Regulatory Issues With Stem Cell Technologies

President Obama’s Executive Order on March 9, 2009 opened many doors for institutions and companies developing stem cell technologies and therapies. Along with new avenues of federal funding come continued questions relating to what and how that funding can be applied:

• The Dickey-Wicker amendment still remains an issue on the use of federal funds for the unrestricted creation of embryonic stem cell lines. This regulatory challenge is an important aspect of compliance with the acceptance of federal funds.
• Questions regarding the ethical requirements related to clinical trials and embryonic research also have been explored. Several entities have already published guidelines related to the treatment of human embryos and the method in which such embryos are obtained.
• International questions will be raised as scientific advancements across the globe and their potential impact on U.S. policy are evaluated.
• Europe’s restriction on the patenting of embryonic stem cell technology remains a challenge.

We work with you to develop standards and guidelines for protections and ethics. With a combination of significant regulatory and public policy experience, our attorneys understand not only current federal and state regulations, but how regulations being considered may impact your stem cell research, including:

• Review of research
• Changes in the way the FDA and other bodies issue drug approvals
• Regulatory compliance with FDA and institutional review boards

We work with you and on your behalf to mitigate the impact of such regulations.