[Congressional Record Volume 151, Number 163 (Saturday, December 17, 2005)]
[House]
[Pages H12063-H12072]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005
Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and
concur in the Senate amendment to the bill (H.R. 2520) to provide for
the collection and maintenance of human cord blood stem cells for the
treatment of patients and research, and to amend the Public Health
Service Act to authorize the C.W. Bill Young Cell Transplantation
Program.
The Clerk read 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 Act of 2005''.
SEC. 2. CORD BLOOD INVENTORY.
(a) In General.--The Secretary of Health and Human Services
shall enter into one-time contracts with qualified cord blood
banks to assist in the collection and maintenance of 150,000
new units of high-quality cord blood to be made available for
transplantation through the C.W. Bill Young Cell
Transplantation Program and to carry out the requirements of
subsection (b).
(b) Requirements.--The Secretary shall require each
recipient of a contract under this section--
(1) to acquire, tissue-type, test, cryopreserve, and store
donated units of cord blood acquired with the informed
consent of the donor, as determined by the Secretary pursuant
to section 379(c) of the Public Health Service Act, in a
manner that complies with applicable Federal and State
regulations;
(2) to encourage donation from a genetically diverse
population;
(3) to make cord blood units that are collected pursuant to
this section or otherwise and meet all applicable Federal
standards available to transplant centers for
transplantation;
(4) to make cord blood units that are collected, but not
appropriate for clinical use, available for peer-reviewed
research;
(5) to make data available, as required by the Secretary
and consistent with section 379(d)(3) of the Public Health
Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act,
in a standardized electronic format, as determined by the
Secretary, for the C.W. Bill Young Cell Transplantation
Program; and
(6) to submit data in a standardized electronic format for
inclusion in the stem cell therapeutic outcomes database
maintained under section 379A of the Public Health Service
Act, as amended by this Act.
(c) Related Cord Blood Donors.--
(1) In general.--The Secretary shall establish a 3-year
demonstration project under which qualified cord blood banks
receiving a contract under this section may use a portion of
the funding under such contract for the collection and
storage of cord blood units for a family where a first-degree
relative has been diagnosed with a condition that will
benefit from transplantation (including selected blood
disorders, malignancies, metabolic storage disorders,
hemoglobinopathies, and congenital immunodeficiencies) at no
cost to such family. Qualified cord blood banks collecting
cord blood units under this paragraph shall comply with the
requirements of paragraphs (1), (2), (3), and (5) of
subsection (b).
(2) Availability.--Qualified cord blood banks that are
operating a program under paragraph (1) shall provide
assurances that the cord blood units in such banks will be
available for directed transplantation until such time that
the cord blood unit is released for transplantation or is
transferred by the family to the C.W. Bill Young Cell
Transplantation Program in accordance with guidance or
regulations promulgated by the Secretary.
(3) Inventory.--Cord blood units collected through the
program under this section shall not be counted toward the
150,000 inventory goal under the C.W. Bill Young Cell
Transplantation Program.
(4) Report.--Not later than 90 days after the date on which
the project under paragraph (1) is terminated by the
Secretary, the Secretary shall submit to Congress a report on
the outcomes of the project that shall include the
recommendations of the Secretary with respect to the
continuation of such project.
(d) Application.--To seek to enter into a contract under
this section, a qualified cord blood bank shall submit an
application to the Secretary at such time, in such manner,
and containing such information as the Secretary may
reasonably require. At a minimum, an application for a
contract under this section shall include a requirement that
the applicant--
(1) will participate in the C.W. Bill Young Cell
Transplantation Program for a period of at least 10 years;
(2) will make cord blood units collected pursuant to this
section available through the C.W. Bill Young Cell
Transplantation Program in perpetuity or for such time as
determined viable by the Secretary; and
(3) if the Secretary determines through an assessment, or
through petition by the applicant, that a cord blood bank is
no longer operational or does not meet the requirements of
section 379(d)(4) of the Public Health Service Act (as added
by this Act) and as a result may not distribute the units,
transfer the units collected pursuant to this section to
another qualified cord blood bank approved by the Secretary
to ensure continued availability of cord blood units.
(e) Duration of Contracts.--
(1) In general.--Except as provided in paragraph (2), the
term of each contract entered into by the Secretary under
this section shall be for 10 years. The Secretary shall
ensure that no Federal funds shall be obligated under any
such contract after the earlier of--
(A) the date that is 3 years after the date on which the
contract is entered into; or
(B) September 30, 2010.
(2) Extensions.--Subject to paragraph (1)(B), the Secretary
may extend the period of funding under a contract under this
section to exceed a period of 3 years if--
(A) the Secretary finds that 150,000 new units of high-
quality cord blood have not yet been collected pursuant to
this section; and
(B) the Secretary does not receive an application for a
contract under this section from any
[[Page H12064]]
qualified cord blood bank that has not previously entered
into a contract under this section or the Secretary
determines that the outstanding inventory need cannot be met
by the one or more qualified cord blood banks that have
submitted an application for a contract under this section.
(3) Preference.--In considering contract extensions under
paragraph (2), the Secretary shall give preference to
qualified cord blood banks that the Secretary determines have
demonstrated a superior ability to satisfy the requirements
described in subsection (b) and to achieve the overall goals
for which the contract was awarded.
(f) Regulations.--The Secretary may promulgate regulations
to carry out this section.
(g) Definitions.--In this section:
(1) The term ``C. W. Bill Young Cell Transplantation
Program'' means the C.W. Bill Young Cell Transplantation
Program under section 379 of the Public Health Service Act,
as amended by this Act.
(2) The term ``cord blood donor'' means a mother who has
delivered a baby and consents to donate the neonatal blood
remaining in the placenta and umbilical cord after separation
from the newborn baby.
(3) The term ``cord blood unit'' means the neonatal blood
collected from the placenta and umbilical cord of a single
newborn baby.
(4) The term ``first-degree relative'' means a sibling or
parent who is one meiosis away from a particular individual
in a family.
(5) The term ``qualified cord blood bank'' has the meaning
given to that term in section 379(d)(4) of the Public Health
Service Act, as amended by this Act.
(6) The term ``Secretary'' means the Secretary of Health
and Human Services.
(h) Authorization of Appropriations.--
(1) Existing funds.--Any amounts appropriated to the
Secretary for fiscal year 2004 or 2005 for the purpose of
assisting in the collection or maintenance of cord blood
shall remain available to the Secretary until the end of
fiscal year 2007.
(2) Subsequent fiscal years.--There are authorized to be
appropriated to the Secretary $15,000,000 for each of fiscal
years 2007, 2008, 2009, and 2010 to carry out this section.
(3) Limitation.--Not to exceed 5 percent of the amount
appropriated under this section in each of fiscal years 2007
through 2009 may be used to carry out the demonstration
project under subsection (c).
SEC. 3. C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM.
(a) National Program.--Section 379 of the Public Health
Service Act (42 U.S.C. 274k) is amended to read as follows:
``SEC. 379. NATIONAL PROGRAM.
``(a) Establishment.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall by one or more contracts establish and
maintain a C.W. Bill Young Cell Transplantation Program
(referred to in this section as the `Program'), successor to
the National Bone Marrow Donor Registry, that has the purpose
of increasing the number of transplants for recipients
suitably matched to biologically unrelated donors of bone
marrow and cord blood, and that meets the requirements of
this section. The Secretary may award a separate contract to
perform each of the major functions of the Program described
in paragraphs (1) and (2) of subsection (d) if deemed
necessary by the Secretary to operate an effective and
efficient system that is in the best interest of patients.
The Secretary shall conduct a separate competition for the
initial establishment of the cord blood functions of the
Program. The Program shall be under the general supervision
of the Secretary. The Secretary shall establish an Advisory
Council to advise, assist, consult with, and make
recommendations to the Secretary on matters related to the
activities carried out by the Program. The members of the
Advisory Council shall be appointed in accordance with the
following:
``(1) Each member of the Advisory Council shall serve for a
term of 2 years, and each such member may serve as many as 3
consecutive 2-year terms, except that
``(A) such limitations shall not apply to the Chair of the
Advisory Council (or the Chair-elect) or to the member of the
Advisory Council who most recently served as the Chair; and
``(B) 1 additional consecutive 2-year term may be served by
any member of the Advisory Council who has no employment,
governance, or financial affiliation with any donor center,
recruitment organization, transplant center, or cord blood
bank.
``(2) A member of the Advisory Council may continue to
serve after the expiration of the term of such member until a
successor is appointed.
``(3) In order to ensure the continuity of the Advisory
Council, the Advisory Council shall be appointed so that each
year the terms of approximately one-third of the members of
the Advisory Council expire.
``(4) The membership of the Advisory Council--
``(A) shall include as voting members a balanced number of
representatives including representatives of marrow donor
centers and marrow transplant centers, representatives of
cord blood banks and participating birthing hospitals,
recipients of a bone marrow transplant, recipients of a cord
blood transplant, persons who require such transplants,
family members of such a recipient or family members of a
patient who has requested the assistance of the Program in
searching for an unrelated donor of bone marrow or cord
blood, persons with expertise in bone marrow and cord blood
transplantation, persons with expertise in typing, matching,
and transplant outcome data analysis, persons with expertise
in the social sciences, basic scientists with expertise in
the biology of adult stem cells, and members of the general
public; and
``(B) shall include as nonvoting members representatives
from the Department of Defense Marrow Donor Recruitment and
Research Program operated by the Department of the Navy, the
Division of Transplantation of the Health Resources and
Services Administration, the Food and Drug Administration,
and the National Institutes of Health.
``(5) Members of the Advisory Council shall be chosen so as
to ensure objectivity and balance and reduce the potential
for conflicts of interest. The Secretary shall establish
bylaws and procedures--
``(A) to prohibit any member of the Advisory Council who
has an employment, governance, or financial affiliation with
a donor center, recruitment organization, transplant center,
or cord blood bank from participating in any decision that
materially affects the center, recruitment organization,
transplant center, or cord blood bank; and
``(B) to limit the number of members of the Advisory
Council with any such affiliation.
``(6) The Secretary, acting through the Advisory Council,
shall submit to the Congress--
``(A) an annual report on the activities carried out under
this section; and
``(B) not later than 6 months after the date of the
enactment of the Stem Cell Therapeutic and Research Act of
2005, a report of recommendations on the scientific factors
necessary to define a cord blood unit as a high-quality unit.
``(b) Accreditation.--The Secretary shall, through a public
process, recognize one or more accreditation entities for the
accreditation of cord blood banks.
``(c) Informed Consent.--The Secretary shall, through a
public process, examine issues of informed consent,
including--
``(1) the appropriate timing of such consent; and
``(2) the information provided to the maternal donor
regarding all of her medically appropriate cord blood
options.
Based on such examination, the Secretary shall require that
the standards used by the accreditation entities recognized
under subsection (b) ensure that a cord blood unit is
acquired with the informed consent of the maternal donor.
``(d) Functions.--
``(1) Bone marrow functions.--With respect to bone marrow,
the Program shall--
``(A) operate a system for identifying, matching, and
facilitating the distribution of bone marrow that is suitably
matched to candidate patients;
``(B) consistent with paragraph (3), permit transplant
physicians, other appropriate health care professionals, and
patients to search by means of electronic access all
available bone marrow donors listed in the Program;
``(C) carry out a program for the recruitment of bone
marrow donors in accordance with subsection (e), including
with respect to increasing the representation of racial and
ethnic minority groups (including persons of mixed ancestry)
in the enrollment of the Program;
``(D) maintain and expand medical contingency response
capabilities, in coordination with Federal programs, to
prepare for and respond effectively to biological, chemical,
or radiological attacks, and other public health emergencies
that can damage marrow, so that the capability of supporting
patients with marrow damage from disease can be used to
support casualties with marrow damage;
``(E) carry out informational and educational activities in
accordance with subsection (e);
``(F) at least annually update information to account for
changes in the status of individuals as potential donors of
bone marrow;
``(G) provide for a system of patient advocacy through the
office established under subsection (h);
``(H) provide case management services for any potential
donor of bone marrow to whom the Program has provided a
notice that the potential donor may be suitably matched to a
particular patient through the office established under
subsection (h);
``(I) with respect to searches for unrelated donors of bone
marrow that are conducted through the system under
subparagraph (A), collect, analyze, and publish data in a
standardized electronic format on the number and percentage
of patients at each of the various stages of the search
process, including data regarding the furthest stage reached,
the number and percentage of patients who are unable to
complete the search process, and the reasons underlying such
circumstances;
``(J) support studies and demonstration and outreach
projects for the purpose of increasing the number of
individuals who are willing to be marrow donors to ensure a
genetically diverse donor pool; and
``(K) facilitate research with the appropriate Federal
agencies to improve the availability, efficiency, safety, and
cost of transplants from unrelated donors and the
effectiveness of Program operations.
``(2) Cord blood functions.--With respect to cord blood,
the Program shall--
``(A) operate a system for identifying, matching, and
facilitating the distribution of donated cord blood units
that are suitably matched to candidate patients and meet all
applicable Federal and State regulations (including informed
consent and Food and Drug Administration regulations) from a
qualified cord blood bank;
``(B) consistent with paragraph (3), allow transplant
physicians, other appropriate health care professionals, and
patients to search by means of electronic access all
available cord blood units made available through the
Program;
``(C) allow transplant physicians and other appropriate
health care professionals to reserve, as defined by the
Secretary, a cord blood unit for transplantation;
``(D) support studies and demonstration and outreach
projects for the purpose of increasing
[[Page H12065]]
cord blood donation to ensure a genetically diverse
collection of cord blood units;
``(E) provide for a system of patient advocacy through the
office established under subsection (h);
``(F) coordinate with the qualified cord blood banks to
support informational and educational activities in
accordance with subsection (g);
``(G) maintain and expand medical contingency response
capabilities, in coordination with Federal programs, to
prepare for and respond effectively to biological, chemical,
or radiological attacks, and other public health emergencies
that can damage marrow, so that the capability of supporting
patients with marrow damage from disease can be used to
support casualties with marrow damage; and
``(H) with respect to the system under subparagraph (A),
collect, analyze, and publish data in a standardized
electronic format, as required by the Secretary, on the
number and percentage of patients at each of the various
stages of the search process, including data regarding the
furthest stage reached, the number and percentage of patients
who are unable to complete the search process, and the
reasons underlying such circumstances.
``(3) Single point of access; standard data.--
``(A) Single point of access.--The Secretary shall ensure
that health care professionals and patients are able to
search electronically for and facilitate access to, in the
manner and to the extent defined by the Secretary and
consistent with the functions described in paragraphs (1)(A)
and (2)(A), cells from bone marrow donors and cord blood
units through a single point of access.
``(B) Standard data.--The Secretary shall require all
recipients of contracts under this section to make available
a standard dataset for purposes of subparagraph (A) in a
standardized electronic format that enables transplant
physicians to compare among and between bone marrow donors
and cord blood units to ensure the best possible match for
the patient.
``(4) Definition.--The term `qualified cord blood bank'
means a cord blood bank that--
``(A) has obtained all applicable Federal and State
licenses, certifications, registrations (including pursuant
to the regulations of the Food and Drug Administration), and
other authorizations required to operate and maintain a cord
blood bank;
``(B) has implemented donor screening, cord blood
collection practices, and processing methods intended to
protect the health and safety of donors and transplant
recipients to improve transplant outcomes, including with
respect to the transmission of potentially harmful infections
and other diseases;
``(C) is accredited by an accreditation entity recognized
by the Secretary under subsection (b);
``(D) has established a system of strict confidentiality to
protect the identity and privacy of patients and donors in
accordance with existing Federal and State law;
``(E) has established a system for encouraging donation by
a genetically diverse group of donors; and
``(F) has established a system to confidentially maintain
linkage between a cord blood unit and a maternal donor.
``(e) Bone Marrow Recruitment; Priorities; Information and
Education.--
``(1) Recruitment; priorities.--The Program shall carry out
activities for the recruitment of bone marrow donors. Such
recruitment program shall identify populations that are
underrepresented among potential donors enrolled with the
Program. In the case of populations that are identified under
the preceding sentence:
``(A) The Program shall give priority to carrying out
activities under this part to increase representation for
such populations in order to enable a member of such a
population, to the extent practicable, to have a probability
of finding a suitable unrelated donor that is comparable to
the probability that an individual who is not a member of an
underrepresented population would have.
``(B) The Program shall consider racial and ethnic minority
groups (including persons of mixed ancestry) to be
populations that have been identified for purposes of this
paragraph, and shall carry out subparagraph (A) with respect
to such populations.
``(2) Information and education regarding recruitment;
testing and enrollment.--
``(A) In general.--The Program shall carry out
informational and educational activities, in coordination
with organ donation public awareness campaigns operated
through the Department of Health and Human Services, for
purposes of recruiting individuals to serve as donors of bone
marrow, and shall test and enroll with the Program potential
bone marrow donors. Such information and educational
activities shall include the following:
``(i) Making information available to the general public,
including information describing the needs of patients with
respect to donors of bone marrow.
``(ii) Educating and providing information to individuals
who are willing to serve as potential bone marrow donors.
``(iii) Training individuals in requesting individuals to
serve as potential bone marrow donors.
``(B) Priorities.--In carrying out informational and
educational activities under subparagraph (A), the Program
shall give priority to recruiting individuals to serve as
donors of bone marrow for populations that are identified
under paragraph (1).
``(3) Transplantation as treatment option.--In addition to
activities regarding recruitment, the recruitment program
under paragraph (1) shall provide information to physicians,
other health care professionals, and the public regarding
bone marrow transplants from unrelated donors as a treatment
option.
``(4) Implementation of subsection.--The requirements of
this subsection shall be carried out by the entity that has
been awarded a contract by the Secretary under subsection (a)
to carry out the functions described in subsection (d)(1).
``(f) Bone Marrow Criteria, Standards, and Procedures.--The
Secretary shall enforce, for participating entities,
including the Program, individual marrow donor centers,
marrow donor registries, marrow collection centers, and
marrow transplant centers--
``(1) quality standards and standards for tissue typing,
obtaining the informed consent of donors, and providing
patient advocacy;
``(2) donor selection criteria, based on established
medical criteria, to protect both the donor and the recipient
and to prevent the transmission of potentially harmful
infectious diseases such as the viruses that cause hepatitis
and the etiologic agent for Acquired Immune Deficiency
Syndrome;
``(3) procedures to ensure the proper collection and
transportation of the marrow;
``(4) standards for the system for patient advocacy
operated under subsection (h), including standards requiring
the provision of appropriate information (at the start of the
search process and throughout the process) to patients and
their families and physicians;
``(5) standards that--
``(A) require the establishment of a system of strict
confidentiality of records relating to the identity, address,
HLA type, and managing marrow donor center for marrow donors
and potential marrow donors; and
``(B) prescribe the purposes for which the records
described in subparagraph (A) may be disclosed, and the
circumstances and extent of the disclosure; and
``(6) in the case of a marrow donor center or marrow donor
registry participating in the program, procedures to ensure
the establishment of a method for integrating donor files,
searches, and general procedures of the center or registry
with the Program.
``(g) Cord Blood Recruitment; Priorities; Information and
Education.--
``(1) Recruitment; priorities.--The Program shall support
activities, in cooperation with qualified cord blood banks,
for the recruitment of cord blood donors. Such recruitment
program shall identify populations that are underrepresented
among cord blood donors. In the case of populations that are
identified under the preceding sentence:
``(A) The Program shall give priority to supporting
activities under this part to increase representation for
such populations in order to enable a member of such a
population, to the extent practicable, to have a probability
of finding a suitable cord blood unit that is comparable to
the probability that an individual who is not a member of an
underrepresented population would have.
``(B) The Program shall consider racial and ethnic minority
groups (including persons of mixed ancestry) to be
populations that have been identified for purposes of this
paragraph, and shall support activities under subparagraph
(A) with respect to such populations.
``(2) Information and education regarding recruitment;
testing and donation.--
``(A) In general.--In carrying out the recruitment program
under paragraph (1), the Program shall support informational
and educational activities in coordination with qualified
cord blood banks and organ donation public awareness
campaigns operated through the Department of Health and Human
Services, for purposes of recruiting pregnant women to serve
as donors of cord blood. Such information and educational
activities shall include the following:
``(i) Making information available to the general public,
including information describing the needs of patients with
respect to cord blood units.
``(ii) Educating and providing information to pregnant
women who are willing to donate cord blood units.
``(iii) Training individuals in requesting pregnant women
to serve as cord blood donors.
``(B) Priorities.--In carrying out informational and
educational activities under subparagraph (A), the Program
shall give priority to supporting the recruitment of pregnant
women to serve as donors of cord blood for populations that
are identified under paragraph (1).
``(3) Transplantation as treatment option.--In addition to
activities regarding recruitment, the recruitment program
under paragraph (1) shall provide information to physicians,
other health care professionals, and the public regarding
cord blood transplants from donors as a treatment option.
``(4) Implementation of subsection.--The requirements of
this subsection shall be carried out by the entity that has
been awarded a contract by the Secretary under subsection (a)
to carry out the functions described in subsection (d)(2).
``(h) Patient Advocacy and Case Management for Bone Marrow
and Cord Blood.--
``(1) In general.--The Secretary shall establish and
maintain, through a contract or other means determined
appropriate by the Secretary, an office of patient advocacy
(in this subsection referred to as the `Office').
``(2) General functions.--The Office shall meet the
following requirements:
``(A) The Office shall be headed by a director.
``(B) The Office shall be staffed by individuals with
expertise in bone marrow and cord blood therapy covered under
the Program.
``(C) The Office shall operate a system for patient
advocacy, which shall be separate from mechanisms for donor
advocacy, and which shall serve patients for whom the Program
is conducting, or has been requested to conduct, a search for
a bone marrow donor or cord blood unit.
[[Page H12066]]
``(D) In the case of such a patient, the Office shall serve
as an advocate for the patient by directly providing to the
patient (or family members, physicians, or other individuals
acting on behalf of the patient) individualized services with
respect to efficiently utilizing the system under paragraphs
(1) and (2) of subsection (d) to conduct an ongoing search
for a bone marrow donor or cord blood unit and assist with
information regarding third party payor matters.
``(E) In carrying out subparagraph (D), the Office shall
monitor the system under paragraphs (1) and (2) of subsection
(d) to determine whether the search needs of the patient
involved are being met, including with respect to the
following:
``(i) Periodically providing to the patient (or an
individual acting on behalf of the patient) information
regarding bone marrow donors or cord blood units that are
suitably matched to the patient, and other information
regarding the progress being made in the search.
``(ii) Informing the patient (or such other individual) if
the search has been interrupted or discontinued.
``(iii) Identifying and resolving problems in the search,
to the extent practicable.
``(F) The Office shall ensure that the following data are
made available to patients:
``(i) The resources available through the Program.
``(ii) A comparison of transplant centers regarding search
and other costs that prior to transplantation are charged to
patients by transplant centers.
``(iii) The post-transplant outcomes for individual
transplant centers.
``(iv) Information concerning issues that patients may face
after a transplant.
``(v) Such other information as the Program determines to
be appropriate.
``(G) The Office shall conduct surveys of patients (or
family members, physicians, or other individuals acting on
behalf of patients) to determine the extent of satisfaction
with the system for patient advocacy under this subsection,
and to identify ways in which the system can be improved to
best meet the needs of patients.
``(3) Case management.--
``(A) In general.--In serving as an advocate for a patient
under paragraph (2), the Office shall provide individualized
case management services directly to the patient (or family
members, physicians, or other individuals acting on behalf of
the patient), including--
``(i) individualized case assessment; and
``(ii) the functions described in paragraph (2)(D)
(relating to progress in the search process).
``(B) Postsearch functions.--In addition to the case
management services described in paragraph (1) for patients,
the Office shall, on behalf of patients who have completed
the search for a bone marrow donor or cord blood unit,
provide information and education on the process of receiving
a transplant, including the post-transplant process.
``(i) Comment Procedures.--The Secretary shall establish
and provide information to the public on procedures under
which the Secretary shall receive and consider comments from
interested persons relating to the manner in which the
Program is carrying out the duties of the Program. The
Secretary may promulgate regulations under this section.
``(j) Consultation.--In developing policies affecting the
Program, the Secretary shall consult with the Advisory
Council, the Department of Defense Marrow Donor Recruitment
and Research Program operated by the Department of the Navy,
and the board of directors of each entity awarded a contract
under this section.
``(k) Contracts.--
``(1) Application.--To be eligible to enter into a contract
under this section, an entity shall submit to the Secretary
and obtain approval of an application at such time, in such
manner, and containing such information as the Secretary
shall by regulation prescribe.
``(2) Considerations.--In awarding contracts under this
section, the Secretary shall give consideration to the
continued safety of donors and patients and other factors
deemed appropriate by the Secretary.
``(l) Eligibility.--Entities eligible to receive a contract
under this section shall include private nonprofit entities.
``(m) Records.--
``(1) Recordkeeping.--Each recipient of a contract or
subcontract under subsection (a) shall keep such records as
the Secretary shall prescribe, including records that fully
disclose the amount and disposition by the recipient of the
proceeds of the contract, the total cost of the undertaking
in connection with which the contract was made, and the
amount of the portion of the cost of the undertaking supplied
by other sources, and such other records as will facilitate
an effective audit.
``(2) Examination of records.--The Secretary and the
Comptroller General of the United States shall have access to
any books, documents, papers, and records of the recipient of
a contract or subcontract entered into under this section
that are pertinent to the contract, for the purpose of
conducting audits and examinations.
``(n) Penalties for Disclosure.--Any person who discloses
the content of any record referred to in subsection (d)(4)(D)
or (f)(5)(A) without the prior written consent of the donor
or potential donor with respect to whom the record is
maintained, or in violation of the standards described in
subsection (f)(5)(B), shall be imprisoned for not more than 2
years or fined in accordance with title 18, United States
Code, or both.''.
(b) Stem Cell Therapeutic Outcomes Database.--Section 379A
of the Public Health Service Act (42 U.S.C. 274l) is amended
to read as follows:
``SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE.
``(a) Establishment.--The Secretary shall by contract
establish and maintain a scientific database of information
relating to patients who have been recipients of a stem cell
therapeutics product (including bone marrow, cord blood, or
other such product) from a donor.
``(b) Information.--The outcomes database shall include
information in a standardized electronic format with respect
to patients described in subsection (a), diagnosis,
transplant procedures, results, long-term follow-up, and such
other information as the Secretary determines to be
appropriate, to conduct an ongoing evaluation of the
scientific and clinical status of transplantation involving
recipients of a stem cell therapeutics product from a donor.
``(c) Annual Report on Patient Outcomes.--The Secretary
shall require the entity awarded a contract under this
section to submit to the Secretary an annual report
concerning patient outcomes with respect to each transplant
center, based on data collected and maintained by the entity
pursuant to this section.
``(d) Publicly Available Data.--The outcomes database shall
make relevant scientific information not containing
individually identifiable information available to the public
in the form of summaries and data sets to encourage medical
research and to provide information to transplant programs,
physicians, patients, entities awarded a contract under
section 379 donor registries, and cord blood banks.''.
(c) Definitions.--Part I of title III of the Public Health
Service Act (42 U.S.C. 274k et seq.) is amended by inserting
after section 379A the following:
``SEC. 379A-1. DEFINITIONS.
``In this part:
``(1) The term `Advisory Council' means the advisory
council established by the Secretary under section 379(a)(1).
``(2) The term `bone marrow' means the cells found in adult
bone marrow and peripheral blood.
``(3) The term `outcomes database' means the database
established by the Secretary under section 379A.
``(4) The term `Program' means the C.W. Bill Young Cell
Transplantation Program established under section 379.''.
(d) Authorization of Appropriations.--Section 379B of the
Public Health Service Act (42 U.S.C. 274m) is amended to read
as follows:
``SEC. 379B. AUTHORIZATION OF APPROPRIATIONS.
``For the purpose of carrying out this part, there are
authorized to be appropriated $34,000,000 for fiscal year
2006 and $38,000,000 for each of fiscal years 2007 through
2010.''.
(e) Conforming Amendments.--Part I of title III of the
Public Health Service Act (42 U.S.C. 274k et seq.) is amended
in the part heading, by striking ``NATIONAL BONE MARROW DONOR
REGISTRY'' and inserting ``C. W. BILL YOUNG CELL
TRANSPLANTATION PROGRAM''.
SEC. 4. REPORT ON LICENSURE OF CORD BLOOD UNITS.
Not later than 90 days after the date of enactment of this
Act, the Secretary of Health and Human Services, in
consultation with the Commissioner of Food and Drugs, shall
submit to Congress a report concerning the progress made by
the Food and Drug Administration in developing requirements
for the licensing of cord blood units.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Georgia (Mr. Deal) and the gentlewoman from Colorado (Ms. DeGette) each
will control 20 minutes.
The Chair recognizes the gentleman from Georgia.
General Leave
Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks and include extraneous material on H.R. 2520.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Georgia?
There was no objection.
Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise in strong support of H.R. 2520, the Stem Cell
Therapeutic and Research Act of 2005. This legislation will expand the
number of stem cell options available to Americans suffering from life-
threatening diseases.
Every year, nearly two-thirds of the approximately 200,000 patients
in need of a bone marrow transplant will not find a marrow donor that
matches within their families. These patients must rely on the help of
strangers to donate bone marrow or transplant. To assist these
patients, Congress established the National Bone Marrow Registry to
quickly facilitate unrelated donor transplants. Through this program,
Congress made a significant investment to connect patients with a rich
source of stem cells that offer immediate clinical benefits.
With scientific advances, Congress must now make changes to reflect
new therapeutic options. Cord blood stem cell units have been shown to
be a suitable alternative to adult bone marrow for the treatment of
many diseases, including sickle cell anemia. This is an
[[Page H12067]]
especially important advancement for those Americans who have
desperately searched for a bone marrow donor, but could not find a
suitable match, even with the help of the National Bone Marrow
Registry. As another rich source of stem cells, cord blood transplant
is another chance at life for many patients.
The bill before us today builds on the critical investments we have
made over the past two decades with the National Bone Marrow Registry
and retools this design into a new, more comprehensive stem cell
transplantation program which will include not only bone marrow but
cord blood units.
Through a competitive contracting process, this new program will
allow transplant doctors and patients to access information about cord
blood units and bone marrow donors at the same time through a single
point of access. This new program does not create a preference for
either cord blood or bone marrow. Instead, it will provide
comprehensive information about both sources to stem cells to doctors
and patients and allow them to make the clinically most appropriate
choice.
I would like to recognize Congressman Bill Young. It is his drive and
steadfast support for an idea of a national registry for bone marrow
that lead to the program's creation. Mr. Young has continuously
supported improving this program and does so today by reformatting the
program's design. I am pleased that Congress is recognizing his
dedication by naming the new program the C.W. Bill Young Cell
Transplantation Program.
Lastly, I would like to note that through the discussions with the
Senate, we have improved the original House bill to make the program
more effective, including improved patient advocacy and case management
services. We have created a new demonstration program to allow families
with a sick child who could be helped with a cord blood transplant from
a sibling to bank cord blood from newborns should they decide to have
another child. We have also expanded the clinical outcomes database to
include biologically related donors in addition to unrelated donors.
Finally, we require the Food and Drug Administration to provide a
report on its progress in developing licensure requirements for cord
blood units.
Mr. Speaker, I reserve the balance of my time.
Ms. DeGETTE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want to thank my colleague and friend from Georgia on
the Energy and Commerce Committee for his leadership on issues like
this.
Mr. Speaker, I rise today in support of this legislation; however, I
am concerned that the other body has chosen to send us only the cord
blood bill today. This bill is essentially the same bill that the House
passed last May by a vote of 431-1. The legislation is important, and
it will help advance medical research which is why I support it and why
we passed it by such an overwhelming majority last spring. What we need
to be clear about, though, is what this bill really will and will not
do; and we also need to be clear that this bill is not a substitute for
embryonic stem cell research, the Castle-DeGette bill, H.R. 810, which
is an important bill to advance scientific research to affect diseases
that will potentially kill millions of Americans.
Like adult stem cells, umbilical cord stem cells have proven over the
last decade or so to be a reliable source of blood-forming stem cells
that are used as a technique to treat blood diseases like leukemia and
lymphoma. That established technique has led to about 600 cord blood
transplants which were performed in the United States in 2004 to treat
blood disorders. But these cord blood cells are not regenerative and
they are not reprogramming, which is why they cannot be used to be made
into other types of stem cells that can cure other types of diseases
besides blood-related diseases.
It is true that cord blood has been reliably used for a number of
years, and that is why it is so important that we pass this cord blood
registry. But we must not overstate or exaggerate the capabilities of
cord stem cells. Significant limitations exists that must be
considered.
Unlike human embryonic stem cells, stem cells from umbilical blood
cord cannot continually reproduce themselves. Instead of proliferating,
they quickly evolve into specialized cells. Umbilical cord stem cells
cannot be induced to form diverse nonblood cell types, as I mentioned.
Although some initial experiments appear to be promising, few stem cell
researcher now believe that umbilical cords will be a reliable source
of replacement cells other than blood cells.
Now, I support this very early research that I talked about, as I
support any kind of research that could lead to stem cells that could
cure diseases. But these studies are few, and they have not shown
conclusive results.
Finally, umbilical cord stem cells are in short supply. Only a small
number of cells can be obtained from each umbilical cord, making it
hard to obtain enough stem cells for treatment.
{time} 1600
Because of the limitations, we must also support embryonic stem cell
research. I do not need to tell the House that, though, because we
already did that with support from both sides of the aisle.
Last May, this House passed both the umbilical cord stem cell
legislation along with H.R. 810, the Stem Cell Research Enhancement
Act. H.R. 810, cosponsored by myself and Congressman Mike Castle,
expands the number of embryonic stem cell lines that are eligible for
federally funded research. The goal of the legislation is to accelerate
scientific progress toward life-saving cures and treatments for a wide
range of diseases, not just blood-related diseases.
Unfortunately, the other body has not yet embraced the wisdom of the
people's House. Here is what has happened in our country because of our
failure to federally fund embryonic stem cell research: As I think we
can all agree, the National Institutes of Health is not only one of the
foremost institutions, probably the foremost institution for medical
research in the world, but it also stands as the gold standard in the
world in defining ethical research. Because NIH is not able to fund
embryonic stem cell research, it is limited in its ability to define
the ethics for that research, certainly in this country but definitely
abroad.
Many here have heard about the embryonic stem cell studies that have
been done in South Korea, and frankly, Mr. Castle and I, the research
community and others have warned for a long time that when you take
embryonic stem cell research offshore, not only do you lose your
ethical ability to oversee that research, but you also lose the ability
to make sure that the studies are done in a scientifically sound
manner. We saw what we hoped to be some tremendous advancements in
South Korea last year, but now what we are seeing is news out of South
Korea that the scientific method and also the ethics have been called
into question.
If we allowed ethical stem cell research, looked over by the National
Institutes of Health, in this country, this would not happen, and we
would have advances in science fueled by the engine of the NIH but also
overseen by their ethical guidelines.
That is why we need to pass H.R. 810. We need to make sure that we
bring the ethics as well as the scientific method back under the
umbrella of the NIH so that we can continue to be a leader in this
research in the world.
Mr. Speaker, it is time for the other body of Congress to move
forward on swift passage of H.R. 810 so that we can retain our
leadership position in the world.
Again, I support the bill that is before us today. It is a very
important registry for cord blood, and it is also important for
expansion of cord blood for blood diseases that affect so many,
including in the minority community, but we also need to move forward
with H.R. 810 so that we can have scientific progress that is done in
an ethical manner and that will cover the waterfront in curing diseases
that will affect millions of Americans.
Mr. Speaker, I reserve the balance of my time.
Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that the
gentleman from Texas (Mr. Burgess) be allowed to control the remainder
of the time on our side.
The SPEAKER pro tempore (Mr. Boozman). Is there objection to the
request of the gentleman from Georgia?
There was no objection.
[[Page H12068]]
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from New
Jersey (Mr. Smith).
Mr. SMITH of New Jersey. Mr. Speaker, I thank my friend for yielding
me the time.
Mr. Speaker, it occurred to me on the way to work this afternoon that
it is especially fitting that during this season of holiness and faith
and surpassing religious significance that Congress send to the
President a bill designed to effectuate cures of some of the most
devastating diseases and cancers on earth.
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 life-saving stem cells. Indeed, it is one of the best kept
secrets in America that umbilical cord blood stem cells and adult stem
cells are curing people of a myriad of terrible conditions and disease
and are now showing the plasticity and pluripotency that my previous
colleague just mentioned. So I would hasten to correct the gentlelady
from Colorado that cord blood stem cells are not just for blood-related
diseases, it also has the capability increasingly, as research shows,
to do other miraculous things as well.
Let me just remind Members that we passed this legislation 6 months
ago. Many things have happened since those 6 months. Much progress has
been made. This bill law will establish a national program to collect
upwards of 150,000 units, with great diversity, so that most Americans
who suffer from anomalies that could be cured by cord blood will be
able to get it.
Let me thank so many people, the Speaker, Tom DeLay, Roy Blunt, Joe
Barton whom we all pray for and wish a very speedy recovery. Let me
thank my friend on the other side of the aisle, the gentleman from
Alabama (Mr. Davis) and the Congressional Black Caucus for the yeoman's
work that they expended in getting this legislation first passed in the
House, then passed over on the Senate side, because there was a
Democratic hold on it regrettably, Tom Harkin, but then he lifted it.
Let me especially thank Senator Frist for the good work he did; Sam
Brownback; Mike Enzi; Orrin Hatch; Jon Kyl; so many others as well as
so many here; the gentleman from Florida (Mr. Weldon); the gentleman
from Pennsylvania (Mr. Pitts); the gentleman from California (Mr.
Daniel E. Lungren); the gentleman from Indiana (Mr. Pence) and I could
go on and on. I have a list of three pages of people who have been
instrumental in getting this legislation to the point where it will be
passed and sent down to the President for signature.
Let me especially thank Cassie Bevan in the Majority Leader's Office
who has worked so hard. She is amazing. John Cusey, on September 11,
2001, put together our first drafting meeting on this legislation. He
too is amazing. That is how far back it goes. It has been a long time
coming, and so many others. Cheryl Jaeger, Chuck Clapton, Kikki Kless
in the Speaker's Office, Nicole Gustafson and Autumn Fredericks in the
ProLife Caucus, Eric Euling in Senator Frist's office and Doug Branch
with Senator Brownback and some of the others were outstanding. I will
put the full statement in regarding all the many, many fine people who
worked on this.
I will insert the remainder of my statement and the material I
referred to previously at this point in the Record.
Cord-blood stem cells are, as we speak, treating and curing patients.
Amazingly, we are on the threshold of systematically turning medical
waste, umbilical cords and placentas, into medical miracles for huge
numbers of very sick and terminally ill patients who suffer from such
maladies as leukemia and sickle cell anemia. And because this
legislation promotes cord-blood research as well, we can expect new and
expanded uses of these very versatile stem cells.
For the first time ever, our bill establishes a nationwide stem cell
transplantation system. It also authorizes the national bone marrow
transplant system and combines both under a new program, providing an
easy, single-access point for information for doctors and patients and
for the purpose of collecting and analyzing outcomes data.
The cord blood stem cell portion of this bill will provide federal
funding to increase the number of cord blood units available to match
and treat patients. The goal is to reach a total inventory of 150,000
units so that matched stem cells will be available to treat more than
90 percent of patients, especially focusing on providing genetic
diversity. The legislation would also link all the cord blood banks
participating in the inventory program into a search system that would
allow transplant physicians to search for cord blood and bone marrow
matches through a single access point. The national program would
promote stem cell research by requiring any participating cord blood
banks to donate units not suitable for transplant because of disease or
size to researchers who are working on new applications for cord blood
stem cells. The National Bone Marrow Registry authorization expired on
September 30, 2003. The bill reauthorizes an updated program through
fiscal year 2010 for $34 million in FY06 and $38 million for each
additional year of the program.
In the more than 6 months since we passed this bill, even more
advances have been made in the field. Peer-reviewed studies have been
published showing increased plasticity and flexibility. In August, it
was released that cord blood stem cells are as flexible as embryonic
stem cells. Two young Maryland siblings have been cured of severe
combined immune deficiency syndrome by cord blood from unrelated
donors. Victims of Krabbe's and Hurler's diseases have found new hope
in cord blood treatments--these are severe genetic neurological
diseases that kill most of their victims before they reach 2 years old.
A Duke University group treated newborns with cord blood--the lead
author, Dr. Maria Escolar, now reports of the oldest survivor that the
seven-year-old is ``now running, jumping and doing well in school.''
Earlier this month, Michelle Farrar from Leesburg, Virginia, traveled
to South Korea to be treated for her spinal cord injury. True hope
exists for countless other medical conditions, ranging from heart
attacks to muscular dystrophy to diabetes.
Just over a month ago, Dr. Brian Mason, an OB/GYN at Detroit's St.
John Hospital, explained that ``People literally are dying on the
transplant list who could be cured with this.'' I am so happy that for
those people, delayed action on this bill has ended. No longer will
they be denied access to the cures that are out there. Those suffering
from the nearly 70 often terminal diseases will now get the cures that
the legislation will make available to them. The door to the treatments
that have cured people like Keone Penn, Steven Sprague, and Jacklyn
Albanese will now be opened for thousands of others.
As I mentioned before, there are so many people who deserve thanks in
helping get this bill moved through the legislative process on both
sides of the Hill. Among those people are Rich Doerflinger and Mark
Gallagher from the U.S. Conference of Catholic Bishops, Dr. David
Prentice and David Christensen from the Family Research Council, the
staff of the New York Blood Center including Pablo Rubenstein, Cladd
Stevens, and Kathleen Reichert, Sue Ramthun who has been so personally
invested in this issue, Dr. Edward Guindi at Cordus and NBA Hall of
Famer Julius ``Dr. J'' Erving, Richie Weiblinger with the Senate Budget
Committee, and the folks at Concerned Women for American, Focus on the
Family, and the Susan B. Anthony List. I am ecstatic that we are
passing it through here today and getting it to the President, so that
we may set up this network that will absolutely save thousands of
lives.
Ms. DeGETTE. Mr. Speaker, I am delighted to yield 2\1/2\ minutes to
the gentleman from Alabama (Mr. Davis).
Mr. DAVIS of Alabama. Mr. Speaker, I thank my friend from Colorado
for yielding.
Let me first begin by congratulating my friend from New Jersey (Mr.
Smith) for what he has done in the last several years, and I thank my
friend from New Jersey for letting me walk just a short stem of this
path with you. You asked me a couple of years ago to join you as the
lead Democratic sponsor on this bill, but let the record very clearly
reflect that way before that this was a cause of yours. It was
something you believed in very strongly, and I thank you for your
persistence, and I thank you for your courage on this issue.
Let me just say a couple of things. First of all, I want to thank our
colleagues in the Senate. As the gentleman from New Jersey just said,
initially, there was a reluctance to move this bill in the Senate, not
because of any doubts about the substance of the bill. This bill has
been the classic example of uncontroversial legislation, but there were
some in the Senate who believed that this bill should not be given a
vote unless the stem cell bill was given a vote.
I understood the force of their argument. I voted for the stem cell
bill on
[[Page H12069]]
this side. I understood the political analysis they were making, but
every now and then, this Chamber gets to do something that shines
beyond politics. Every now and then, this Chamber gets to find
something that we can give the American people that does not admit to a
liberal or conservative or Democrat or Republican level, and in the
last 24 hours, that happened.
So I thank Senator Harkin and I thank Senator Reid for deciding to
take the politics out of this issue, on our side of the aisle,
Democratic side. I thank them for letting this bill come to a vote, and
this is a good Christmas present to give to many families around this
country who have the tragedy of sickle cell anemia, who have the
tragedy of diabetes in their family and who count on some look to
science to improve it.
The final point that I will make, I will pick up on what my friend,
the gentlewoman from Colorado (Ms. DeGette), said. I happen to think
that God gave us the power of genius for a reason. God gave us the
power of genius to somehow close the gap between this imperfect world
and what we could be. This is an example of that power of genius being
used to save lives.
I agree with her that stem cell research is an example of the power
of genius. So I simply say in conclusion, this is what happens when we
find a paradigm, a way of talking about issues that cuts us out of the
crisscross of politics.
This is good legislation. I thank the gentleman from New Jersey for
working with me on it and urge the Members of this House to pass it.
Mr. BURGESS. Mr. Speaker, it is now my pleasure to yield 2 minutes to
the gentlewoman from Ohio (Mrs. Schmidt).
(Mrs. SCHMIDT asked and was given permission to revise and extend her
remarks.)
Mrs. SCHMIDT. Mr. Speaker, I thank the gentleman from Texas for
yielding me this time.
Mr. Speaker, I rise in strong support of H.R. 2520, the Stem Cell
Therapeutic Research Act. Cord blood is already making a groundbreaking
difference in the treatment of patients who are suffering from over 67
diseases, including leukemia and sickle cell disease. Cord blood is
tremendously versatile. Its transplants do not require exact matches.
It is frozen, and it is ready to go. It works for adults. Cord blood
benefits minority patients who have difficulty finding exact matches
and others with rare tissue types.
The possibilities for cord blood in research are almost limitless
since cord blood can potentially become any cell type in the body, and
it is plentiful, since it is derived from umbilical cords that
hospitals routinely discard.
H.R. 2520 will provide Federal funding to increase the number of cord
blood units available for patient genetic matching and treatment, link
all cord blood banks in a searchable inventory and promote research in
cord blood stem cell research.
This is a bill we can truly support. I urge my colleagues to vote for
this legislation that will help create new hope and new opportunities
for doctors and patients who are urgently seeking cures.
God always gives us a spare part. Umbilical cords are that spare
part.
Ms. DeGETTE. Mr. Speaker, I am happy to yield 2 minutes to the
gentleman from Illinois (Mr. Lipinski).
Mr. LIPINSKI. Mr. Speaker, I would like to thank my friend from
Colorado for yielding me time.
Mr. Speaker, this is a great day for the countless number of
Americans who may receive the gift of health and prolonged life because
of what will be provided in this bill.
Cord blood and bone marrow stem cell treatments have been proven
effective in combating over 65 different debilitating diseases,
including leukemia, sickle cell anemia and osteoporosis.
Cord blood transplants have proven to be a viable alternative for
those with difficulty finding an exact bone marrow match. Since the
match does not have to be exact, this research benefits both children
and adults alike and is especially helpful for people of various races
and ethnicities. This bill will offer a much greater opportunity for a
cure for thousands of Americans around this country who often struggle
with blood matches.
But cord blood also holds the great potential of producing pleural
potential cells that could cure many other diseases such as juvenile
diabetes, a disease that I live with every day.
Mr. Speaker, I am proud that we are acting to advance the possibility
that this type of treatment will provide. A national cord blood bank
will facilitate the expanded use of proven treatment to improve the
health of so many Americans inflicted with these horrible diseases.
This is a great Christmas gift of health to the American people.
Mr. BURGESS. Mr. Speaker, it is now my pleasure to yield 2 minutes to
the gentleman from Florida (Mr. Weldon), someone who has really been a
leader in this issue.
Mr. WELDON of Florida. Mr. Speaker, I thank the gentleman from Texas
for yielding me the time, and I rise in strong support of this piece of
legislation. I am extremely pleased that we were able to see the Senate
finally move it forward and that it is going to move from here on to
the President's desk.
The reason I am very pleased is this is not theoretical, as some
treatment modalities that we often talk about in this body. This is
real and now. There have been 67 different diseases in humans reported
in the medical literature successfully treated with cord blood. So we
are not even talking about research anymore. We are talking about
clinical applications.
Indeed, one of those diseases I am most excited about, and that is
sickle cell anemia. I had the opportunity to treat sickle cell anemia
in my clinical practice, and I can tell my colleagues here that is one
of the most unfortunate conditions to see a young child writhing in
pain on a gurney in an emergency room in a sickle cell crisis. And to
be told that cord blood stem cells have cured children with sickle cell
anemia, I never thought in my life that I would actually see the day
when sickle cell anemia could be cured.
This bill authorizes funds for the expansion of the existing bone
marrow bank, which is a bank that essentially I am registered with. It
has my name, and if somebody needs a transplant, they can try to find
me and get my blood, but in this case, we are taking the placental
blood and the cord blood from 3 million live births a year and creating
a bank so that everybody would have a match and the potential for
regenerative medicine would be here and now.
{time} 1615
So I am very, very pleased that we are bringing this to the floor. I
am very glad it is finally going to move on to the President's desk,
because people will be helped by this now. I am also very delighted to
have been part of it, and Mr. Smith deserves a tremendous amount of
credit for his unflagging efforts on this.
Ms. DeGETTE. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Delaware (Mr. Castle), my compadre and cosponsor of H.R.
810.
Mr. CASTLE. Mr. Speaker, I thank the gentlewoman from Colorado for
yielding me this time, and I am also pleased to rise in support of this
legislation, as we did before when it was on the floor of the House of
Representatives. I think it does make a difference.
But we do need to understand some of the differences amongst the
various things that we are talking about, because this is essentially
dealing with a blood type of stem cell. It is great for use in a lot of
blood diseases, as has been pointed out, particularly leukemia,
lymphoma, and perhaps others at a later time.
But even with those benefits, we need to stress some of the
limitations. And one of them is just the difficulty of getting these
and the lack of them. I have actually visited a storage location for
these and have seen that as a real problem.
Embryonic stem cells, which are in H.R. 810, which Senator Frist
promises will be brought up sometime in the course of the next year, do
not have those limitations. It allows these embryonic stem cells to be
used in a way that they could be formed into any stem cell in your
body, and that is just not true of the cells that are before us here
today. They have the potential to treat a wide range of diseases and
injuries because they can reproduce themselves almost indefinitely. The
best scientific evidence in this country indicates that umbilical stem
cells can do neither at this time.
[[Page H12070]]
My point is this: we need, as far as I am concerned, to advance all
of this type of research. That is really what it is all about. We need
to give people an opportunity. We need to understand that one out of
three people in the United States of America, and I assume across the
world, and perhaps a greater percentage across the world, suffer from
some type of disease that could be helped by stem cell research.
For that reason, in my judgment, we need to do everything in our
power here in the Congress of the United States to pass any of this
legislation that would help advance the medical research that could
save or help the lives of so many people across the United States and
across the world. For that reason, I absolutely support this
legislation.
But I would beseech everybody to really understand the science and
the medicine behind all of the stem cell legislation, including
embryonic stem cell legislation, so that we can come to agreement as to
complete stem cell research to aid everybody. And the sooner we do
that, the better. Every day that is lost is a day that somebody is
going to be ill longer. And we need to get about it as soon as we
possibly can.
Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the
gentlewoman from Pennsylvania (Ms. Hart).
Ms. HART. Mr. Speaker, I thank the gentleman for yielding me this
time and for the opportunity to speak in support of this bill.
I was here when we passed the bill on the House side earlier in the
year; and I am very pleased, especially pleased today, that the Senate
chose to agree with us that this is an exceptionally valuable treatment
now. And it is one that we must address and make more easily available
to all Americans now.
People talk about all different kinds of stem cell research, but cord
blood stem cells are being used today. Cord blood has cured people
today. Cord blood, if made available, can cure a whole lot of people
tomorrow. It is rich in the type of stem cell that is similar to those
found in bone marrow, and bone marrow transplants have been done for
years. However, cord blood is better. Physicians tell us that it is a
better treatment and a treatment that is more likely to be successful.
It makes sense for us in Congress to work hard to try to fund the NIH
to help cure diseases. It makes most sense for us to help make
available cures that are already known to work. This bill will allow
more collection of cord blood stem cells. It will allow the collection
and storage of those from diverse populations that currently may not be
able to access this kind of treatment. It will help many, many more
people who can be cured with cord blood to be cured.
That is what we are about here, Mr. Speaker. The story of Keone Penn,
who actually had a connection to my hometown of Pittsburgh, his doctor,
now at the university, helped cure him of a very severe form of sickle
cell anemia with treatment from cord blood. Anthony Dones, who had a
cord blood transplant, was cured of a very rare form of osteoporosis
using cord blood. Katherine Marguerite Sutter, at only 5 months was
diagnosed with AML. She too was cured by use of cord blood, and the
story I like the most, because on the Web site for the New York Cord
Blood Center, it shows a picture of her in her wedding gown. She
suffered through transfusions for 20 years before she too was cured
with cord blood.
Mr. Speaker, I am very pleased to be here today and also very pleased
to have bipartisan support for this bill, because it will help many,
many more people tomorrow.
Ms. DeGETTE. Mr. Speaker, I am happy to yield 2 minutes to the
gentlewoman from California (Ms. Millender-McDonald).
Ms. MILLENDER-McDONALD. Mr. Speaker, I want to thank Representative
Chris Smith for his tireless efforts in bringing this very important
lifesaving legislation forward and getting me to work with him to get
the Senate to do the right thing and put this forward.
I would also like to say I supported the stem cell research bill also
because I feel it has a broader significance to lifesaving measures. In
this 21st century, we cannot afford to not look at both of these as
provisions for helping to save the lives of American people. This is
why I stand before you today in support of H.R. 2520.
Too many members of the minority population live with life-
threatening diseases. We must provide them with the benefits of cord
blood stem cells. Cord blood stem cells can be used for bone marrow
reconstitution by transplantation to recipients with certain
abnormalities such as leukemia and lymphoma, genetic disorders such as
sickle cell anemia, and acquired diseases.
The promise of using stem cells for medical treatment has been the
focus of research projects that are showing encouraging results. Cord
blood stem cells have been triggered to differentiate into neural
cells, which could lead to treatments for diseases such as Alzheimer's
and Parkinson's. They have also proven their ability to turn into blood
vessel cells, which could someday benefit treatment for heart disease,
allowing patients to essentially grow their own bypass.
We need the hope that cord blood stem cells can bring. Sickle cell
anemia is the most common inherited blood disorder in the United
States, affecting 70,000 to 80,000 Americans. The disease occurs in
approximately one in 500 African American newborns. People with sickle
cell disease have a diminished quality of life and greatly enhanced
fatality rate.
The suffering has gone on far too long. We must use every resource at
our disposal to cure this and other blood-related diseases. In my
district, I have a lot of young children who have sickle cell disease.
These cord blood cells would certainly help in furthering their lives.
I ask all my colleagues to please support H.R. 2520. I believe it
should pass today.
Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Nebraska (Mr. Fortenberry).
Mr. FORTENBERRY. Mr. Speaker, this is a bright day for many
individuals suffering from previously untreatable diseases, and I
commend our colleagues in the Senate for passing the Stem Cell
Therapeutic Research Act of 2005. It was the right thing to do. It will
save many lives and avoid the ethically divisive issue of the
destruction of human embryos for stem cell research.
As we have heard today, cord blood stem cells have helped effectively
treat over 67 diseases in human beings, including leukemia, sickle
cell, lupus, multiple sclerosis, type I diabetes, Parkinson's, and even
blindness. Cord blood cells show great promise for helping spinal cord
patients, many of whom have experienced improved sensation and movement
from cord blood stem cell treatments.
Cord blood stem cells also possess the regenerative flexibility to
form virtually every type of human tissue. And research has shown these
cells are far less susceptible to transplant rejection than bone
marrow.
I want to commend my colleague, Mr. Smith, for his tireless effort in
this regard, and for the leadership of Mr. Davis on this important
issue. Their efforts transcend political differences. Mr. Speaker, this
bill truly represents good science.
Ms. DeGETTE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from Texas (Ms. Jackson-Lee).
Ms. JACKSON-LEE of Texas. Mr. Speaker, I want to thank the
distinguished gentlewoman from Colorado for yielding me this time and
for the leadership she has given, along with the Congressman from
Delaware on this stem cell legislation, and we hope that we will see
that move.
I want to thank Mr. Smith, Mr. Davis, Ms. Millender-McDonald, and the
many others who have been so supportive on this legislation, the
collection and maintenance of human cord blood stems. Just a few
minutes from now we will be discussing the NASA reauthorization bill,
and I raise that point because I believe it is the mission of the
United States to be at the forefront of science and research to save
lives.
The world looks to our leadership, our labs, our scientists, our
inventors, our medical professionals as they do to the Texas Medical
Center to be able to add enhancement to the quality of lives. In my
community alone, I realize that the organizations that fight against
leukemia, multiple sclerosis,
[[Page H12071]]
lupus, and sickle cell anemia are looking forward to the passage of
this legislation and a new day of research.
Those newborn African American babies who are born with sickle cell
also will benefit from this kind of research. But this does not
highlight a particular minority group. This research, this maintenance
of the human cord blood stem cells will in actuality provide the
underpinnings of the research for all kinds of medical science.
So I ask my colleagues to support this legislation. And the important
aspect of it singularly is for America to take her rightful and
prominent place in medical research to save lives around the world.
Mr. BURGESS. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from California (Mr. Daniel E. Lungren).
Mr. DANIEL E. LUNGREN of California. Mr. Speaker, I rise in strong
support of H.R. 2520. The fact of the matter is, I believe all of us
would like to support the application of science and technical research
to the problems of the day. There are times when we have moral
dilemmas, and reference has been made to another bill involving
embryonic stem cells which does divide many people in this country
because of the ethical dilemma that is presented.
That is why it is so wonderful we have come today in support, those
who may find themselves on the other side of the dilemma in the other
respect, and come in common support for the cord blood stem cell bill.
This is both a therapeutic and research bill. It is therapeutic in that
it affords the banking of units that will be allowed to help people
now, diseases that can be affected by the use of these units now.
So much of what we do here is theoretical. We hope that things might
be accomplished by what we do. But we know that this will accomplish
success right away. Secondly, it allows for research to see how far we
can go in this area. It gives the opportunity for this which would
otherwise be thrown away, placenta blood and the blood from the cord
that is thrown away now on every single day, to be utilized for both
research and for life-giving purposes.
{time} 1630
Mr. Speaker, if I had the ability to, I would change the name of this
bill to the Giving Life Twice bill, once with the production of new
life and secondly with the use of that blood that otherwise would be
thrown away to help someone else sustain their life; or we could call
this the Lifeline bill. We are extending a lifeline of hope to those
who otherwise would have no hope.
This is a joyous day here in this body. People may disagree on other
matters, coming together in strong support for a bill that will save
lives and save lives now.
Ms. DeGETTE. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, today we are fortunate to take the first step of what I
see as a two-step process, and that is passage of this cord blood bill
which, as I said, we passed last May in this House by an overwhelming
vote.
The second step, of course, will be when the other body passes H.R.
810, which also passed last May, and when that bill is finally signed
into law.
The two bills working together will greatly expand availability of
research and of cures for Americans who suffer not just from blood-
related diseases but from diseases like Alzheimer's, Parkinson's, nerve
damage, and so many other diseases that cannot be reached simply by
cord blood. That is the day that a true dawning of a new scientific era
will occur in this country.
This is a good bill today, and I urge all of my colleagues to support
it, and I want to thank my colleagues on both sides of the aisle for
their co-sponsorship. But let us be clear exactly what this bill does.
It authorizes a new granted program to provide subsidies to cord blood
stem cell banks to expand the inventory of high quality cord blood
units. It sets up a registry for cord blood, which will in some cases
take the place of bone marrow transplants which it is beginning to
supersede. This will be enormously important, particularly for sickle
cell patients who will be helped. The bill also authorizes research on
the clinical outcomes of patients who are recipients of a stem cell
therapeutics product from biologically related and unrelated donors.
That is what this bill does. This bill does not set up any cures for
any diseases, nor does it do anything to put ethical controls onto stem
cell research and other types of research that are scientifically being
explored now and need the oversight of the National Institutes of
Health.
So this is a good start. I commend all my colleagues. It is going to
make us all feel good to go home for the holidays knowing that certain
classes of patients will be helped. But I would say to my friends on
both sides of the aisle, let us not stop there. In the second session
of this Congress, let us take the bold scientific step necessary to
provide cures for diseases that affect tens of millions of Americans
and citizens around the world.
Mr. Speaker, I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself the remaining time.
Mr. Speaker, I believe this is a bold scientific step to pass this
legislation today, and I am pleased that the Senate released their hold
on it and passed this bill. It is good legislation.
We heard during the arguments on the previous bill that was debated
here on the floor, science certainly moves a lot more swiftly than the
legislative process, and that is certainly true in this case today. By
allowing this bill, we are going to allow hundreds, perhaps thousands
of Americans the opportunity for a cure that we were withholding by
delaying passage of this bill.
I have heard diseases like Alzheimer's and Parkinson's referenced.
Alzheimer's and Parkinson's, unfortunately, are unlikely to be cured by
umbilical cord stem cells, but they are also unlikely to be cured by
embryonic stem cell research. The promise for cure for these diseases
lies in protein science and our understanding of the human genome, not
in stem cell research.
This bill is a good bill because it authorizes a significant amount
of money for the collection, the documentation and the maintenance of
150,000 new stem cell lives. These are pluripotential cells.
What has changed since we had our debate on the stem cell lines here
last spring? Well, we have read a lot of stuff in the newspapers just
the past 2 weeks about some of the changes, some of the research that
has now been withdrawn. Think about this, Mr. Speaker: We do not even
know what research is just out there over the horizon. What if we
unlock some of the proteinemic keys that allow us to understand what
signals one cell to another? What if we could make the umbilical cord
stem cell behave more like the embryonic stem cell? Think of that, Mr.
Speaker. Then we have got 150,000 lines banked and ready to go when
that research which is being done in my home State of Texas at the
University of Texas Southwestern Medical School, if that research shows
the promise that it one day may, we will have 150,000 cell lines banked
and ready to go.
Mr. Speaker, this procedure, this technique, this ability to bank
umbilical cord cells allows for there to be greater diversity within
the marrow donor pool than was previously known. It has been difficult
to get minority populations to become marrow donors. Now we will be
able to collect that cell material at the time of birth painlessly, at
no risk to anyone, material that was otherwise going to be discarded,
and it will be put into these stem cell lines. And the database will be
there for people to reference and find these life-saving cures that
will be now available by umbilical cord stem cells.
We are expanding America's inventory of cord blood cells today, and
that is a good thing for all Americans. Whether they are sick or not,
one day they may need this technology. We have the ability and the
capacity within our hands to expand this program and save American
lives, and I say that is a good thing.
Ms. EDDIE BERNICE JOHNSON of Texas. Mr. Speaker, I rise today in
support of H.R. 2520, the Stem Cell Therapeutic and Research Act of
2005.
Long before my days as the Ranking Member on the Research
Subcommittee, I have been a strong advocate of all types of research.
Stem cell research holds the potential to help paralyzed people walk,
help blind people see, and re-generate organ tissue without immune
rejection.
[[Page H12072]]
As our colleagues on the other side of the Capitol concur, H.R. 2520
is a good start. This bill would allow the Secretary of Health and
Human Services to work with cord blood banks to collect and maintain
cord blood for the purpose of stem cell research.
The cord blood would be collected with informed consent, in a manner
that complies with Federal and State regulations, and from a
genetically diverse population.
It is my hope that this legislation will give us a taste of the
marvelous potential of stem cell research, and I urge my colleagues to
support this legislation.
Mr. HOLT. Mr. Speaker, I rise to congratulate the State of New Jersey
on its national leadership in efforts to treat deadly and debilitating
illnesses. Yesterday, New Jersey became the first State in the Nation
to award public funds to conduct human embryonic stem cell research.
Under the leadership of Acting Governor Richard Codey and NJCST
Executive Director Sherrie Preische, the New Jersey Commission on
Science and Technology (NJCST) will award 17 grants totaling $5 million
to scientists at corporate, non-profit, and university laboratories to
research the potential of stem cells as a means to diagnose, treat,
cure, and prevent disease. Each scientist will receive around $300,000
to conduct their research. Three of these grants will go to scientists
researching embryonic stem cells.
Since the formation of the New Jersey Stem Cell Institute, New Jersey
has established itself as a leader in furthering potentially life-
saving research on adult stem cells. And by awarding these research
grants, New Jersey is actively working to support groundbreaking
research on embryonic stem cells, which hold great promise in improving
health care as we know it.
Embryonic stems cells--undifferentiated cells produced early in
embryonic development--offer possible treatments for a variety of
diseases from cancer to Parkinson's disease to diabetes. Ultimately,
scientists may be able to develop reparative tissue, treat a host of
debilitating diseases, and even generate organs specifically tailored
to a person's unique genetic blueprint. This research offers mankind
the prospect of overcoming devastating diseases, affording us the
opportunity to live longer, healthier lives. For these advances to take
place, we must invest public funding in critical research to support
scientists, rather than restrict them.
I am proud that the people of New Jersey have committed public funds
for this important research, and I am glad that New Jersey has moved
quickly to distribute grants to researchers so that their work can
begin. I am particularly pleased that these grants were awarded after
exhaustive ethical review led by former Princeton University President
Harold Shapiro, and that research ethics will play an important role as
the awardees move forward with their research.
I am confident that States who have established programs with similar
goals will move quickly to support this research as well. But despite
the forward thinking and progressive research that New Jersey and other
states are exploring, it is unfortunate that the Federal Government has
delayed and restricted research using federal dollars. I am hopeful
that the leadership of New Jersey to fund embryonic stem cell research
will have tremendous dividends, not just for New Jersey, but for
society. New Jersey understands that it is ethical and wise to invest
in research that will benefit so many. The Federal Government must
recognize this fact as well.
Again, I congratulate New Jersey for supporting ground-breaking
research on embryonic stem cells. I ask unanimous consent to include a
list of the researchers who have received these important stem cell
research grants in the Record.
Mr. BURGESS. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Boozman). The question is on the motion
offered by the gentleman from Georgia (Mr. Deal) that the House suspend
the rules and concur in the Senate amendment to the bill, H.R. 2520.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. BURGESS. 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 and the
Chair's prior announcement, further proceedings on this question will
be postponed.
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