell Therapeutic Outcomes Database tracks results.
  Again, if you want to know how something is working or not, you track 
it, and you are constantly recalibrating it in order to make it better.
  Today's bill is the second reauthorization of the Stem Cell 
Therapeutic and Research Act of 2005, a law that I authored a decade 
ago, joined by Artur Davis of Alabama, legislation that, again, cleared 
the Senate with the great help of Senator Orrin Hatch.
  That law built upon the excellent work of our distinguished, late 
colleague Bill Young of Florida to facilitate bone marrow transplants 
and created a brand-new national umbilical cord blood donation and 
transplantation program.
  Dr. Jeffrey Chell, the CEO of NMDP/Be The Match, has noted that, for 
many diseases, including blood cancers and sickle cell anemia disease, 
cellular therapy is the best hope for a cure.
  As he told Chairman Pitts and his committee, the patient population 
rising the most quickly is the elderly population, growing by double 
digits every year. The reason for that is that the medical conditions 
for which transplant is often the only cure tend to occur in older 
populations; diseases like acute leukemia, myelofibrosis, and others.
  Breathtaking scientific breakthroughs have turned medical waste, 
post-birth placentas, and umbilical cord blood into medical miracles, 
treating more than 70 diseases--some say as many as 80--including 
leukemia, lymphoma, and sickle cell anemia.
  Let me just conclude by pointing out that, during consideration of 
the Senate HELP Committee, language was added to direct relevant 
agencies to study the state of science using adult stem cells and 
birthing tissues to develop new therapies for patients.
  Last year I visited Celgene Corporation in Summit, New Jersey, to 
learn of their extraordinary efforts to use cord blood to heal diabetic 
foot ulcers and how they turn amniotic membrane, an old placenta, into 
wound management that now has advanced past stage 3 clinical trials to 
the approval and regulatory filings stage.
  Again, I want to thank the chief cosponsor, Ms. Matsui; Mr. Jolly; 
and Mr. Fattah. Again, this is a bipartisan bill.
  Mr. Speaker, the bill under consideration by the House today 
reauthorizes through 2020 two critically important and complementary 
programs--the C.W. Bill Young Cell Transplantation Program and National 
Cord Blood Inventory.
  During this time of gift-giving, it is incredibly timely to 
reauthorize these life-giving programs. Americans willing to give the 
gift of life to others are at the heart of the success of this program. 
In reauthorizing it we are grateful for the adult donors willing to 
provide bone marrow or peripheral blood stem cells, as well as mothers 
who donate their child's cord blood through public cord blood banks.
  Today, Mr. Speaker, under the National Cord Blood Inventory Program 
(NCBI), contracts are awarded to cord blood banks to collect cord blood 
units donated after mothers give birth. These units are then made 
available through the C.W. Bill Young Cell Transplantation Program also 
called the Be the Match Registry. The Program provides a single point 
of access, enabling those in need of lifesaving transplants to search 
for a match via an integrated nationwide network of bone marrow donors 
and cord blood stem cells. Americans have access to more than 12 
million adult volunteer donors and 209,000 cord blood units through Be 
The Match. The Program's Bone Marrow and Cord Blood Coordinating 
Centers makes information about bone marrow and cord blood transplant 
available to donors and patients, and the Office of Patient Advocacy 
helps support patients and families dealing with a life-threatening 
diagnosis. And the Stem Cell Therapeutic Outcomes Database tracks 
results.
  The leadership of Senators Orrin Hatch, Jack Reed, Richard Burr and 
Al Franken was invaluable in shepherding this vital bill through the 
Senate. And special thanks to both Chairmen Upton and Pitts for their 
outstanding leadership and help on this bill, as well as the strong 
support by Ranking Members Pallone and Green. I am deeply grateful to 
original cosponsors Ms. Matsui, Mr. Jolly and Mr. Fattah for their 
important contributions.
  Today's bill is the second reauthorization of the Stem Cell 
Therapeutic and Research Act of 2005, a law that I sponsored a decade 
ago joined by Artur Davis of Alabama; legislation that cleared the 
Senate with the incomparable help of Senator Orrin Hatch. That law 
built upon the excellent work of our distinguished late colleague Bill 
Young of Florida to facilitate bone marrow transplants and created a 
brand new national umbilical cord blood donation and transplantation 
program.
  Dr. Jeffrey W. Chell, CEO of NMDP/Be the Match has noted that for 
many diseases including blood cancers and sickle cell disease, cellular 
therapy is the best hope for a cure. He told Chairman Pitts' 
subcommittee that the patient population ``rising the most quickly is 
the elderly population . . . growing by double digits every year, and 
the reason for that is the medical conditions for which transplant is 
often the only cure tend to occur in older populations for diseases 
like acute myeloid leukemia, myelodysplastic syndrome, myelofibrosis 
and others.''
  Breathtaking scientific breakthroughs have turned medical waste--post 
birth placentas and umbilical cord blood--into medical miracles 
treating more than 70 diseases including leukemia, lymphoma and sickle 
cell anemia.
  Not only has God in His wisdom and goodness created a placenta and 
umbilical cord to nurture and protect the precious life of an unborn 
child, but now we know that another gift awaits us immediately after 
birth. Something very special is left behind--cord blood that is 
teeming with lifesaving stem cells.
  In addition to currently treating more than 70 diseases like sickle 
cell anemia and leukemia, cord blood units from NCBI banks are also 
made available for research on future therapies. In groundbreaking 
research, Dr. Kurtzberg of Duke University also testified last June 
that ``in addition to use in patients with malignant and genetic 
diseases, cord blood is showing enormous potential for use in cellular 
therapies and regenerative medicine. Cord blood derived vaccines 
against viruses and certain types of cancers are currently under 
development and in early phase clinical trials. Cells, manufactured 
from cord blood units are being developed to boost recovery of the 
immune system. Cells regulating autoimmunity (Regulatory T cells) are 
also in clinical trials. These approaches, which often utilize cord 
blood banked in family banks, may help patients with Type 1 Diabetes, 
as well as other diseases.''
  Dr. Kurtzberg further testified that she and others are developing 
uses for cord blood to treat acquired brain disorders. ``Over the past 
six years'' she said ``we have initiated trials of autologous (the 
patient's own) cord blood in babies with birth asphyxia, cerebral 
palsy, hearing loss and autism . . .''
  Dr. Kurtzberg has also said ``We've learned that when donor cells are 
infused into one's body, they go to the brain and help heal the brain. 
When a child has a brain injury around birth, we can use their own cord 
blood cells to correct the damage that's occurred.''
  Inportantly, during consideration in the Senate HELP Committee, 
language was added to direct the relevant agencies to study the state 
of science using adult stem cells and birthing tissues to develop new 
therapies for patients. Last year, Mr. Speaker, I visited Celgene 
Corporation of Summit, New Jersey to learn of their extraordinary 
efforts to use cord blood to heal diabetic foot ulcers and how they've 
turned amniotic membrane--an old placenta--into wound management that 
has now advanced past stage 3 clinical trials to the approval and 
regulatory filings stage.
  H.R. 2820 authorizes $265 million over five years and will ensure 
that thousands of present-day and future patients benefit from the 
exciting field of regenerative medicine.
  Mr. PITTS. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the 
rules and concur in the Senate amendment to the bill, H.R. 2820.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PITTS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

                          ____________________