Stem Cell Research
Americans Support Stem Cell Research
Do you favor or oppose expanding federal funding for research using embryonic stem cells?
Source: A Research!America poll of U.S. adults conducted in partnership with Zogby Analytics in January 2015.
U.S. stem cell policy:
Former President George W. Bush permitted federal funding for embryonic stem (ES) cell research only if the stem cells were obtained from a limited number of previously existing stem cell lines. In 2009, President Barack Obama issued an executive order expanding the opportunities for federally funded ES cell research by permitting the use of ES cells other than those obtained from the previously designated stem cell lines. However, legislation to protect this expansion in research opportunities has not been signed into law, giving future administrations the discretion to curtail or eliminate federally funded stem cell research.
On August 23, 2012, in a decision favorable to proponents of ES cell research, the U.S. Court of Appeals for the D.C. Circuit upheld a lower court ruling dismissing a lawsuit that challenged the Obama administration’s expansion of federal funding ES cell research.
The Supreme Court declined to hear the appeal in an announcement on January 7, 2013. The announcement allows the decision of the appeals court to stand.
Many congressional members in the House and Senate seek to codify the stem cell rules established under President Obama’s executive order, preventing future administrations from unilaterally restricting or eliminating federal funding for stem cell research. Bills such as the Stem Cell Research Advancement Act, which would permit funding for research on stem cells derived from embryos produced but ultimately not used for in vitro fertilization, have been regularly introduced in the House and Senate since 2009, but no legislation has been enacted.
The debate over stem cell research continues to be fought at the state level. As described in this analysis by the National Conference of State Legislatures, some states encourage embryonic stem cell research, while others ban such research in whole or in part.
Stem cell research has been particularly important in advancing the field of “regenerative medicine,” which focuses on replacing, engineering or regenerating cells, tissues and organs in order to achieve normal function. Over the past several years, there has been a heightened focus on ensuring the Food and Drug Administration (FDA) is equipped to properly and efficiently review the safety and effectiveness of the treatments arising from this rapidly evolving category of medicine.
In 2016, Congress passed and President Obama signed into law a bill that includes provisions designed to facilitate FDA regulatory review and approval of regenerative therapies. Among the relevant provisions in the “21st Century Cures Act” are those that require FDA to provide guidance to industry on the information needed for the agency to assess these therapies, empower the FDA to establish manufacturing standards for regenerative therapies, and authorize the agency to review these therapies on an accelerated basis when they are intended to address an unmet medical need. More information on the 21st Century Cures Act can be found here.