108th Congress

Stem Cell Research

H.R. 3960, H.R. 4531, H.R. 4682, H.R. 4812

Background

In November 1998, two groups of scientists reported the successful isolation and culture of human embryonic stem cells. Such cells, generally referred to as pluripotent stem cells, can develop into most of the specialized cells and tissues in the human body and divide indefinitely in culture. Because these cells can become many different types of cells, including muscle cells, nerve cells, heart cells, and blood cells, their derivation represents a major advance in human biology. This research holds great promise for advances in health care and has generated interest among scientists, patients and their advocates, and the public.

The Clinton Administration published guidelines governing the use of human embryonic stem cells in the Federal Register on August 23, 2000. On April 25, 2001, a scheduled review of pending grant applications was postponed to provide President Bush and the new Administration with the opportunity to review the issue. On August 9, President Bush issued his long-awaited decision on stem cell research. He authorized funding for stem cell research using existing pluripotent stem cell lines that were derived from human embryos before August 9. At that time, it was estimated that there were 78 derivations that would be eligible for funding. Research using these derivations is eligible for Federal funding if the following criteria are met: 1) there must have been informed consent from the donors, 2) the embryos must have been created for reproductive purposes and in excess of clinical need, 3) there must not have been any financial inducements to the donors, and 4) the embryos must not have been created for research purposes.

Although there was little congressional activity on stem cells during the first session of the 108th Congress, some Members and many patient advocacy groups continued to express concern that the President’s policy hinders the progress of research. With the knowledge that there are only approximately 20 widely available stem cell lines, several Members of Congress introduced bills during the spring of 2004 that would have required funding for human embryonic stem cell research, notwithstanding the President’s 2001 policy. On April 28, 2004, more than 200 Members of the House sent a letter to the President urging an expansion of the policy; this letter was followed by a similar letter from the Senate. Former President Ronald Reagan’s death from Alzheimer’s disease on June 5 and Nancy Reagan’s subsequent pleas to expand the policy led to significant media coverage during the summer of 2004. The issue of stem cell research also figured prominently in the 2004 Presidential campaign.

Provisions of the Legislation/Impact on NIH

H.R. 3960—Stem Cell Replenishment Act of 2004

As introduced, H.R. 3960 would have:

• Permitted Federal funds to be used for research on human embryonic stem cells regardless of the date on which the derivation process for the stem cells was initiated or completed
• Required the National Institutes of Health (NIH) to review and revise the guidelines published in 2000 to ensure the availability of not less than 60 stem cell lines that are scientifically fit for distribution for research purposes

H.R. 4531-Ronald Reagan Memorial Stem Cell Research Act of 2004

As introduced, H.R. 4531 would have:

• Required the Secretary of Health and Human Services (HHS), acting through the Director of NIH, to conduct and support research using human embryonic stem cells
• Required that such research be conducted in accordance with the guidelines published in 2000. This requirement would have applied regardless of any Federal administrative policies established after the publication of such guidelines, including restrictions on the sources of human embryonic stem cells.
• Authorized appropriations in the amount of $87,000,000 in fiscal year 2005 and such sums as may be necessary thereafter

H.R. 4682-Stem Cell Research Enhancement Act of 2004

As introduced, H.R. 4682 would have:

• Required the Secretary of HHS to conduct and support research using human embryonic stem cells
• Required that the following criteria be met:
  • The stem cells must be derived from embryos that were created for fertility purposes, in excess of clinical need, and donated from in vitro fertilization clinics.
  • Prior to consideration of embryo donation, it must be determined that the embryos will never be implanted in a woman and would otherwise be discarded.
  • Donation must be made with written informed consent and without any financial or other inducements.
• Required the Secretary, in consultation with NIH, to promulgate guidelines within 60 days
• Required that the guidelines apply only to those stem cells that are derived after 60 days from the date that the bill would have been enacted. For all other stem cells, the requirements described above would have applied.
• Required the Secretary to submit an annual report to Congress on activities carried out under the bill

H.R. 4812-Stem Cell Discovery Through Diversity

As introduced, H.R. 4812 would have:

• Required the Director of NIH to conduct and support research using human embryonic stem cells
• Required that such research be conducted in accordance with the guidelines published in 2000
• Prohibited the use of Federal funds to derive such stem cells
• Prohibited the imposition of Federal administrative policies in addition to the 2000 guidelines
• Established an office within the Office of the Director of NIH (the Ronald Reagan Office of Human Stem Cell Research) to coordinate human embryonic stem cell research
• Required the Director of NIH to ensure that the program includes donation from a significant number of individuals who are members of racial or ethnic minority groups

Status and Outlook

H.R. 3960 was introduced by Representative Juanita Millender-McDonald (D-CA) on March 11, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

H.R. 4531 was introduced by Representative Gary L. Ackerman (D-NY) on June 9, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

H.R. 4682 was introduced by Representatives Michael Castle (R-DE) and Diana L. DeGette (D-CO) on June 24, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

H.R. 4812 was introduced by Representative Peter Deutsch (D-FL) on July 12, 2004, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

Representatives Castle and DeGette have indicated publicly that they will reintroduce their stem cell research bill when the 109th Congress convenes. This bill had 190 cosponsors at the end of the 108th Congress, and it is expected that these supporters of an expansion of the stem cell policy will also support the reintroduced version of the Castle/DeGette bill.