Abstract

This Article challenges the view that the US. 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.

This Article argues that the regulation of numerous current and forthcoming innovative therapies requires the recognition of a state-federal partnership not only because both federal and state Jurisdiction already coexist but also because a cooperative form of shared governance would improve the transparency and quality of regulation. This Article provides a structural framework for that shared governance that draws on existing federal-state cooperative programs and applies the advantages of cooperative federalism, with an emphasis on often neglected actors in the realm of regulating innovative therapies: states. Incorporating this Article's cooperative structural framework would (I) curtail the federal usurpation of state Jurisdiction, (2) minimize the significance of the FDA 's resource shortage by complementing federal regulation, and (3) reduce the likelihood that the FDA would continue to unlawfully incorporate political and social motivations into its decision-making process. Applying this Article's cooperative framework would also serve to recognize the continued existence of both state and federal Jurisdiction over innovative therapies

Document Type

Article

Publication Date

Winter 2020

Publication Information

92 Temple Law Review 383-443 (2020)

Download

Share

COinS