[Congressional Record Volume 161, Number 128 (Tuesday, September 8, 2015)]
[House]
[Pages H5801-H5804]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STEM CELL THERAPEUTIC AND RESEARCH REAUTHORIZATION ACT OF 2015
Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass 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 bill is as follows:
H.R. 2820
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 ``Stem Cell Therapeutic and
Research Reauthorization Act of 2015''.
SEC. 2. AMENDMENTS TO THE STEM CELL THERAPEUTIC AND RESEARCH
ACT OF 2005.
(a) Cord Blood Inventory.--Section 2 of the Stem Cell
Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is
amended in subsection (h)--
(1) in paragraph (1)--
(A) by striking ``$23,000,000 for each of fiscal years 2011
through 2014 and''; and
(B) by inserting before the period at the end the
following: ``and $23,000,000 for each of fiscal years 2016
through 2020''; and
(2) in paragraph (2), by striking ``2011 through 2015'' and
inserting ``2015 through 2020''.
(b) National Program.--Section 379B of the Public Health
Service Act (42 U.S.C. 274m) is amended by striking ``2011
through 2014'' and inserting ``2016 through 2020''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Kentucky (Mr. Guthrie) and the gentleman from Texas (Mr. Gene Green)
each will control 20 minutes.
The Chair recognizes the gentleman from Kentucky.
General Leave
Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Kentucky?
There was no objection.
Mr. GUTHRIE. 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 of 2015, introduced by my
colleagues Chris Smith and Doris Matsui.
Bone marrow transplantation has been used for more than 50 years to
treat blood-related diseases, such as leukemia, different anemias, and
lymphoma. It is a rich source of blood stem cells. In more recent
years, breakthroughs have been made using blood stem cells from
umbilical cord blood in the treatment of those various blood-related
diseases and conditions.
It can be very difficult to find a bone marrow transplant match, and
in some cases, cord blood can be used instead. Bone marrow and cord
blood donation are critical to ensure those in need of transplant can
find a match. The need for this lifesaving transplantation has risen 25
percent since 2005.
H.R. 2820 reauthorizes the National Marrow Donor Program and creates
a national network of public cord blood banks. The legislation also
provides healthcare professionals the ability to search for bone marrow
and umbilical cord blood units for transplantation.
H.R. 2820 also bolsters patient and advocacy services; provides for
public and professional education; and collects, analyzes, and reports
data on transplant outcomes.
Mr. Speaker, I urge my colleagues to support this important
legislation.
I reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise in support of H.R. 2820, the Stem Cell
Therapeutic Research Reauthorization Act. This important legislation is
championed by Representatives Doris Matsui and Chris Smith.
According to the Health Resources and Services Administration, nearly
20,000 patients in the United States need a bone marrow or cord blood
transplant each year. Stem cells from both cord blood and bone marrow
are used to treat nearly 80 lifesaving diseases, including cancers,
blood diseases, and immune disorders.
H.R. 2820 provides Federal support for cord blood donation, the
continuation of the national bone marrow registry, and critical medical
research. This legislation reauthorizes the C. W. Bill Young Cell
Transplantation Program, which includes the National Marrow Donor
Program.
The program helps patients in need of lifesaving transplants find
matching bone marrow donors or cord blood units. It also includes a
stem cell therapeutic outcomes database, which facilitates research to
better understand the matching process. This legislation will give hope
of access to patients and their families in need of a curative
transplant.
I want to thank Representatives Matsui and Smith for their leadership
[[Page H5802]]
on this issue. I also want to thank Chairman Upton, Ranking Member
Pallone, Chairman Pitts, and my colleagues on the Committee on Energy
and Commerce for advancing this important legislation. I urge my
colleagues to support H.R. 2820.
Mr. Speaker, I reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield 6 minutes to the gentleman from New
Jersey (Mr. Smith), my good friend.
Mr. SMITH of New Jersey. I thank my good friend Mr. Guthrie for
yielding and for his support on this important legislation.
Mr. Speaker, Maalik was diagnosed with Hurler syndrome at 15 months
old, a rare and life-threatening metabolic disorder. He had a curved
spine, and he could not walk.
After receiving an umbilical cord blood transplant facilitated
through the Carolinas Cord Blood Bank, Maalik is running around and is
expected to have a normal lifespan. His mother, Krystal, said: ``My son
is extremely happy now. He is energetic and more independent. The
transplant saved his life.''
In like manner, bone marrow donations provide lifesaving transplants
for a myriad of diseases. Clara was only 4 months old when she was
diagnosed with acute myeloid leukemia. John had registered with the
National Marrow Donor Program Be The Match as a bone marrow donor when
Clara was only 17 days old. It turned out it was a perfect match for
Clara. John's donation saved Clara's life. She is now thriving at 2
years of age.
Mr. Speaker, not only has God in His wisdom and goodness created a
placenta and an umbilical cord to nurture and protect the precious life
of an unborn child, but now, we find He has left a great gift behind.
Immediately after birth, something very special is left behind, cord
blood that is teeming with lifesaving stem cells.
Breathtaking scientific breakthroughs have turned medical waste--
postbirth placentas and umbilical cord blood--into medical miracles,
treating more than 80 diseases, including leukemia, lymphoma, and
sickle cell anemia.
As a matter of fact, Dr. Joanne Kurtzberg of Duke University and
president of the Cord Blood Association told Chairman Pitts'
subcommittee on June 25 that sickle cell anemia can be cured with cord
blood transplantation and that it has become one of the most optimal
donor sources for patients with sickle cell disease.
H.R. 2820, under consideration by the House today, reauthorizes
through 2020 the Stem Cell Therapeutic and Research Act of 2005, a law
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.
Special thanks, Mr. Speaker, 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 my good friend and
colleague Mr. Green.
I am deeply grateful to our original sponsors, Ms. Matsui, Mr. Jolly,
and Mr. Fattah, for their contributions and special thanks to Adrianna
Simonelli, Katie Novaria, and Megan McCrum.
Today, Mr. Speaker, under the National Cord Blood Inventory program,
contracts are awarded to cord blood banks to collect cord blood units
donated after their 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 and cord blood stem cells.
Americans willing to volunteer are at the heart of the success of
this program. In reauthorizing it, we are grateful for the adult donors
willing to donate bone marrow or peripheral blood stem cells, as well
as mothers who donate their baby's cord blood to public cord blood
banks.
There are 13 public banks contracted through the NCBI, including the
New Jersey Cord Blood Bank in my home State, which collects cord blood
from five participating hospitals.
{time} 1645
Mr. Speaker, it ought to be noted as well that, in addition to
treating more than 80 diseases, cord blood units from the NCBI banks
are also available for research on future therapies.
Indeed, Dr. Kurtzberg pointed out that, ``in addition to use in
patients with malignant and genetic diseases, cord blood is showing
enormous potential for use in cellular therapies and other 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
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,'' she testified just a few months ago.
She also pointed out that ``over the past 6 years, we have initiated
trials of the patient's own cord blood in babies with birth asphyxia,
cerebral palsy, hearing loss''; and she is doing some incredible work
on an issue that I have worked on for over 20 years, and that is the
issue and the disability known as autism.
Dr. Kurtzberg finally said, ``We've learned that when a 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.''
Dr. Jeffrey Chell, of Be the Match--he is the CEO for it--noted that
for many diseases, including blood cancers and sickle cell disease,
cellular therapy is the best hope for a cure.
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 they now have turned amniotic membrane,
an old placenta, into wound management that has now advanced--it is on
the market--past stage 3 clinical trials.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. GUTHRIE. I yield the gentleman another 30 seconds.
Mr. SMITH of New Jersey. H.R. 2820 authorizes $265 million over 5
years and will ensure that thousands of present-day and future patients
benefit from this exciting field of regenerative medicine.
We have only just begun. This legislation furthers that work. And
again, I thank my colleagues for this bipartisan support.
Mr. Speaker, Maalik was diagnosed with Hurler Syndrome at 15 months
old--a rare and life-threatening metabolic disorder. He had a curved
spine and could not walk. After receiving an umbilical cord blood
transplant facilitated through the Carolina Blood Bank, Maalik is
running around and expected to have a normal lifespan. His mother
Krystal told the Herald Sun newspaper in North Carolina, ``My son is
extremely happy now . . . He's energetic, and more independent. The
transplant saved his life.''
In like manner, bone marrow donations provide lifesaving transplants
to treat diseases like blood cancer or inherited metabolic or immune
system disorders. Clara was only 4 months old when she was diagnosed
with acute myeloid leukemia. John had registered with the National
Marrow Donor Program (NMDP) Be the Match as a bone marrow donor when
Clara was only 17 days old. It turned out he was a perfect match for
Clara. John's donation saved Clara's life, she is now a thriving 2 year
old.
Valentina was 10 months old and only 13 pounds--and diagnosed with
severe combined immunodeficiency (SCID). Her doctor treated her with
chemotherapy followed by a cord blood transplant. 5 months after the
transplant Valentina weighed 21 pounds and doctors credited her
strengthened immune system from the stem cells in cord blood.
Jennifer, 45, was suffering from acute myeloid leukemia but unable to
find a matched bone-marrow transplant. Because of the high rate of
tissue type diversity among racial and ethnic minorities it can be
difficult to find a matched bone marrow transplant, but umbilical cord
blood can be successfully used for treatment with a less perfect match
of tissue type. After undergoing chemotherapy and radiation she
received a cord blood transplant, and is now living cancer free.
[[Page H5803]]
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.
Breathtaking scientific breakthroughs have turned medical waste--post
birth placentas and umbilical cord blood--into medical miracles
treating more than 80 diseases including leukemia, lymphoma and sickle
cell anemia.
As a matter of fact, Dr. Joanne Kurtzberg of Duke University and
President of the Cord Blood Association told Chairman Pitts' Health
Subcommittee on June 25 that sickle cell anemia can be ``cured'' with
cord blood transplantation and that ``it has become one of the optimal
donor sources for patients with sickle cell disease'' because it
doesn't have to be perfectly matched.
H.R. 2820 under consideration by the House today reauthorizes through
2020 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.
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. And special thanks to Katie Novaria, Adrianna Simonelli,
and Megan McCrum.
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. 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.
Americans willing to volunteer are the heart of the success of this
program. In reauthorizing it we are grateful for the adult donors
willing to donate bone marrow or peripheral blood stem cells, as well
as mothers who donate their babies' cord blood through public cord
blood banks.
There are 13 public banks contracted through NCBI, including the New
Jersey Cord Blood Bank in my home state, which collects cord blood from
5 participating hospitals.
According to the Health Resources and Services Administration (HRSA),
every year 18,000 people in the U.S. are diagnosed with illnesses for
which blood stem cell transplantation from a matched donor is their
best treatment option. Of this number, only about 30% have a sibling
who can be the ideal matched donor, so about 12,600 people annually
depend on the programs made available by this law to find an unrelated
adult marrow donor or cord blood unit for treatment.
Cord blood transplants have accounted for about one half of the
growth in stem cell transplants since NCBI was established in 2005.
More NCBI units have been released for transplantation with each
successive year since the program's inception.
In addition to currently treating more than 80 diseases, 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.''
Dr. Jeffrey W. Chell, CEO of NMDP/Be the Match 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.''
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. GENE GREEN of Texas. Mr. Speaker, I have no other speakers.
I yield back the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield myself the balance of my time to
close with a quick story.
There is a good friend of mine. His name is Philip Schardein, and I
am great friends with his family. He went off to play golf in college--
great athlete. All of a sudden, he came down with leukemia, and I
remember that there were some issues at first about his sister being
able to donate bone marrow.
So my town, Bowling Green, Kentucky, organized a bone marrow drive to
see if anybody could match Philip Schardein. I have probably never been
more proud to call myself a resident of the hometown of Bowling Green
than that day. I remember going three times, and it was so overwhelmed
with volunteers trying to have their bone marrow, the blood type, to
see if they matched, that it just overwhelmed the system.
I remember finally getting through late in the afternoon, and people
waited all day to see if they could match and help Philip Schardein.
And God bless, for whatever reason his sister couldn't donate, it
turned out that she could donate, and he is a healthy person now with
family and children, and everything is going well.
But just about a year after that, I was in Holiday World with my
family. I was having a day with them. My cell phone rang, and it turned
out I had matched, because of going to get my bone marrow tested, or my
blood tested, that I matched someone. The lady got on the phone, and
she told me what it takes to be a donor and, Will you be willing to
move forward? I said, Of course.
I remember the reason I said I was at Holiday World was because I
remember standing there going, here I am with my family having fun,
laughing and having a great afternoon, and there is some family
somewhere that is anonymous, not having the same experience, probably
trying to figure out if their loved one is going to live or survive or
what is going to be the prognosis.
So I went through the process, and I remember going through, having
my blood taken and several of the steps. Just getting close to the
actual time to do the bone marrow transplant, for whatever reason, we
got notified that it wasn't going forward. It could do that for many
reasons. One, hopefully, is the anonymous person was cured or the
prognosis was better, or maybe a sibling or something matched like it
did for Philip Schardein.
But I've often wondered about the life on the other end, because they
don't tell you for reason of anonymity, and it is just something that
has always weighed on my mind. Even sitting here and getting ready to
close, I was thinking about who was on the other end, and I hope that
they have a good story, as well as Philip Schardein.
But what I want to stress is how important it is that families in
need and worry and wondering what is going to happen with their loved
ones, and the loved ones themselves, and this is something we can do.
It was a little thing that I was able to do, that we all were able to
do in my community, and
[[Page H5804]]
people across this country can do to try to help people live long and
fruitful lives.
Our prayers were answered with Philip Schardein, and this is an
opportunity for us to come together, in a bipartisan way, as all the
bills were.
I want to close with this. We have been through four bills in the
last hour, and they are dealing with touching families, and every one
of them has been bipartisan. We have been able to come together and
find where we agree and work together, that we can work for infants,
for families suffering with leukemia and other blood disorders, for
infants with opioid addiction, for parents who have children with early
hearing detection, and that is where we have been able to come together
and work together.
I appreciate the effort of Ranking Member Green in bringing us all
together, and our subcommittee chairman, Mr. Pitts.
I look forward to voting for this bill, and I urge my colleagues to
vote for H.R. 2820. I appreciate my friend, Mr. Smith, for bringing it
forward.
I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, H.R. 820, the ``Stem Cell Therapeutic and
Research Reauthorization Act,'' would continue critical federal support
for the C.W. Bill Young Cell Transplantation Program. This program
includes the Be the Match registry for bone marrow and umbilical cord
blood transplantation which continues to provide hope to people in need
of a lifesaving transplants.
Each year thousands of patients in need of life saving transplants
are unable to find a match within their family and therefore require a
nonrelative donor. That is why 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. The Program also supports the
collection and use of transplantation data to advance medical research.
I'd like to thank Representative Doris Matsui for her leadership in
this area and I urge my colleagues to support H.R. 2820 to ensure that
the lifesaving Be the Match registry continues.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Kentucky (Mr. Guthrie) that the House suspend the rules
and pass the bill, H.R. 2820.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
____________________