Stem cell therapy, an exciting and evolving branch of medicine that holds great promise for the treatment of certain conditions, is also a battleground for arguments over the proper role of the Food and Drug Administration in regulating related therapies and treatments.
The complex issues were clearly laid out by fourth year evening student Kathryn Spates, Class of 2014, whose April 23rd presentation, “The Commerce Clause and the FDA Regulation of Stem Cells: Regenerative Sciences Serves as the Example,” was the third and final installment of the 2013-2014 Student Scholar Series at the Catholic University of America’s Columbus School of Law.
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.
Adult autologous stem cells are extracted from a body and then transplanted back into the same body. Spates acknowledged that for a layperson, the FDA’s reasoning is a stretch.
“How can the FDA regulate my body as a drug?” she asked rhetorically.
But upon closer inspection, the federal government’s position makes sense, Spates said.
Procedures where stem cells are more than minimally manipulated satisfies the definition of a “drug” under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, and the FDA has jurisdiction to regulate drugs shipped in interstate commerce under the Commerce Clause.