The Catholic University of America

The Commerce Clause and the FDA Regulation of Stem Cells: Regenerative Sciences Serves as the Example


Description: Kathryn Spates, Class of 2014, discussed the complex issues surrounding stem cell therapy, a field that has become a battleground for arguments over the proper role of the Food and Drug Administration in regulating related therapies and treatments. Spates’ address was largely an analysis of U.S. v. Regenerative Sciences, a recent decision in which the United States District Court of the District of Columbia held that a procedure using adult autologous stem cells should be regulated by the FDA, based on the rationale that it amounts to the use of a drug. Spate’s address was part of the 2013-2014 Student Scholar Series at the Catholic University of America’s Columbus School of Law.