107th Congress

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107th Congress Stem Cell Research

H.R. 2059/S. 723, H.R. 2096/S. 1349, H. Con. Res. 17, H.R. 2747, H.R. 2838, H.R. 2863, and H.R. 4011

The Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS) and Education (Senator Tom Harkin [D-IA], Chairman) held four hearings on the issue during the 107th Congress—July 18, 2001; August 1, 2001; October 31, 2001; and September 25, 2002. The July 18 hearing focused on the release of a comprehensive report prepared by NIH that described the current state of the science on stem cells derived from human embryos, fetal tissue, and adult tissue. In addition, several Senators holding pro-life views testified in support of stem cell research. The August 1 hearing focused on intellectual property issues and ethical issues. The October 31 hearing focused on testimony from the various derivers of the existing stem cell lines. The September 25 hearing was held to provide the new Director of NIH with an opportunity to update the Subcommittee on the implementation of the President's stem cell decision by NIH, and to hear from researchers on their efforts to obtain the eligible stem cell lines listed in the NIH Stem Cell Registry. The Senate Health, Education, Labor and Pensions Committee (Senator Edward M. Kennedy [D-MA], Chairman) held one hearing on this topic on September 5, 2001. The hearing focused on the quality and viability of the existing stem cell lines. The Secretary of HHS, Tommy G. Thompson, testified.

The House was not particularly active on this issue as a body. The House Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources held one hearing on this issue on July 17, 2001, which focused on testimony from individuals who had adopted frozen embryos from in vitro fertilization clinics.

H.R. 2059 and S. 723, the Stem Cell Research Act of 2001, were introduced by Representative Jim McDermott (D-WA) and Senators Arlen Specter (R-PA) and Harkin, respectively, to amend the Public Health Service Act to provide for human embryonic stem cell generation and research.

H.R. 2096 and S. 1349, the Responsible Stem Cell Research Act of 2001, were introduced by Representative Christopher H. Smith (R-NJ) and Senator John Ensign (R-NV), respectively, to require the Secretary of HHS to maintain a stem cell donor bank containing stem cells derived from adult tissue, placentas, and umbilical cord blood.

H. Con. Res. 17 was introduced by Representative Carolyn Maloney (D-NY) to express the Sense of Congress regarding pluripotent stem cell research.
H.R. 2747 was introduced by Representative Diana L. DeGette (D-CO) to codify the Clinton Administration's guidelines governing research using human pluripotent stem cells.

H.R. 2838 was introduced by Representative Juanita Millender-McDonald (D-CA) to require NIH to conduct human embryonic stem cell research and repeal the Human Embryo Research Ban contained within the Labor, HHS, and Education Appropriations Act.

H.R. 2863 was introduced by Representative McDermott to require the establishment of an additional Food and Drug Administration (FDA) Advisory Committee to make recommendations on the field of cell development, including human embryonic stem cell research and therapeutic cloning.

H.R. 4011 was introduced by Representative Maloney to establish a Stem Cell Research Board within the legislative branch to conduct research on the effects of the President's August 9, 2001, stem cell policy.

While no further action on this legislation occurred during the 107th Congress, stem cell research continues to be a source of considerable controversy and discussion within Congress. As many predicted, there was considerable debate on this issue when the Senate considered H.R. 3061, the Departments of Labor, HHS, Education, and Related Agencies Appropriation Act of 2002. Rather than passing new legislation, most Members of Congress appeared willing to accept the President's policy and await the results of its implementation before determining whether any specific legislative remedies were needed. It is possible, however, that if the 108th Congress considers the Labor, HHS, Education, and Related Agencies Appropriations bill this spring, rather than one omnibus spending bill, stem cell amendments may be added. It is also possible that Members of Congress who have been active on this issue, such as Senator Specter and Senator Sam Brownback (R-KS), will introduce legislation to either expand or limit the President's policy. Given comments by the Senate majority leader during debate on the Labor, HHS, Education, and Related Agencies appropriations bill, it is possible that Senator Specter's bill will be the subject of debate when the Senate considers this issue again in spring 2003.

The Senate Report to the FY 2003 Labor, HHS, Education, and Related Agencies Appropriations bill currently contains language that would 1) require DHHS to submit a report to Congress explaining how the Agency plans to encourage more stem cell grant applications and make more stem cell lines available to researchers, 2) encourage NIH to expand the stem cell registry to include more detailed information regarding the availability and characteristics of the existing lines, and 3) encourage NIH to consider developing a stem cell repository.

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Provisions of the Legislation/Impact on NIH

S. 723/H.R. 2059—Stem Cell Research Act of 2001

These bills would have permitted the U.S. Department of Health and Human Services (DHHS) to fund both the derivation and use of human pluripotent stem cells. Section 2 of the bills would have added a new section (489C) to the Public Health Service Act, which would have stipulated the following:

• Notwithstanding any other provision of law, "the Secretary of Health and Human Services (HHS) may only conduct, support, or fund research on, or utilizing, human embryos for the purpose of generating embryonic stem cells and utilizing stem cells that have been derived from embryos in accordance with this section" (Section 489C).
• The only embryos that may be used for such activities are "those embryos that otherwise would be discarded that have been donated from in-vitro fertilization clinics with the written informed consent of the progenitors."
• The research involved shall not result in the creation of human embryos.
• The research involved shall not result in the reproductive cloning of a human being.
• Any person receiving Federal funds would be prohibited from knowingly acquiring or transferring embryos for "valuable consideration." Valuable consideration would not include reasonable payments associated with transportation, transplantation, processing, preservation, quality control, or storage.
• The Secretary of HHS would be required to develop guidelines that would "expand on the rules governing human embryonic stem cell research to include rules that govern the derivation of stem cells from donated embryos under this section."

H.R. 2096/S. 1349—Responsible Stem Cell Research Act of 2001

These bills would have required the Secretary of HHS to establish a stem cell donor bank containing stem cells derived from umbilical cord blood, placental tissue, and adult tissues. The bills contained the following key provisions:

• The Secretary of HHS would have been required to establish and maintain by contract a National Stem Cell Donor Bank for the purpose of seeking and preserving donations of "qualifying human stem cells" and shall make such donated cells available for biomedical research and therapeutic purposes
• "Qualifying stem cells" were defined as human cells obtained from human placentas, umbilical cord blood, organs or tissues of a living or deceased human being who has been born, or organs or tissues of unborn human offspring who died of natural causes (such as spontaneous abortion).
• The bills would have authorized appropriations of $30 million for FY 2002 and such sums as may be necessary for each of the FYs 2003 through 2006 for NIH to conduct and support research using qualifying human stem cells.

H. Con. Res. 17—Support for Pluripotent Stem Cell Research

• H. Con. Res. 17 would have expressed the "Sense of the Congress supporting Federal funding of pluripotent stem cell research."

H.R. 2747—Stem Cell Research for Patient Benefit Act of 2001

The bill would have codified the NIH guidelines for research using human pluripotent stem cells. The bill contained the following key provisions:

• The Director of NIH would have been required to conduct or support research using human pluripotent stem cells from embryos and fetal tissue in accordance with the NIH guidelines published in the Federal Register on August 25, 2000
• The Director of NIH would have been required to conduct a study on the current state of knowledge regarding stem cells derived from embryos, fetal tissue, and adult tissues.
• The Institute of Medicine would have been required to conduct a study on the current state of knowledge regarding therapies, including somatic cell nuclear transfer and therapies using pharmaceuticals, that may be used to address immunologic rejection of stem cells and differentiated cells and tissue derived from stem cells.
• A Biomedical Advisory Commission would have been established, with members appointed by Congress, to conduct studies and make recommendations regarding bioethical issues arising from research on human biology and the applications of such research.

H.R. 2838—New Century Health Advantage Act

The bill contained the following key provisions:

• The Director of NIH would have been required to conduct or support research using human pluripotent stem cells derived from excess embryos created for purposes of fertility treatment and in excess of clinical need.
• Section 510 of the FY 2001 Labor, HHS, and Education Appropriations Act, which prohibits certain research involving human embryos, would have been repealed.

H.R. 2863—Cell Development Research Act of 2001

The bill contained the following key provision:

• A Cell Development Advisory Panel would have been created to provide recommendations to the FDA regarding the field of cell development, including human embryonic stem cell research and therapeutic cloning.

H.R. 4011—Science of Stem Cell Research Act

The bill would have established a Stem Cell Research Board within the legislative branch to conduct research on the effects of the President's August 9, 2001, stem cell policy. The bill contained the following key provisions:

• A bipartisan commission to be known as the Stem Cell Research Board would have been established in the legislative branch.
• The Board would have been required to conduct research on the effects of the President's August 9 stem cell policy, including the progress in advances in curing certain diseases, and all aspects of the NIH funding process for both embryonic and adult stem cell research.
• The Board would have been required to make recommendations to Congress regarding any changes in legislation that may be warranted to reduce any inefficiencies in Federal funding of human embryonic stem cell research.
• The Board would have included members appointed by the President, Speaker of the House, minority leader of the House, and majority and minority leaders of the Senate. There was no specification in the bill that any of the members be individuals with scientific expertise.

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Status and Outlook

On April 5, 2001, Senator Specter introduced S. 723, the Stem Cell Research Act of 2001. The bill had 18 cosponsors and was referred to the Senate Health, Education, Labor and Pensions Committee. A series of amendments to the bill were also referred to the Committee in June and July. An identical companion measure, H.R. 2059, was introduced by Representative McDermott on June 5. H.R. 2059 had 31 cosponsors and was referred to the House Energy and Commerce Committee. On June 18, the bill was referred to the House Energy and Commerce Subcommittee on Health.

On June 7, 2001, Representative Smith introduced H.R. 2096, the Responsible Stem Cell Research Act of 2001. The bill had 70 cosponsors and was referred to the House Energy and Commerce Committee. On June 18, H.R. 2096 was referred to the House Energy and Commerce Subcommittee on Health. An identical companion measure, S. 1349, was introduced by Senator Ensign on August 3. S. 1349 had three cosponsors and was referred to the Senate Health, Education, Labor and Pensions Committee.

On January 30, 2001, Representative Maloney introduced H. Con. Res. 17. The resolution had 85 cosponsors and was referred to the House Energy and Commerce Committee. On February 14, the resolution was referred to the House Energy and Commerce Subcommittee on Health.

On August 2, 2001, Representative DeGette introduced H.R. 2747, the Stem Cell Research for Patient Benefit Act of 2001. The bill had 15 cosponsors and was referred to the House Energy and Commerce Committee.

On September 5, 2001, Representative Millender-McDonald introduced H.R. 2838, the New Century Health Advantage Act. The bill had no cosponsors and was referred to the House Energy and Commerce Committee.

On September 6, 2001, Representative McDermott introduced H.R. 2863, the Cell Development Research Act of 2001. The bill had 17 cosponsors and was referred to the House Energy and Commerce Committee.

On March 20, 2002, Representative Maloney introduced H.R. 4011, the Science of Stem Cell Research Act. The bill had 25 cosponsors and was referred to the House Energy and Commerce Committee.

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