Innovating Federalism in the Life Sciences
Volume 92, No. 2, Winter 2020
By Myrisha S. Lewis [PDF]

This Article challenges the view that the U.S. Food and Drug Administration (FDA) has exclusive jurisdiction over life sciences innovations. Many current and forthcoming life sciences innovations are “innovative therapies” such as gene editing, gene therapy, and regenerative stem cell treatments, which are actually “hybrids” of state and federal jurisdiction. Thus, both state and federal jurisdiction coexist: federal jurisdiction exists to the extent that these medical innovations use drugs or biologics, but state jurisdiction exists to the extent that these innovations are procedures regulated by states as the practice of medicine.

Myrisha S. Lewis is Assistant Professor, William & Mary Law School.