New Bipartisan Stem Cell Legislation Introduced

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WASHINGTON – U.S. Rep. Diana DeGette (D-CO), Vice Chair of theCommittee on Energy and Commerce, and Michael Castle (R-DE), both chiefarchitects of the Stem Cell Research Enhancement Act, today introduced new bipartisan stem cell research legislation that builds upon the original bill – H.R. 3 – in preparation for the new Administration and 111th Congress.

"The Stem Cell Research Enhancement Act of 2008 builds upon theoriginal legislation," said DeGette. "This new legislation iscomprehensive – it not only reverses President Bush's draconianrestrictions, but it also puts in place an overarching ethicalframework for all stem cell research, adult and embryonic, to moveforward. Embryonic stem cell research holds the promise of unlockingthe cures to many diseases – from Parkinson's disease to spinal cordinjuries to diabetes."

H.R. 3 has been reworked to ensure it is current with theever-expanding field of stem cell research and to bring the NIH back tothe forefront of stem cell research worldwide. The top priority inthis new legislation was to retain the integrity and language of H.R. 3– specifically, to expand the federal policy on embryonic stem cellresearch and set forth the ethical requirements. The goal was toexpand the scope of H.R. 3 to allow for NIH to establish guidelines forcarrying out all stem cell research (not just embryonic) asscientifically warranted. With this change, the NIH will be able toestablish guidelines for the research based on scientific needs andadvances. Recognizing the link between beginning basic scientificresearch and the potential for eventual clinical trials using stem cellapplications, this new legislation encourages the NIH and Food and DrugAdministration (FDA) to communicate on this important area of research.

"As the world's premier biomedical research institution, the NIH shouldhave a robust stem cell research program," said Rep. Castle. "Icontinue to share in the view of so many scientists that stem cellresearch holds great promise for alleviating the suffering of the 100million American patients who are living with devastating diseases forwhich there are no good treatments or cures. We have lost valuabletime since the President's Directive in 2001, but Rep. DeGette and Iare committed to driving this issue in Congress and with thePresidential nominees to form an expanded and comprehensive federalpolicy for all stem cell research."

The Stem Cell Research Enhancement Act of 2008 delegates to theNational Institutes of Health (NIH) the development of guidelines forhuman stem cell research—both for embryonic and adult—within ninetydays of enactment and provides for periodic updates to the guidelinesas scientifically warranted, but at least every three years. Althoughnumerous entities have published guidelines for stem cell research,there is currently no overarching set of federal guidelines to serve asthe gold standard. As a result, scientists must constantly worry aboutmeeting a patchwork of ethical requirements. The reportingrequirements section from H.R. 3 has also been updated to comply withthe biennial reporting requirements set out in the NIH Reform Act of2006.

"Despite strong bipartisan support in both the House and Senate and theAmerican public, President Bush laid down the political marker byvetoing common-sense stem cell research legislation twice. However, ourallies in Congress and among the public remain undeterred – Rep. Castleand I look forward to a new Administration and a pro-stem cell Congressto realize the great potential of this research. With all the recentadvances in stem cell techniques, it is imperative we allow all formsto flourish; scientists, not politicians, should decide whichtechniques have the best potential for progress in developingtherapies," concluded DeGette.

The legislation further expresses that it is the sense of Congress thatthe NIH should consult with the FDA in developing and implementing theguidelines, as well as to facilitate research at NIH that can help theFDA evaluate the safety and efficacy of stem cell related therapies. Finally, the bill expresses that it is the sense of Congress that allresearch using human stem cells should comply with the NIHgold-standard guidelines, regardless of funding source.

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