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WASHINGTON – U.S. Rep. Diana DeGette (D-CO), Vice Chair of the Committee on Energy and Commerce, and Michael Castle (R-DE), both chief architects 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 the original legislation,” said DeGette. “This new legislation is comprehensive – it not only reverses President Bush’s draconian restrictions, but it also puts in place an overarching ethical framework for all stem cell research, adult and embryonic, to move forward. Embryonic stem cell research holds the promise of unlocking the cures to many diseases – from Parkinson’s disease to spinal cord injuries to diabetes.” 

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

“As the world's premier biomedical research institution, the NIH should have a robust stem cell research program,” said Rep. Castle.  “I continue to share in the view of so many scientists that stem cell research holds great promise for alleviating the suffering of the 100 million American patients who are living with devastating diseases for which there are no good treatments or cures.  We have lost valuable time since the President's Directive in 2001, but Rep. DeGette and I are committed to driving this issue in Congress and with the Presidential nominees to form an expanded and comprehensive federal policy for all stem cell research.”

The Stem Cell Research Enhancement Act of 2008 delegates to the National Institutes of Health (NIH) the development of guidelines for human stem cell research—both for embryonic and adult—within ninety days of enactment and provides for periodic updates to the guidelines as scientifically warranted, but at least every three years.  Although numerous entities have published guidelines for stem cell research, there is currently no overarching set of federal guidelines to serve as the gold standard.  As a result, scientists must constantly worry about meeting a patchwork of ethical requirements.  The reporting requirements section from H.R. 3 has also been updated to comply with the biennial reporting requirements set out in the NIH Reform Act of 2006. 

“Despite strong bipartisan support in both the House and Senate and the American public, President Bush laid down the political marker by vetoing common-sense stem cell research legislation twice. However, our allies in Congress and among the public remain undeterred – Rep. Castle and I look forward to a new Administration and a pro-stem cell Congress to realize the great potential of this research. With all the recent advances in stem cell techniques, it is imperative we allow all forms to flourish; scientists, not politicians, should decide which techniques have the best potential for progress in developing therapies,” concluded DeGette.

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

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