Timely Reauthorization of Necessary Stem-Cell Programs Lends Access to Needed Therapies Act of 2019
Floor Speech
BREAK IN TRANSCRIPT
Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 4764) to reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows: H.R. 4764
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 2020'' or the ``TRANSPLANT Act of 2020''. 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 than every two 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, 2024, 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 ``$30,000,000 for each of fiscal years 2021 through 2025''. 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 2021 through 2025.''. 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 Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that assesses the national blood stem cell workforce, including those related to the C.W. Bill Young Cell Transplantation Program established under section 379 of the Public Health Service Act (42 U.S.C. 274k). 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.
BREAK IN TRANSCRIPT
Mr. PALLONE. 4764.
BREAK IN TRANSCRIPT
Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, the C.W. Bill Young Transplantation Program was first established through a partnership with the Navy in 1986, transferred to the National Institutes of Health for oversight in 1987, and then authorized by the Energy and Commerce Committee in 1990. The program has since been reauthorized four times, and every time it has been accomplished with strong bipartisan support.
I believe that bipartisan support will continue today with H.R. 4764, the TRANSPLANT Act of 2019, which will reauthorize the C.W. Bill Young Transplantation Program for the fifth time.
Year after year, this program provides lifesaving bone marrow and umbilical cord blood transplants to help patients suffering from over 70 diseases. The program assists transplant patients by providing additional information about bone marrow and cord blood transplants, maintaining an efficient process for identifying donor matches, increasing the number of unrelated donors available for transplant, and collecting data and expanding research to improve patient outcomes.
I thank my committee colleagues, Representatives Matsui and Bilirakis, for their leadership on this bill.
Madam Speaker, I urge my colleagues to support this bill, and I reserve the balance of my time.
BREAK IN TRANSCRIPT
Mr. PALLONE. Madam Speaker, I also ask for bipartisan support for this legislation. I mention that I do intend to seek a recorded vote.
Madam Speaker, I yield back the balance of my time.
Mr. SMITH of New Jersey. Madam Speaker, Margaret Hahn--my mother-in- law--passed away on Friday and a Mass of Christian burial will be held today at St. Mary Church in South Amboy, New Jersey. She was 96 and was deeply loved and will be deeply missed.
Margaret--Peg--was a great woman--wife, mother, grandmother, and great-grandmother. She selflessly devoted her life to public service including her amazing work as Sayreville Borough Clerk for twenty years. She had an incredible reputation for getting things done for the people. No matter who served as mayor or on Council, everyone knew she was the power.
My wife Marie and I will join family and friends today at her funeral and internment making it impossible for me to speak today during the debate on the reauthorization of a law I originally authored fifteen years ago--the Stem Cell Therapeutic and Research Act of 2005--and the Stem Cell Therapeutic and Research Act of 2015.
So, I submit these comments for the Record:
Madam Speaker, today the House of Representatives will vote to reauthorize the Stem Cell Therapeutic and Research Act.
This was an original idea of mine 20 years ago. Joined by 70 cosponsors, I introduced it in 2001 and again in 2003.
After five long years of hard work and numerous setbacks, my bill was finally enacted into law in 2005.
Beginning in 2001, Dr. Joanne Kurtzberg, who is President of the Cord Blood Association, helped draft my original law. Dr. Kurtzberg has said, ``Cord blood transplantation is now an established field with enormous potential. In the future, it may emerge as a source of cells for cellular therapies focused on tissue repair and regeneration.''
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 to even cure serious disease. Pursuant to the law, it also provided stem cells for research. The new cord blood program was combined in our 2005 law with an expanded bone marrow initiative, which was crafted over several years by our distinguished colleague, Congressman Bill Young.
I was the prime sponsor again when it was reauthorized in 2015.
Umbilical cord blood stem cells, obtained after the birth of a child, have proved highly efficacious in treating 70 diseases, including sickle-cell disease, lymphoma, and leukemia. And scientists are continuing to study and better understand the regenerative effects of cord blood cell therapies for other diseases and conditions. Bone marrow donations provide lifesaving transplants to treat diseases like blood cancer, sickle cell anemia, or inherited metabolic or immune system disorders.
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, including 150,000 NCBI units. Within the Be the Match registry, there are more than 783,000 NCBI units worldwide.
The Program registry allows patients and physicians to locate matching cord blood units, as well as adult donors for marrow and peripheral blood stem cells, when a family donor is not available. The Program is the world's largest, most diverse donor registry, with more than 22 million volunteers and more than 300,000 public cord blood units. To date, the National Marrow Donor Program/Be The Match (NMDP), through its operation of the Program, has facilitated more than 100,000 transplants. More than 45,000 patients have received cord blood transplants, according to Dr. Joanne Kurtzberg.
The reauthorization before us authorizes $23 million to be appropriated for fiscal year 2021 through fiscal year 2025. It also authorizes $30 million to be appropriated for fiscal years 2021 through 2025 for the bone marrow transplant program. This continues funding at the same levels authorized in the 2015 authorization bill.
Madam 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 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. Indeed, it remains one of the best kept secrets in America that umbilical cord blood stem cells and adult stem cells in general are curing people of a myriad of terrible conditions and diseases--over 70 diseases in adults as well as in children.
The legislation that is before us will enable even more patients to receive the treatments that they so desperately need.
BREAK IN TRANSCRIPT
Mr. PALLONE. Madam Speaker, on that I demand the yeas and nays.
BREAK IN TRANSCRIPT
Source