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.
Courts long ago established that the FDA has jurisdiction over drugs even when only an ingredient of the drug is shipped in interstate commerce.
Spates argued that the FDA’s asserted regulatory jurisdiction over the stem cell field is not only legally justified, but necessary to ensure that Americans receive medically competent therapies.
The FDA’s deliberate pace is assessing the viability of drugs and therapies has resulted in “stem cell tourism,” by which frustrated or impatient Americans seek such treatment available in other countries, but which are often unregulated and unreliable.
Spates said that U.S. v. Regenerative Sciences
will not settle the debate over whether the FDA over-regulates aspects of the health care system that should be left to state control, but at the same time, the decision should serve notice to companies involved with stem cell therapies.
“They seem to be surprised [at the court’s ruling] but why they are doesn’t make sense,” Spates said. “If you’re in the biomedical field, you’ve got to know what the regulations are.”
Spates was introduced by CUA Law Professor A.G. Harmon. Allison W. Shuren, with Arnold and Porter, LLP, served as respondent.
The Columbus School of Law Student Scholars Series was instituted by Professor Harmon to recognize notable legal scholarship produced by members of the student body during the academic year and to foster the skills associated with presenting and defending that scholarship in a professional conference-style setting.
Including Spates, 18 Student Scholars have presented since the founding of the series in the 2008-2009 academic year.