[Congressional Record Volume 167, Number 64 (Wednesday, April 14, 2021)]
[House]
[Pages H1752-H1754]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
{time} 1300
TIMELY REAUTHORIZATION OF NECESSARY STEM-CELL PROGRAMS LENDS ACCESS TO
NEEDED THERAPIES ACT OF 2021
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 941) 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. 941
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 ``Timely ReAuthorization of
Necessary Stem-cell Programs Lends Access to Needed Therapies
Act of 2021'' or the ``TRANSPLANT Act of 2021''.
SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL
TRANSPLANTATION PROGRAM.
(a) Advisory Council Meetings.--Subsection (a) of section
379 of the Public Health Service Act (42 U.S.C. 274k) is
amended by adding at the end the following new paragraph:
``(7) The Secretary shall convene the Advisory Council at
least two times each calendar year.''.
(b) Increasing Collection.--
(1) Technical clarification.--Effective as if included in
the enactment of Public Law 114-104 (the Stem Cell
Therapeutic and Research Reauthorization Act of 2015), the
amendment to section 379(d)(2)(B) of the Public Health
Service Act (42 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of
Public Law 114-104 is amended by inserting ``goal of
increasing collections of high quality'' before ``cord blood
units,''.
(2) Eliminating deadwood.--Subparagraph (B) of section
379(d)(2) of the Public Health Service Act (42 U.S.C.
274k(d)(2)) is amended by striking the second and third
sentences in such subparagraph.
(c) Periodic Review of State of Science.--Section 379 of
the Public Health Service Act (42 U.S.C. 274k) is amended by
adding at the end the following new subsection:
``(o) Periodic Review of State of Science.--
``(1) Review.--Not less frequently than every 2 years, the
Secretary, in consultation with the Director of the National
Institutes of Health, the Commissioner of Food and Drugs, the
Administrator of the Health Resources and Services
Administration, the Advisory Council, 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 Program.
``(2) Recommendations.--Not later than June 30, 2025, the
Secretary shall--
``(A) complete the second review required by paragraph (1);
and
``(B) informed by such review, 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 the
inclusion of new types of therapies in the Program.''.
(d) Authorization of Appropriations.--Section 379B of the
Public Health Service Act (42 U.S.C. 274m) is amended by
striking ``$33,000,000 for fiscal year 2015 and $30,000,000
for each of fiscal years 2016 through 2020'' and inserting
``$31,009,000 for each of fiscal years 2022 through 2026''.
SEC. 3. CORD BLOOD INVENTORY.
Subsection (g) of section 2 of the Stem Cell Therapeutic
and Research Act of 2005 (42 U.S.C. 274k note) is amended to
read as follows:
``(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $23,000,000
for each of fiscal years 2022 through 2026.''.
SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDICINE.
Section 402 of the Public Health Service Act (42 U.S.C.
282) is amended by adding at the end the following:
``(o) Regenerative Medicine.--The Director of NIH shall, as
appropriate, continue to consult with the directors of
relevant institutes and centers of the National Institutes of
Health, other relevant experts from such institutes and
centers, and relevant experts within the Food and Drug
Administration, to further the field of regenerative medicine
using adult stem cells, including autologous stem cells,
therapeutic tissue engineering products, human cell and
tissue products, human gene therapies, and genetically
modified cells.''.
SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORKFORCE.
Not later than 2 years after the date of enactment of this
Act, the Comptroller General of the United States shall
submit to the Committee on Health, Education, Labor, and
[[Page H1753]]
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report that
assesses a specialized health care workforce in the field of
regenerative medicine. The report shall include--
(1) an overview of the current employment levels, in both
commercial and academic settings, for--
(A) positions necessary for the collection and
transplantation of stem cell therapeutics, including bone
marrow and cord blood; and
(B) positions in the field of regenerative medicine using
adult stem cells and related to product development;
(2) the identification of gaps, if any, in the projected
workforce capacity for--
(A) positions described in paragraph (1)(A); and
(B) the field of regenerative medicine using adult stem
cells, including workforce gaps related to the development of
new cellular therapies using adult stem cells;
(3) an overview of the availability of training programs
related to the development, refinement, and utilization of
adult stem cells, including training on good manufacturing
practices for such activities, and the performance of such
programs; and
(4) recommendations, if any, for improving the workforce
capacity related to--
(A) the positions described in paragraph (1)(A); or
(B) the field of regenerative medicine using adult stem
cells.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Florida (Mr. Bilirakis)
each will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 941.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, the C.W. Bill Young Transplant Program and the National
Cord Blood Inventory Program facilitate lifesaving bone marrow and
umbilical cord blood donations to help patients suffering from blood
cancers, disorders, and diseases.
These critical programs assist transplant patients by providing
additional information about bone marrow and cord blood transplants,
maintaining an efficient process for identifying donor matches, and
increasing the number of unrelated donors available for transplant. The
programs also collect data and expand research to improve patient
outcomes.
I thank my colleagues--Representatives Matsui, Bilirakis, and
Pingree--for their bipartisan leadership on this bill, and I would urge
my colleagues to support H.R. 941.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 941, the Timely
Reauthorization of Necessary Stem-Cell Programs Lends Access to Needed
Therapies Act, or the TRANSPLANT Act.
As co-chair of the Blood Cancers Caucus, I urge my colleagues to
support the TRANSPLANT Act. This bill is about providing hope to those
who are struggling with life-threatening illnesses. The TRANSPLANT Act
reauthorizes the C.W. Bill Young Transplant Program, in addition to the
National Cord Blood Inventory Program.
I remember Bill Young, Chairman Young, a great friend of ours, and he
said that this was one of his greatest accomplishments. I also know
that Chris Smith, who will be speaking later, was also involved in
this. He has been a champion on this issue, Mr. Speaker. So I
appreciate both of them.
This Federal program provides critical support in the advancement of
research for better treatments and the infrastructure necessary to
organize registries, which will help ensure transplant patients have
access to lifesaving procedures. Simply put, its continued
reauthorization is vital for patients with diseases like blood cancer,
sickle cell anemia, and inherited metabolic or immune system disorders.
I sincerely appreciate the work of my friend and colleague and fellow
Blood Cancers Caucus co-chair, Congresswoman Matsui, in addition to the
legacy of bipartisan leadership and support of these programs by
Members like, as I said, Chris Smith.
I thank the chairman, as well and the ranking member, for placing
this particular bill on the agenda. I know it will get through the
Senate this time.
Additionally, I appreciate the critical daily work of the National
Marrow Donor Program, operating the Be the Match national registry,
connecting patients in search of a cure with lifesaving bone marrow
donors, even in the midst of this historic pandemic.
I would also like to take a moment to recognize the great work of Dr.
Joanne Kurtzberg, the president of the Cord Blood Association. She also
serves in multiple roles at Duke University, including the director of
Carolinas Cord Blood Bank. Dr. Kurtzberg has dedicated her professional
career to cord blood research, banking, and transplantation; and she is
an internationally recognized umbilical cord blood transplanter. She
advised Congress on the creation of the public cord blood banking
program, which was part of the Stem Cell Therapeutic and Research Act
of 2005. Dr. Kurtzberg continues to be a trusted adviser to Congress on
this important program.
Mr. Speaker, I urge all my colleagues to join us in expediting
passage of this lifesaving bipartisan bill.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I have no additional speakers, but I think
my colleague does, so I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield 4 minutes to the gentleman from
New Jersey (Mr. Smith).
Mr. SMITH of New Jersey. Mr. Speaker, I thank the gentleman for
yielding.
Mr. Speaker, today, the House of Representatives will vote to
reauthorize the Stem Cell Therapeutic and Research Act, a law that I
authored in 2005. This was an original idea of mine 20 years ago.
My good friend from Florida just mentioned Dr. Kurtzberg. Dr.
Kurtzberg was in the meetings that we held in drafting this
legislation, and she provided incredible insights as to what we should
do, what path we should follow. So I appreciate him recognizing her.
I also thank Artur Davis, who was my Democratic colleague and the
principal Democratic cosponsor of the bill during those several years.
It took 5 long years of hard work and numerous setbacks, but the bill
was finally signed into law on December 20, 2005.
The new law created a nationwide umbilical cord blood stem cell
program designed to collect, derive, type, and freeze cord blood units
for transplantation into patients to mitigate and even cure serious
disease. Pursuant to the law, it also provided stem cells for research.
The new cord blood program was combined with an expanded bone marrow
initiative, which was crafted over several years by our distinguished
colleague, Congressman Bill Young.
Umbilical cord blood stem cells, Mr. Speaker, obtained after the
birth of a child have proved to be highly efficacious in treating some
70 diseases, including sickle cell disease, lymphoma, leukemia, and in
treating metabolic and immune deficiencies. Scientists are continuing
to study and better understand the regenerative effects of cord blood
cell therapies for other diseases and disabilities, including autism. I
would say in like manner, bone marrow donations are also providing
lifesaving transplants for some of those very same diseases. So we have
great regenerative initiatives that will be continued.
The National Cord Blood Inventory, NCBI, provides funding to public
cord blood banks participating in the program to allow them to expand
the national inventory of cord blood units available for transplant.
These units are then listed on the registry by the Be the Match
program. The funds appropriated thus far have led to an important
increase in the overall number of high-quality cord blood units
available through the national registry, now totaling 111,000 NCBI
units. Within the Be the Match Registry, there are now more than
800,000 worldwide.
The program registry, Mr. Speaker, allows patients and physicians to
locate matching cord blood units, as well as adult donors for marrow
and peripheral blood stem cells. The program is the world's largest,
most diverse donor registry, with more than 23 million volunteers. To
date, the National Marrow Donor Program/Be the Match, through its
operation of the program, has facilitated more than 105,000
transplants.
[[Page H1754]]
According to Be the Match, more than 40,000 patients have received cord
blood transplants.
The reauthorization before us authorizes $23 million each year for 5
years for the cord blood side and, again, some $30 million each year
for the bone marrow program.
Mr. Speaker, each year, nearly 4 million babies are born in America.
In the past, virtually every placenta and umbilical cord was tossed as
medical waste. Today, doctors have turned this medical waste into
medical miracles.
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 know that another gift awaits immediately after
birth. Something very special is left behind: Cord blood that is
teeming with lifesaving stem cells.
Mr. BILIRAKIS. Mr. Speaker, this is a very important bill and needs
to pass as soon as possible. I really appreciate the chairman placing
the bill on the agenda. I urge the Senate to pass it as soon as
possible, and, of course, my colleagues today, if we can pass this bill
immediately so we can get it to the Senate.
Mr. Speaker, I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I also urge support for the bill, and I
yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 941.
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. CLINE. Mr. Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
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